European Union - English - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - carcinoma, squamous cell - antineoplastic agents - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation.basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi).non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc.libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc.cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

European Union - English - EMA (European Medicines Agency)

regeneron uk limited - rilonacept - cryopyrin-associated periodic syndromes - immunosuppressants - rilonacept regeneron is indicated for the treatment of cryopyrin-associated periodic syndromes (caps) with severe symptoms, including familial cold auto-inflammatory syndrome (fcas) and muckle-wells syndrome (mws), in adults and children aged 12 years and older.

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

regeneron pharmaceuticals, inc. - cemiplimab (unii: 6qvl057int) (cemiplimab - unii:6qvl057int) - libtayo is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (mcscc) or locally advanced cscc (lacscc) who are not candidates for curative surgery or curative radiation. libtayo is indicated for the treatment of patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. libtayo in combination with platinum‐based chemotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) with no egfr, alk or ros1 aberrations and is: - locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or - metastatic. libtayo as a single agent is indicated for the first-line treatment of adult patients with nsclc whose tumors have high pd-l1 expression [tumor proportion score (tps) ≥ 50%] as determined by an fda-approved test [see dosage and administration (2.1)] , with no egfr, alk or ros1 aberrations, and is: - locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or - metastatic. none. risk summary based on its mechanism of action, libtayo can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of libtayo 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 placenta; therefore, libtayo 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 libtayo 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 libtayo 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 cemiplimab-rwlc 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 cemiplimab-rwlc in human milk, or its effects on the breastfed child or on milk production. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for at least 4 months after the last dose of libtayo. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating libtayo [see use in specific populations (8.1)] . contraception libtayo can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . females advise females of reproductive potential to use effective contraception during treatment with libtayo and for at least 4 months after the last dose. the safety and effectiveness of libtayo have not been established in pediatric patients. libtayo as a single agent of the 1281 patients who received libtayo as a single agent in clinical studies, 26% were 65 years up to 75 years and 22% were 75 years or older. no overall differences in safety or effectiveness were observed between these patients and younger patients. of the 358 patients with mcscc or lacscc who received libtayo as a single agent in study 1540, 30% were 65 years up to 75 years and 48% were 75 years or older. no overall differences in safety or effectiveness were observed between these patients and younger patients. of the 138 patients with bcc who received libtayo as a single agent in study 1620, 27% were 65 years up to 75 years, and 31% were 75 years or older. no overall differences in safety or effectiveness were observed between these patients and younger patients. libtayo in combination with platinum-based chemotherapy of the 312 patients with nsclc who received libtayo in combination with platinum-based chemotherapy in study 16113, 35% were 65 years up to 75 years and 6% 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)

regeneron pharmaceuticals, inc. - pozelimab (unii: 0jj21k6l2i) (pozelimab - unii:0jj21k6l2i) - veopoz is indicated for the treatment of adult and pediatric patients 1 year of age and older with cd55-deficient protein-losing enteropathy (ple), also known as chaple disease. veopoz is contraindicated in: - patients with unresolved neisseria meningitidis infection [see warnings and precautions (5.1)] . risk summary although there are no data on veopoz use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, monoclonal antibodies can be actively transported across the placenta. in an animal reproduction study in monkeys, pozelimab-bbfg did not adversely affect embryofetal or postnatal development when administered from pregnancy confirmation through parturition at doses that produced exposure up to 3.3 to 3.8 times the predicted clinical exposures (on an auc basis; see data ). 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 outcome. 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 in an enhanced pre- and postnatal development study, pregnant female monkeys were subcutaneously administered pozelimab-bbfg at doses of 5 or 50 mg/kg once weekly from confirmation of pregnancy (gestation day 20) through parturition (approximately gestation day 160). no adverse effects were observed on maintenance of pregnancy, pregnancy outcome, or on the development of offspring through postnatal day 90 at doses up to 3.3-3.8 times the predicted clinical exposures. risk summary there are no data on the presence of pozelimab-bbfg in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. endogenous maternal igg and monoclonal antibodies are transferred into human milk. the effects of local gastrointestinal exposure and the extent of systemic exposure in the breastfed infant to pozelimab are unknown. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for veopoz and any potential adverse effects on the breastfed infant from veopoz or from the underlying maternal condition. the safety and effectiveness of veopoz for the treatment of cd55-deficient ple have been established in pediatric patients 1 year of age and older. use of veopoz for this indication is supported by a single-arm study in 10 patients with active cd55-deficient ple [see adverse reactions (6.1) and clinical studies (14)]. the safety and effectiveness of veopoz have not been established in pediatric patients less than 1 year of age. cd55-deficient ple is largely a disease of pediatric patients. veopoz has not been studied in the geriatric population.

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

regeneron pharmaceuticals, inc. - rilonacept (unii: 8k80yb5gmg) (rilonacept - unii:8k80yb5gmg) - rilonacept 160 mg in 2 ml - arcalyst® (rilonacept) is an interleukin-1 blocker indicated for the treatment of cryopyrin-associated periodic syndromes (caps), including familial cold autoinflammatory syndrome (fcas), and muckle-wells syndrome (mws) in adults and pediatric patients 12 years and older. arcalyst is indicated for the maintenance of remission of deficiency of interleukin-1 receptor antagonist (dira) in adults and pediatric patients weighing at least 10 kg. arcalyst is indicated for the treatment of recurrent pericarditis (rp) and reduction in risk of recurrence in adults and pediatric patients 12 years and older. none. risk summary rare pregnancy outcomes reported postmarketing and from clinical trials, with very limited use of arcalyst in pregnant women, are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there may be risks to the mother and fetus associated with cryopyrin associated periodic syndromes (caps) (see clinical considerations) . in an

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

regeneron pharmaceuticals, inc. - aflibercept (unii: 15c2vl427d) (aflibercept - unii:15c2vl427d) - aflibercept 40 mg in 1 ml - eylea is indicated for the treatment of: eylea is contraindicated in patients with ocular or periocular infections. eylea is contraindicated in patients with active intraocular inflammation. eylea is contraindicated in patients with known hypersensitivity to aflibercept or any of the excipients in eylea. hypersensitivity reactions may manifest as rash, pruritus, urticaria, severe anaphylactic/anaphylactoid reactions, or severe intraocular inflammation. risk summary adequate and well-controlled studies with eylea have not been conducted in pregnant women. aflibercept produced adverse embryofetal effects in rabbits, including external, visceral, and skeletal malformations. a fetal no observed adverse effect level (noael) was not identified. at the lowest dose shown to produce adverse embryofetal effects, systemic exposures (based on auc for free aflibercept) were approximately 6 times higher than auc values observed in humans after a single intravitreal treatment at the recommended clinical dose [see animal data]. animal reproduction studies are not always predictive of human response, and it is not known whether eylea can cause fetal harm when administered to a pregnant woman. based on the anti-vegf mechanism of action for aflibercept [see clinical pharmacology (12.1)], treatment with eylea may pose a risk to human embryofetal development. eylea should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the 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 2-4% and 15-20%, respectively. data animal data in two embryofetal development studies, aflibercept produced adverse embryofetal effects when administered every three days during organogenesis to pregnant rabbits at intravenous doses ≥3 mg per kg, or every six days during organogenesis at subcutaneous doses ≥0.1 mg per kg. adverse embryofetal effects included increased incidences of postimplantation loss and fetal malformations, including anasarca, umbilical hernia, diaphragmatic hernia, gastroschisis, cleft palate, ectrodactyly, intestinal atresia, spina bifida, encephalomeningocele, heart and major vessel defects, and skeletal malformations (fused vertebrae, sternebrae, and ribs; supernumerary vertebral arches and ribs; and incomplete ossification). the maternal no observed adverse effect level (noael) in these studies was 3 mg per kg. aflibercept produced fetal malformations at all doses assessed in rabbits and the fetal noael was not identified. at the lowest dose shown to produce adverse embryofetal effects in rabbits (0.1 mg per kg), systemic exposure (auc) of free aflibercept was approximately 6 times higher than systemic exposure (auc) observed in adult patients after a single intravitreal dose of 2 mg. risk summary there is no information regarding the presence of aflibercept in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production/excretion. because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, eylea is not recommended during breastfeeding. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for eylea and any potential adverse effects on the breastfed child from eylea. contraception females of reproductive potential are advised to use effective contraception prior to the initial dose, during treatment, and for at least 3 months after the last intravitreal injection of eylea. infertility there are no data regarding the effects of eylea on human fertility. aflibercept adversely affected female and male reproductive systems in cynomolgus monkeys when administered by intravenous injection at a dose approximately 1500 times higher than the systemic level observed in adult patients with an intravitreal dose of 2 mg. a no observed adverse effect level (noael) was not identified. these findings were reversible within 20 weeks after cessation of treatment [see nonclinical toxicology (13.1)]. the safety and effectiveness of eylea have been demonstrated in two clinical studies of pre-term infants with rop. these two studies randomized pre-term infants between initial treatment with eylea or laser. efficacy of each treatment is supported by the demonstration of a clinical course which was better than would have been expected without treatment [see dosage and administration (2.9), adverse reactions (6.1), clinical pharmacology (12.3) and clinical studies (14.6)] . in the clinical studies, approximately 76% (2049/2701) of patients randomized to treatment with eylea were ≥65 years of age and approximately 46% (1250/2701) were ≥75 years of age. no significant differences in efficacy or safety were seen with increasing age in these studies.

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

regeneron pharmaceuticals, inc. - alirocumab (unii: pp0shh6v16) (alirocumab - unii:pp0shh6v16) - praluent® is indicated: - to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. - as an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (ldl-c)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh), to reduce ldl-c. - as an adjunct to other ldl-c-lowering therapies in adult patients with homozygous familial hypercholesterolemia (hofh) to reduce ldl-c. praluent is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any of the excipients in praluent. hypersensitivity vasculitis, angioedema, and hypersensitivity reactions requiring hospitalization have occurred [see warnings and precautions (5.1)]. risk summary available data from clinical trials and postmarketing reports on praluent use in pregnant women are insufficient to evaluate for a drug-associated risk of maj

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

regeneron pharmaceuticals, inc. - atoltivimab (unii: fjz07q63vy) (atoltivimab - unii:fjz07q63vy), maftivimab (unii: kop95331m4) (maftivimab - unii:kop95331m4), odesivimab (unii: uy9lq8p6hw) (odesivimab - unii:uy9lq8p6hw) - inmazeb is indicated for the treatment of infection caused by zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is rt-pcr positive for zaire ebolavirus infection [see dosage and administration (2.2), and clinical studies (14)] . limitations of use the efficacy of inmazeb has not been established for other species of the ebolavirus and marburgvirus genera. zaire ebolavirus can change over time, and factors such as emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. consider available information on drug susceptibility patterns for circulating zaire ebolavirus strains when deciding whether to use inmazeb. none. risk summary zaire ebolavirus infection is life-threatening for both the mother and fetus and treatment should not be withheld due to pregnancy (see clinical considerations). available data from the palm trial and an expanded access program in which pregnant women with zaire ebolavirus infection we

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

regeneron pharmaceuticals, inc. - casirivimab (unii: j0fi6we1qn) (casirivimab - unii:j0fi6we1qn) - treatment the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) to permit the emergency use of the unapproved product, regen-cov (casirivimab and imdevimab) co-formulated product and regen-cov (casirivimab and imdevimab) supplied as individual vials to be administered together, for the treatment of mild to moderate coronavirus disease 2019 (covid-19) in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct sars-cov-2 viral testing, and who are at high risk for progression to severe covid-19, including hospitalization or death. limitations of authorized use - regen-cov is not authorized for treatment of mild to moderate covid-19 in geographic regions where infection is likely to have been caused by a non-susceptible sars-cov-2 variant based on available information such as variant susceptibility to this drug and regional variant frequency. - fda's determination and any updates will be available at: https://www.fda

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

regeneron pharmaceuticals, inc. - evinacumab (unii: t8b2orp1dw) (evinacumab - unii:t8b2orp1dw) - evkeeza is indicated as an adjunct to other low-density lipoprotein-cholesterol (ldl-c) lowering therapies for the treatment of adult and pediatric patients, aged 5 years and older, with homozygous familial hypercholesterolemia (hofh). limitations of use: - the safety and effectiveness of evkeeza have not been established in patients with other causes of hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (hefh). - the effects of evkeeza on cardiovascular morbidity and mortality have not been determined. evkeeza is contraindicated in patients with a history of serious hypersensitivity reaction to evinacumab-dgnb or to any of the excipients in evkeeza. serious hypersensitivity reactions, including anaphylaxis, have occurred [see warnings and precautions (5.1)]. risk summary based on data from animal reproduction studies, evkeeza may cause fetal harm when administered to pregnant patients. available human data are insufficient to evaluate for a drug-associated risk of major bir