Israel - English - Ministry of Health

astrazeneca (israel) ltd - selumetinib as hyd-sulfate - hard capsule - selumetinib as hyd-sulfate 10 mg - selumetinib - koselugo is indicated for the treatment of pediatric patients 2 years of age and older withneurofibromatosis type 1 (nf1) who have symptomatic, inoperable plexiform neurofibromas (pn).

Israel - English - Ministry of Health

astrazeneca (israel) ltd - selumetinib as hyd-sulfate - hard capsule - selumetinib as hyd-sulfate 25 mg - selumetinib - koselugo is indicated for the treatment of pediatric patients 2 years of age and older withneurofibromatosis type 1 (nf1) who have symptomatic, inoperable plexiform neurofibromas (pn).

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - selumetinib sulfate - neurofibromatosis 1 - antineoplastic agents - koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (pn) in paediatric patients with neurofibromatosis type 1 (nf1) aged 3 years and above

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

janssen biotech, inc. - guselkumab (unii: 089658a12d) (guselkumab - unii:089658a12d) - guselkumab 100 mg in 1 ml - tremfya is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. tremfya is indicated for the treatment of adult patients with active psoriatic arthritis. tremfya is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients [see warnings and precautions (5.1)] . pregnancy exposure registry there is a pregnancy registry that monitors pregnancy outcomes in women exposed to tremfya during pregnancy. patients should be encouraged to enroll in the registry by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing mothertobaby@health.ucsd.edu. risk summary there are no available data on tremfya use in pregnant women to inform a drug associated risk of adverse developmental outcomes. human igg antibodies are known to cross the placental barrier; therefore, tremfya may be transmitted from the mother to the devel

Canada - English - Health Canada

alexion pharma gmbh - selumetinib (selumetinib sulfate) - capsule - 10mg - selumetinib (selumetinib sulfate) 10mg

Canada - English - Health Canada

alexion pharma gmbh - selumetinib (selumetinib sulfate) - capsule - 25mg - selumetinib (selumetinib sulfate) 25mg

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

astrazeneca pharmaceuticals lp - selumetinib (unii: 6uh91i579u) (selumetinib - unii:6uh91i579u) - koselugo is indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (nf1) who have symptomatic, inoperable plexiform neurofibromas (pn). none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , koselugo can cause fetal harm when administered to a pregnant woman. there are no available data on the use of koselugo in pregnant women to evaluate drug-associated risk. in animal reproduction studies, administration of selumetinib to mice during organogenesis caused reduced fetal weight, adverse structural defects, and effects on embryofetal survival at exposures approximately > 5 times the human exposure at the clinical dose of 25 mg/m2 twice daily (see data ). advise pregnant women of the potential risk to the 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 in embryo-fetal development studies in mice at doses > 2.5 mg/kg twice daily (~5-times the human exposure based on area under the curve [auc] at the clinical dose of 25 mg/m2 twice daily), selumetinib caused increases in post-implantation loss, a reduction in mean fetal and litter weights, and an increased occurrence of open eye and cleft palate, but did not induce significant maternal toxicity. administration of selumetinib to pregnant mice from gestation day 6 through lactation day 20 resulted in reduced pup body weights and fewer pups met the pupil constriction criterion on day 21 post-partum. the incidence of malformations (e.g., prematurely open eye(s) and cleft palate) was increased even at the lowest dose of 0.5 mg/kg twice daily (maternal maximal concentration [cmax ] of ~0.6 times the human cmax at the clinical dose of 25 mg/m2 twice daily). risk summary there are no data on the presence of selumetinib or its active metabolite in human milk or their effects on the breastfed child or milk production. selumetinib and its active metabolite were present in the milk of lactating mice (see data ). due to the potential for adverse reactions in a breastfed child, advise women not to breastfeed during treatment with koselugo and for 1 week after the last dose. data animal data selumetinib and its active metabolite were present in milk from mice dosed with selumetinib throughout gestation and lactation, with a mean plasma/milk ratio of 1.5 in lactating dams dosed at 5 mg/kg twice daily. administration of selumetinib to dams during gestation and early lactation was associated with adverse events in pups, including reduced growth rates and incidence of malformations [see use in specific populations (8.1)]. koselugo 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 koselugo [see use in specific populations (8.1)] . contraception females advise females of reproductive potential to use effective contraception during treatment and for 1 week after the last dose. males advise male patients with female partners of reproductive potential to use effective contraception during treatment with koselugo and for 1 week after the last dose. the safety and effectiveness have been established in pediatric patients 2 years of age and older with nf1 who have inoperable pn and the information on this use is discussed throughout the labeling. the safety and effectiveness of koselugo have not been established in pediatric patients younger than 2 years of age. animal toxicity data in 3-month general toxicology studies, male rats receiving selumetinib at doses ≥ 10 mg/kg daily (~60-times the human exposure based on auc at the clinical dose of 25 mg/m2 twice daily) showed growth plate dysplasia. clinical studies did not include patients 65 years of age and older. no dose adjustment is recommended in patients with renal impairment or those with end stage renal disease [see clinical pharmacology (12.3)]. selumetinib exposures increased in patients with moderate or severe hepatic impairment [see clinical pharmacology (12.3)] . reduce the dose of koselugo for patients with moderate hepatic impairment (child-pugh b). a recommended dosage of koselugo for use in patients with severe hepatic impairment (child-pugh c) has not been established [see dosage and administration (2.3)] .

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

alexion pharmaceuticals australasia pty ltd - selumetinib sulfate, quantity: 30.25 mg (equivalent: selumetinib, qty 25 mg) - capsule, hard - excipient ingredients: carnauba wax; hypromellose; titanium dioxide; carrageenan; shellac; iron oxide red; purified water; iron oxide yellow; tocofersolan; indigo carmine aluminium lake; glyceryl monooleate; potassium chloride; indigo carmine - koselugo is indicated for the treatment of paediatric patients aged 2 years and above, with neurofibromatosis type 1 (nf1) who have symptomatic, inoperable plexiform neurofibromas (pn).

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

alexion pharmaceuticals australasia pty ltd - selumetinib sulfate, quantity: 12.1 mg (equivalent: selumetinib, qty 10 mg) - capsule, hard - excipient ingredients: titanium dioxide; carnauba wax; potassium chloride; iron oxide black; tocofersolan; strong ammonia solution; shellac; propylene glycol; purified water; carrageenan; hypromellose - koselugo is indicated for the treatment of paediatric patients aged 2 years and above, with neurofibromatosis type 1 (nf1) who have symptomatic, inoperable plexiform neurofibromas (pn).

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

viiv healthcare company - maraviroc (unii: md6p741w8a) (maraviroc - unii:md6p741w8a) - maraviroc 25 mg - selzentry is indicated in combination with other antiretroviral agents for the treatment of only ccr5‑tropic human immunodeficiency virus type 1 (hiv‑1) infection in adult and pediatric patients weighing at least 2 kg. limitations of use selzentry is contraindicated in patients with severe renal impairment or esrd (creatinine clearance [crcl] less than 30 ml per minute) who are concomitantly taking potent cyp3a inhibitors or inducers [see warnings and precautions (5.3)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to selzentry during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary limited data on the use of selzentry during pregnancy from the apr and case reports are not sufficient to inform a drug-associated risk of birth defects and miscarriage. in animal reproduction studies, no evidence of adverse developmental outcomes was observed with