Emgality

Generic name: galcanezumab
Drug class: CGRP inhibitors

Medically reviewed by A Ras MD.

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.

Description

Galcanezumab-gnlm is a humanized IgG4 monoclonal antibody specific for calcitonin-gene related peptide (CGRP) ligand. Galcanezumab-gnlm is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Galcanezumab-gnlm is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight of approximately 147 kDa.

EMGALITY (galcanezumab-gnlm) injection is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution, for subcutaneous use. EMGALITY is supplied in a 1 mL single-dose prefilled pen to deliver 120 mg of galcanezumab-gnlm or a 1 mL single-dose prefilled syringe to deliver 100 mg or 120 mg of galcanezumab-gnlm. Each mL of solution contains 100 mg or 120 mg of galcanezumab-gnlm; L-histidine (0.5 mg); L-histidine hydrochloride monohydrate (1.5 mg); Polysorbate 80 (0.5 mg); Sodium Chloride (8.8 mg); Water for Injection, USP. The pH range is 5.3 – 6.3.

Mechanism of Action

Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

Who should not take Emgality?

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

What should I tell my healthcare provider before taking 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.
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 take Emgality?

Your healthcare provider will prescribe the type that is best for you.

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
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

Label

PACKAGE CARTON – EMGALITY Prefilled Syringe 120 mg

NDC 0002-2377-11
EMGALITY®
(galcanezumab-gnlm) injection
120 mg/mL
1x 120 mg/mL Single-Dose prefilled syringe
For Subcutaneous Use Only
Single-Dose Only
Lilly
Rx only

PACKAGE CARTON – EMGALITY Prefilled Syringe 100 mg

NDC 0002-3115-09
EMGALITY®
(galcanezumab-gnlm)
100 mg/mL injection
All 3 syringes must be administered to receive the 300 mg dose.
3 x 100 mg/mL Single-Dose prefilled syringe
For Subcutaneous Use Only
Single-Dose Only
Rx only
Lilly

SRC: NLM .

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