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Dosing During a Cluster Cycle

Experience once-monthly dosing during an episodic cluster headache cycle

Take Emgality 300 mg at the beginning of your cluster headache cycle.

One 300 mg dose of Emgality comes in 3 prefilled syringes.

At the beginning of your cluster headache cycle, take 1 dose (3 syringes) of Emgality and then continue monthly until the end of your cluster cycle.

  • One dose (300 mg) comes in 3 prefilled syringes

  • Administer the 3 injections (100 mg each) one after the other

  • Continue to take monthly until the end of the cluster cycle

Select Safety Information

Do not use Emgality if you are allergic to galcanezumab-gnlm or any of the
ingredients in Emgality

How to Inject

Prior to injecting, choose an area for injection: the abdomen or thigh if self-injecting, or buttocks or back of upper arm if another person is injecting. Be sure not to inject in the exact same spot each time. Always clean the injection site with an alcohol wipe and let it dry before injecting.

uncap

1. Uncap the pen

2. Gently pinch and hold a fold of skin and insert the needle at a 45-degree angle

3. Inject slowly until the gray syringe plunger is pushed to the needle end of the syringe

IMPORTANT: These are the abbreviated steps for using the prefilled syringe. When injecting Emgality, please refer to the Instructions for Use that comes with your prefilled syringe.

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

Visit the following link: Instructions for Use 100 mg Syringe for Episodic Cluster Headache.

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.

Watch this video to learn how to inject Emgality 300 mg

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

  • 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

IMPORTANT: These are not the complete instructions for using your device. Please see Instructions for Use that comes with your device or visit Emgality.com.

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

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-ē) 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.