Galcanezumab-gnlm injection is used to help prevent migraine headaches (severe, throbbing headaches that sometimes are accompanied by 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 headaches.

Galcanezumab-gnlm injection comes as a solution (liquid) in a prefilled syringe and a prefilled injection pen to be injected subcutaneously (under the skin). When galcanezumab-gnlm injection is used to prevent a migraine, it is usually given as 2 separate injections with a prefilled injection pen or a prefilled syringe given one after the other for the first dose and then 1 injection once a month. When galcanezumab-gnlm injection is used to treat a cluster headache, it is usually given as 3 separate injections with a prefilled syringe given one after the other for the first dose and then 1 injection once a month. Use galcanezumab-gnlm injection at around the same day every 1 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 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.

Galcanezumab-gnlm injection comes as a prefilled syringe and as a prefilled injection pen. Allow the syringe or injection pen 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 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.

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.

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.

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.

Before using galcanezumab-gnlm injection,

• tell your doctor and pharmacist if you are allergic to galcanezumab-gnlm injection, any other medications, or any of the ingredients in galcanezumab-gnlm injection. Ask your pharmacist for a list of the ingredients.
• 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 are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using galcanezumab-gnlm injection, call your doctor.

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.

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.

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.

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.

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

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
• shortness of breath
• hives
• itching
• swelling of the face, eyes, mouth, throat, tongue, or lips

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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

Keep all appointments with your doctor.

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.

• Emgality®