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

promius pharma, llc - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone 0.5 mg in 1 g - sernivo spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. none. pregnancy category c there are no adequate and well-controlled studies in pregnant women. sernivo spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. the abnormalities observed included umbilical hernias, cephalocele, and cleft palate. systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in human milk. because many drugs are excreted in human milk, caution should be exercised when sernivo spray is administered to a nursing woman. safet

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

encore dermatology inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - sernivo spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. none. risk summary there are no available data on sernivo spray use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that sernivo spray may increase the risk of having a low birthweight infant and to use sernivo spray on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits during the period of organogenesis (see data ). the available data do not allow the calculation of relevant comparis

Canada - English - Health Canada

bristol-myers squibb canada - nivolumab - solution - 10mg - nivolumab 10mg - antineoplastic agents

Canada - English - Health Canada

bristol-myers squibb canada - nivolumab - solution - 10mg - nivolumab 10mg - antineoplastic agents

European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab, relatlimab - melanoma - antineoplastic agents, monoclonal antibodies - opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell pd l1 expression < 1%.

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

e.r. squibb & sons, l.l.c. - nivolumab (unii: 31yo63lbsn) (nivolumab - unii:31yo63lbsn), relatlimab (unii: af75xof6w3) (relatlimab - unii:af75xof6w3) - opdualag™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. none.       risk summary based on findings in animals and mechanism of action, opdualag can cause fetal harm when administered to a pregnant woman. administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death (see data ). human igg4 is known to cross the placenta; therefore, nivolumab and relatlimab have the potential to be transmitted from the mother to the developing fetus. the effects of opdualag are likely to be greater during the second and third trimesters of pregnancy. there are no available data on opdualag in pregnant women to evaluate a drug-associated risk. advise the patient 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 opdualag injection for intravenous use contains nivolumab and relatlimab [see description (11)] . nivolumab: one function of the pd-1/pd-l1 pathway is to preserve pregnancy by maintaining immune tolerance to the fetus. the effects of nivolumab on prenatal and postnatal development were evaluated in monkeys that received nivolumab twice weekly from the onset of organogenesis through delivery, at exposure levels of between 9 and 42 times higher than those observed at the clinical dose of 3 mg/kg (based on auc). nivolumab administration resulted in a non-dose-related increase in spontaneous abortion and increased neonatal death. in surviving infants (18 of 32 compared to 11 of 16 vehicle-exposed infants) of cynomolgus monkeys treated with nivolumab, there were no apparent malformations and no effects on neurobehavioral, immunological, or clinical pathology parameters throughout the 6-month postnatal period. relatlimab: there are no available animal data on relatlimab. the effects of a murine surrogate anti-lag-3 antibody was evaluated in mice using syngeneic and allogeneic breeding models. when anti-lag-3 antibodies were administered beginning on gestation day 6, there were no maternal or developmental effects in either syngeneic or allogeneic breedings. risk summary there are no data on the presence of nivolumab and relatlimab in human milk, the effects on the breastfed child, or the effects on milk production. because nivolumab and relatlimab may be excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with opdualag and for at least 5 months after the last dose [see pharmacokinetics (12.3)] . opdualag can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating opdualag [see use in specific populations (8.1)] . contraception advise females of reproductive potential to use effective contraception during treatment and for at least 5 months following the last dose of opdualag [see clinical pharmacology (12.3)] . the safety and effectiveness of opdualag for the treatment of unresectable or metastatic melanoma have been established in pediatric patients 12 years of age or older who weigh at least 40 kg. use of opdualag for this indication is supported by evidence from an adequate and well-controlled study in adults and additional data analyses that suggest that nivolumab and relatlimab exposures in pediatric patients 12 years of age who weigh at least 40 kg are expected to result in similar safety and efficacy to that of adults. the pharmacokinetics of monoclonal antibodies and the course of unresectable or metastatic melanoma are sufficiently similar in adults and pediatric patients 12 years of age or older to allow extrapolation of data from adult patients to pediatric patients 12 years of age or older (who weigh at least 40 kg). a recommended dosage for pediatric patients 12 years of age or older who weigh less than 40 kg has not been established [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . the safety and effectiveness of opdualag have not been established in pediatric patients 12 years of age or older who weigh less than 40 kg, and pediatric patients younger than 12 years of age. of the 355 patients treated with opdualag in relativity-047, 47% of patients were 65 years or older, 29% were 65 to 74 years, 17% were 75 to 84 years, and 1.7% were 85 years and older. no overall differences in safety or effectiveness were observed between elderly patients and younger patients.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol-myers squibb pharmaceuticals ltd - nivolumab - solution for infusion - 10mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol-myers squibb pharmaceuticals ltd - nivolumab - solution for infusion - 10mg/1ml

United Kingdom - English - myHealthbox

bristol-myers squibb pharma eeig - nivolumab - concentrate for solution for infusion - 10 mg/ml - antineoplastic agents, monoclonal antibodies - as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults

United Kingdom - English - VMD (Veterinary Medicines Directorate)

norbrook laboratories limited - cobalt, oxfendazole - oral suspension - anthelmintic anticestodal - sheep