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

glaxosmithkline llc - belimumab (unii: 73b0k5s26a) (belimumab - unii:73b0k5s26a) - belimumab 400 mg in 5 ml - benlysta (belimumab) is indicated for the treatment of: limitations of use the efficacy of benlysta has not been evaluated in patients with severe active central nervous system (cns) lupus. use of benlysta is not recommended in this situation. benlysta is contraindicated in patients who have had anaphylaxis with belimumab. pregnancy exposure registry there is a pregnancy exposure registry that evaluates pregnancy outcomes in women with lupus exposed to benlysta during pregnancy. healthcare professionals are encouraged to refer patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/benlysta-belimumab/. risk summary available data on use of benlysta in pregnant women, from observational studies, published case reports, and postmarketing surveillance, are insufficient to determine whether there is a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with sle (see clinical considerations) . monoclonal antibodies, such as belimumab, are actively transported 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 animal combined embryo-fetal and pre- and post-natal development study with monkeys that received belimumab by intravenous administration, there was no evidence of fetal harm with exposures approximately 9 times (based on intravenous administration) and 20 times (based on subcutaneous administration) the exposure at the maximum recommended human dose (mrhd). belimumab-related findings in monkey fetuses and/or infants included reductions of b-cell counts, reductions in the density of lymphoid tissue b-lymphocytes in the spleen and lymph nodes, and altered igg and igm titers. the no-adverse-effect-level (noael) was not identified for these findings; however, they were reversible within 3 to 12 months after the drug was discontinued (see data) . based on animal data and the mechanism of action of belimumab, the immune system in infants of treated mothers may be adversely affected. it is unknown, based on available data, whether immune effects, if identified, are reversible [see clinical pharmacology (12.1)]. the estimated 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 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: pregnant women with sle are at increased risk of adverse pregnancy outcomes, including worsening of the underlying disease, premature birth, miscarriage, and intrauterine growth restriction. maternal lupus nephritis increases the risk of hypertension and preeclampsia/eclampsia. passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block. fetal/neonatal adverse reactions: monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to benlysta in utero. monitor an infant of a treated mother for b-cell reduction and other immune dysfunction [see warnings and precautions (5.5)]. data animal data: in a combined embryo-fetal and pre- and post-natal development study, pregnant cynomolgus monkeys received belimumab at intravenous doses of 0, 5, or 150 mg/kg every 2 weeks from confirmation of pregnancy at gestation days (gd) 20 to 22, throughout the period of organogenesis (up to approximately gd 50), and continuing to either the day of scheduled cesarean section (gd 150 [late third trimester]) or the day of parturition. there was no evidence of maternal toxicity, effects on embryofetal and infant survival, or structural abnormalities at exposure approximately 9 times the mrhd of 10 mg/kg intravenously or 20 times the mrhd of 200 mg subcutaneously (on an auc basis with maternal animal intravenous doses up to 150 mg/kg). belimumab-related findings in mothers included reductions of immature and mature b-cell counts and in fetuses and/or infants included reductions of immature and mature b-cell counts, reductions in the density of lymphoid tissue b-lymphocytes in the spleen and lymph nodes, reduced spleen weights, increased igg titers, and reduced igm titers. b-cell counts in infant monkeys exposed to belimumab in utero recovered by 3 months of age and in mothers after 1 year. igg and igm levels in infant monkeys recovered by 6 months of age and the reductions in b-lymphocytes in the lymph nodes and spleen were reversed by 1 year of age. belimumab crossed the placenta, as it was detected in fetal cord blood and amniotic fluid on gd 150. risk summary no information is available on the presence of belimumab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. belimumab was detected in the milk of cynomolgus monkeys; however, due to species-specific differences in lactation physiology, animal data may not predict drug levels in human milk. maternal igg is known to be present in human milk. if belimumab is transferred into human milk, the effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to belimumab are unknown. the lack of clinical data during lactation precludes clear determination of the risk of benlysta to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for benlysta, and any potential adverse effects on the breastfed child from benlysta or from the underlying maternal condition. contraception following an assessment of benefit versus risk, if prevention of pregnancy is warranted, females of reproductive potential should use effective contraception during treatment and for at least 4 months after the final treatment. safety and effectiveness of benlysta have been established for the treatment of sle and lupus nephritis in pediatric patients 5 to 17 years old. use of benlysta in pediatric patients with sle is supported by evidence from pharmacokinetic (pk) and efficacy results from a pediatric study (trial 6), as well as pk exposure and extrapolation of the established efficacy of benylsta plus standard therapy from the phase 3 intravenous studies in adults with sle. a randomized, double‑blind, placebo‑controlled, pk, efficacy, and safety study (trial 6) to evaluate intravenously administered benlysta 10 mg/kg plus standard therapy compared with placebo plus standard therapy over 52 weeks was conducted in 93 pediatric patients with sle. the proportion of pediatric patients achieving an sri-4 response was higher in patients receiving benlysta plus standard therapy compared with placebo plus standard therapy. pediatric patients receiving benlysta plus standard therapy also had a lower risk of experiencing a severe flare compared with placebo plus standard therapy [see clinical studies (14.3)] . pharmacokinetics were evaluated in a total of 53 pediatric patients with sle and were consistent with the adult population with sle [see clinical pharmacology (12.3)] . use of benlysta in pediatric patients with active lupus nephritis is based on the extrapolation of efficacy from the intravenous study in adults (n = 224) with active lupus nephritis, and supported by pharmacokinetic data from intravenous studies in adults (n = 224) with active lupus nephritis and from pediatric patients (n = 53) with sle. estimated belimumab exposures for pediatric patients were comparable to adults with active lupus nephritis [see clinical pharmacology (12.3)] . the safety and effectiveness of intravenous administration of benlysta have not been established in pediatric patients younger than 5 years of age. the safety and effectiveness of subcutaneous administration of benlysta have not been established in pediatric patients younger than 18 years of age. clinical studies of benlysta did not include sufficient numbers of subjects aged 65 or older to determine whether they respond differently from younger subjects. use with caution in geriatric patients. the safety and efficacy of benlysta were evaluated in studies that included patients with sle who had mild (creatinine clearance [crcl] ≥60 and <90 ml/min), moderate (crcl ≥30 and <60 ml/min), or severe (crcl ≥15 and <30 ml/min) renal impairment. no dosage adjustment is recommended in patients with renal impairment. no formal trials were conducted to examine the effects of hepatic impairment on the pharmacokinetics of belimumab. no dosage adjustment is recommended in patients with hepatic impairment. in trial 2 and trial 3 (intravenous dosing), sle responder index-4 (sri-4) response rates were lower for black patients receiving benlysta plus standard therapy relative to black patients receiving placebo plus standard therapy [see clinical studies (14.1)] . in trial 4 (intravenous dosing), a 2:1 randomized, placebo-controlled trial in black patients, sle responder index (sri-s2k) response rates were higher for black patients receiving benlysta plus standard therapy (49%) relative to black patients receiving placebo plus standard therapy (42%). however, the treatment difference was not statistically significant [see clinical studies (14.1)] . in trial 7 (subcutaneous dosing), sri-4 response was 45% (26/58) in black patients receiving benlysta plus standard therapy compared with 39% (13/33) in black patients receiving placebo plus standard therapy [see clinical studies (14.4)] . the safety profile of benlysta in black patients was consistent with the known safety profile of benlysta administered in the overall population [see adverse reactions (6.1)] . instructions for use benlysta (ben-list-ah) (belimumab) injection, for subcutaneous use prefilled syringe read this instructions for use before you start to use benlysta and each time you refill your prescription. there may be new information. you should also receive training from your healthcare provider on how to use the prefilled syringe the right way. if you do not follow these instructions the prefilled syringe may not work properly. benlysta is for use under the skin only (subcutaneous). important storage information important warnings benlysta prefilled syringe parts before use after use – needle is covered by needle guard supplies needed for the injection benlysta prefilled syringe alcohol swab (not included) gauze pad or cotton ball (not included) sharps container (not included) 1 gather and check supplies gather supplies check expiration date 2 prepare and inspect the benlysta prefilled syringe allow to come to room temperature inspect benlysta solution 3 choose and clean the injection site choose the injection site clean the injection site 4 prepare for the injection remove the needle cap 5 inject benlysta insert the needle complete the injection 6 dispose of used prefilled syringe and inspect dispose of the used prefilled syringe throw away (dispose of) the used syringe and needle cap in a sharps container. see figure j. inspect the injection site additional information for more information about benlysta, go to www.benlysta.com or call 1-877-423-6597. this instructions for use has been approved by the u.s. food and drug administration. trademarks are owned by or licensed to the gsk group of companies. manufactured by glaxosmithkline llc philadelphia, pa 19104, u.s. license no. 1727, and distributed by glaxosmithkline durham, nc 27701 ©2022 gsk group of companies or its licensor. bnl:5ifu-s revised july 2022 instructions for use benlysta (ben-list-ah) (belimumab) injection, for subcutaneous use prefilled autoinjector read this instructions for use before you start to use benlysta and each time you refill your prescription. there may be new information. you should also receive training from your healthcare provider on how to use the autoinjector the right way. if you do not follow these instructions the autoinjector may not work properly. benlysta is for use under the skin only (subcutaneous). important storage information important warnings benlysta autoinjector parts supplies needed for the injection benlysta autoinjector alcohol swab (not included) gauze pad or cotton ball (not included) sharps container (not included) 1 gather and check supplies gather supplies check expiration date 2 prepare and inspect the benlysta autoinjector allow to come to room temperature inspect benlysta solution 3 choose and clean the injection site choose the injection site clean the injection site 4 prepare for the injection remove the ring cap position the autoinjector 5 inject benlysta start the injection complete the injection 6 dispose of used autoinjector and inspect dispose of the used autoinjector throw away (dispose of) the used autoinjector and ring cap in a sharps container. see figure k. inspect the injection site additional information for more information about benlysta, go to www.benlysta.com or call 1-877-423-6597. this instructions for use has been approved by the u.s. food and drug administration. trademarks are owned by or licensed to the gsk group of companies. manufactured by glaxosmithkline llc philadelphia, pa 19104, u.s. license no. 1727, and distributed by glaxosmithkline durham, nc 27701 ©2022 gsk group of companies or its licensor. bnl:5ifu-a revised july 2022

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

glaxosmithkline llc - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - adjunctive therapy lamictal is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: monotherapy lamictal is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (aed). safety and effectiveness of lamictal have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from aeds other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. lamictal is indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see clinical studies (14.2)] . limitations of use treatment of acute manic or mixed episodes is

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen: a/vietnam/1194/2004 (h5n1) like strain used (nibrg-14) - influenza, human; immunization; disease outbreaks - vaccines - active immunisation against h5n1 subtype of influenza a virus.this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from a/vietnam/1194/2004 nibrg-14 (h5n1) (see section 5.1).prepandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted) glaxosmithkline biologicals 3.75 µg should be used in accordance with official guidance.

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

glaxosmithkline llc - albiglutide (unii: 5e7u48495e) (albiglutide - unii:5e7u48495e) - albiglutide 30 mg in 0.5 ml - tanzeum 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: tanzeum is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (mtc) or in patients with multiple endocrine neoplasia syndrome type 2 (men 2) [see warnings and precautions (5.1)] . tanzeum is contraindicated in patients with a prior serious hypersensitivity reaction to albiglutide or to any of the product components. serious hypersensitivity reactions including angioedema have been reported with tanzeum [see warnings and precautions (5.4)]. pregnancy category c there are no adequate and well-controlled studies of tanzeum in pregnant women. nonclinical studies have shown reproductive toxicity, but not teratogenicity, in mice treated with albiglutide at up to 39 times human exposure resulting from the maximum recommended dose of 50 mg/week, based on auc [see nonclinical toxicology (13.1, 13.3)]. tan

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

glaxosmithkline llc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - zyban is indicated as an aid to smoking cessation treatment. pregnancy category c. risk summary data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. all pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. no clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately 2 times the maximum recommended human dose (mrhd) and greater and decreased fetal weights were seen at doses three times the mrhd and greater. zyban should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. clinical considerations pregnant smokers should be encouraged to attempt cessation using educational and behavioral i

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

glaxosmithkline llc - umeclidinium bromide (unii: 7an603v4jv) (umeclidinium - unii:ge2t1418sv), vilanterol trifenatate (unii: 40aho2c6dg) (vilanterol - unii:028lzy775b) - umeclidinium 62.5 ug - anoro ellipta is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (copd). limitations of use anoro ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma. the safety and effectiveness of anoro ellipta in asthma have not been established. anoro ellipta is contraindicated in: risk summary there are insufficient data on the use of anoro ellipta or its individual components, umeclidinium and vilanterol, in pregnant women to inform a drug-associated risk. (see clinical considerations.) in animal reproduction studies, umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effects on embryofetal development at exposures approximately 50 and 200 times, respectively, the human exposure at the maximum recommended human daily inhaled dose (mrhdid). vilanterol administered via inhalation to pregnant rats and rabbits produced no fetal structural abnormalities at exposures approximately 70 times the mrhdid. (see data.) the estimated risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations labor or delivery: anoro ellipta should be used during late gestation and labor only if the potential benefit justifies the potential for risks related to beta-agonists interfering with uterine contractility. data animal data: the combination of umeclidinium and vilanterol has not been studied in pregnant animals. studies in pregnant animals have been conducted with umeclidinium and vilanterol individually. umeclidinium: in separate embryofetal developmental studies, pregnant rats and rabbits received umeclidinium during the period of organogenesis at doses up to approximately 50 and 200 times the mrhdid, respectively (on an auc basis at maternal inhalation doses up to 278 mcg/kg/day in rats and at maternal subcutaneous doses up to 180 mcg/kg/day in rabbits). no evidence of teratogenic effects was observed in either species. in a perinatal and postnatal developmental study in rats, dams received umeclidinium during late gestation and lactation periods with no evidence of effects on offspring development at doses up to approximately 26 times the mrhdid (on an auc basis at maternal subcutaneous doses up to 60 mcg/kg/day). vilanterol: in separate embryofetal developmental studies, pregnant rats and rabbits received vilanterol during the period of organogenesis at doses up to approximately 13,000 and 450 times, respectively, the mrhdid (on a mcg/m2 basis at maternal inhalation doses up to 33,700 mcg/kg/day in rats and on an auc basis at maternal inhaled doses up to 5,740 mcg/kg/day in rabbits). no evidence of structural abnormalities was observed at any dose in rats or in rabbits up to approximately 70 times the mrhdid (on an auc basis at maternal doses up to 591 mcg/kg/day in rabbits). however, fetal skeletal variations were observed in rabbits at approximately 450 times the mrhdid (on an auc basis at maternal inhaled or subcutaneous doses of 5,740 or 300 mcg/kg/day, respectively). the skeletal variations included decreased or absent ossification in cervical vertebral centrum and metacarpals. in a perinatal and postnatal developmental study in rats, dams received vilanterol during late gestation and the lactation periods at doses up to approximately 3,900 times the mrhdid (on a mcg/m2 basis at maternal oral doses up to 10,000 mcg/kg/day). no evidence of effects in offspring development was observed. risk summary there is no information available on the presence of umeclidinium or vilanterol in human milk, the effects on the breastfed child, or the effects on milk production. umeclidinium was detected in the plasma of offspring of lactating rats treated with umeclidinium suggesting its presence in maternal milk. (see data.) the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for anoro ellipta and any potential adverse effects on the breastfed child from umeclidinium or vilanterol or from the underlying maternal condition. data subcutaneous administration of umeclidinium to lactating rats at greater than or equal to 60 mcg/kg/day resulted in a quantifiable level of umeclidinium in 2 of 54 pups, which may indicate transfer of umeclidinium in rat milk. the safety and effectiveness of anoro ellipta have not been established in pediatric patients. anoro ellipta is not indicated for use in pediatric patients. based on available data, no adjustment of the dosage of anoro ellipta in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out. clinical trials of anoro ellipta for copd included 2,143 subjects aged 65 years and older and 478 subjects aged 75 years and older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects. patients with moderate hepatic impairment (child-pugh score of 7-9) showed no relevant increases in cmax or auc, nor did protein binding differ between subjects with moderate hepatic impairment and their healthy controls. studies in subjects with severe hepatic impairment have not been performed [see clinical pharmacology (12.3)] . there were no significant increases in either umeclidinium or vilanterol exposure in subjects with severe renal impairment (crcl <30 ml/min) compared with healthy subjects. no dosage adjustment is required in patients with renal impairment [see clinical pharmacology (12.3)] .

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

glaxosmithkline llc - belantamab mafodotin (unii: db1041cxdg) (belantamab mafodotin - unii:db1041cxdg) - blenrep is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-cd38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. this indication is approved under accelerated approval based on response rate [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). none. risk summary based on its mechanism of action, blenrep can cause fetal harm when administered to a pregnant woman, because it contains a genotoxic compound (the microtubule inhibitor, mmaf) and it targets actively dividing cells [see clinical pharmacology (12.1), nonclinical toxicology (13.1)] . human immunoglobulin g (igg) is known to cross the placenta; therefore, belantamab mafodotin-blmf has the potential to be transmitted from the mother to the developing fetus. there are no available data on the use of blenrep in pregnan

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

glaxosmithkline llc - dostarlimab (unii: p0gvq9a4s5) (dostarlimab - unii:p0gvq9a4s5) - jemperli, in combination with carboplatin and paclitaxel, followed by jemperli as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer (ec) that is mismatch repair deficient (dmmr), as determined by an fda-approved test, or microsatellite instability-high (msi-h) [see dosage and administration ( 2.1)]. jemperli, as a single agent, is indicated for the treatment of adult patients with dmmr recurrent or advanced endometrial cancer, as determined by an fda-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation [see dosage and administration ( 2.1)]. jemperli, as a single agent, is indicated for the treatment of adult patients with dmmr recurrent or advanced solid tumors, as determined by an fda-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options [see dosage and administration ( 2.1)]. this indication is approved under accelerated approval based on tumor response rate and durability of response [see clinical studies ( 14.2)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). none. risk summary based on its mechanism of action, jemperli can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of jemperli in pregnant women. animal studies have demonstrated that inhibition of the pd-1/pd-l1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death (see data). human igg4 immunoglobulins (igg4) are known to cross the placental barrier; therefore, dostarlimab-gxly has the potential to be transmitted from the mother to the developing fetus. advise 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: animal reproduction studies have not been conducted with jemperli to evaluate its effect on reproduction and fetal development. a central function of the pd-1/pd-l1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. in murine models of pregnancy, blockade of pd-l1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering jemperli during pregnancy include increased rates of abortion or stillbirth. as reported in the literature, there were no malformations related to the blockade of pd-1/pd-l1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in pd-1 and pd-l1 knockout mice. based on its mechanism of action, fetal exposure to dostarlimab-gxly may increase the risk of developing immune-mediated disorders or altering the normal immune response. risk summary there is no information regarding the presence of dostarlimab-gxly in human milk or its effects on the breastfed child or 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 jemperli are unknown. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 4 months after the last dose of jemperli. jemperli 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 jemperli [see use in specific populations (8.1)]. contraception females: advise females of reproductive potential to use effective contraception during treatment with jemperli and for 4 months after the last dose. the safety and efficacy of jemperli have not been established in pediatric patients. in combination with carboplatin and paclitaxel of the 241 patients treated with jemperli in ruby, 52.3% were younger than 65 years, 36.5% were aged 65 through 75 years, and 11.2% were 75 years or older. no overall differences in safety or effectiveness were observed between these patients and younger patients. as a single agent of the 605 patients treated with jemperli in garnet, 51.6% were younger than 65 years, 36.9% were aged 65 through 75 years, and 11.5% were 75 years or older. no overall differences in safety or effectiveness were observed between these patients and younger patients.

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

glaxosmithkline llc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 100 mg - wellbutrin sr (bupropion hydrochloride) is indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)] . the efficacy of wellbutrin sr in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo‑controlled trial [see clinical studies (14)] . pregnancy exposure registry there is an independent pregnancy exposure registry that monitors pregnancy outcomes in women exposed to any antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/. risk summary da

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

glaxosmithkline llc - daprodustat (unii: jvr38zm64b) (daprodustat - unii:jvr38zm64b) - jesduvroq is indicated for the treatment of anemia due to chronic kidney disease (ckd) in adults who have been receiving dialysis for at least four months. limitations of use jesduvroq has not been shown to improve quality of life, fatigue, or patient well-being. jesduvroq is not indicated for use: jesduvroq is contraindicated in patients: risk summary available data with jesduvroq use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there are risks to the mother and the fetus associated with ckd (see clinical considerations ). daprodustat administered orally to pregnant rats and rabbits during the period of organogenesis was associated with adverse fetal outcomes, including embryonic and fetal loss and reduced fetal weight, at doses that caused maternal toxicity and polycythemia (see data). advise pregnant women of the potential risk to the fetus. the background risk of major birth defects and miscarriage for