Medically reviewed on Oct 1, 2018
Generic Name: galcanezumab-gnlm
Dosage Form: Injection, for Subcutaneous Use
Date of Approval: September 27, 2018
Company: Eli Lilly and Company
Treatment for: Prevention of Migraine
FDA Approves Emgality
The U.S. Food and Drug Administration (FDA) has approved Emgality (galcanezumab-gnlm), a calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of migraine in adults.
Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is Emgality?
Emgality is a prescription medicine used for the preventive treatment of migraine in adults.
It is not known if this medicine is safe and effective in children.
Who should not use Emgality?
Do not use this medicine if you are allergic to galcanezumab-gnlm or any of the other ingredients. See the end of this Patient Information for a complete list of ingredients.
Before using Emgality
Before you start treatment, tell your healthcare provider if you:
- are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk.
Talk to your healthcare provider about the best way to feed your baby during treatment.
Tell your healthcare provider about all the medicines you take, including prescription and overthe-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 leaflet that comes with your prescription for information about the correct use of this medicine.
- Use this medicine exactly as your healthcare provider tells you to.
- Emgality is given by injection under the skin (subcutaneous injection).
- Your healthcare provider should show you or a caregiver on how to prepare and inject your dose the right way before you start to use it.
- Emgality comes in two different types of devices: a single-dose (1 time) prefilled pen or 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.
- Inject your dose of Emgality one time each month.
- For the first dose (loading dose), you will get two separate injections one time. You will need two prefilled pens or two prefilled syringes for your first dose (one-time loading dose).
- You will need one prefilled pen or one prefilled syringe for your regular monthly dose.
- Inject the dose in your stomach area (abdomen), thigh, back of the upper arm, or buttocks.
- If you miss a dose, inject the missed dose as soon as possible. Then, inject Emgality one month after your last dose to get back on a monthly dosing schedule. If you have questions about your schedule, ask your healthcare provider.
Emgality side effects
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 you inject your dose. 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 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. 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.
How should I store Emgality?
- Store Emgality in the refrigerator between 36°F to 46°F (2°C to 8°C).
- The injections 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 back in the refrigerator. Do not store above 86°F (30°C).
- Do not freeze.
- Keep the injection in the carton it comes in to protect it from light until time of use.
- Do not shake.
- Throw away Emgality if any of the above conditions are not followed.
Keep all medicines out of the reach of children.
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 this medicine for a condition for which it was not prescribed. Do not give it 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 that is written for health professionals.
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.
The prefilled pen and prefilled syringe are not made with natural rubber latex.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.