Emgality

Generic name: galcanezumab-gnlm

Reviewed by Medicine.com on June 29, 2022

What is Emgality?

Emgality is a prescription medicine used in adults for the:

preventive treatment of migraine.
treatment of episodic cluster headache.

It is not known if Emgality is safe and effective in children.

Who should not use Emgality?

Do not use Emgality if you are allergic to galcanezumab-gnlm or any of the ingredients in Emgality. See below for a complete list of ingredients in Emgality.

What should I tell my healthcare provider before using Emgality?

Before you use Emgality, tell your healthcare provider if you:

are pregnant or plan to become pregnant. It is not known if Emgality will harm your unborn baby.
- 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.
are breastfeeding or plan to breastfeed. It is not known if Emgality passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using Emgality.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Emgality?

See the Instructions for Use that come with Emgality prefilled pen or prefilled syringe about how to use Emgality the right way.
Use Emgality exactly as your healthcare provider tells you to.
Emgality is given by injection under the skin (subcutaneous injection).
Inject Emgality in your stomach area (abdomen), thigh, back of the upper arm, or buttocks.
Your healthcare provider should show you or a caregiver how to prepare and inject Emgality the right way before you start to use it.
Emgality comes in 2 different types of devices:
- a single-dose (1 time) prefilled pen
- a single-dose (1 time) prefilled syringe
  Your healthcare provider will prescribe the type that is best for you.
If you have questions about injecting the medicine, talk to your pharmacist or healthcare provider.
If you are using the Emgality 120 mg prefilled pen or prefilled syringe for migraine:
- Inject Emgality 1 time each month.
- For the first dose (loading dose), you will get 2 separate injections one time, right after each other. You will need 2 prefilled pens or 2 prefilled syringes for your first dose (1-time loading dose).
- For your regular monthly dose, you will get 1 injection. You will need 1 prefilled pen or 1 prefilled syringe for your regular monthly dose.
- If you miss a dose of Emgality, inject the missed dose as soon as possible. Then inject Emgality 1 month from the date of your last dose to get back on a monthly dosing schedule. If you have questions about your schedule, ask your healthcare provider.
If you are using the Emgality 100 mg prefilled syringe for episodic cluster headache:
- You will get 3 separate injections, right after each other, using 3 prefilled syringes for each of your doses.
- Use Emgality at the start of a cluster period and then every month until the end of the cluster period.
If you miss a dose of Emgality, inject the missed dose as soon as possible. Then, if the cluster headache period has not yet ended, inject Emgality 1 month after your last dose to get back on a monthly dosing schedule. If you have questions about when you should use Emgality, ask your healthcare provider.

What are the possible side effects of Emgality?

Emgality may cause serious side effects, including:

Allergic reactions. Allergic reactions, including itching, rash, hives, and trouble breathing, can happen after receiving Emgality. This 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 the face, mouth, tongue, or throat
- trouble breathing

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 that does not go away.
These are not all of the possible side effects of Emgality. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Emgality

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information. Do not use Emgality for a condition for which it was not prescribed. Do not give Emgality to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Emgality that is written for health professionals.

How should I store Emgality?

Store Emgality in the refrigerator between 36°F to 46°F (2°C to 8°C).
Emgality may be stored out of the refrigerator in the original carton at temperatures up to 86°F (30°C) for up to 7 days. After storing out of the refrigerator, do not place Emgality back in the refrigerator.
Do not freeze Emgality.
Keep Emgality in the carton it comes in to protect it from light until time of use.
Do not shake Emgality.
Throw away Emgality if any of the above conditions are not followed.

Keep Emgality and all medicines out of the reach of children.

What are the ingredients in Emgality?

Active ingredient: galcanezumab-gnlm

Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, Polysorbate 80, Sodium Chloride, and Water for Injection, USP.

Emgality prefilled pen and prefilled syringes are not made with natural rubber latex.

For more information, call 1-833-EMGALITY (1-833-364-2548) or go to www.emgality.com.

Instructions for use for Emgality

Emgality (em-GAL-it-ē)
(galcanezumab-gnlm)
injection, for subcutaneous use

Emgality pre-filled syringe (teal ) for migraine
Emgality pre-filled syringe (coral) for episodic cluster headaches
Emgality pre-filled pen for migraine

Instructions For Use For Emgality Pre-Filled Syringe (Teal) For Migraine

picture of syringe.image

This Instructions for Use is for patients with migraine.

If you are using Emgality for episodic cluster headache, there is a different Instructions for Use because the dose and number of syringes needed is different.

For subcutaneous injection only.

Before you use the Emgality prefilled syringe, read and carefully follow all the step-by-step instructions.

Important Information

Your healthcare provider or nurse should show you how to prepare and inject Emgality using the prefilled syringe. Do not inject yourself or someone else until you have been shown how to inject Emgality.
Keep this Instructions for use and refer to it as needed.
Each Emgality prefilled syringe is for one-time use only. Do not share or reuse your Emgality prefilled syringe. You may give or get an infection.
Your healthcare provider may help you decide where on your body to inject your dose. You can also read the “Choose your injection site” section of these instructions to help you choose which area can work best for you.
If you have vision problems, do not use Emgality prefilled syringe without help from a caregiver.
See “Storage and handling information” for important storage information.

Parts of the Emgality Prefilled Syringe

parts of the syringe.image

Before You Get Started

Take the Prefilled Syringe from the refrigerator

Check your prescription.

Emgality comes as a single-dose prefilled syringe.
You will need 2 prefilled syringes for your first dose (1-time loading dose). You will need 1 prefilled syringe for your monthly dose.

Put the original package with any unused syringes back in the refrigerator.
Leave the needle cap on until you are ready to inject.
Leave the prefilled syringe at room temperature for 30 minutes before injecting.
Do not microwave the prefilled syringe, run hot water over it, or leave it in direct sunlight.
Do not shake.

Gather Supplies

For each injection you will need:

1 alcohol wipe
1 cotton ball or piece of gauze
1 sharps disposal container. See “After you inject your medicine.”

Inspect the Prefilled Syringe and the medicine

Make sure you have the right medicine. The medicine inside should be clear. Its color may be colorless to slightly yellow to slightly brown.

Do not use the prefilled syringe, and throw away (dispose of) as directed by your healthcare provider or pharmacist if:

it looks damaged
the medicine is cloudy, is discolored, or has small particles
the expiration date (Exp.) printed on the label has passed
the medicine is frozen

check the expiration date on the syringe.image

Prepare for injection

Wash your hands with soap and water before you inject your Emgality. Make sure a sharps disposal container is close by.

Choose your injection site

Your healthcare provider can help you choose the injection site that is best for you.

You may inject the medicine into your stomach area (abdomen). Do not inject within 2 inches of the belly button (navel).
You may inject the medicine into the front of your thighs. This area should be at least 2 inches above the knee and 2 inches below the groin.
Another person may give you the injection in the back of your upper arm, or buttocks.
Do not inject in the exact same spot. For example, if you are giving 2 injections for your first dose (1-time loading dose) and want to use the same body site for the two separate injections, choose a different injection spot. If your first injection was in your abdomen, your next injection could be in another area of your abdomen.
Do not inject into areas where the skin is tender, bruised, red, or hard.
Clean your injection site with an alcohol wipe. Let the injection site dry before you inject.

1. Uncap

Leave the needle cap on until ready to inject. Pull the needle cap off and throw it away.image

Leave the needle cap on until you are ready to inject.
Pull the needle cap off and throw it away in your household trash.
Do not put the needle cap back on. You could damage the needle or stick yourself by accident.
Do not touch the needle.

2. Insert

Gently pinch and hold a fold of skin where you will inject. Insert the needle at a 45-degree angle.image

Gently pinch and hold a fold of skin where you will inject.
Insert the needle at a 45-degree angle.

3. Inject

Slowly push on the thumb pad to push the plunger all the way in until all the medicine is injected.image

Slowly push on the thumb pad to push the plunger all the way in until all the medicine is injected.
The gray syringe plunger should be pushed all the way to the needle end of the syringe.

You should see the teal plunger rod show through the syringe body when the injection is complete as shown.image

You should see the teal plunger rod show through the syringe body when the injection is complete as shown.
Remove the needle from your skin and gently let go of your skin.
If you have bleeding at the injection site, press a cotton ball or gauze over the injection site. Do not rub the injection site.
Do not put the needle cap back on the prefilled syringe.

After You Inject Your Medicine

After you inject your medicine throw away the syringe in an FDA-cleared sharps disposal container.image

Throw away the used prefilled syringe

Put the used Emgality prefilled syringe in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the Emgality prefilled syringe in your household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
Do not recycle your used sharps disposal container.

Commonly Asked Questions

Q. What if I see air bubbles in my Emgality prefilled syringe?

A. It is normal to have air bubbles in the prefilled syringe. Emgality is injected under your skin (subcutaneous injection), so these air bubbles will not harm you.

Q. What if there is a drop of liquid on the tip of the needle when I remove the needle cap?

A. It is okay to see a drop of liquid on the tip of the needle.

Q. What if I cannot push in the plunger?

A. If the plunger is stuck or damaged:

Do not continue to use the syringe
Remove the needle from your skin
Dispose of the syringe and get a new one

Q. What if there is a drop of liquid or blood on my skin after my injection?

A. This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.

Q. How can I tell if my injection is complete?

A. When your injection is complete:

The teal plunger rod should show through the body of the syringe.
The gray syringe plunger should be pushed all the way to the needle end of the syringe.

If you have more questions about how to use the Emgality prefilled syringe:

Call your healthcare provider
Call 1-833-Emgality (1-833-364-2548)
Visit www.Emgality.com

Storage and Handling Information

Store your prefilled syringe in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC).
Your prefilled syringe may be stored out of the refrigerator in the original carton at temperatures up to 86°F (30°C) for up to 7 days. After storing out of the refrigerator, do not place Emgality back in the refrigerator.
Do not freeze your prefilled syringe.
Keep your prefilled syringe in the carton it comes in to protect it from light until time of use.
Do not shake your prefilled syringe.
Throw away your prefilled syringe if any of the above conditions are not followed.
Keep your prefilled syringe and all medicines out of the reach of children.

Read the full Prescribing Information and Patient Information for Emgality inside this box to learn more about your medicine.

Instructions for use revised 06/2019.