Ajovy (fremanezumab-vfrm)
AJOVY 225 MG in 1.5 mL Auto-Injector
NO BOXED WARNING
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Ajovy FAQs
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.
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