Emgality comes in an easy-to-use, self-injectable pen that can be used once a month in the comfort of your home

Emgality is for adults only. For patients with migraine, your first dose will be a loading dose of 240 mg, or 2 injections of 120 mg each, which may be administered in your doctor’s office, or on your own. After that, you can inject just 1 dose, or injection, on your own each month to help prevent migraine.

In a study, 94% of people agreed that the Emgality Pen was easy to use at first use

And 96% of people were confident in their ability to use the Emgality Pen

Once-monthly Emgality is designed to help prevent migraine all month long

Select Safety Information

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

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Emgality.

See how Amanda fought to be present for her family and how Emgality worked for her

Join Amanda on her journey

3 basic steps to inject with the Emgality Pen

Before you inject for the first time, your healthcare provider should show you how to prepare and inject Emgality.

Leave the pen at room temperature for 30 minutes before injecting. Wash your hands, select an injection site, clean it with an alcohol wipe, and let it dry before you inject. Inspect the pen and the medicine. Make sure the pen is locked and the base cap is on until you inject.

1. Uncap the pen

Twist off base cap and throw it away. Do not put the base cap back on, as this could damage the needle. Do not touch the needle.

2. Place and unlock

Place the clear base flat and firmly at the injection site and unlock the pen.

3. Press, hold, and listen

Press and hold the teal button. Listen for a loud click. Keep holding the pen against your skin. After about 10 seconds, you will hear a second click. That means the full dose has been delivered.

IMPORTANT: These are not the complete instructions for using the Pen. Please see Instructions for Use that comes with your device or visit the following links: Pen or 120 mg Syringe

For migraine, a 120 mg prefilled syringe is also available. Talk to your doctor about which type of device is right for you.

The most common side effects of Emgality were injection site reactions such as pain, redness, and itching. In a clinical study, less than 2% of people discontinued Emgality due to injection site reactions.

Watch this video to learn how to inject Emgality

Prescribing Information

Patient Information

Instructions for Use - 120 mg Pen for migraine

When taking Emgality, please remember:

Before you inject for the first time, your healthcare provider should show you how to prepare and inject Emgality
Store your pen in the refrigerator between 36°F to 46°F (2°C to 8°C)
Leave the pen (with the cap on) at room temperature for 30 minutes before injecting
Do not microwave the pen, run it under hot water, shake it, freeze it, or leave it in direct sunlight
You can inject in your abdomen (at least 2 inches away from belly button) or front of thighs (at least 2 inches above the knee and 2 inches below the groin). Another person can inject in the back of your arm or buttocks
Rotate the injection site

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.