Is QULIPTA safe to use in pediatric patients? 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. In lactating rats, oral dosing with atogepant resulted in levels of atogepant in milk approximately 2-fold higher than that in maternal plasma. 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. Women who are pregnant or planning to become pregnant should consult with their healthcare provider to determine the best treatment option for their migraine. 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. There are no adequate data on the developmental risk associated with the use of QULIPTA in pregnant women. 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 AIMOVIG safe for use in geriatric patients?Ĭlinical studies of AIMOVIG did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Safety and effectiveness in pediatric patients have not been established. Is AIMOVIG safe for use in pediatric patients? The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AIMOVIG and any potential adverse effects on the breastfed infant from AIMOVIG or from the underlying maternal condition. There are no data on the presence of erenumab-aooe in human milk, the effects on the breastfed infant, or the effects on milk production. Is it safe to use AIMOVIG while breastfeeding?
Serum erenumab-aooe exposures (AUC) in pregnant monkeys were approximately 20 times that in humans at a dose of 140 mg once monthly. In a study in which female monkeys were administered erenumab-aooe (0 or 50 mg/kg) twice weekly by subcutaneous injection throughout pregnancy (gestation day 20-22 to parturition), no adverse effects on offspring were observed. What animal data is available for AIMOVIG use during pregnancy? Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Is there any clinical consideration for women with migraine during pregnancy? Healthcare providers are advised to consider the potential risks and benefits of AIMOVIG for pregnant women. 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.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. No adverse effects on offspring were observed when pregnant monkeys were administered erenumab-aooe throughout gestation. There are no adequate data on the developmental risk associated with the use of AIMOVIG in pregnant women. Is it safe to use AIMOVIG during pregnancy?
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