United States - English - NLM (National Library of Medicine)

amgen inc - blinatumomab (unii: 4fr53sif3a) (blinatumomab - unii:4fr53sif3a) - blinatumomab 12.5 ug in 1 ml - blincyto is indicated for the treatment of cd19-positive b-cell precursor acute lymphoblastic leukemia (all) in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1% in adult and pediatric patients. blincyto is indicated for the treatment of relapsed or refractory cd19-positive b-cell precursor acute lymphoblastic leukemia (all) in adult and pediatric patients. blincyto is contraindicated in patients with known hypersensitivity to blinatumomab or to any component of the product formulation. risk summary based on its mechanism of action, blincyto may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of blincyto in pregnant women to evaluate for a drug-associated risk. in animal reproduction studies, a murine surrogate molecule administered to pregnant mice crossed the placental barrier (see data) . blinatumomab causes t-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. in addition, based on expression of cd19 on b-cells and the finding of b-cell depletion in non-pregnant animals, blinatumomab can cause b-cell lymphocytopenia in infants exposed to blinatumomab in-utero. advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations fetal/neonatal adverse reactions due to the potential for b-cell lymphocytopenia in infants following exposure to blincyto in utero , the infant's b lymphocytes should be monitored before the initiation of live virus vaccination [see warnings and precautions (5.11)] . data animal data animal reproduction studies have not been conducted with blinatumomab. in embryo-fetal developmental toxicity studies, a murine surrogate molecule was administered intravenously to pregnant mice during the period of organogenesis. the surrogate molecule crossed the placental barrier and did not cause embryo-fetal toxicity or teratogenicity. the expected depletions of b and t cells were observed in the pregnant mice, but hematological effects were not assessed in fetuses. risk summary there is no information regarding the presence of blinatumomab in human milk, the effects on the breastfed infant, or the effects on milk production. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants from blincyto, including b-cell lymphocytopenia, advise patients not to breastfeed during treatment with blincyto and for 48 hours after the last dose. blincyto may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating blincyto treatment. contraception females advise females of reproductive potential to use effective contraception during treatment with blincyto and for 48 hours after the last dose. minimal residual disease (mrd)-positive b-cell precursor all the safety and efficacy of blincyto for the treatment of cd19-positive b-cell precursor acute lymphoblastic leukemia (all) in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1% have been established in pediatric patients. use of blincyto is supported by evidence from two randomized, controlled trials (study aall1331 nct02101853 and study 20120215 nct02393859) in pediatric subjects with first relapsed b-cell precursor all. both studies included pediatric patients with mrd-positive b-cell precursor all. the studies included pediatric patients treated with blincyto in the following age groups: 6 infants (1 month up to less than 2 years), 165 children (2 years up to less than 12 years), and 70 adolescents (12 years to less than 17 years). in general, the adverse reactions in blincyto-treated pediatric patients were similar in type to those seen in adult patients with mrd-positive all [see adverse reactions (6.1)] , and no differences in safety were observed between the different pediatric age subgroups. relapsed or refractory b-cell precursor all the safety and efficacy of blincyto have been established in pediatric patients with relapsed or refractory b-cell precursor all. use of blincyto is supported by a single-arm trial in pediatric patients with relapsed or refractory b-cell precursor all. this study included pediatric patients in the following age groups: 10 infants (1 month up to less than 2 years), 40 children (2 years up to less than 12 years), and 20 adolescents (12 years to less than 18 years). no differences in efficacy were observed between the different age subgroups [see clinical studies (14.2)] . in general, the adverse reactions in blincyto-treated pediatric patients with relapsed or refractory all were similar in type to those seen in adult patients with relapsed or refractory b-cell precursor all [see adverse reactions (6.1)] . adverse reactions that were observed more frequently (≥ 10% difference) in the pediatric population compared to the adult population were pyrexia (80% vs. 61%), hypertension (26% vs. 8%), anemia (41% vs. 24%), infusion-related reaction (49% vs. 34%), thrombocytopenia (34% vs. 21%), leukopenia (24% vs. 11%), and weight increased (17% vs. 6%). in pediatric patients less than 2 years old (infants) with relapsed or refractory all, the incidence of neurologic toxicities was not significantly different than for the other age groups, but its manifestations were different; the only event terms reported were agitation, headache, insomnia, somnolence, and irritability. infants also had an increased incidence of hypokalemia (50%) compared to other pediatric age cohorts (15-20%) or adults (17%). benzyl alcohol toxicity in neonates serious and fatal adverse reactions, including "gasping syndrome," can occur in very low birth weight (vlbw) neonates born weighing less than 1500 g, and early preterm neonates (infants born less than 34 weeks gestational age) treated with benzyl alcohol-preserved drugs intravenously. the "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. in these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high concentrations of benzyl alcohol and its metabolite in the blood and urine (blood concentration of benzyl alcohol were 0.61 to 1.378 mmol/l). additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. the minimum amount of benzyl alcohol at which serious adverse reactions may occur in neonates is not known [see warnings and precautions (5.12)] . use the preservative-free formulations of blincyto where possible in neonates. when prescribing blincyto (with preservative) in neonatal patients, consider the combined daily metabolic load of benzyl alcohol from all sources including blincyto (with preservative). the blincyto 7-day bag (with preservative) contains 7.4 mg of benzyl alcohol per ml [see warnings and precautions (5.12)] . benzyl alcohol administration may contribute to metabolic acidosis in pediatric patients, particularly those with immaturity of the metabolic pathway for alcohol, or those with underlying conditions or receiving concomitant medications that could predispose to acid base imbalance. monitor these patients during use of blincyto (with preservative) for new or worsening metabolic acidosis. of the total number of patients with all treated in clinical studies of blincyto, approximately 12% were 65 and over, while 2% were 75 and older. no overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. however, elderly patients experienced a higher rate of serious infections and neurological toxicities, including cognitive disorder, encephalopathy, and confusion [see warnings and precautions (5.2, 5.3)] .

Australia - English - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - blinatumomab, quantity: 38.5 microgram/g - injection, solution - excipient ingredients: citric acid monohydrate; lysine hydrochloride; polysorbate 80; sodium hydroxide; water for injections - blincyto is indicated for the treatment of relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).,blincyto is indicated for the treatment of minimal residual disease (mrd) positive b-cell precursor acute lymphoblastic leukaemia (all) in patients in complete haematological remission.,note to indication: the indications in philadelphia positive, mrd positive and paediatric patients were approved based on phase ii, non-randomised evidence. an improvement in clinical outcomes by direct prospective comparison in a randomised setting relative to other standard-of-care salvage therapies has not been established.

Israel - English - Ministry of Health

amgen europe b.v. - blinatumomab - powder for concentrate for solution for infusion - blinatumomab 35 mcg / 1 vial - blinatumomab - • blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b- precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options.• blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1%.• blincyto is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b-cell precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.• blincyto is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b precursor all as part of the consolidation therapy.limitations of use: after failure of two previous treatments and with no cns involvement.

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1%. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.2).,

United States - English - NLM (National Library of Medicine)

amgen inc - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - amjevita is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. amjevita can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). amjevita is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. amjevita can be used alone or in combination with methotrexate. amjevita is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. amjevita can be used alone or in combination with non-biologic dmards. amjevita is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. amjevita is indicated for the treatment of moderately to severely active crohn's disease in adults and pediatric patients 6 years of age and older. amjevita is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. limitations of use the effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to tnf-blockers [see clinical studies (14.7)] . amjevita is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. amjevita should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see boxed warning and warnings and precautions (5)] . amjevita is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. amjevita is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. none. risk summary available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. clinical data are available from the organization of teratology information specialists (otis)/mothertobaby pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn's disease (cd) treated with adalimumab. registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with ra or cd and a rate of 7.5% for major birth defects in the disease-matched comparison cohort. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see data). adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant (see clinical considerations). in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (mrhd) of 40 mg subcutaneous without methotrexate (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with ra or inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester [see data ]. risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see use in specific populations (8.4)] . data human data a prospective cohort pregnancy exposure registry conducted by otis/mothertobaby in the u.s. and canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 ra, 152 cd) treated with adalimumab during the first trimester and 106 women (74 ra, 32 cd) not treated with adalimumab. the proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% ra, 10.5% cd) and 7.5% (6.8% ra, 9.4% cd), respectively. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. this study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design. in an independent clinical study conducted in ten pregnant women with ibd treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n = 10) and infant serum (n = 8) on the day of birth. the last dose of adalimumab was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16-19.7 mcg/ml in cord blood, 4.28-17.7 mcg/ml in infant serum, and 0-16.1 mcg/ml in maternal serum. in all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. in addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 mcg/ml), 7 weeks (1.31 mcg/ml), 8 weeks (0.93 mcg/ml), and 11 weeks (0.53 mcg/ml), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth. animal data in an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the mrhd without methotrexate (on an auc basis with maternal iv doses up to 100 mg/kg/week). adalimumab did not elicit harm to the fetuses or malformations. risk summary limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. however, the effects of local exposure in the gastrointestinal tract are unknown. there are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for amjevita and any potential adverse effects on the breastfed child from amjevita or from the underlying maternal condition. the safety and effectiveness of amjevita have been established for: - reducing signs and symptoms of moderately to severely active polyarticular jia in pediatric patients 2 years of age and older. - the treatment of moderately to severely active crohn's disease in pediatric patients 6 years of age and older. pediatric assessments for amjevita demonstrate that amjevita is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, amjevita is not approved for such indications due to marketing exclusivity for humira (adalimumab). due to their inhibition of tnfα, adalimumab products administered during pregnancy could affect immune response in the in utero -exposed newborn and infant. data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see use in specific populations (8.1)] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. post-marketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including adalimumab products [see warnings and precautions (5.2)] . juvenile idiopathic arthritis in study jia-i, adalimumab was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies (14.2)] . in study jia-ii, the safety profile for patients 2 to < 4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions (6.1)] . adalimumab products have not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of adalimumab in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions (6.1)] . the safety and effectiveness of adalimumab products have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn's disease the safety and effectiveness of adalimumab products for the treatment of moderately to severely active crohn's disease have been established in pediatric patients 6 years of age and older. use of adalimumab products for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions (6.1), clinical pharmacology (12.2, 12.3), clinical studies (14.6)] . the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of adalimumab products have not been established in pediatric patients with crohn's disease less than 6 years of age. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among adalimumab treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of amjevita in patients 65 years of age and older. in patients treated with amjevita, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2)] . instructions for use welcome! the amjevita™ sureclick® autoinjector is a single-dose prefilled autoinjector. consult your doctor if you have any questions about your dose. your doctor has prescribed amjevita sureclick autoinjector for your injections. if your doctor decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your doctor or nurse. please read all of the instructions before using amjevita sureclick autoinjector. call your doctor if you or your caregiver have any questions about the right way to inject amjevita. instructions for use amjevita™(am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use single-dose prefilled sureclick® autoinjector guide to parts important: needle is inside important before you use an amjevita sureclick autoinjector, read this important information: storing your amjevita sureclick autoinjectors - keep the amjevita sureclick autoinjector and all medicines out of the reach of children. - keep the amjevita sureclick autoinjector in the original carton to protect from light or physical damage. - the amjevita sureclick autoinjector should be kept in the refrigerator at 36°f to 46°f (2°c to 8°c). - if needed, you may store the amjevita sureclick autoinjector at room temperature up to 77°f (25°c) for up to 14 days. throw away amjevita if it has been kept at room temperature and not been used within 14 days. - do not store the amjevita sureclick autoinjector in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. - do not freeze. using your amjevita sureclick autoinjector - it is important that you do not try to give the injection unless you or your caregiver has received training from your doctor or nurse. - do not use the amjevita sureclick autoinjector after the expiration date on the label. - do not shake the amjevita sureclick autoinjector. - do not remove the yellow cap from the amjevita sureclick autoinjector until you are ready to inject. - do not use the amjevita sureclick autoinjector if it has been frozen. - do not use the amjevita sureclick autoinjector if it has been dropped on a hard surface. part of the amjevita sureclick autoinjector may be broken even if you cannot see the break. use a new amjevita sureclick autoinjector, and call 1-800-77-amgen (1-800-772-6436). - the amjevita sureclick autoinjector is not made with natural rubber latex. for more information or help or call 1-800-77-amgen (1-800-772-6436). step 1: prepare a remove 1 amjevita sureclick autoinjector from the package. carefully lift the autoinjector straight up out of the box. put the original package with any unused autoinjectors back in the refrigerator. for a more comfortable injection, leave the autoinjector at room temperature for 15 to 30 minutes before injecting. - do not put the autoinjector back in the refrigerator once it has reached room temperature. - do not try to warm the autoinjector by using a heat source such as hot water or microwave. - do not shake the autoinjector. - do not remove the yellow cap from the autoinjector yet. b inspect the amjevita sureclick autoinjector. make sure the medicine in the window is clear and colorless to slightly yellow. - do not use the autoinjector if: the medicine is cloudy or discolored, or contains flakes or particles. any part appears cracked or broken. the autoinjector has been dropped. the yellow cap is missing or not securely attached. the expiration date printed on the label has passed. - the medicine is cloudy or discolored, or contains flakes or particles. - any part appears cracked or broken. - the autoinjector has been dropped. - the yellow cap is missing or not securely attached. - the expiration date printed on the label has passed. in all cases, use a new autoinjector, and call 1-800-77-amgen (1-800-772-6436). c gather all materials needed for your injection. wash your hands thoroughly with soap and water. on a clean, well-lit work surface, place the: - new autoinjector - alcohol wipes - cotton ball or gauze pad - adhesive bandage - sharps disposal container d prepare and clean your injection site. you can use: - your thigh - stomach area (abdomen), except for a 2 -inch area right around your navel (belly button) clean your injection site with an alcohol wipe. let your skin dry. - do not fan or blow on the clean area. - do not touch this area again before injecting. - choose a different site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the injection site you used the last time. do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - if you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion. - do not inject through your clothes. step 2: get ready e pull yellow cap straight off, only when you are ready to inject. it is normal to see a drop of liquid at the end of the needle or yellow safety guard. - do not twist or bend the yellow cap. - do not put the yellow cap back onto the autoinjector. - do not remove the yellow cap from the autoinjector until you are ready to inject. f stretch or pinch your injection site to create a firm surface. stretch method stretch the skin firmly by moving your thumb and fingers in opposite directions, creating an area about 2 inches wide. pinch method pinch the skin firmly between your thumb and fingers, creating an area about 2 inches wide. important: keep the skin stretched or pinched while injecting. step 3: inject g hold the stretch or pinch. with the yellow cap off, place the autoinjector on your skin at 90 degrees. h firmly push the autoinjector down onto skin until it stops moving. push down important: you must push all the way down but do not touch blue start button until you are ready to inject. i when you are ready to inject, press the blue start button. j keep pushing down on your skin. your injection could take about 10 seconds. window turns yellow when injection is done important: when you remove the autoinjector, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose. call your doctor immediately. step 4: finish k discard (throw away) the used autoinjector and the yellow cap. - put the used sureclick autoinjector in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the sureclick autoinjector in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not reuse the autoinjector. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. important: always keep the sharps disposal container out of the reach of children. l examine the injection site. if there is blood, press a cotton ball or gauze pad on your injection site. do not rub the injection site. apply an adhesive bandage if needed. please see the medication guide for amjevita and accompanying prescribing information. commonly asked questions what will happen if i press the blue start button before i am ready to do the injection on my skin? can i move the autoinjector around on my skin while i am choosing an injection site? can i release the blue start button after i start my injection? will the blue start button pop up after i release my thumb? what do i do if i didn't hear a click after pushing the device down on my skin for 10 seconds? whom do i contact if i need help with the autoinjector or my injection? this instructions for use has been approved by the u.s. food and drug administration. manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 © 2022 amgen inc. all rights reserved. 1xxxxxx revised: 07/2022 v2 turn over to continue……… welcome! amjevita™ is supplied as a single-dose prefilled syringe. consult your doctor if you have any questions about your dose. your doctor has prescribed amjevita prefilled syringe for your injections. if your doctor decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your doctor or nurse. please read all of the instructions before using the amjevita prefilled syringe. call your doctor if you or your caregiver have any questions about the right way to inject amjevita. instructions for use amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use single-dose prefilled amjevita syringe guide to parts important: the needle is covered by the needle cap before use. important before you use an amjevita prefilled syringe, read this important information: storing your amjevita prefilled syringes - keep the amjevita prefilled syringe and all medicines out of the reach of children. - keep the amjevita prefilled syringe in the original carton to protect from light or physical damage. - the amjevita prefilled syringe should be kept in the refrigerator at 36° f to 46° f (2° c to 8° c). - if needed, you may store the amjevita prefilled syringe at room temperature up to 77° f (25° c) for up to 14 days. throw away amjevita if it has been kept at room temperature and has not been used within 14 days. - do not store the amjevita prefilled syringe in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. - do not freeze. using your amjevita prefilled syringe - it is important that you do not try to give the injection unless you or your caregiver has received training from your doctor or nurse. - do not use the amjevita prefilled syringe after the expiration date on the label. - do not shake the amjevita prefilled syringe. - do not remove the needle cap from the amjevita prefilled syringe until you are ready to inject. - do not use the amjevita prefilled syringe if it has been frozen. - do not use the amjevita prefilled syringe if it has been dropped on a hard surface. part of the amjevita prefilled syringe may be broken even if you cannot see the break. use a new amjevita prefilled syringe, and call 1-800-77-amgen (1-800-772-6436). - the amjevita prefilled syringe is not made with natural rubber latex. - for more information or help call 1-800-77-amgen (1-800-772-6436). step 1: prepare a   remove the prefilled syringe carton from the refrigerator. remove the number of amjevita prefilled syringes you need for your injection from the carton. grab the syringe barrel to remove the prefilled syringe from the tray as shown. put the original carton with any unused prefilled syringes back in the refrigerator. for safety reasons: - do not grab the plunger rod. - do not grab the needle cap. - do not remove the needle cap until you are ready to inject. - do not remove the finger flange. the finger flange is part of the syringe. for a more comfortable injection, leave the syringe at room temperature for 15 to 30 minutes before injecting. - do not put the syringe back in the refrigerator once it has reached room temperature. - do not try to warm the syringe by using a heat source such as hot water or microwave. - do not leave the syringe in direct sunlight. - do not shake the syringe. important: always hold the prefilled syringe by the syringe barrel. b   inspect the amjevita prefilled syringe. always hold the syringe by the syringe barrel. make sure the medicine in the syringe is clear and colorless to slightly yellow. - do not use the syringe if: the medicine is cloudy or discolored, or contains flakes or particles. any part appears cracked or broken. the needle cap is missing or not securely attached. the expiration date printed on the label has passed. - the medicine is cloudy or discolored, or contains flakes or particles. - any part appears cracked or broken. - the needle cap is missing or not securely attached. - the expiration date printed on the label has passed. in all cases, use a new syringe, and call 1-800-77-amgen (1-800-772-6436). c   gather all materials needed for your injection(s). wash your hands thoroughly with soap and water. on a clean, well-lit work surface, place the: - new syringe(s) - alcohol wipes - cotton ball or gauze pad - adhesive bandage - sharps disposal container d   prepare and clean your injection site(s).          you can use: - your thigh - stomach area (abdomen), except for a 2 -inch area right around your navel (belly button) clean your injection site with an alcohol wipe. let your skin dry. - do not fan or blow on the clean area. - do not touch this area again before injecting. - choose a different site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the injection site you used the last time. do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - if you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion. - do not inject through your clothes. step 2: get ready e   hold the prefilled syringe by the syringe barrel with the needle cap pointing up. carefully pull the needle cap straight off and away from your body when you are ready to inject. it is normal to see a drop of liquid at the end of the needle. - do not twist or bend the needle cap. - do not put the needle cap back onto the syringe. - do not remove the needle cap from the syringe until you are ready to inject. important: throw the needle cap into the sharps disposal container provided. f   pinch your injection site to create a firm surface. pinch the skin firmly between your thumb and fingers, creating an area about 2 inches wide. important: keep the skin pinched while injecting. step 3: inject g   hold the pinch. with the needle cap off, insert the syringe into your skin at 45 to 90 degrees. do not place your finger on the plunger rod while inserting the needle. h   using slow and constant pressure, push the plunger rod all the way down until it reaches the bottom. do not pull back the plunger rod while the needle is inserted. i   when done, release your thumb, and gently pull the syringe off of your skin. step 4: finish j   discard (throw away) the used prefilled syringe and the needle cap. do not use any medicine that is left in the used syringe. - put the used amjevita prefilled syringe in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the prefilled syringe in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not reuse the syringe. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. important: always keep the sharps disposal container out of the reach of children. k   examine the injection site. if there is blood, press a cotton ball or gauze pad on your injection site. do not rub the injection site. apply an adhesive bandage if needed. please see the medication guide for amjevita and accompanying prescribing information. this instructions for use has been approved by the u.s. food and drug administration. manufactured by : amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 © 2022 amgen inc. all rights reserved. 1xxxxxx revised: 7/2022 v2 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) 10 mg/0.2 ml injection, for subcutaneous use single-dose prefilled syringe this instructions for use contains information on how to inject amjevita with a prefilled syringe. if your healthcare provider decides that a caregiver may be able to give your injections of amjevita at home, they should receive training on the right way to prepare and inject amjevita. do not try to inject until they have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita prefilled syringe is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the syringe if the carton is damaged or the seal is broken. - do not use the syringe after the expiration date on the label. - do not shake the syringe. - do not remove the needle cap from the syringe until you are ready to inject. - do not use the syringe if it has been frozen. - do not use the syringe if it has been dropped on a hard surface. part of the syringe may be broken even if you cannot see the break. use a new syringe, and call 1-800-77-amgen (1-800-772-6436). - the syringe is not made with natural rubber latex.   important: keep the syringe and sharps disposal container out of the sight and reach of children. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com, or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the syringe carton until you are ready to use it. - keep the syringe in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the syringe in the original carton to protect it from light or physical damage. - do not freeze the syringe. - do not store the syringe in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. important: keep the syringe out of the sight and reach of children. 2b grasp the syringe by the body and remove it from the carton. - do not grab the finger grip, plunger rod, or the needle cap. - remove the number of syringes you need for your injection. - put any unused syringes back into the refrigerator. 2c wait 15 to 30 minutes for the syringe to reach room temperature. - let the syringe warm up naturally. - do not heat the syringe with hot water, a microwave or direct sunlight. - do not shake the syringe at any time. - using the syringe at room temperature allows for a more comfortable injection. 2d you may keep amjevita at room temperature for up to 14 days, if needed. - for example when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68° f to 77° f (20° c to 25° c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68° f to 77° f (20° c to 25° c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2e gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita syringe (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3. getting ready for your injection 3a inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the syringe. - do not use amjevita if the medicine is cloudy, discolored or has flakes. 3b check the expiration date (exp.) and inspect the syringe for damage. - do not use the syringe if the expiration date has passed. - do not use the syringe if: the needle cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the needle cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3c inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3d wash hands thoroughly with soap and water. 3e clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a pull the needle cap straight off while holding the syringe body. - do not twist or bend the needle cap. - never put the needle cap back on. it may damage the needle. - do not let anything touch the needle after you remove the needle cap. - do not place the uncapped syringe on any surface after you remove the needle cap. - do not try to push air bubbles out of the syringe. it is okay to see air bubbles. - it is normal to see a drop of medicine come out of the needle. 4b place the needle cap in the sharps disposal container. 4c pinch the skin around the injection site before injection. - pinch the skin between the thumb and pointer (index) finger to create a bump for injection. - if possible, the bump should be about 2 inches wide. 4d insert the needle into the pinched skin at about a 45-degree angle. - do not place your finger on the plunger rod while inserting the needle, as this may result in lost medicine. 4e slowly press the plunger rod all the way down until it reaches the bottom to inject the medicine. - do not pull back on the plunger rod at any time. - do not remove the syringe until all of the medicine has been injected. 5. disposing of amjevita and checking the injection site 5a place the used syringe in an fda-cleared sharps disposal container right away after use. - do not reuse the syringe. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on the injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the us food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 04/2023 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use 40 mg/0.4 ml single-dose prefilled sureclick® autoinjector this instructions for use contains information on how to inject amjevita with a sureclick autoinjector. if your healthcare provider decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita autoinjector is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the autoinjector if the carton is damaged or the seal is broken. - do not use the autoinjector after the expiration date on the label. - do not shake the autoinjector. - do not remove the yellow cap from the autoinjector until you are ready to inject. - do not use the autoinjector if it has been frozen. - do not use the autoinjector if it has been dropped on a hard surface. part of the autoinjector may be broken even if you cannot see the break. use a new autoinjector, and call 1-800-77-amgen (1-800-772-6436). - the autoinjector is not made with natural rubber latex. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com , or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the autoinjector carton until you are ready to use it. - keep the autoinjector in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the autoinjector in the original carton to protect it from light or physical damage. - do not freeze the autoinjector. - do not store the autoinjector in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. 2b wait 15 to 30 minutes for the autoinjector to reach room temperature. - remove the number of autoinjectors you need for your injection and put any unused autoinjectors back into the refrigerator. - let the autoinjector warm up naturally. - do not heat the autoinjector with hot water, a microwave, or direct sunlight. - do not shake the autoinjector at any time. - using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection. 2c you may keep amjevita at room temperature for up to 14 days, if needed. - for example, when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68°f to 77°f (20°c to 25°c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68°f to 77°f (20°c to 25°c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2d inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the autoinjector. - do not use amjevita if the medicine is cloudy, discolored, or has flakes or particles. 2e check the expiration date (exp.) and inspect the autoinjector for damage. - do not use the autoinjector if the expiration date has passed. - do not use the autoinjector if: the yellow cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the yellow cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3. getting ready for your injection 3a gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita autoinjector (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3b inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3c wash hands thoroughly with soap and water. 3d clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a grasp the autoinjector so you can see the window. pull the yellow cap straight off. you may need to pull hard. - do not twist, bend or wiggle the yellow cap to pull it off. - never put the yellow cap back on. it may damage the needle. - do not put your finger inside the cream safety guard. - it is normal to see a drop of medicine at the end of the needle or cream safety guard. 4b pinch the skin to create a firm surface at the injection site. place the cream safety guard straight against the pinched skin. - keep the skin pinched until the injection is finished. - make sure you can see the window. - make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle). 4c firmly push the autoinjector down until the cream safety guard stops moving. hold the autoinjector down, do not lift. - the cream safety guard pushes in and unlocks the light blue start button. 4d keep pushing the autoinjector down and press the light blue start button to start the injection. - you may hear or feel a click. - the window starts to turn yellow. - it is okay to let go of the light blue start button. 4e keep pushing the autoinjector down. when the window is fully yellow, the injection is complete. - the injection may take up to 10 seconds to complete. - you may hear or feel a click. - lift the autoinjector away from your skin. - the cream safety guard locks around the needle. 5. disposing of amjevita and checking the injection site 5a place the used autoinjector and yellow cap in an fda-cleared sharps disposal container right away after use. - do not reuse the autoinjector. - do not touch the cream safety guard. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on your injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps disposal containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the u.s. food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 8/2023 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use 80 mg/0.8 ml single-dose prefilled sureclick® autoinjector this instructions for use contains information on how to inject amjevita with a sureclick autoinjector. if your healthcare provider decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita autoinjector is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the autoinjector if the carton is damaged or the seal is broken. - do not use the autoinjector after the expiration date on the label. - do not shake the autoinjector. - do not remove the yellow cap from the autoinjector until you are ready to inject. - do not use the autoinjector if it has been frozen. - do not use the autoinjector if it has been dropped on a hard surface. part of the autoinjector may be broken even if you cannot see the break. use a new autoinjector, and call 1-800-77-amgen (1-800-772-6436). - the autoinjector is not made with natural rubber latex. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com , or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the autoinjector carton until you are ready to use it. - keep the autoinjector in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the autoinjector in the original carton to protect it from light or physical damage. - do not freeze the autoinjector. - do not store the autoinjector in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. 2b wait 15 to 30 minutes for the autoinjector to reach room temperature. - remove the number of autoinjectors you need for your injection and put any unused autoinjectors back into the refrigerator. - let the autoinjector warm up naturally. - do not heat the autoinjector with hot water, a microwave, or direct sunlight. - do not shake the autoinjector at any time. - using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection. 2c you may keep amjevita at room temperature for up to 14 days, if needed. - for example, when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68°f to 77°f (20°c to 25°c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68°f to 77°f (20°c to 25°c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2d inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the autoinjector. - do not use amjevita if the medicine is cloudy, discolored, or has flakes or particles. 2e check the expiration date (exp.) and inspect the autoinjector for damage. - do not use the autoinjector if the expiration date has passed. - do not use the autoinjector if: the yellow cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the yellow cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3. getting ready for your injection 3a gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita autoinjector (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3b inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3c wash hands thoroughly with soap and water. 3d clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a grasp the autoinjector so you can see the window. pull the yellow cap straight off. you may need to pull hard. - do not twist, bend or wiggle the yellow cap to pull it off. - never put the yellow cap back on. it may damage the needle. - do not put your finger inside the cream safety guard. - it is normal to see a drop of medicine at the end of the needle or cream safety guard. 4b pinch the skin to create a firm surface at the injection site. place the cream safety guard straight against the pinched skin. - keep the skin pinched until the injection is finished. - make sure you can see the window. - make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle). 4c firmly push the autoinjector down until the cream safety guard stops moving. hold the autoinjector down, do not lift. - the cream safety guard pushes in and unlocks the light blue start button. 4d keep pushing the autoinjector down and press the light blue start button to start the injection. - you may hear or feel a click. - the window starts to turn yellow. - it is okay to let go of the light blue start button. 4e keep pushing the autoinjector down. when the window is fully yellow, the injection is complete. - the injection may take up to 15 seconds to complete. - you may hear or feel a click. - lift the autoinjector away from your skin. - the cream safety guard locks around the needle. 5. disposing of amjevita and checking the injection site 5a place the used autoinjector and yellow cap in an fda-cleared sharps disposal container right away after use. - do not reuse the autoinjector. - do not touch the cream safety guard. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on your injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps disposal containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the u.s. food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 8/2023 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use 20 mg/0.2 ml 40 mg/0.4 ml 80 mg/0.8 ml single-dose prefilled syringe this instructions for use contains information on how to inject amjevita with a prefilled syringe. if your healthcare provider decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita prefilled syringe is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita dosing: - amjevita comes in 3 different doses: 20 mg/0.2 ml, 40 mg/0.4 ml, and 80 mg/0.8 ml. check your prescription to make sure you have the correct dose. - the color and look of the prefilled syringe will be different for each dose. the amount of medicine in the syringe will also be different for each dose. - for example, it is okay for the 20 mg/0.2 ml dose to have a small amount of medicine and the 80 mg/0.8 ml to have a large amount of medicine. check the illustrations below to see what your dose looks like in the syringe. 20 mg/0.2 ml 40 mg/0.4 ml 80 mg/0.8 ml - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the syringe if the carton is damaged or the seal is broken. - do not use the syringe after the expiration date on the label. - do not shake the syringe. - do not remove the needle cap from the syringe until you are ready to inject. - do not use the syringe if it has been frozen. - do not use the syringe if it has been dropped on a hard surface. part of the syringe may be broken even if you cannot see the break. use a new syringe, and call 1-800-77-amgen (1-800-772-6436). - the syringe is not made with natural rubber latex. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com , or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the syringe carton until you are ready to use it. - keep the syringe in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the syringe in the original carton to protect it from light or physical damage. - do not freeze the syringe. - do not store the syringe in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. 2b grasp the syringe by the body and remove it from the carton. - do not grab the finger grip, plunger rod, or the needle cap. - remove the number of syringes you need for your injection. - put any unused syringes back into the refrigerator. 2c wait 15 to 30 minutes for the syringe to reach room temperature. - let the syringe warm up naturally. - do not heat the syringe with hot water, a microwave, or direct sunlight. - do not shake the syringe at any time. - using the syringe at room temperature allows for a more comfortable injection. 2d you may keep amjevita at room temperature for up to 14 days, if needed. - for example, when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68°f to 77°f (20°c to 25°c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68°f to 77°f (20°c to 25°c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2e gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita syringe (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3. getting ready for your injection 3a inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the syringe. - do not use amjevita if the medicine is cloudy, discolored, or has flakes or particles. 3b check the expiration date (exp.) and inspect the syringe for damage. - do not use the syringe if the expiration date has passed. - do not use the syringe if: the needle cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the needle cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3c inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3d wash hands thoroughly with soap and water. 3e clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a pull the needle cap straight off while holding the syringe body. - do not twist or bend the needle cap. - never put the needle cap back on. it may damage the needle. - do not let anything touch the needle after you remove the needle cap. - do not place the uncapped syringe on any surface after you remove the needle cap. - do not try to push air bubbles out of the syringe. it is okay to see air bubbles. - it is normal to see a drop of medicine come out of the needle. 4b place the needle cap in the sharps disposal container. 4c pinch the skin around the injection site before injection. - pinch the skin between the thumb and pointer (index) finger to create a bump for the injection. - if possible, the bump should be about 2 inches wide. 4d insert the needle into the pinched skin at a 45-degree angle. - do not place your finger on the plunger rod while inserting the needle, as this may result in lost medicine. 4e slowly press the plunger rod all the way down until it reaches the bottom of the syringe to inject the medicine. - do not pull back on the plunger rod at any time. - do not remove the syringe until all of the medicine has been injected. 5. disposing of amjevita and checking the injection site 5a place the used syringe in an fda-cleared sharps disposal container right away after use. - do not reuse the syringe. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on your injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps disposal containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the u.s. food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 8/2023

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

amgen south africa (pty)ltd - infusion (parenteral) - see ingredients - each vial contains blinatumomab 38,5 ug

United States - English - NLM (National Library of Medicine)

amgen inc - rituximab (unii: 4f4x42syq6) (rituximab - unii:4f4x42syq6) - riabni is indicated for the treatment of adult patients with: - relapsed or refractory, low-grade or follicular, cd20-positive, b-cell nhl as a single agent. - previously untreated follicular, cd20-positive, b-cell nhl in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. - non-progressing (including stable disease), low-grade, cd20-positive, b-cell nhl as a single agent after first-line cyclophosphamide, vincristine, and prednisone (cvp) chemotherapy. - previously untreated diffuse large b-cell, cd20-positive nhl in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (chop) or other anthracycline-based chemotherapy regimens. riabni, in combination with fludarabine and cyclophosphamide (fc), is indicated for the treatment of adult patients with previously untreated and previously treated cd20-positive cll. riabni, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to severely- active rheumatoid arthritis who have had an inadequate response to one or more tnf antagonist therapies. riabni, in combination with glucocorticoids, is indicated for the treatment of adult patients with granulomatosis with polyangiitis (gpa) (wegener's granulomatosis) and microscopic polyangiitis (mpa). none. risk summary based on human data, rituximab products can cause adverse developmental outcomes including b-cell lymphocytopenia in infants exposed in utero (see clinical considerations ). in animal reproduction studies, intravenous administration of rituximab to pregnant cynomolgus monkeys during the period of organogenesis caused lymphoid b-cell depletion in the newborn offspring at doses resulting in 80% of the exposure (based on auc) of those achieved following a dose of 2 grams in humans. advise pregnant women of the risk to a fetus. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. the background risk of major birth defects and miscarriage for the indicated populations is unknown. the estimated background risk in the u.s. general population of major birth defects is 2%-4% and of miscarriage is 15%-20% of clinically recognized pregnancies. clinical considerations fetal/neonatal adverse reactions observe newborns and infants for signs of infection and manage accordingly. data human data postmarketing data indicate that b-cell lymphocytopenia generally lasting less than 6 months can occur in infants exposed to rituximab in utero . rituximab was detected postnatally in the serum of infants exposed in utero . animal data an embryo-fetal developmental toxicity study was performed on pregnant cynomolgus monkeys. pregnant animals received rituximab via the intravenous route during early gestation (organogenesis period; post coitum days 20 through 50). rituximab was administered as loading doses on post coitum (pc) days 20, 21 and 22, at 15, 37.5 or 75 mg/kg/day, and then weekly on pc days 29, 36, 43 and 50, at 20, 50 or 100 mg/kg/week. the 100 mg/kg/week dose resulted in 80% of the exposure (based on auc) of those achieved following a dose of 2 grams in humans. rituximab crosses the monkey placenta. exposed offspring did not exhibit any teratogenic effects but did have decreased lymphoid tissue b cells. a subsequent pre-and postnatal reproductive toxicity study in cynomolgus monkeys was completed to assess developmental effects including the recovery of b cells and immune function in infants exposed to rituximab in utero . animals were treated with a loading dose of 0, 15, or 75 mg/kg every day for 3 days, followed by weekly dosing with 0, 20, or 100 mg/kg dose. subsets of pregnant females were treated from pc day 20 through postpartum day 78, pc day 76 through pc day 134, and from pc day 132 through delivery and postpartum day 28. regardless of the timing of treatment, decreased b cells and immunosuppression were noted in the offspring of rituximab-treated pregnant animals. the b-cell counts returned to normal levels, and immunologic function was restored within 6 months postpartum. there are limited data on the presence of rituximab in human milk and the effect on the breastfed child, and there are no data on the effect on milk production. rituximab is detected in the milk of lactating cynomolgus monkeys, and maternal igg is present in human breast milk. rituximab has also been reported to be excreted at low concentrations in human breast milk. given that the clinical significance of this finding for children is not known, advise women not to breastfeed during treatment with riabni and for 6 months after the last dose due to the potential of serious adverse reactions in breastfed children. rituximab products can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating riabni. contraception females advise females of reproductive potential to use effective contraception during treatment with riabni and for 12 months after the last dose. a pediatric assessment for riabni demonstrates that riabni is safe and effective for pediatric patients in an indication for which rituxan (rituximab) is approved. however, riabni is not approved for such indication due to marketing exclusivity for rituxan (rituximab). the safety and effectiveness of rituximab products, including riabni, have not been established in pediatric patients less than 2 years of age for gpa and mpa. the safety and effectiveness of rituximab products, including riabni, have not been established in pediatric patients with cll. rheumatoid arthritis the safety and effectiveness of rituximab products have not been established in pediatric patients with ra. rituximab was not studied in pediatric patients with polyarticular juvenile idiopathic arthritis (pjia) due to concerns regarding the potential for prolonged immunosuppression as a result of b-cell depletion in the developing juvenile immune system. diffuse large b-cell nhl among patients with dlbcl evaluated in three randomized, active-controlled trials, 927 patients received rituximab in combination with chemotherapy. of these, 396 (43%) were age 65 or greater and 123 (13%) were age 75 or greater. no overall differences in effectiveness were observed between these patients and younger patients. cardiac adverse reactions, mostly supraventricular arrhythmias, occurred more frequently among elderly patients. serious pulmonary adverse reactions were also more common among the elderly, including pneumonia and pneumonitis. low-grade or follicular non-hodgkin's lymphoma patients with previously untreated follicular nhl evaluated in nhl study 5 were randomized to rituximab as single-agent maintenance therapy (n = 505) or observation (n = 513) after achieving a response to rituximab in combination with chemotherapy. of these, 123 (24%) patients in the rituximab arm were age 65 or older. no overall differences in safety or effectiveness were observed between these patients and younger patients. other clinical studies of rituximab in low-grade or follicular, cd20-positive, b-cell nhl did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. chronic lymphocytic leukemia among patients with cll evaluated in two randomized active-controlled trials, 243 of 676 rituximab-treated patients (36%) were 65 years of age or older; of these, 100 rituximab-treated patients (15%) were 70 years of age or older. in exploratory analyses defined by age, there was no observed benefit from the addition of rituximab to fludarabine and cyclophosphamide among patients 70 years of age or older in cll study 1 or in cll study 2; there was also no observed benefit from the addition of rituximab to fludarabine and cyclophosphamide among patients 65 years of age or older in cll study 2 [see clinical studies (14.5)] . patients 70 years or older received lower dose intensity of fludarabine and cyclophosphamide compared to younger patients, regardless of the addition of rituximab. in cll study 1, the dose intensity of rituximab was similar in older and younger patients, however in cll study 2 older patients received a lower dose intensity of rituximab. the incidence of grade 3 and 4 adverse reactions was higher among patients receiving r-fc who were 70 years or older compared to younger patients for neutropenia [44% vs. 31% (cll study 1); 56% vs. 39% (cll study 2)], febrile neutropenia [16% vs. 6% (nhl study 10 (nct00719472)], anemia [5% vs. 2% (cll study 1); 21% vs. 10% (cll study 2)], thrombocytopenia [19% vs. 8% (cll study 2)], pancytopenia [7% vs. 2% (cll study 1); 7% vs. 2% (cll study 2)] and infections [30% vs. 14% (cll study 2)]. rheumatoid arthritis among the 2,578 patients in global ra studies completed to date, 12% were 65–75 years old and 2% were 75 years old and older. the incidences of adverse reactions were similar between older and younger patients. the rates of serious adverse reactions, including serious infections, malignancies, and cardiovascular events were higher in older patients. granulomatosis with polyangiitis (gpa) (wegener's granulomatosis) and microscopic polyangiitis of the 99 rituximab-treated gpa and mpa patients in gpa/mpa study 1, 36 (36%) were 65 years old and over, while 8 (8%) were 75 years and over. no overall differences in efficacy were observed between patients that were 65 years old and over and younger patients. the overall incidence and rate of all serious adverse events was higher in patients 65 years old and over. the clinical study did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. in gpa/mpa study 2, 30 (26%) of the enrolled patients were at least 65 years old, of which 12 patients were exposed to non-u.s.-licensed rituximab and 18 were exposed to azathioprine. the clinical study did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects.

United States - English - NLM (National Library of Medicine)

amgen inc - epoetin (unii: 64fs3bfh5w) (erythropoietin - unii:64fs3bfh5w) - erythropoietin 2000 [iu] in 1 ml - epogen is indicated for the treatment of anemia due to chronic kidney disease (ckd), including patients on dialysis and not on dialysis to decrease the need for red blood cell (rbc) transfusion. epogen is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in patients with hiv-infection with endogenous serum erythropoietin levels of ≤ 500 munits/ml. epogen is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. epogen is indicated to reduce the need for allogeneic rbc transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dl who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. epogen is not indicated for patients who are willing to donate autologous blood pre-operatively. epogen has not been shown to improve quality of

United States - English - NLM (National Library of Medicine)

amgen inc - denosumab (unii: 4eqz6yo2hi) (denosumab - unii:4eqz6yo2hi) - denosumab 60 mg in 1 ml - prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. in postmenopausal women with osteoporosis, prolia reduces the incidence of vertebral, nonvertebral, and hip fractures [see clinical studies (14.1)] . prolia is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy [see clinical studies (14.2)] . prolia is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. high risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy [see clinical studies (14.3)] . prolia is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (adt) for nonmetastatic prostate cancer. in these patients prolia also reduced the incidence of vertebral fractures [see clinical studies (14.4)] . prolia is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer [see clinical studies (14.5)] . prolia is contraindicated in: - patients with hypocalcemia: pre-existing hypocalcemia must be corrected prior to initiating therapy with prolia [see warnings and precautions (5.1)] . - pregnant women: prolia may cause fetal harm when administered to a pregnant woman. in women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with prolia [see use in specific populations (8.1)] . - patients with hypersensitivity to prolia: prolia is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. reactions have included anaphylaxis, facial swelling, and urticaria [see warnings and precautions (5.3), adverse reactions (6.2)] . risk summary prolia is contraindicated for use in pregnant women because it may cause harm to a fetus. there are insufficient data with denosumab use in pregnant women to inform any drug-associated risks for adverse developmental outcomes. in utero denosumab exposure from cynomolgus monkeys dosed monthly with denosumab throughout pregnancy at a dose 50-fold higher than the recommended human dose based on body weight resulted in increased fetal loss, stillbirths, and postnatal mortality, and absent lymph nodes, abnormal bone growth, and decreased neonatal growth [see data] . data animal data the effects of denosumab on prenatal development have been studied in both cynomolgus monkeys and genetically engineered mice in which rank ligand (rankl) expression was turned off by gene removal (a "knockout mouse"). in cynomolgus monkeys dosed subcutaneously with denosumab throughout pregnancy starting at gestational day 20 and at a pharmacologically active dose 50-fold higher than the recommended human dose based on body weight, there was increased fetal loss during gestation, stillbirths, and postnatal mortality. other findings in offspring included absence of axillary, inguinal, mandibular, and mesenteric lymph nodes; abnormal bone growth, reduced bone strength, reduced hematopoiesis, dental dysplasia, and tooth malalignment; and decreased neonatal growth. at birth out to 1 month of age, infants had measurable blood levels of denosumab (22-621% of maternal levels). following a recovery period from birth out to 6 months of age, the effects on bone quality and strength returned to normal; there were no adverse effects on tooth eruption, though dental dysplasia was still apparent; axillary and inguinal lymph nodes remained absent, while mandibular and mesenteric lymph nodes were present, though small; and minimal to moderate mineralization in multiple tissues was seen in one recovery animal. there was no evidence of maternal harm prior to labor; adverse maternal effects occurred infrequently during labor. maternal mammary gland development was normal. there was no fetal noael (no observable adverse effect level) established for this study because only one dose of 50 mg/kg was evaluated. mammary gland histopathology at 6 months of age was normal in female offspring exposed to denosumab in utero ; however, development and lactation have not been fully evaluated. in rankl knockout mice, absence of rankl (the target of denosumab) also caused fetal lymph node agenesis and led to postnatal impairment of dentition and bone growth. pregnant rankl knockout mice showed altered maturation of the maternal mammary gland, leading to impaired lactation [see use in specific populations (8.2), nonclinical toxicology (13.2)] . the no effect dose for denosumab-induced teratogenicity is unknown. however, a cmax of 22.9 ng/ml was identified in cynomolgus monkeys as a level in which no biologic effects (noel) of denosumab were observed (no inhibition of rankl) [see clinical pharmacology (12.3)] . risk summary there is no information regarding the presence of denosumab in human milk, the effects on the breastfed infant, or the effects on milk production. denosumab was detected in the maternal milk of cynomolgus monkeys up to 1 month after the last dose of denosumab (≤ 0.5% milk:serum ratio) and maternal mammary gland development was normal, with no impaired lactation. however, pregnant rankl knockout mice showed altered maturation of the maternal mammary gland, leading to impaired lactation [see use in specific populations (8.1), nonclinical toxicology (13.2)] . based on findings in animals, prolia can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating prolia treatment. contraception females advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of prolia. males denosumab was present at low concentrations (approximately 2% of serum exposure) in the seminal fluid of male subjects given prolia. following vaginal intercourse, the maximum amount of denosumab delivered to a female partner would result in exposures approximately 11000 times lower than the prescribed 60 mg subcutaneous dose, and at least 38 times lower than the noel in monkeys. therefore, male condom use would not be necessary as it is unlikely that a female partner or fetus would be exposed to pharmacologically relevant concentrations of denosumab via seminal fluid [see clinical pharmacology (12.3)] . the safety and effectiveness of prolia have not been established in pediatric patients. in one multicenter, open-label study conducted in 153 pediatric patients with osteogenesis imperfecta, aged 2 to 17 years, evaluating fracture risk reduction, efficacy was not established. hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab products, including prolia. some cases required hospitalization and were complicated by acute renal injury [see warnings and precautions (5.11)]. clinical studies in pediatric patients with osteogenesis imperfecta were terminated early due to the occurrence of life-threatening events and hospitalizations due to hypercalcemia. based on results from animal studies, prolia may negatively affect long-bone growth and dentition in pediatric patients below the age of 4 years. juvenile animal toxicity data treatment with prolia may impair long-bone growth in children with open growth plates and may inhibit eruption of dentition. in neonatal rats, inhibition of rankl (the target of prolia therapy) with a construct of osteoprotegerin bound to fc (opg-fc) at doses ≤ 10 mg/kg was associated with inhibition of bone growth and tooth eruption. adolescent primates treated with denosumab at doses 10 and 50 times (10 and 50 mg/kg dose) higher than the recommended human dose of 60 mg administered every 6 months, based on body weight (mg/kg), had abnormal growth plates, considered to be consistent with the pharmacological activity of denosumab [see nonclinical toxicology (13.2)]. cynomolgus monkeys exposed in utero to denosumab exhibited bone abnormalities, an absence of axillary, inguinal, mandibular, and mesenteric lymph nodes, reduced hematopoiesis, tooth malalignment, and decreased neonatal growth. some bone abnormalities recovered once exposure was ceased following birth; however, axillary, and inguinal lymph nodes remained absent 6 months post-birth [see use in specific populations (8.1)] . of the total number of patients in clinical studies of prolia, 9943 patients (76%) were ≥ 65 years old, while 3576 (27%) were ≥ 75 years old. of the patients in the osteoporosis study in men, 133 patients (55%) were ≥ 65 years old, while 39 patients (16%) were ≥ 75 years old. of the patients in the glucocorticoid-induced osteoporosis study, 355 patients (47%) were ≥ 65 years old, while 132 patients (17%) were ≥ 75 years old. no overall differences in safety or efficacy were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dose adjustment is necessary in patients with renal impairment. severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported postmarketing. in clinical studies, patients with advanced chronic kidney disease (i.e., egfr < 30 ml/min/1.73 m2 ), including dialysis-dependent patients, were at greater risk of developing hypocalcemia. the presence of underlying chronic kidney disease-mineral bone disorder (ckd-mbd, renal osteodystrophy) markedly increases the risk of hypocalcemia. concomitant use of calcimimetic drugs may also worsen hypocalcemia risk. consider the benefits and risks to the patient when administering prolia to patients with advanced chronic kidney disease. monitor calcium and mineral levels (phosphorus and magnesium). adequate intake of calcium and vitamin d is important in patients with advanced chronic kidney disease including dialysis-dependent patients [see dosage and administration (2.2),warnings and precautions (5.1), adverse reactions (6.1) and clinical pharmacology (12.3)] .

United States - English - NLM (National Library of Medicine)

amgen inc - romosozumab (unii: 3vhf2zd92j) (romosozumab - unii:3vhf2zd92j) - evenity is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.  the anabolic effect of evenity wanes after 12 monthly doses of therapy. therefore, the duration of evenity use should be limited to 12 monthly doses. if osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered [see dosage and administration ( 2.2 ) and clinical studies ( 14.1 )] . evenity is contraindicated in patients with: - hypocalcemia. pre-existing hypocalcemia must be corrected prior to initiating therapy with evenity [ see warnings and precautions ( 5.3 ) , adverse reactions ( 6.1 ) and use in specific populations ( 8.7 )] . - a history of systemic hypersensitivity to romosozumab or to any component of the product formulation. reactions have included angioedema, erythema m