What is the most important information I should know about AJOVY®?
Do not use AJOVY if you are allergic to fremanezumab-vfrm or any of the ingredients in AJOVY.
What should I tell my healthcare provider before taking AJOVY?
Before you use AJOVY, tell your healthcare provider if you:
- have high blood pressure.
- have circulation problems in your fingers and toes.
- are pregnant or plan to become pregnant. It is not known if AJOVY will harm your unborn baby.
Pregnancy Registry: There is a registry for women who become pregnant during treatment with AJOVY. The purpose of this registry is to collect information about the safety of AJOVY during pregnancy. Contact the registry as soon as you learn that you are pregnant, or ask your healthcare provider to contact the registry for you. You or your healthcare provider can get information and enroll you in the registry by calling 1-833-927-2605 or visiting www.tevamigrainepregnancyregistry.com.
- are breastfeeding or plan to breastfeed. It is not known if AJOVY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using AJOVY.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.
What are the possible side effects of AJOVY?
AJOVY may cause serious side effects, including:
- Allergic reactions. Allergic reactions, including itching, rash, and hives, can happen within hours and up to 1 month after receiving AJOVY. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction:
- swelling of your face, mouth, tongue, or throat
- trouble breathing
- High blood pressure. High blood pressure or worsening of high blood pressure can happen after receiving AJOVY. Contact your healthcare provider if you have an increase in blood pressure.
- Raynaud’s phenomenon. A type of circulation problem can worsen or happen after receiving AJOVY. Symptoms may include:
- fingers or toes may feel numb, cool, or painful
- fingers and toes may change color from pale, to blue, to red
Stop taking AJOVY and contact your healthcare provider if these symptoms occur.
The most common side effects of AJOVY include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of AJOVY. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
AJOVY is a prescription medicine used for the preventive treatment of migraine in adults and episodic migraine in children who are 6 to 17 years of age and who weigh 99 pounds (45 kg) or more.
Please read the Patient Information Leaflet in the full Prescribing Information.
