ubrogepant 100 MG Oral Tablet [Ubrelvy]ubrogepant 50 MG Oral Tablet [Ubrelvy]
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Is it safe to take UBRELVY during pregnancy?There are no adequate data on the developmental risk associated with the use of UBRELVY in pregnant women. Patients should be encouraged to enroll in the pregnancy exposure registry that monitors outcomes in women who become pregnant while taking UBRELVY by calling 1-833-277-0206 or visiting http://empresspregnancyregistry.com.
What is the risk of birth defects or miscarriage when taking UBRELVY during pregnancy?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. However, no adequate data on the developmental risk associated with the use of UBRELVY in pregnant women is available.
What are the clinical considerations when taking UBRELVY during pregnancy?Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.
What does animal data suggest about the use of UBRELVY during pregnancy?In animal studies, adverse effects on embryofetal development were observed following administration of ubrogepant during pregnancy or during pregnancy and lactation at doses greater than those used clinically and which were associated with maternal toxicity. No adverse effects on embryofetal development were observed when ubrogepant was administered to pregnant rats during the period of organogenesis. However, no adequate data on the developmental risk associated with the use of UBRELVY in pregnant women is available.
What is the risk of taking UBRELVY while breastfeeding?There are no data on the presence of ubrogepant in human milk, the effects of ubrogepant on the breastfed infant, or the effects of ubrogepant on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for UBRELVY and any potential adverse effects on the breastfed infant from UBRELVY or from the underlying maternal condition.
Is it safe to use UBRELVY in pediatric patients?Safety and effectiveness in pediatric patients have not been established.
Are there any pharmacokinetic differences between elderly and younger patients when taking UBRELVY?Pharmacokinetic studies have shown no clinically significant differences between elderly and younger patients when taking UBRELVY.
Was the use of UBRELVY studied in elderly patients?Clinical studies of UBRELVY did not include enough elderly patients to determine if they respond differently from younger patients. Dose selection for elderly patients should be cautious and typically start at the low end of the dosing range.
How does hepatic impairment affect the exposure to UBRELVY?In patients with mild, moderate, or severe hepatic impairment, exposure to UBRELVY was increased by 7%, 50%, and 115%, respectively. No dose adjustment is necessary for mild or moderate hepatic impairment. However, for patients with severe hepatic impairment, dose adjustment is recommended.
How does renal impairment affect the use of UBRELVY?Renal impairment has a minor effect on the clearance of UBRELVY. No dose adjustment is needed for patients with mild or moderate renal impairment. For those with severe renal impairment (CLcr 15-29 mL/min), dose adjustment is necessary. Patients with end-stage renal disease (CLcr <15 mL/min) should avoid the use of UBRELVY.
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