European Union - English - EMA (European Medicines Agency)

theratechnologies europe limited - ibalizumab - hiv infections - antivirals for systemic use - trogarzo, in combination with other antiretroviral(s), is indicated for the treatment of adults infected with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen.

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

theratechnologies inc. - tesamorelin acetate (unii: lgw5h38ve3) (tesamorelin - unii:mqg94m5eeo) - egrifta sv is indicated for the reduction of excess abdominal fat in hiv-infected adult patients with lipodystrophy. limitations of use: - long-term cardiovascular safety of egrifta sv has not been established. consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. - egrifta sv is not indicated for weight loss management as it has a weight neutral effect. - there are no data to support improved compliance with anti-retroviral therapies in hiv-positive patients taking egrifta sv. egrifta sv is contraindicated in: - patients with disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma. - patients with active malignancy. any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy [see warnings and precautions (5.1)] . - patients with known hypersensitivity to tesamorelin or the excipients in egrifta sv [see warnings and precautions (5.5)]. - pregnant women because modifying visceral adipose tissue offers no benefit in a pregnant woman and could result in fetal harm [see use in specific populations (8.1)]. risk summary egrifta sv is contraindicated in pregnant women because modifying visceral adipose tissue offers no benefit in pregnant women and could result in fetal harm [see clinical considerations and contraindications (4)] . administration of tesamorelin acetate to rats during organogenesis resulted in hydrocephaly in offspring at a dose of approximately two and four times the clinical dose, based on measured drug exposure (auc). if egrifta sv is used during pregnancy, or if the patient becomes pregnant while taking it, discontinue egrifta sv.  the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk during pregnancy, visceral adipose tissue increases due to normal metabolic and hormonal changes. modifying pregnancy-associated physiologic changes in visceral adipose tissue with egrifta sv offers no known benefit and could result in fetal harm. data animal data tesamorelin acetate administration to rats during organogenesis and lactation resulted in hydrocephaly in offspring at a dose of approximately two and four times the clinical dose, respectively, based on measured drug exposure (auc). actual animal dose was 1.2 mg/kg. during organogenesis, lower doses approximately 0.1 to 1-times the clinical dose caused delayed skull ossification in rats. actual animal doses were 0.1 to 0.6 mg/kg. no adverse developmental effects occurred in rabbits using doses up to approximately 500 times the clinical dose. risk summary the centers for disease control and prevention recommend that hiv-infected mothers in the united states not breastfeed their infants to avoid risking postnatal transmission of hiv-1 infection. there are no data on the presence of tesamorelin in human milk, the effects on the breastfed child, or the effects on milk production. because of both the potential for (1) hiv-1 infection transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive patients), and (3) any possible adverse effects of tesamorelin, mothers should not breastfeed if they receive egrifta sv. the safety and effectiveness of egrifta sv in pediatric patients have not been established. in pediatric patients with open epiphyses, treatment with egrifta sv may result in linear growth acceleration and excessive growth. egrifta sv is not indicated for use in pediatric patients with open or closed epiphyses. there is no information on the use of egrifta sv in patients greater than 65 years of age. instructions for use egrifta sv® (eh-grif-tuh ess-vee) (tesamorelin) for injection for subcutaneous use this instructions for use contains step-by-step information on how to use the 2 mg vial of egrifta sv. each 2 mg vial of egrifta sv must be mixed with 0.5 ml of the sterile water for injection provided in the injection box given to you by the pharmacy. use only one egrifta sv 2 mg vial from the medication box to prepare your dose. the recommended dose of egrifta sv is 1.4 mg (0.35 ml). be sure that you read, understand, and follow this instructions for use before using egrifta sv. your healthcare provider should show you how to mix and inject egrifta sv before you inject it for the first time. ask your healthcare provider if you have any questions. keep this instructions for use in case you need to look at it again later. important information for use of egrifta sv - do not use a syringe or needle more than 1 time. - do not share your syringe or needles with other people, even if the needle has been changed. you may give other people a serious infection, or get a serious infection from them.  - if you are missing any supplies from the boxes given to you by the pharmacy or if any of the supplies look damaged, call your pharmacist or contact  toll-free at 1-833-23thera (1-833-238-4372) right away. if you are missing any supplies from the boxes given to you by the pharmacy or if any of the supplies look damaged, call your pharmacist or contact  toll-free at 1-833-23thera (1-833-238-4372) right away. preparing for your egrifta sv injection step 1: find a well-lit, clean, and flat surface, such as a table. step 2: gather your supplies: - medication box that contains 30 egrifta sv 2 mg single-dose vials - injection box that contains the following: 30 single-dose 10 ml bottles of sterile water for injection, used for mixing 60 sterile 1 ml syringes 60 sterile 1" 20-gauge needles, used for mixing 30 sterile ½” 30-gauge needles, used for injection - 30 single-dose 10 ml bottles of sterile water for injection, used for mixing - 60 sterile 1 ml syringes - 60 sterile 1" 20-gauge needles, used for mixing - 30 sterile ½” 30-gauge needles, used for injection - other supplies needed two alcohol pads one sterile gauze one adhesive bandage sharps disposal container or a puncture resistant container for throwing away used needles and syringes after you are done with them. (see “how should i dispose of the used syringes, needles, bottles and vials?” ) - two alcohol pads - one sterile gauze - one adhesive bandage - sharps disposal container or a puncture resistant container for throwing away used needles and syringes after you are done with them. (see “how should i dispose of the used syringes, needles, bottles and vials?” ) for each injection using egrifta sv 2 mg vial you will need: (see figure a) figure a step 3: take out the following from the injection box: - one sterile water for injection bottle - two 1 ml syringes - two 1" 20-gauge needles used for mixing - one ½" 30-gauge needle used for injection step 4: take 1 vial of egrifta sv 2 mg from the medication box. step 5: prepare to use your supplies: - wash your hands with soap and water. dry your hands with a clean towel. - take off the plastic caps from the egrifta sv 2 mg vial and the sterile water for injection bottle. - clean the rubber stoppers on the top of the egrifta sv 2 mg vial and sterile water for injection bottle with an alcohol pad. how to mix egrifta sv 2 mg vial step 1: place a 1" 20-gauge needle used for mixing, with its protective needle cap in place, onto a 1 ml syringe. hold the syringe firmly and twist the needle cap clockwise (to the right) until it closes securely. (see figure b) figure b step 2: carefully remove the protective needle cap by pulling it straight off. do not twist the needle cap. insert the needle through the rubber stopper of the sterile water for injection bottle. (see figure c) figure c step 3:  with the needle still in the sterile water for injection bottle, turn the bottle and syringe upside down. pull back the plunger until the sterile water reaches the 0.5 ml mark on the syringe. (see figure d) figure d step 4: remove the syringe with needle attached from the sterile water bottle.throw away the bottle containing the unused sterile water for injection. (see “how should i dispose of the used syringes, needles, bottles and vials? ”) insert the needle into the rubber stopper of the egrifta sv 2 mg vial. with the needle at a slight angle, slowly push the plunger of the syringe all the way down so that the sterile water goes down the inside wall of the egrifta sv 2 mg vial instead of directly onto the powder to avoid foaming. (see figure e) figure e step 5: remove the needle from the egrifta sv 2 mg vial (see figure f) and throw away the syringe and needle. (see “how should i dispose of the used syringes, needles, bottles and vials?” ) figure f step 6: roll the egrifta sv 2 mg vial gently in your hands for 30 seconds, until the sterile water and egrifta sv powder are mixed well. do not shake the vial. (see figure g) figure g note: - after mixing, the solution should look clear and colorless, with no particles in it. - do not use egrifta sv if it looks cloudy, discolored, or if you see particles in it. - call your healthcare provider, pharmacist, or contact  toll-free at 1-833-23thera (1-833-238-4372) right away if the solution is cloudy, discolored, or contains particles. step 7: place a new unused 1" 20-gauge needle used for mixing, with its protective needle cap in place, onto a new unused 1 ml syringe. hold the syringe firmly and twist the needle cap clockwise (to the right) until it closes securely. (see figure h) figure h step 8: carefully remove the protective needle cap by pulling it straight off. do not twist the needle cap. do not throw away the needle cap. insert the needle through the rubber stopper of the egrifta sv 2 mg vial. (see figure i) figure i step 9: with the needle still in the egrifta sv 2 mg vial, turn the vial and syringe upside down. pull the syringe back until you see just the tip of the needle going through the rubber stopper. pull back on the plunger of the syringe until all of the liquid inside the vial is in the syringe. the medicine should be at around the 0.4 ml mark on the syringe. (see figure j) figure j step 10:  remove the needle from the vial. (see figure k) figure k step 11:  place the protective needle cap on its side on a clean flat surface. without touching the needle, hold the syringe and slide the needle carefully into the needle cap. (see figure l). figure l step 12:  push the protective needle cap all the way in or until it snaps shut (see figure m). do not touch the needle cap until it covers the needle completely. figure m step 13:  with the protective needle cap securely on the needle, remove the needle by holding the syringe firmly and twisting the needle cap counterclockwise (to the left). (see figure n)  throw away the needle. (see “how should i dispose of the used syringes, needles, bottles and vials?” ) figure n step 14: place a ½" 30-gauge needle to be used for your injection, with its protective needle cap and pink needle shield in place, onto the syringe. hold the syringe firmly and twist the needle cap and pink needle shield clockwise (to the right) until it closes securely. (see figure o) figure o where do i inject egrifta sv 2 mg vial? inject egrifta sv into the stomach-area (abdomen). (see figure p) - choose an injection site that is at least 2 inches (5 cm) away from your belly button. (see the shaded area in figure p) - do not inject into areas with scar tissue or bruises. - do not inject into your belly button. - avoid areas with any hard bumps from previous injections. - rotate the site for each injection. this may help prevent bruising or irritation. you may want to write down the date and location of each daily injection to help you remember. figure p how to inject your 1.4 mg dose of egrifta sv do not remove the needle cap until you are ready to inject. step 1:  hold the syringe with the needle facing up. pull the pink needle shield down away from the white protective needle cap. carefully remove the needle cap by pulling it straight off the needle. do not twist the needle cap. (see figure q) do not touch the needle. figure q step 2:  tap the syringe gently with your finger to force any air bubbles to rise to the top. slowly push up on the plunger to remove any air and bubbles and until the medicine in the syringe is at the 0.35 ml mark of the syringe. (see figure r) figure r step 3:  clean the injection site you have selected with an alcohol pad and let it dry. hold the syringe in one hand. with your other hand, gently pinch a fold of skin at your cleaned injection site. hold the skin between your thumb and fingers. (see figure s) figure s step 4:  hold the syringe at a 90 degree angle to the skin. with a quick, dart-like motion, insert the needle straight into the skin. most of the needle should go beneath the skin. (see figure t) figure t step 5:  remove your hand from the pinched area of skin after the needle is inserted. be careful not to remove the needle from the skin. step 6: slowly push the plunger of the syringe all the way down until all of the medicine in the syringe has been injected. (see figure u) figure u pull the needle out of your skin. be careful to pull the needle out at the same angle as it was inserted. step 7: while holding the syringe in one hand, gently press the pink needle shield against a hard, flat surface until you hear a “click” and the injection needle is covered by the pink needle shield. (see figure v) figure v - apply pressure to the injection site with gauze for 30 seconds. if there is bleeding, apply an adhesive bandage to the site. - throw away the syringe. (see “how should i dispose of the used syringes, needles, bottles and vials?” ) how should i dispose of the used syringes, needles, bottles and vials? - do not recap the needle or remove the needle from the syringe after you inject egrifta sv. - put your used egrifta sv needles and syringes in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - if you do not have a 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 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. - if another person receives a needle stick with a used needle, that person should be told to contact a healthcare provider right away. - keep the sharps container away from children and pets. if you have any questions, call your healthcare provider. you can call  toll-free at 1-833-23thera (1-833-238-4372) or visit the egrifta sv website at: www.egriftasv.com for more information. how should i store egrifta sv 2 mg vials, sterile water for injection, syringes and needles? - you will be given 2 boxes from the pharmacy when you get your prescription of egrifta sv: store the 2 mg egrifta sv vials in the medication box they come in, at room temperature between 68°f to 77°f (20°c to 25°c). store the sterile water for injection, syringes and needles that come in the injection box at room temperature between 68°f to 77°f (20°c to 25°c). - store the 2 mg egrifta sv vials in the medication box they come in, at room temperature between 68°f to 77°f (20°c to 25°c). - store the sterile water for injection, syringes and needles that come in the injection box at room temperature between 68°f to 77°f (20°c to 25°c). - keep egrifta sv vials out of the light. - after mixing, use egrifta sv right away . throw away any unused egrifta sv after mixing. - do not store, freeze or refrigerate egrifta sv after it has been mixed with the sterile water. - throw away any sterile water for injection left in the bottle after use. - do not use egrifta sv after the expiration date (exp) printed on the carton and vial labels. keep egrifta sv and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. egrifta sv® is a registered trademark of theratechnologies inc. manufactured by: theratechnologies inc., 2015 peel street, suite 1100, montréal, québec, canada h3a 1t8 us licence no. 2091 for theratechnologies inc. revised: 03/2024

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

theratechnologies inc. - tesamorelin acetate (unii: lgw5h38ve3) (tesamorelin - unii:mqg94m5eeo) - egrifta is indicated for the reduction of excess abdominal fat in hiv-infected adult patients with lipodystrophy. limitations of use: - long-term cardiovascular safety of egrifta has not been established. consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. - egrifta is not indicated for weight loss management as it has a weight neutral effect. - there are no data to support improved compliance with anti-retroviral therapies in hiv-positive patients taking egrifta egrifta is contraindicated in patients with: - disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma. - active malignancy. any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy [see warnings and precautions (5.1)] . - known hypersensitivity to tesamorelin or the excipients in egrifta [see warnings and precautions (5.5)]. - pregnant women because mod

Canada - English - Health Canada

theratechnologies inc - tesamorelin (tesamorelin acetate) - kit - 2mg - tesamorelin (tesamorelin acetate) 2mg - somatotropin agonists*

Canada - English - Health Canada

theratechnologies inc - tesamorelin (tesamorelin acetate) - kit - 1mg - tesamorelin (tesamorelin acetate) 1mg - somatotropin agonists*

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

theratechnologies inc. - tesamorelin acetate (unii: lgw5h38ve3) (tesamorelin - unii:mqg94m5eeo) - tesamorelin 1 mg in 1 ml - egrifta is indicated for the reduction of excess abdominal fat in hiv-infected adult patients with lipodystrophy. limitations of use: - long-term cardiovascular safety of egrifta has not been established. consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. - egrifta is not indicated for weight loss management as it has a weight neutral effect. - there are no data to support improved compliance with anti-retroviral therapies in hiv-positive patients taking egrifta. egrifta is contraindicated in patients with: - disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma. - active malignancy. any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy [see warnings and precautions (5.1)] . - known hypersensitivity to tesamorelin or the excipients in egrifta [see warnings and precautions (5.5)]. - pregnant women because mo

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

theratechnologies inc. - ibalizumab (unii: lt369u66ce) (ibalizumab - unii:lt369u66ce) - ibalizumab 150 mg in 1 ml - trogarzo, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in heavily treatment-experienced adults with multidrug resistant hiv-1 infection failing their current antiretroviral regimen. trogarzo is contraindicated in patients with a prior hypersensitivity reaction to trogarzo or any components of the product [see warnings and precautions (5.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiretrovirals during pregnancy. this registry does not include trogarzo, but likely includes patients’ concomitant antiretroviral drugs.  healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1–800–258–4263. risk summary based on animal data, ibalizumab-uiyk use during pregnancy may cause reversible immunosuppression (cd4+ t cell and b cell lymphocytopenia) in infants exposed to ibalizumab-uiyk in utero. immunoglobulin g (igg) antibodies, such as ibalizumab-uiyk, are transported across the placenta in significant amounts, especially near term; therefore, ibalizumab-uiyk has the potential to be transferred from the mother to the developing fetus (see clinical considerations). there are no available data on ibalizumab-uiyk use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. the background risk of major birth defects and miscarriage for the indicated population 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. in a reproductive study in monkeys, reversible decreases in cd4+ t cells and b cells and increases in cd8+ t cells were observed within the first 4 weeks after birth in infants born to pregnant monkeys receiving ibalizumab-uiyk intravenously (see data ). lymphocyte counts returned to near normal levels by 3 months of age. one infant monkey died from a systemic viral infection that may be related to ibalizumab-uiyk-induced immunosuppression. no malformations or premature births were observed in this study. clinical considerations fetal/neonatal adverse reactions immunoglobulin g (igg) antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. administration of trogarzo during pregnancy may affect immune responses in the in utero-exposed infant. for infants with perinatal exposure to trogarzo, immune phenotyping of the peripheral blood, including cd4+ t cell and b cell counts, is recommended. expert consultation is also recommended to provide guidance on monitoring and management (e.g., need for antibiotic or immunoprophylaxis) of exposed infants based on the degree of immunosuppression observed. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. data animal data in an enhanced pre- and post-natal development (eppnd) study, pregnant cynomolgus monkeys were administered intravenous doses of either vehicle or 110 mg/kg ibalizumab-uiyk every week from gestation day 20-22 (gd 20-22) until parturition on gd 160 ± 10. significant changes in infant monkey immune cell levels on postnatal day (pnd) 14 (mean decreases of 78% in cd4+ t cells and 46% in b cells and increases of 2.3-fold in cd8+ t cells) and pnd 28 (mean decreases of 73% in cd4+ t cells and increases of 2.2-fold in cd8+ t cells), attributed to in utero ibalizumab-uiyk exposure, were observed relative to concurrent controls. the lymphocyte changes correlated with infant ibalizumab-uiyk serum concentrations and appeared to return to near normal levels between pnd 28-91, when ibalizumab-uiyk concentrations were nearly undetectable. although ibalizumab-uiyk exposure in these infant monkeys may be significantly higher than in human infants following in utero exposure at the recommended human maintenance dose, the risk of ibalizumab-uiyk-induced immunosuppression in human infants is possible. no meaningful differences in infant monkey lymphocyte counts were observed on pnd 180. further, no differences in immune cell function were observed in a t cell-dependent response assay conducted on pnd 138 to 180 ± 2 following immunization of the infant monkeys with keyhole limpet hemocyanin. one treatment-group infant monkey died on pnd 24 from a systemic viral infection with secondary superficial bacterial infection which was acquired during the postnatal period. despite the low incidence (1 of 20 infants), the death may be related to ibalizumab-uiyk-induced immunosuppression. decreases in cd4+ t cells (93%), and b cells (92%) were observed in this infant on pnd 14, and decreased cellularity was observed in the spleen, thymus and mandibular lymph node. unlike the rest of the ibalizumab-exposed infant monkey population, this infant also exhibited a decrease in cd8+ t cells of 71% on pnd 14. body weight was also decreased in this infant between pnd 14 and 24. no structural abnormalities were observed among the ibalizumab-uiyk-exposed infants. in addition, no maternal toxicities, including no changes in maternal lymphocyte subsets or effects on embryo-fetal survival, were observed. risk summary the centers for disease control and prevention recommend that hiv-1-infected mothers in the united states not breastfeed their infants to avoid the risk of postnatal transmission of hiv-1 infection. no data are available regarding the presence of trogarzo in human milk, the effects on the breastfed child, or the effects on milk production. human igg is present in human milk, although published data indicate that antibodies in breast milk do not enter the neonatal or infant circulation system in substantial amounts. because of the potential for hiv-1 transmission, instruct mothers not to breastfeed if they are receiving trogarzo. the safety and effectiveness of trogarzo in pediatric patients have not been established. no studies have been conducted with trogarzo in geriatric patients.

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

emd serono, inc. - tesamorelin acetate (unii: lgw5h38ve3) (tesamorelin - unii:mqg94m5eeo) - tesamorelin 2 mg in 2 ml

Singapore - English - HSA (Health Sciences Authority)

medsci research & supply pte. ltd. - neurology - kinesia one is intended to monitor physical motion and muscle activity to quantify kinematics of movement disorder symptoms such as tremor and assess activity in any instance where quantifiable analysis of motion and muscle activity is desired.

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

vicki partridge pty ltd - 17929 - analyser, physiologic, neuromuscular function - the device is intended to monitor physical motion and muscle activity to quantify kinematics of movement disorder symptoms such as tremor and assess activity in any instance where quantifiable analysis of motion and muscle activity is desired.