Erenumab-aooe Injection

WHY is this medicine prescribed?

Erenumab-aooe injection is used to help prevent migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound or light). Erenumab-aooe 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?

Erenumab-aooe injection comes as a solution (liquid) to be injected subcutaneously (under the skin). It is usually given once a month. Use erenumab-aooe injection at around the same day every month. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use erenumab-aooe 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 friend or relative perform the injections. Ask your doctor to show you or the person who will be performing the injections how to inject the medication.

Erenumab-aooe injection comes as a prefilled syringe and as a prefilled autoinjector. Allow the syringe and autoinjector to warm to room temperature for 30 minutes away from direct sunlight before you inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method. Use each syringe or autoinjector only once and inject all the solution in the syringe. Dispose of used syringes and autoinjector in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Inject erenumab-aooe injection into thigh or stomach area. If someone else will be injecting the medication for you, that person can also inject it into your upper arm. 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 erenumab-aooe before you inject it. It should be clear and colorless. Do not use erenumab-aooe injection, if it is colored, cloudy, or contains flakes or solid particles. Do not shake it.

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

Erenumab-aooe injection helps to prevent migraines but does not cure them. Continue to inject erenumab-aooe injection even if you feel well. Do not stop using erenumab-aooe injection without talking to your doctor.

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

What SPECIAL PRECAUTIONS should I follow?

Before using erenumab-aooe injection,

• tell your doctor and pharmacist if you are allergic to erenumab-aooe, any other medications, or any of the ingredients in erenumab-aooe injection such as latex. Ask your pharmacist for a list of the ingredients. If you will be using the prefilled syringe or autoinjector, tell your doctor if you or the person who will be injecting the medication for you are allergic to rubber or latex.

• 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.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using erenumab-aooe 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?

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

• injection site pain, redness, or itching
• constipation
• cramps
• muscle spasms

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• rash; hives; itching; swelling of the face, throat, tongue, lips, and eyes; or difficulty swallowing or breathing

Erenumab-aooe injection may cause other side effects. Call your doctor if you have any unusual problems while using 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 (http://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 in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator and away from light, excess heat and moisture (not in the bathroom). If it is removed from the refrigerator, it can be stored at room temperature in the original container for up to 7 days. Dispose of erenumab-aooe injection if it has been left at room temperature more than 7 days. Do not freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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 doctor will monitor your blood pressure regularly during your treatment with erenumab-aooe injection.

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.