Product Summary

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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

FREMANEZUMAB-VFRM - SUBCUTANEOUS INJECTION

(FREE-ma-NEZ-ue-mab)

COMMON BRAND NAME(S): Ajovy

USES: This medication is used to help prevent migraine. This medication may work by changing the amounts of certain natural substances in the brain. Fremanezumab-vfrm belongs to a class of drugs known as monoclonal antibodies. Preventing frequent migraine attacks can help improve your ability to concentrate and do your usual tasks.

HOW TO USE: Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using fremanezumab-vfrm and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Before use, take this medication out of the refrigerator. Remove the syringe from the package and let it warm up to room temperature for at least 30 minutes. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. Do not leave in direct sunlight. Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into areas of skin that are tender, bruised, red, tattooed, or hard. Avoid injecting into skin areas with scars or stretch marks. Inject this medication under the skin of the thigh, abdomen, or upper arm as directed by your doctor, usually once every month, or once every 3 months. The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when you need to use the medication. Learn how to store and discard medical supplies safely. Tell your doctor if your migraines happen more often or get worse.

SIDE EFFECTS: Redness, pain, or swelling at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using fremanezumab-vfrm, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. After that, continue to use this medication once every month or once every 3 months from the date of your last dose. Do not double the dose to catch up. If you have questions about your schedule, ask your doctor or pharmacist.

STORAGE: Store in the original package in the refrigerator. Do not freeze. After removing from the refrigerator, this medication can be stored at room temperature for up to 24 hours. Do not put the medication back in the refrigerator after it has reached room temperature. Do not leave the syringe in direct sunlight. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised October 2018. Copyright(c) 2018 First Databank, Inc.