galcanezumab

What is the most important information I should know about galcanezumab?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is galcanezumab?

Galcanezumab is used to prevent migraine headaches in adults.

Galcanezumab is also used to treat cluster headache episodes in adults.

Galcanezumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using galcanezumab?

Tell your doctor if you are pregnant. It is not known whether this medicine will harm an unborn baby. However, having migraine headaches during pregnancy may cause preeclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of preventing migraines may outweigh any risks to the baby.

How should I use galcanezumab?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Galcanezumab is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

For prevention of migraine headaches: Galcanezumab is usually given as a first dose of 2 injections, followed by 1 injection once per month.

For treatment of a cluster headache episodes: Galcanezumab is usually given as 3 injections at the start of the cluster period, followed by 1 injection once per month until the end of the cluster period.

Follow your doctor's dosing instructions very carefully.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not warm the medicine with hot water, sunlight, or a microwave.

Each prefilled syringe or pen is for one use only. Throw it away after one use, even if there is still medicine left inside.

What happens if I miss a dose?

Use the medicine as soon as you remember, and then restart your regular injection schedule 1 month later. Do not use two doses at one time to make up a missed dose.

What happens if I overdose?

What should I avoid while using galcanezumab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of galcanezumab?

An allergic reaction to galcanezumab can occur several days after an injection.

Common side effects may include:

• pain, redness, itching, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect galcanezumab?

Other drugs may affect galcanezumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about galcanezumab.