Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - atogepant as monohydrate - tablets - atogepant as monohydrate 10 mg - atogepant - qulipta is indicated for the preventive treatment of migraine in adults

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - atogepant as monohydrate - tablets - atogepant as monohydrate 30 mg - atogepant - qulipta is indicated for the preventive treatment of migraine in adults

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - atogepant as monohydrate - tablets - atogepant as monohydrate 60 mg - atogepant - qulipta is indicated for the preventive treatment of migraine in adults

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

abbvie inc. - atogepant (unii: 7crv8rr151) (atogepant - unii:7crv8rr151) - qulipta is indicated for the preventive treatment of migraine in adults. qulipta is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of qulipta. reactions have included anaphylaxis and dyspnea [see warnings and precautions ( 5.1 )] . risk summary there are no adequate data on the developmental risk associated with the use of qulipta in pregnant women. in animal studies, oral administration of atogepant during the period of organogenesis (rats and rabbits) or throughout pregnancy and lactation (rats) resulted in adverse developmental effects (decreased fetal and offspring body weight in rats; increased incidence of fetal structural variations in rabbits) at exposures greater than those used clinically [see data ] . in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the estimated rate of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. clinical considerations disease-associated maternal and/or embryo/fetal risk published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. data animal data oral administration of atogepant (0, 5, 15, 125, or 750 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreases in fetal body weight and in skeletal ossification at the two highest doses tested (125 and 750 mg/kg), which were not associated with maternal toxicity.  at the no-effect dose (15 mg/kg/day) for adverse effects on embryofetal development, plasma exposure (auc) was approximately 4 times that in humans at the maximum recommended human dose (mrhd) of 60 mg/day. oral administration of atogepant (0, 30, 90, or 130 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in an increase in fetal visceral and skeletal variations at the highest dose tested (130 mg/kg/day), which was associated with minimal maternal toxicity. at the no-effect dose (90 mg/kg/day) for adverse effects on embryofetal development, plasma exposure (auc) was approximately 3 times that in humans at the mrhd. oral administration of atogepant (0, 15, 45, or 125 mg/kg/day) to rats throughout gestation and lactation resulted in decreased pup body weight at the highest dose tested (125 mg/kg/day), which persisted into adulthood. at the no-effect dose (45 mg/kg/day) for adverse effects on pre- and postnatal development, plasma exposure (auc) was approximately 5 times that in humans at the mrhd. there are no data on the presence of atogepant in human milk, the effects of atogepant on the breastfed infant, or the effects of atogepant on milk production. in lactating rats, oral dosing with atogepant resulted in levels of atogepant in milk approximately 2-fold higher than that in maternal plasma. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for qulipta and any potential adverse effects on the breastfed infant from qulipta or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established.  population pharmacokinetic modeling suggests no clinically significant pharmacokinetic differences between elderly and younger subjects. clinical studies of qulipta did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. the renal route of elimination plays a minor role in the clearance of atogepant [see clinical pharmacology ( 12.3 )] . for episodic migraine, in patients with severe renal impairment (clcr 15-29 ml/min) and in patients with end-stage renal disease (esrd) (clcr <15 ml/min), the recommended dosage of qulipta is 10 mg once daily; in patients with esrd undergoing intermittent dialysis, qulipta should preferably be taken after dialysis [see dosage and administration ( 2.2 ) ] . for chronic migraine, avoid use of qulipta in patients with severe renal impairment and in patients with esrd. no dose adjustment is recommended for patients with mild or moderate renal impairment. no dose adjustment of qulipta is recommended for patients with mild or moderate hepatic impairment. avoid use of qulipta in patients with severe hepatic impairment [see adverse reactions ( 6.1 ) and clinical pharmacology ( 12.3 )] .

European Union - English - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - atogepant - migraine disorders - aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month

Canada - English - Health Canada

abbvie corporation - atogepant - tablet - 10mg - atogepant 10mg

Canada - English - Health Canada

abbvie corporation - atogepant - tablet - 30mg - atogepant 30mg

Canada - English - Health Canada

abbvie corporation - atogepant - tablet - 60mg - atogepant 60mg

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

abbvie pty ltd - atogepant, quantity: 10 mg - tablet - excipient ingredients: mannitol; sodium stearylfumarate; silicon dioxide; tocofersolan; croscarmellose sodium; copovidone; sodium chloride; microcrystalline cellulose - aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

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

abbvie pty ltd - atogepant, quantity: 30 mg - tablet - excipient ingredients: mannitol; sodium stearylfumarate; silicon dioxide; tocofersolan; croscarmellose sodium; copovidone; sodium chloride; microcrystalline cellulose - aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.