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

astrazeneca pharmaceuticals lp - exenatide (unii: 9p1872d4ol) (exenatide - unii:9p1872d4ol) - exenatide 250 ug in 1 ml - byetta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see clinical studies (14)] . limitations of use byetta is contraindicated in patients with: risk summary limited data with byetta in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). based on animal reproduction studies, there may be risks to the fetus from exposure to byetta during pregnancy. byetta should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. animal reproduction studies identified increased adverse fetal and neonatal outcomes from exposure to exenatide during pregnancy and lactation in association with maternal effects. in mice, exenatide administered during gestation and lactation caused increased neonatal deaths at systemic exposure 3-times the human exposure resulting from the maximum recommended human dose (mrhd) of 20 mcg/day for byetta (see data) . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with an hba1c >7 and has been reported to be as high as 20-25% in women with hba1c >10. the estimated background risk of 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 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryofetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data animal data in studies evaluating reproduction and development in pregnant mice and rabbits, maternal animals were administered exenatide, the active ingredient in byetta, by subcutaneous injection twice a day. in pregnant mice given 6, 68, 460, or 760 mcg/kg/day exenatide during fetal organogenesis, skeletal variations associated with slowed fetal growth, including changes in number of rib pairs or vertebral ossifications sites, and wavy ribs were observed at 760 mcg/kg/day, a dose that produced maternal toxicity and yielded systemic exposure 390-times the human exposure resulting from the mrhd of byetta based on auc comparison. in pregnant rabbits given 0.2, 2, 22, 156, or 260 mcg/kg/day exenatide during fetal organogenesis, irregular fetal skeletal ossifications were observed at 2 mcg/kg/day, a dose yielding systemic exposure up to 12-times the human exposure from the mrhd of byetta based on auc comparison. in maternal mice given 6, 68, or 760 mcg/kg/day exenatide from gestation day 6 through lactation day 20 (weaning), an increased number of neonatal deaths was observed on postpartum days 2 to 4 in dams given 6 mcg/kg/day, a dose yielding a systemic exposure 3-times the human exposure from the mrhd of byetta based on auc comparison. risk summary there is no information regarding the presence of byetta, in human milk, the effects of byetta on the breastfed infant, or the effects of byetta on milk production. exenatide was present in the milk of lactating mice. however, due to species-specific differences in lactation physiology, the clinical relevance of these data is not clear (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for byetta and any potential adverse effects on the breastfed child from byetta or from the underlying maternal condition. data in lactating mice subcutaneously injected twice a day with exenatide, the concentration of exenatide in milk was up to 2.5% of the concentration in maternal plasma. the safety and effectiveness of byetta have not been established in pediatric patients. effectiveness of byetta was not demonstrated in a randomized, double-blind, placebo-controlled study conducted in 120 pediatric patients (78 received byetta and 42 received placebo) aged 10 to 17 years with type 2 diabetes mellitus. population pharmacokinetic analysis of patients ranging from 22 to 73 years of age suggests that age does not influence the pharmacokinetic properties of exenatide [see clinical pharmacology (12.3)] . byetta was studied in 282 patients 65 years of age or older and in 16 patients 75 years of age or older. no differences in safety or effectiveness were observed between these patients and younger patients. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly based on renal function. byetta is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance <30 ml/min) and should be used with caution in patients with renal transplantation. in patients with end-stage renal disease receiving dialysis, single doses of byetta 5 mcg were not well-tolerated due to gastrointestinal side effects. no dosage adjustment of byetta is required in patients with mild renal impairment (creatinine clearance 50-80 ml/min). caution should be applied when initiating or escalating doses of byetta from 5 to 10 mcg in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) [see clinical pharmacology (12.3)] . no pharmacokinetic study has been performed in patients with a diagnosis of acute or chronic hepatic impairment. because exenatide is cleared primarily by the kidney, hepatic dysfunction is not expected to affect blood concentrations of exenatide [see clinical pharmacology (12.3)] . instructions for use byetta® (bye-a-tuh) (exenatide) injection for subcutaneous use 250 mcg/ml, 1.2 ml   do not share your byetta pen 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.   section 1 read this section completely before you begin. then, move on to section 2–getting started.   what you need to know about your byetta pen   instructions for use   read these instructions carefully before using your byetta pen. for complete dosing and safety information, also read the byetta medication guide that comes with the byetta pen carton.   it is important that you use your pen correctly. failure to follow these instructions completely may result in a wrong dose, a broken pen or an infection.   these instructions do not take the place of talking with your healthcare provider about your medical condition or your treatment. if you are having problems using your byetta pen, call toll free 1-800-236-9933.   important information about your byetta pen   about pen needles   what kinds of needles can be used with my byetta pen?   do i use a new needle for each injection?   how do i throw away my needles? put your used needles 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: 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.   do not share your byetta pen 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.   storing your byetta pen   how do i store my byetta pen?   keep your pen and needles out of the reach of children.   how long can i use a byetta pen?   date of first use                                         date to throw away pen                                  how do i clean my byetta pen?   see the complete byetta medication guide that comes with byetta. for more information, call toll free 1-800-236-9933.   section 2 read and follow the directions in this section only after you've read section 1—what you need to know about your byetta pen. getting started   set up your new pen just before you use it the first time. for routine use, do not repeat this one-time-only new pen setup. if you do, you will run out of byetta before 30 days of use.     one-time-only new pen setup   step a check the pen note: small air bubbles in the cartridge are normal.   step b attach the needle   step c dial the dose   note: if you cannot turn the dose knob away from you to the , see commonly asked questions, number 7, in section 4 of these instructions for use.   step d prepare the pen push & hold   note: if you do not see liquid after 4 times, see commonly asked questions, number 3, in section 4 of these instructions for use.   step e complete new pen setup   note: if you cannot turn the dose knob, see commonly asked questions, number 7, in section 4 of instructions for use. section 3 now that you have done the one-time-only new pen setup, follow section 3 for all of your injections.   routine use step 1 check the pen note: small air bubbles will not harm you or affect your dose.   step 2 attach the needle   step 3 dial the dose   note: if you cannot turn the dose knob away from you to the , see commonly asked questions, number 7, in section 4 of these instructions for use.   step 4 inject the dose push & hold   note: if you see several drops of byetta leaking from the needle after the injection, you may not have received a complete dose. see commonly asked questions, number 4, in section 4 of these instructions for use.   step 5 reset the pen note: if you cannot turn the dose knob, or if your pen leaks, your full dose has not been delivered. see commonly asked questions, numbers 4 and 7, in section 4 of these instructions for use.   step 6 remove and dispose of the needle   step 7 store pen for next dose section 4 commonly asked questions 1. do i need to do the one-time-only new pen setup before every dose?   2. why are there air bubbles in the cartridge?   3. what should i do if byetta does not come out of the needle tip after four tries during one-time-only new pen setup?   4. why do i see byetta leaking from my needle after i have finished my injection?   it is normal for a single drop to remain on the tip of your needle after your injection is complete. if you see more than one drop:   5. how can i tell when the injection is complete?   the injection is complete when: and and   if you hear a click sound from your byetta pen, ignore it. you must follow all the steps listed above to make sure your injection is complete. 6. where should i inject byetta? inject byetta into your abdomen, thigh, or upper arm using the injection method explained to you by your healthcare provider.   7. what if i cannot pull, turn, or push the dose knob?   check the symbol in the dose window. follow the steps next to the matching symbol.   if is in the dose window:   if is in the dose window and the dose knob will not turn: if and part of are in the dose window and the dose knob cannot be pushed in:   if part of and part of are in the dose window and the dose knob cannot be pushed in:     if is in the dose window and the dose knob will not turn:     see the complete byetta medication guide that comes with byetta. for more information, call toll free 1-800-236-9933.   distributed by: astrazeneca pharmaceuticals lp wilmington, de 19850     byetta® is a registered trademark of the astrazeneca group of companies. this instructions for use has been approved by the u.s. food and drug administration.   revised: december 2022 instructions for use byetta® (bye-a-tuh) (exenatide) injection for subcutaneous use 250 mcg/ml, 2.4 ml   do not share your byetta pen 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.   section 1 read this section completely before you begin. then, move on to section 2−getting started.   what you need to know about your byetta pen   pen instructions for use   read these instructions carefully before using your byetta pen . for complete dosing and safety information, also read the byetta medication guide that comes with the byetta pen carton.   it is important that you use your pen correctly. failure to follow these instructions completely may result in a wrong dose, a broken pen or an infection.   these instructions do not take the place of talking with your healthcare provider about your medical condition or your treatment. if you are having problems using your byetta pen, call toll free 1-800-236-9933.   important information about your byetta pen about pen needles   what kinds of needles can be used with my byetta pen? do i use a new needle for each injection? how do i throw away my needles? put your used needles 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: 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. do not share your byetta pen 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.   storing your byetta pen   how do i store my byetta pen?   keep your pen and needles out of the reach of children. how long can i use a byetta pen?   date of first use                                         date to throw away pen                                    how do i clean my byetta pen?     see the complete byetta medication guide that comes with byetta. for more information, call toll free 1-800-236-9933. section 2 read and follow the directions in this section only after you've read section 1—what you need to know about your byetta pen .   getting started   set up your new pen just before you use it the first time. for routine use, do not repeat this one-time-only new pen setup. if you do, you will run out of byetta before 30 days of use.   one-time-only new pen setup   step a check the pen note: small air bubbles in the cartridge are normal.   step b attach the needle   step c dial the dose   note: if you cannot turn the dose knob away from you to the , see commonly asked questions, number 7, in section 4 of these instructions for use.   step d prepare the pen push & hold   note: if you do not see liquid after 4 times, see commonly asked questions, number 3, in section 4 of these instructions for use.   step e complete new pen setup    note: if you cannot turn the dose knob, see commonly asked questions, number 7, in section 4 of these instructions for use.  section 3 now that you have done the one-time-only new pen setup, follow section 3 for all of your injections.   routine use step 1 check the pen note: small air bubbles will not harm you or affect your dose.   step 2 attach the needle   step 3 dial the dose   note: if you cannot turn the dose knob away from you to the , see commonly asked questions, number 7, in section 4 of these instructions for use.   step 4 inject the dose push & hold   note: if you see several drops of byetta leaking from the needle after the injection, you may not have received a complete dose. see commonly asked questions, number 4, in section 4 of these instructions for use.   step 5 reset the pen note: if you cannot turn the dose knob, or if your pen leaks, your full dose has not been delivered. see commonly asked questions, numbers 4 and 7, in section 4 of these instructions for use.   step 6 remove and dispose of the needle   step 7 store pen for next dose     section 4 commonly asked questions   1. do i need to do the one-time-only new pen setup before every dose?   2. why are there air bubbles in the cartridge?   3. what should i do if byetta does not come out of the needle tip after four tries during one-time-only new pen setup?   4. why do i see byetta leaking from my needle after i have finished my injection?   it is normal for a single drop to remain on the tip of your needle after your injection is complete. if you see more than one drop:   5. how can i tell when the injection is complete?   the injection is complete when: and and   if you hear a click sound from your byetta pen, ignore it. you must follow all the steps listed above to make sure your injection is complete. 6. where should i inject byetta? inject byetta into your abdomen, thigh, or upper arm using the injection method explained to you by your healthcare provider.   7. what if i cannot pull, turn, or push the dose knob?   check the symbol in the dose window. follow the steps next to the matching symbol.   if is in the dose window:   if is in the dose window and the dose knob will not turn:  if and part of are in the dose window and the dose knob cannot be pushed in:   if part of and part of are in the dose window and the dose knob cannot be pushed in: if is in the dose window and the dose knob will not turn:   see the complete byetta medication guide that comes with byetta. for more information, call toll free 1-800-236-9933.     distributed by: astrazeneca pharmaceuticals lp wilmington, de 19850       byetta® is a registered trademark of the astrazeneca group of companies. this instructions for use has been approved by the u.s. food and drug administration revised: december 2022

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astrazeneca pharmaceuticals lp - pramlintide acetate (unii: 726i6te06g) (pramlintide - unii:d3fm8fa78t) - pramlintide 1000 ug in 1 ml - symlin is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. symlin is contraindicated in patients with any of the following: risk summary available data from a small number of reports in the manufacturer’s safety database on symlin use in pregnant women are not sufficient to determine a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). ex-vivo studies using term perfused human, rabbit, and rat placentas indicate that symlin has low potential to cross the maternal/fetal placental barrier. in animal reproduction studies, congenital abnormalities were observed in fetuses of pregnant rats but not in fetuses of pregnant rabbits exposed during organogenesis to pramlintide at 10 times the clinical dose of 360 mcg/day, based on exposure (see data ). the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with an hba1c >7 and has been reported to be as high as 20-25% in women with hba1c >10. the estimated background risk of 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 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data animal data developmental and reproductive toxicity studies with symlin were performed in pregnant rats and rabbits. increases in congenital abnormalities (neural tube defect, cleft palate, exencephaly) were observed in fetuses of pregnant rats administered pramlintide subcutaneously during organogenesis at 0.3 and 1 mg/kg/day (10 and 47 times the human dose of 360 mcg/day based on auc, respectively), but not at 3mg/kg/day. administration of pramlintide to pregnant rabbits during organogenesis resulted in maternal toxicity but did not increase fetal malformations at doses up to 0.3 mg/kg/day (9 times the human dose of 360 mcg/day based on auc). risk summary there is no data on the presence of pramlintide in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for symlin and any potential adverse effects on the breastfed child from symlin or from the underlying maternal condition. safety and effectiveness of symlin in pediatric patients have not been established. symlin has been studied in patients ranging in age from 15 to 84 years of age, including 769 patients ≥65 to 75 years of age and 87 patients ≥75 years of age. no consistent differences in the efficacy and safety of symlin have been observed in older patients, but greater sensitivity in some older individuals cannot be ruled out. as is recommended for all patients, symlin and insulin regimens should be carefully managed to minimize the risk of severe hypoglycemia. the dosing requirements for symlin are not altered in patients with mild (creatinine clearance [clcr ] 60-89 ml/min), moderate (clcr 30-59 ml/min) or severe renal impairment (clcr 15-29 ml/min). symlin has not been studied in patients with end-stage renal disease [see clinical pharmacology (12.3)] . symlin use has not been studied in patients with hepatic impairment [see clinical pharmacology (12.3)] . no consistent differences in the efficacy and safety of symlin have been observed between men and women in symlin clinical trials (n=2799 for male and n=2085 for female). no consistent differences in the efficacy and safety of symlin have been observed among patients of differing race/ethnicity in symlin clinical trials (n=4257 for caucasian, n=229 for black, n=337 for hispanic or latino, and n=61 for asian and one or more races) although the smaller sample sizes for non-caucasians, particularly asians, limit conclusions. (pramlintide acetate) pen-injector read the medication guide and these instructions for use before you start using symlin and each time you get a refill. there may be new information. do not share your symlinpen 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. important: supplies you will need to give each injection of symlin: (figure a) (figure b) preparing your symlinpen: (figure c) attaching a needle: step 1: figure d step 2: figure e step 3: figure f step 4: figure g new pen setup - priming your symlinpen: note: selecting your routine dose: step 8: figure k step 9: figure l step 10: figure m figure n giving your symlin injection: step 14: step 15: step 16: step 17: after your injection: how should i store my symlinpen? unused symlinpens: used symlinpens: general information about the safe and effective use of symlinpens. if you are having problems using your symlinpen, go to www.symlin.com or call information support at 1-800-236-9933. these instructions for use have been approved by the u.s. food and drug administration. symlin and symlinpen are registered trademarks of the astrazeneca group of companies. distributed by: astrazeneca pharmaceuticals lp wilmington, de 19850 revised: march 2015 symlinpen® (sĬm-lĭnpεn) 60 (pramlintide acetate) pen-injector read the medication guide and these instructions for use before you start using symlin and each time you get a refill. there may be new information. do not share your symlinpen 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. important: supplies you will need to give each injection of symlin: (figure a) (figure b) preparing your symlinpen: (figure c) attaching a needle: step 1: figure d step 2: figure e step 3: figure f step 4: figure g new pen setup - priming your symlinpen: note: step 5: figure h step 6: figure i step 7: figure j selecting your routine dose: step 8: figure k step 9: figure l step 10: figure m figure n giving your symlin injection: step 11: figure o step 12: figure p step 13: figure q step 14: figure r step 15: figure s step 16: figure t step 17: figure u after your injection: how should i store my symlinpen? unused symlinpens: used symlinpens: general information about the safe and effective use of symlinpens. these instructions for use have been approved by the u.s. food and drug administration. symlin and symlinpen are registered trademarks of the astrazeneca group of companies. distributed by: astrazeneca pharmaceuticals lp wilmington, de 19850 revised: march 2015

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astrazeneca pharmaceuticals lp - azd-1222 (unii: b5s3k2v0g8) (azd-1222 - unii:b5s3k2v0g8) -

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astrazeneca pharmaceuticals lp - olaparib (unii: woh1jd9ar8) (olaparib - unii:woh1jd9ar8) - olaparib 50 mg - lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline brca -mutated (gbrcam ) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. select patients for therapy based on an fda-approved companion diagnostic for lynparza. none. risk summary based on findings in animals and its mechanism of action [see clinical pharmacology (12.1)] , lynparza can cause fetal harm when administered to a pregnant woman. there are no available data on lynparza use in pregnant women to inform the drug associated risk. in an animal reproduction study, the administration of olaparib to pregnant rats during the period of organogenesis caused teratogenicity and embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 400 mg twice daily [see data] . apprise pregnant women of the potential hazard to the fetus and the potential risk for loss of the pregnancy. the estimated background risk of major birth d

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astrazeneca pharmaceuticals lp - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - esomeprazole 20 mg - adults esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed ee in adults. for those patients who have not healed after 4 to 8 weeks of treatment, an additional 4‑ to 8‑ week course of esomeprazole magnesium delayed-release capsules may be considered. pediatric patients 12 years to 17 years of age esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of ee in pediatric patients 12 years to 17 years of age. pediatric patients 1 year to 11 years of age esomeprazole magnesium is indicated for the short-term treatment (8 weeks) for the healing of ee in pediatric patients 1 year to 11 years of age. pediatric patients 1 month to less than 1 year of age esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (up to 6 weeks) of ee due to acid-mediated gerd in pediatric patients 1 month to less than 1

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astrazeneca pharmaceuticals lp - naloxegol oxalate (unii: 65i14tnm33) (naloxegol - unii:44t7335bke) - naloxegol 12.5 mg - movantik® is indicated for the treatment of opioid-induced constipation (oic) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. movantik is contraindicated in: risk summary limited available data with movantik use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. movantik may precipitate opioid withdrawal in the pregnant women and the fetus (see clinical considerations) . in animal development studies, no effects on embryo-fetal development were observed following administration of naloxegol in pregnant rats during the period of organogenesis at doses up to 1452 times the human auc (area under the plasma concentration-time curve) at the maximum recommended human dose. no effects on embryo-fetal development were observed following administration of naloxegol in pregnant rabbits during the period of organogenesis at

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astrazeneca pharmaceuticals lp - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - seroquel is indicated for the treatment of schizophrenia. the efficacy of seroquel in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). the effectiveness of seroquel for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1)]. seroquel is indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10-17 years) [see clinical studies (14.2)]. seroquel is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monotherapy trials in adult patients with bipolar i and bipolar ii disorder [see clinical studies (14.2)]. seroq

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astrazeneca pharmaceuticals lp - olaparib (unii: woh1jd9ar8) (olaparib - unii:woh1jd9ar8) - olaparib 100 mg - lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic brca -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. select patients for therapy based on an fda-approved companion diagnostic for lynparza [see dosage and administration (2.1) ] . lynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd)-positive status defined by either: select patients for therapy based on an fda-approved companion diagnostic for lynparza [see dosage and administration (2.1)]. lynparza is indicated for the maintenance treatment of adult patients with deleterious or su

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astrazeneca pharmaceuticals lp - gefitinib (unii: s65743jhbs) (gefitinib - unii:s65743jhbs) - gefitinib 250 mg - iressa is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (nsclc) whose tumors have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations as detected by an fda-approved test [see clinical studies (14)] . limitation of use: safety and efficacy of iressa have not been established in patients with metastatic nsclc whose tumors have egfr mutations other than exon 19 deletions or exon 21 (l858r) substitution mutations [see clinical studies (14)] . none. risk summary based on its mechanism of action and animal data, iressa can cause fetal harm when administered to a pregnant woman. in animal reproductive studies, oral administration of gefitinib from organogenesis through weaning resulted in fetotoxicity and neonatal death at doses below the recommended human dose (see animal data ). advise pregnant women of the potential hazard to a fetus or potential risk for loss of the pregnancy. the background risk of major birth defect

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astrazeneca pharmaceuticals lp - durvalumab (unii: 28x28x9okv) (durvalumab - unii:28x28x9okv) - durvalumab 120 mg in 2.4 ml - imfinzi, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc). imfinzi, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (btc). none. risk summary based on findings from animal studies and its mechanism of action, imfinzi can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of imfinzi in pregnant women. in animal reproduction studies, administration of durvalumab to pregnant cynomolgus monkeys from the confirmation of pregnancy through delivery at exposure levels approximately 6 to 20 times higher than those observed at the clinical dose of 10 mg/kg based on area under the curve (auc), resulted in an increase in premature delivery, fetal loss, and premature neonatal death (see data). human immunoglobulin g1 (igg1) is known to cross the placental barrier; therefore, durvalumab has the potential to be transmitted from the mother to the developing fetus. apprise 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 to 4% and 15 to 20%, respectively. data animal data as reported in the literature, the pd-1/pd-l1 pathway plays a central role in preserving pregnancy by maintaining maternal immune tolerance to the fetus. in mouse allogeneic pregnancy models, disruption of pd-l1 signaling was shown to result in an increase in fetal loss. the effects of durvalumab on prenatal and postnatal development were evaluated in reproduction studies in cynomolgus monkeys. durvalumab was administered from the confirmation of pregnancy through delivery at exposure levels approximately 6 to 20 times higher than those observed at a clinical dose of 10 mg/kg (based on auc). administration of durvalumab resulted in premature delivery, fetal loss (abortion and stillbirth), and increase in neonatal deaths. durvalumab was detected in infant serum on postpartum day 1, indicating the presence of placental transfer of durvalumab. based on its mechanism of action, fetal exposure to durvalumab may increase the risk of developing immune-mediated disorders or altering the normal immune response and immune-mediated disorders have been reported in pd-1 knockout mice. risk summary there are no data on the presence of durvalumab in human milk, its effects on the breastfed child, or the effects on milk production. maternal igg is known to be present in human milk. the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to imfinzi are unknown. durvalumab was present in the milk of lactating cynomolgus monkeys and was associated with premature neonatal death (see data ). because of the potential for adverse reactions in a breastfed child, advise women not to breastfeed during treatment with imfinzi and for 3 months after the last dose. refer to the prescribing information for the agents administered in combination with imfinzi for recommended duration to not breastfeed, as appropriate. data in lactating cynomolgus monkeys, durvalumab was present in breast milk at about 0.15% of maternal serum concentrations after administration of durvalumab from the confirmation of pregnancy through delivery at exposure levels approximately 6 to 20 times higher than those observed at the recommended clinical dose of 10 mg/kg (based on auc). administration of durvalumab resulted in premature neonatal death. pregnancy testing verify pregnancy status of females of reproductive potential prior to initiating treatment with imfinzi. contraception females imfinzi can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with imfinzi and for 3 months following the last dose of imfinzi. refer to the prescribing information for the agents administered in combination with imfinzi for recommended contraception duration, as appropriate. the safety and effectiveness of imfinzi have not been established in pediatric patients. of the 476 patients treated with imfinzi in the pacific study, 45% were 65 years or older, while 7.6% were 75 years or older. no overall differences in safety or effectiveness were observed between patients 65 years or older and younger patients. the pacific study did not include sufficient numbers of patients aged 75 years and over to determine whether they respond differently from younger patients. of the 265 patients with es-sclc treated with imfinzi in combination with chemotherapy 101 (38%) patients were 65 years or older and 19 (7.2%) patients were 75 years or older. there were no clinically meaningful differences in safety or efficacy between patients 65 years or older and younger patients. of the 330 patients with metastatic nsclc treated with imfinzi in combination with tremelimumab-actl and platinum-based chemotherapy, 143 (43%) patients were 65 years or older and 35 (11%) patients were 75 years or older. there were no clinically meaningful differences in safety or efficacy between patients 65 years or older and younger patients. of the 338 patients with btc treated with imfinzi in combination with chemotherapy in the topaz-1 study, 158 (47%) patients were 65 years or older and 38 (11%) patients were 75 years or older. no overall differences in safety or effectiveness of imfinzi have been observed between patients 65 years of age and older and younger adult patients. of the 393 patients with uhcc treated with imfinzi in combination with tremelimumab-actl, 50% of patients were 65 years of age or older and 13% of patients were 75 years of age or older. no overall differences in safety or effectiveness of imfinzi have been observed between patients 65 years of age and older and younger adult patients.