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|Dosage & Administration|
Out-Of-Pocket Costs With Copay Card
No lower-cost generic available
No lower-cost generic available
Mechanism of Actions (MoA)
Is there a pregnancy exposure registry for AJOVY?
Yes, there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AJOVY during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-833-927-2605 or visiting www.tevamigrainepregnancyregistry.com.
What is the risk associated with the use of AJOVY during pregnancy?
There are no adequate data on the developmental risk associated with the use of AJOVY in pregnant women. AJOVY has a long half-life, which should be taken into consideration for women who are pregnant or plan to become pregnant while using AJOVY. However, administration of fremanezumab-vfrm (the active ingredient in AJOVY) to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at doses resulting in plasma levels greater than those expected clinically did not result in adverse effects on development.
What is the estimated background risk of major birth defects and miscarriage for the indicated population?
The estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively, for the U.S. general population. The estimated rate of major birth defects and miscarriage among deliveries to women with migraine are similar to rates reported in women without migraine.
Is AJOVY safe to use during lactation?
There are no data on the presence of fremanezumab-vfrm (the active ingredient in AJOVY) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for AJOVY and any potential adverse effects on the breastfed infant from AJOVY or from the underlying maternal condition.
Is AJOVY safe and effective for use in pediatric patients?
Safety and effectiveness in pediatric patients have not been established.
Is there any information on the use of AJOVY in geriatric patients?
Clinical studies of AJOVY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
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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