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SAFETY SUMMARY

Warnings -

Do not use Emgality if you are allergic to galcanezumab-gnlm or any of the ingredients in Emgality.
Emgality may cause allergic reactions, such as itching, rash, hives, and trouble breathing. Allergic reactions can happen days after using Emgality. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, which may be part of an allergic reaction: swelling of your face, mouth, tongue, or throat, or trouble breathing.

Common side effects

The most common side effects of Emgality are injection site reactions.

These are not all the possible side effects of Emgality. Tell your doctor if you have any side effects.

You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch .

Before using

Before you use Emgality, discuss these questions with your doctor:

❑ Do you have other medical conditions?

❑ Do you take other medicines? Tell your doctor about all the prescription and over-the-counter drugs, vitamins, and herbal supplements you take.

Tell your doctor if:

❑ You are pregnant or breastfeeding.

❑ Pregnancy Registry: There is a pregnancy registry for women who take EMGALITY. The purpose of this registry is to collect information about the health of you and your baby. You may enroll yourself by calling 1-833-464-4724 or by visiting www.migrainepregnancyregistry.com or you may talk to your healthcare provider about how you can take part in this registry.

❑ You are under age 18. It is not known if Emgality is safe and effective in children.

How to take

  • Read the Instructions for Use that come with Emgality. There you will find information about how to store, prepare, and inject Emgality.
  • Use Emgality exactly as your doctor says.
  • If you miss a dose, inject it as soon as possible. Then do the following:
    • For migraine: Continue to take Emgality monthly from the date of your last dose.
    • For episodic cluster headache: If your cluster period has not ended, inject Emgality one month after your last dose to get back on a monthly dosing schedule.

Learn more

Emgality is a prescription medicine. For more information, call 1-833-EMGALITY (1-833-364-2548).

This summary provides basic information about Emgality, but does not include all information known about this medicine. Read the information that comes with your prescription every time you have a prescription filled. This information does not take the place of talking to your doctor. Be sure to talk to your doctor or other healthcare provider about Emgality and how to take it. Your doctor is the best person to help you decide if Emgality is right for you.

GZ CON COMBO BS 14SEP2022

Please see Instructions for Use that come with the device.

INDICATIONS

Emgality® (em-GAL-it-e¯ ) is used in adults for:

  • The preventive treatment of migraine. The medicine (120 mg) comes in a prefilled pen or syringe and is taken once a month.
  • The treatment of episodic cluster headache. The medicine (300 mg) comes in three (100 mg) prefilled syringes, which are taken one after the other at the start of a cluster period and then every month until the end of the cluster period.