Fremanezumab-vfrm Injection

WHY is this medicine prescribed?

Fremanezumab-vfrm injection is used to help prevent migraine headaches (severe, throbbing headaches that may cause nausea and sensitivity to sound or light). Fremanezumab-vfrm injection is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body that causes migraine headaches.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Fremanezumab-vfrm injection comes as a solution (liquid) in a prefilled syringe and autoinjection device to be injected subcutaneously (under the skin). It is given either once a month (as 1 injection) or once every 3 months (as 3 separate injections given one right after the other). Use fremanezumab-vfrm injection at around the same day every 1 or 3 month(s), depending on your dose.

Use fremanezumab-vfrm injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You may be able to inject the medication yourself at home or have a caregiver perform the injections. Ask your doctor to show you or the person who will be performing the injections how to inject the medication.

Remove the syringe or autoinjection device from the refrigerator. Place on a flat surface away fromdirect sunlight. Do not remove the needle or device cap. Allow it to warm to room temperature for 30 minutes before injecting. Do not try to warm the medication by heating it in a microwave, placing it in hot water, leaving it in sunlight, or through any other method.

Use each syringe or autoinjection device only once and inject all the solution in the syringe or device. Dispose of used syringes or devices in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Inject fremanezumab-vfrm into thigh, upper arm, or stomach area. Do not inject into an area where the skin is tender, thick, bruised, red, scaly, hard, or has scars or stretch marks.

Always look at fremanezumab-vfrm before you inject it. It should be clear and colorless. Do not use fremanezumab-vfrm injection, if it is colored, cloudy, or contains flakes or solid particles. Do not shake it.

If your doctor tells you to inject three separate injections one after another, use a different syringe or autoinjection device for each injection. If you use the same body site (upper arm, thigh, or stomach) for the separate injections, make sure that each injection it is not at the exact same spot you used for the other injections.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using fremanezumab-vfrm injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had high blood pressure or circulation problems in yourfingers and toes such as Raynaud's disease (fingers and toes feel numb and change skin colorto white or blue when exposed to cold temperatures or stress).

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using fremanezumab-vfrm injection, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you forget to inject your dose at the regular time, inject it as soon as you remember. Then continue your dosing schedule from the date of your last dose.

What SIDE EFFECTS can this medicine cause?

Fremanezumab-vfrm injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• injection site pain, swelling, or redness

Some side effects can be serious and may occur up to 1 month after you receive your injection. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• hives; itching; flushing of the face; difficulty breathing; or swelling of your face, mouth, tongue, or throat
• numb, cold, painful, or discolored fingers or toes

Fremanezumab-vfrm injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication tightly closed in the container it came in to protect from light. Store it in the refrigerator, but do not freeze it. After removal from the refrigerator, the medication may be kept in the original carton at room temperature for up to 7 days. Dispose of fremanezumab-vfrm injection if it has been left at room temperature for more than 7 days.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor. Your blood pressure should be checked regularly during your treatment with fremanezumab-vfrm injection.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.