Qulipta
(atogepant)atogepant 10 MG Oral Tablet [Qulipta]atogepant 30 MG Oral Tablet [Qulipta]
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NO BLACK BOX WARNING
Dosage & administration
• The recommended dosage is 10 mg, 30 mg, or 60 mg taken orally once daily with or without food.
• Severe Renal Impairment or End-Stage Renal Disease: 10 mg once daily.
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Qulipta FAQs
Is QULIPTA safe to use during pregnancy?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. Women who are pregnant or planning to become pregnant should consult with their healthcare provider to determine the best treatment option for their migraine.
Is QULIPTA safe to use during lactation?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.
Is QULIPTA safe to use in pediatric patients?Safety and effectiveness in pediatric patients have not been established. QULIPTA is not recommended for use in pediatric patients.
Is QULIPTA safe to use in elderly patients?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.
Is QULIPTA safe to use in patients with hepatic 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.
Is QULIPTA safe to use in patients with renal impairment?The renal route of elimination plays a minor role in the clearance of atogepant. No dose adjustment is recommended for patients with mild or moderate renal impairment.
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