Emgality
Pronunciation: em-GAL-it-ē
Generic name: galcanezumab [ GAL-ka-NEZ-ue-mab ]
Dosage forms: prefilled pen (120 mg/mL), prefilled syringe (100 mg/mL, 120 mg/mL)
Drug class: CGRP inhibitors
What is 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.
Emgality side effects
Common side effects of Emgality may include:
- pain;
- redness;
- itching;
- irritation where the medicine was injected.
Serious side effects of Emgality
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.
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 FDA at 1-800-FDA-1088.
Related/similar drugs
Qulipta, prednisone, propranolol, topiramate, Botox, Depakote, sumatriptan
Warnings
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.
Before taking this medicine
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 risk.
How should I use Emgality?
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. A healthcare provider may teach you how to properly use the medication by yourself.
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.
Dosing information
Usual Adult Emgality Dose for Migraine Prophylaxis:
Initial dose: 240 mg subcutaneously once
Maintenance dose: 120 mg subcutaneously monthly
Comments:
-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)
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Emgality?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect Emgality?
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.
Storage
- 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.
Ingredients
Active ingredient: galcanezumab-gnlm
Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, Polysorbate 80, Sodium Chloride, and Water for Injection, USP.
Company
Eli Lilly and Company Indianapolis, IN 46285, US.
Popular FAQ
Weight gain is not listed as a side effect in the product information for Emgality (galcanezumab) and phase 3 studies reported that there was no difference in the amount of weight gained between people taking Emgality and those assigned placebo (an inactive treatment). Anecdotally, however, some people have reported gaining weight. Continue reading
When Emgality (galcanezumab) is administered to prevent migraine, it starts working within one month of initiation, but it may take up to five or six months for the full effects of Emgality to be seen. When Emgality is administered for the treatment of cluster headache, it starts working within one week of starting treatment, but it may take up to three weeks for the full effects to be seen. Continue reading
Yes, Emgality injections may hurt. Pain at the injection site is one of the most common side effects reported with Emgality, with 18% of people experiencing it. Some people also experience excessive amounts of pain with Emgality with comments on blog sites stating "It was one of the most painful things I've ever felt" and "Thigh, thigh, then arm, all were unreal painful....coming from the girl who falls asleep and takes naps during 6hr tattoo sessions". Continue reading
Emgality (galcanezumab) works by blocking the effect of a protein, called CGRP (calcitonin gene-related peptide) which is involved in pain transmission. Emgality binds to CGRP and prevents it from interacting with the CGRP receptor. Continue reading
Injection site reactions are the most common side effect of Emgality, affecting around 18% of people. People have reported feeling pain or itching at the injection site, or other symptoms such as mild or temporary redness, bruising, or swelling. Emgality injections can hurt and some people appear to experience excessive amounts of pain with Emgality and other CGRP inhibitors, according to postings on blog sites. Some liken the shot to a bee made of lead traveling at 100mph, and punching you with its stinger, or describe the pain as horrific. Continue reading
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