Medically reviewed on September 14, 2018
Generic Name: fremanezumab-vfrm
Dosage Form: Injection, for Subcutaneous Use
Date of Approval: September 14, 2018
Company: Teva Pharmaceuticals USA, Inc.
Treatment for: Prevention of Migraine
FDA Approves Ajovy
The U.S. Food and Drug Administration (FDA) has approved Ajovy (fremanezumab-vfrm), the second in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide (CGRP) for the preventive treatment of migraine.
Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is Ajovy?
Ajovy is a prescription medicine used for the preventive treatment of migraine in adults.
It is not known if this medicine 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 other ingredients. See the end of this page for a complete list of the ingredients.
Before you use Ajovy
Before you use Ajovy, tell your healthcare provider if you:
- are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.
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 leaflet that comes with your prescription for information on how to prepare and inject each dose.
- Use this medicine 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 before you or your caregiver give your Ajovy the first time.
- Your healthcare provider will tell you how much of this medicine 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 675 mg every 3 months, you must use three separate syringes. You will give three separate injections one time every 3 months.
- If you are giving three injections for your prescribed dose, you may use the same body site for all three 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 on the day it was due to be given on your old schedule.
- If you miss a dose, take it as soon as possible. If you need to take the dose late, you will need to adjust 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.
Ajovy side effects
Ajovy may cause serious side effects, including:
- Allergic reactions. Allergic reactions, including itching, rash, and hives, can happen within hours and up to one month after receiving a dose. 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 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. 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 prefilled syringe in the refrigerator between 36°F to 46°F (2°C to 8°C).
- Keep the prefilled syringe in the carton it comes in to protect from light.
- If needed, the prefilled syringe may be stored at room temperature between 68°F to 77°F (20°C to 25°C) in the carton it comes in for up to 24 hours. Do not use Ajovy if it has been out of the refrigerator for 24 hours or longer. Dispose of (throw away) the prefilled syringe in a sharps disposal container if it has been out of the refrigerator for 24 hours or longer.
- 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 the prefilled syringe.
Keep the 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 this medicine for a condition for which it was not prescribed. Do not give it 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 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
The prefilled syringe cap is not made with natural rubber latex.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.