Emgality

Emgality is a prescription medicine used to prevent migraines and treat episodic cluster headaches in adults. Emgality can help reduce the number of migraine days per month and reduce the number of cluster headache attacks each week.

Emgality is calcitonin-gene related peptide antagonist. Emgality works by blocking a protein called calcitonin-gene related peptide (CGRP) which is involved in migraines and episodic cluster headaches, blocking CGRP helps reduce migraines and cluster headaches.

Emgality is given as a monthly injection under the skin (subcutaneous injection) using a single-dose prefilled pen or a single-dose prefilled syringe after the first loading dose.

Emgality received FDA approval on September 27, 2018, for the preventive treatment of migraine in adults, then on June 4, 2019, it received FDA approval for the treatment of episodic cluster headaches in adults.

Use Emgality exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Emgality is injected under the skin (subcutaneously). Your doctor or nurse will show you how to give yourself Emgality injections correctly, including how to keep things clean and sterile and how to use the prefilled pen or syringe. Make sure you read the Instructions for Use leaflet every time you give yourself an injection.

For prevention of migraine headaches: Emgality is usually given as a first dose of 2 injections, followed by 1 injection once per month.

For treatment of cluster headache episodes: Emgality is usually given as 3 injections at the start of the cluster period, followed by 1 injection once per month until the end of the cluster period.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all the instructions.

Prepare an injection only when you are ready to give it. Do not use the injection if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Take a syringe or injection pen out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not warm the syringe with hot water, sunlight, or a microwave.

Inject under the skin (subcutaneously) into the abdomen, thigh, or back of the upper arm or buttocks.

Avoid injecting into skin that is hard, red, bruised, or tender.

Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.

You should not use Emgality if you are allergic to galcanezumab.

Emgality is not approved for use by anyone younger than 18 years old.

Tell your doctor if you are pregnant. It is not known whether galcanezumab will harm an unborn baby. However, having migraine headaches during pregnancy may cause preeclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of preventing migraines may outweigh any risks to the baby.

It may not be safe to breast-feed while using galcanezumab. Ask your doctor about any risks.

Common side effects

The most common side effects of Emgality are:

• pain;
• redness;
• itching;
• irritation where the medicine was injected.

Serious side effects and warnings

Constipation with serious complications

Emgality can cause severe constipation with serious complications. Contact your doctor straight away if you experience severe constipation while taking Emgality.

High blood pressure

Emgality can cause high blood pressure or make existing high blood pressure worse. Contact your doctor if you notice your blood pressure has increased.

Raynaud's phenomenon

Emgality can cause or worsen Raynaud's phenomenon, a condition where fingers and toes become numb, cold, or change colour in response to cold or stress. Stop taking Emgality and contact your doctor straight away if you develop these symptoms.

Pregnancy

If you become pregnant while taking Emgality, you are encouraged to enrol in a pregnancy registry that monitors the health outcomes of babies born to mothers who took Emgality during pregnancy. Ask your doctor for details.

Allergic reactions

Emgality can cause allergic (hypersensitivity) reactions. Get emergency medical help if you have signs of an allergic reaction to Emgality: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. An allergic reaction to the active ingredient galcanezumab can occur several days after an injection.

Notes:

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Emgality Dose for Migraine Prophylaxis:

Initial dose: 240 mg subcutaneously onceMaintenance dose: 120 mg subcutaneously monthlyComments:-The first dose is a loading dose consisting of 2 consecutive subcutaneous injections of 120 mg each.-If a dose is missed, administer as soon as possible. Thereafter, dose can be scheduled from the date of the last dose.

Usual Adult Emgality Dose for Cluster Headache:

Initial Dose: 300 mg (three consecutive subcutaneous injections of 100 mg each) at the onset of the cluster period.Maintenance Dose: 300 mg subcutaneously once a month until the end of the cluster period.

Comments:

-Each dose is administered as 3 consecutive subcutaneous injections of 100 mg each.-This drug is to be injected once a month for the length of a cluster period which may extend from several weeks to months.-If a dose is missed, administer as soon as possible. Thereafter, dose can be scheduled monthly from the date of the last dose.

Emgality injection is available as

• single-dose prefilled pen (120 mg/mL solution)
• single-dose prefilled syringe (120 mg/mL solution)
• single-dose prefilled syringe (100 mg/mL solution)

Use the medicine as soon as you remember, and then restart your regular injection schedule 1 month later. Do not use two doses at one time to make up a missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with galcanezumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

• Store in the refrigerator between 36°F to 46°F (2°C to 8°C).
• 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 the injection back in the refrigerator.Do not freeze.Keep injections in the carton it comes in to protect it from light until the time of use.Do not shake
• Throw away any injections if any of the above conditions are not followed.

Active ingredient: galcanezumab-gnlm

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

Eli Lilly and Company Indianapolis, IN 46285, US.