Galcanezumab-gnlm Injection

WHY is this medicine prescribed?

Galcanezumab-gnlm injection is used to help prevent migraine headaches (severe, throbbing headaches that may cause nausea and sensitivity to sound or light). It is also used to treat the symptoms of a cluster headache (severe headaches usually on one side of the head or around one eye). Galcanezumab-gnlm 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 and cluster 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?

Galcanezumab-gnlm injection comes as a solution (liquid) in a prefilled syringe and a prefilled injection pen to be injected subcutaneously (under the skin). For the first dose, it is given as 2 or 3 separate injections, one after the other, based on your condition. After that, it is given as 1 injection once a month. Use galcanezumab-gnlm 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 galcanezumab-gnlm 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 caregiver how to inject the medication.

Removethe syringe or injection pen from the refrigerator. Place on a flat surface away fromdirect sunlight. Do not remove the needle cover. Allow the syringe or injection pen to warm to room temperature for 30 minutes before you inject the medication. 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.

Always look at galcanezumab-gnlm solution before you inject it. It should be a clear to colorless to slightly yellow or slightly brown solution. Do not use galcanezumab-gnlm injection, if it is cloudy or contains flakes or solid particles. Do not shake it.

Inject galcanezumab-gnlm into the thigh, back of the upper arm, buttocks, or stomach area. Do not inject into an area where the skin is tender, thick, bruised, red, scaly, or hard.

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

Galcanezumab-gnlm injection helps to prevent migraines but does not cure them. Continue to inject galcanezumab-gnlm injection even if you feel well. Do not stop using galcanezumab-gnlm 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 galcanezumab-gnlm 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 galcanezumab-gnlm 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?

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

• pain, swelling, or redness at the site of injection

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

• rash; hives; itching; difficulty breathing; shortness of breath; or swelling of the face, eyes, mouth, throat, tongue, or lips
• numb, cold, painful, or discolored fingers or toes

Galcanezumab-gnlm 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 in the container it came in, tightly closed, and out of reach of children. 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.

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 duringyour treatment with galcanezumab-gnlm 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.