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

quality care products, llc - naloxegol oxalate (unii: 65i14tnm33) (naloxegol - unii:44t7335bke) - naloxegol 25 mg - movantik® (naloxegol) is indicated for the treatment of opioid-induced constipation (oic) in adult patients with chronic non-cancer pain. movantik is contraindicated in: pregnancy category c risk summary there are no adequate and well-controlled studies with movantik in pregnant women. the use of movantik during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood brain barrier. 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 doses up to 409 times the human auc at the maximum recommended human dose. movantik should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

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

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

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

redhill biopharma ltd - naloxegol oxalate (unii: 65i14tnm33) (naloxegol - unii:44t7335bke) - 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 doses up to 409 times the human auc at the maximum recommended human dose. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. clinical considerations maternal and fetal/neonatal adverse reactions the use of movantik may be associated with opioid withdrawal in the pregnant woman and the fetus. data animal data oral administration of up to 750 mg/kg/day naloxegol in rats (1452 times the human auc at the maximum recommended human dose) and 450 mg/kg/day naloxegol in rabbits (409 times the human auc at the maximum recommended human dose) during the period of organogenesis produced no adverse effects on embryo-fetal development. oral administration of up to 500 mg/kg/day in rats (195 times the maximum recommended human dose based on body surface area) during the period of organogenesis through lactation produced no adverse effects on parturition or the offspring. there are no data on the presence of naloxegol in human milk, the effects in nursing infants, or the effects on milk production. naloxegol is present in rat milk (see data ). because of the potential for adverse reactions, including opioid withdrawal in breastfed infants, advise women that breastfeeding is not recommended during treatment with movantik. data following oral administration of naloxegol in lactating rats, concentrations of naloxegol in milk were approximately 3- to 4-fold higher than concentrations of naloxegol in maternal plasma. naloxegol was detected in plasma from pups. the safety and effectiveness of movantik have not been established in pediatric patients. of the total number of subjects in clinical studies of movantik, 11% were 65 and over, while 2% were 75 and over. 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 patients, but greater sensitivity of some older individuals cannot be ruled out. movantik exposure was higher in elderly healthy japanese subjects compared to young subjects [see clinical pharmacology (12.3)] . no dosage adjustment is needed in elderly patients. some subjects with creatinine clearance (clcr) values <60 ml/minute (i.e., moderate, severe, or end-stage renal disease) were shown to exhibit markedly higher systemic exposure of naloxegol compared to subjects with normal renal function. the reason for these high exposures is not understood. however, as the risk of adverse reactions increases with systemic exposure, a lower starting dosage of 12.5 mg once daily is recommended. no dosage adjustment is needed in patients with mild renal impairment [see dosage and administration (2.3) and clinical pharmacology (12.3)] . the effect of severe hepatic impairment (child-pugh class c) on the pharmacokinetics of naloxegol has not been evaluated. avoid use of movantik in patients with severe hepatic impairment, as the dosage in these patients has not been determined. no dosage adjustment is required for patients with mild or moderate hepatic impairment [see clinical pharmacology (12.3)] .

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

avera mckennan hospital - naloxegol oxalate (unii: 65i14tnm33) (naloxegol - unii:44t7335bke) - naloxegol 25 mg

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

valinor pharma, llc - naloxegol oxalate (unii: 65i14tnm33) (naloxegol - unii:44t7335bke) - 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

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

quality care products, llc - naloxegol oxalate (unii: 65i14tnm33) (naloxegol - unii:44t7335bke) - 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

Canada - English - Health Canada

knight therapeutics inc. - naloxegol (naloxegol oxalate) - tablet - 12.5mg - naloxegol (naloxegol oxalate) 12.5mg - miscellaneous gi drugs

Canada - English - Health Canada

knight therapeutics inc. - naloxegol (naloxegol oxalate) - tablet - 25mg - naloxegol (naloxegol oxalate) 25mg - miscellaneous gi drugs

European Union - English - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - naloxegol oxalate - constipation; opioid-related disorders - peripheral opioid receptor antagonists, drugs for constipation - treatment of opioid-induced constipation (oic) in adult patients who have had an inadequate response to laxative(s).

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

accelagen pty ltd - purified water; naloxegol oxalate, quantity: 14.2 mg (equivalent: naloxegol, qty 12.5 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; propyl gallate; iron oxide black; microcrystalline cellulose; titanium dioxide; macrogol 400; iron oxide red; mannitol; magnesium stearate; hypromellose - movantik is indicated for the treatment of opioid-induced constipation (oic) in adult patients who have had an inadequate response to laxative(s).