AJOVY® (a-JO-vee) (fremanezumab-vfrm) injection for subcutaneous use
What is AJOVY? AJOVY is a prescription medicine used for the preventive treatment of migraine in adults. It is not known if AJOVY is safe and effective in children.
Who should not use AJOVY? Do not use AJOVY if you are allergic to fremanezumab-vfrm or any of the ingredients in AJOVY. See the end of this information for a complete list of the ingredients in AJOVY. Before you use AJOVY, tell your healthcare provider if you: • 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 doctor to contact the registry for you. You or your doctor can get information and enroll you in the registry by calling 1-833-927-2605 or visiting https://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.
How should I use AJOVY? • See the detailed “Instructions for Use” for information on how to prepare and inject a dose of AJOVY. • Use AJOVY exactly as your healthcare provider tells you to use it. • AJOVY is given by injection under your skin (subcutaneously). • Your healthcare provider should show you or your caregiver how to prepare and inject your dose of AJOVY before you or your caregiver give your AJOVY the first time. • Your healthcare provider will tell you how much AJOVY to use and when to use it. ◦ Your healthcare provider will tell you if you should use AJOVY 225 mg one time every month or AJOVY 675 mg one time every 3 months. ◦ If your prescribed dose is AJOVY 675 mg every 3 months, you must use 3 separate autoinjectors or 3 separate syringes. You will give 3 separate injections one time every 3 months. • If you are giving 3 injections of AJOVY for your prescribed dose, you may use the same injection area for all 3 injections, but not the same spot. • Do not inject AJOVY in the same injection site that you inject other medicine. • If you are switching from using AJOVY one time every month to one time every 3 months or if you are switching from using AJOVY one time every 3 months to one time every month, give the first dose of AJOVY on the day it was due to be given on your old schedule. • If you miss a dose of AJOVY, take it as soon as possible. If you need to take the dose late, you will need to change your schedule: if you take 225 mg of AJOVY, inject your next dose 1 month after the late dose. If you take 675 mg of AJOVY, inject your next dose 3 months after the late dose. If you have questions about your schedule, ask your healthcare provider
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 The most common side effects of AJOVY include: • injection site reactions 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.
How should I store AJOVY? • Store AJOVY in the refrigerator between 36°F to 46°F (2°C to 8°C). • Keep AJOVY in the carton it comes in to protect from light. • If needed, AJOVY may be stored at room temperature up to 86°F (30°C) in the carton it comes in for up to 7 days. Do not use AJOVY if it has been out of the refrigerator for 7 days or longer. Throw away (dispose of) AJOVY in a sharps disposal or puncture-resistant container if it has been out of the refrigerator for 7 days or longer. Once stored at room temperature, do not place back in the refrigerator. • Do not freeze. If AJOVY freezes, throw it away in a sharps disposal container. • Keep AJOVY out of extreme heat and direct sunlight. • Do not shake AJOVY. Keep AJOVY prefilled autoinjector and AJOVY prefilled syringe out of the reach of small children.
General information about the safe and effective use of AJOVY. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AJOVY for a condition for which it was not prescribed. Do not give AJOVY to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about AJOVY that is written for health professionals.
What are the ingredients in AJOVY? Active ingredient: fremanezumab-vfrm Inactive ingredients: disodium ethylenediaminetetraacetic acid dihydrate (EDTA), L-histidine, L-histidine hydrochloride monohydrate, polysorbate-80, sucrose, and Water for Injection. AJOVY prefilled syringe and prefilled autoinjector are not made with natural rubber latex.
Manufactured by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 US License No. 2016 AJOPL-005 For more information, go to www.AJOVY.com or call 1-888-483-8279