Eptinezumab is used to prevent migraine headaches in adults.

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

Before using eptinezumab tell your doctor about all your medical conditions or allergies, all medicines you use, and if you are pregnant or breastfeeding.

Eptinezumab is given as an infusion into a vein. A healthcare provider will give you this injection.

Eptinezumab is usually given once every 3 months.

This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

Usual Adult Dose for Migraine Prophylaxis:

Initial dose: 100 mg via IV infusion every 3 months
Maintenance dose: 100 mg or 300 mg via IV infusion every 3 months.

Comments:
-Some patients may benefit from the higher dose (300 mg every 3 months).
-See administration advice for infusion administration instructions.

Use: For the preventative treatment of migraine in adults

You should not be treated with eptinezumab if you are allergic to eptinezumab, polysorbate 80, or sorbitol.

Tell your doctor about all your medical conditions or allergies.

Tell your doctor if you are pregnant or breastfeeding.

It is not known whether eptinezumab will harm an unborn baby. However, having migraine headaches may cause complications during pregnancy such as 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.

Call your doctor for instructions if you miss an appointment for your eptinezumab injection.

Since eptinezumab is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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

Get emergency medical help if you have signs of an allergic reaction: hives, rash; sudden warmth or tingling; difficult breathing; redness or swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel warm, itchy, or light-headed.

Common side effects of eptinezumab may include:

• stuffy nose;

• throat irritation; or

• allergic reaction.

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.

Other drugs may affect eptinezumab, 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.