Emgality is a monthly subcutaneous injection used to prevent episodic and chronic migraine. Migraine is a condition that causes intense throbbing or pulsating on one side of the head. Migraine may also cause other symptoms such as nausea, vomiting, and sensitivity to light or sound.
Emgality is also approved to treat cluster headache. Cluster headaches are a disorder that causes short, painful headache attacks. Most people have multiple attacks per day, and they can last for weeks to months at a time.
Emgality was approved in 2018 to prevent migraine. It was approved in 2019 as the first calcitonin gene-related peptide (CGRP) antagonist to treat cluster headache. Emgality contains the active ingredient galcanezumab.
According to studies, Emgality decreased migraine and cluster headache attacks. Below are common questions and answers about Emgality and whether it may be a treatment option for you.
How Does It Work?
Emgality is a monoclonal antibody that targets the calcitonin gene-related peptide (CGRP). CGRP causes inflammation and dilation (widening) of blood vessels, which causes pain during headaches and migraines. Levels of CGRP are elevated during migraine and cluster headache attacks. Emgality blocks the CGRP pathway, reducing inflammation and pain.
How Was It Studied for Preventing Migraine?
Episodic migraine
The effect of Emgality on monthly migraine days was studied in people with episodic migraine. People with episodic migraine have less than 15 headache days per month. To be included in these studies, people had to have a diagnosis of migraine and have between 4 to 14 headaches a month. People in these two studies had an average of 9 headache days per month.
People in these studies were between the ages of 18 and 65, with an average age between 41 and 42. The majority were female.
People in these studies were given either Emgality or a placebo each month. Both the people in the study and the people conducting the study did not know who received which medicine. Other medicines to treat a migraine, such as triptans, opioids, NSAIDS, and barbiturates, were allowed. Preventative migraine medicine was not allowed. People in the study completed a daily electronic diary about their headache symptoms.
Chronic migraine
The effect of Emgality on monthly migraine days was studied in people with chronic migraine. People with chronic migraine have at least 15 headache days per month with at least 8 of those being migraine. People in this study had an average of 19 headache days per month.
People in these studies were between the ages of 18 to 65, with an average age of 41. The majority of people were female.
People were given either Emgality or placebo each month. Both the people in the study and the people helping with the study did not know who received which medicine. Acute medicine was allowed as well as both propranolol and topiramate. People in the study completed a daily electronic diary about headache symptoms and their impact.
What Are the Main Benefits Based on Studies for Preventing Migraines?
Episodic migraine
- Fewer headaches and migraines. People taking Emgality had headache days reduced by about 50%. At the beginning of the study, people had an average of 9 headache days per month. In the first study, Emgality reduced monthly headache days by about 4.7 days per month versus 2.8 days with placebo. In the second study, Emgality reduced headache days by 4.3 days per month versus 2.3 days with placebo.
- Fast results. People in the study reported fewer migraines within the first month of treatment.
- The majority of people responded. In the first study, about 62% of people had at least a 50% reduction in monthly headache days. In the second study, 59% had at least a 50% reduction in monthly headache days.
- Improvement in quality of life. People reported an improvement in their daily living. After Emgality, migraines had a less severe impact on their life.
Chronic migraine
- Less monthly headache days. At the start of the study, people had an average of 19 headache days per month. Emgality decreased monthly headache days by about 5 per month versus about 3 with placebo.
- Fewer hours with headaches. Monthly hours spent with headaches decreased by about 36 hours with Emgality versus 14 hours with placebo.
- Better quality of life. Those taking Emgality reported an improvement in quality of life due to fewer days and hours spent with headaches.
- Greater than 50% reduction in headaches. Twenty-eight percent of people taking Emgality had a 50% or greater reduction in headaches compared to 15% with placebo.
How Was It Studied for the Treatment of Cluster Headache?
The change in the weekly amount of cluster headaches was studied. To be included, people had to have a history of cluster headaches with at least one attack every other day, with at least four total attacks but no more than eight attacks per day. People in this study had an average of 17.5 attacks per week.
People in these studies were between the ages of 18 and 65, with an average age of 46. The majority were male.
People were given either 300 milligrams of Emgality or a placebo. Both the people in the study and the people conducting the study did not know who received which medicine. Acute medicine was allowed but preventative medicine was not. People in the study completed a daily electronic diary about their headaches and how it impacted their life.
What Are the Main Benefits Based on Studies for Treatment of Cluster Headaches?
- Weekly cluster attacks reduced by 52%. During weeks 1 to 3 following treatment with Emgality, people had an average of 8.7 fewer attacks per week. Those who received placebo had about five fewer attacks per week.
- The majority had at least a 50% reduction in cluster headaches. Seventy-one percent of people taking Emgality had at least a 50% reduction in attacks. People taking placebo had a 53% reduction in cluster headache attacks.
How Do I Use It?
The pen and the syringe should be stored in the refrigerator. It should be taken out of the refrigerator at least 30 minutes before you plan to inject it. It can be left out of the refrigerator for up to 7 days. After 7 days, the injection is no longer usable.
The pen and syringe can be used to inject the drug into the thigh, belly area, upper arm, or buttocks. Only health care providers or caregivers should give the injection in the upper arm area or buttocks. Do not inject into areas that are tender, bruised, red, or hard. If you are giving more than one injection, you must use two different sites.
How to Use the Prefilled Pen for Migraine Prevention
The first time you use Emgality, you will use two pens. Then you will use one pen monthly.
- Take it out of the refrigerator and leave it out at room temperature for at least 30 minutes. Do not warm by using a heat source such as hot water or a microwave.
- Do not shake the product.
- Wash your hands.
- Inspect the pen. Discard the pen if it appears cloudy, discolored, or has particles floating in it. It may appear clear, slightly yellow, or slightly brown.
- Clean the injection site with alcohol and let it dry.
- Make sure the pen is in the locked position and twist off the base cap.
- Place the pen on the injection site.
- Unlock the pen and press down on the teal button. Hold it down for at least 10 seconds. You may hear two clicks; keep holding. The gray plunger will be visible when the injection is complete.
- Safely throw the pen away in a sharps container.
- Report any issues to your health care provider.
How to Use the Prefilled Syringe for Migraine Prevention
The first time you use Emgality, you will use two syringes. Then you will use one syringe monthly.
- Take it out of the refrigerator and leave it out at room temperature for at least 30 minutes. Do not warm by using a heat source such as hot water or a microwave.
- Do not shake the product.
- Wash your hands
- Inspect the syringe. Discard the syringe if it appears cloudy, discolored, or has particles floating in it. It may appear clear, slightly yellow, or slightly brown.
- Clean the injection site with alcohol and let it dry.
- Pull off the needle cap and throw it away.
- Gently pinch and hold your skin at the injection site.
- Insert the needle at a 45-degree angle.
- Slowly push the plunger all the way down.
- Remove the needle from your skin and safely throw it away in a sharps container.
- Report any issues to your health care provider.
How to Use the Prefilled Syringe for Cluster Headaches
To treat cluster headaches, Emgality is given as three 100-milligram injections at the start of the cluster headache period and then every month until the end of the cluster period.
- Take it out of the refrigerator and leave it out at room temperature for at least 30 minutes. Do not warm by using a heat source such as hot water or a microwave.
- Do not shake the product.
- Wash your hands.
- Inspect the syringe. Discard the syringe if it appears cloudy, discolored, or has particles floating in it. It may appear clear, slightly yellow, or slightly brown.
- Clean the injection site with alcohol and let it dry.
- Pull off the needle cap and throw it away.
- Gently pinch and hold your skin at the injection site.
- Insert the needle at a 45-degree angle.
- Slowly push the plunger all the way down.
- Remove the needle from your skin and safely throw it away in a sharps container.
- Repeat the steps with the other two syringes at different sites.
- Report any issues to your health care provider.
How Long Does It Take to Work?
In studies, some people began to see a decrease in headaches and migraines within the first month of treatment. It may take several months for Emgality to decrease your headaches. Talk to your health care provider if you do not notice an improvement in 3 months.
How Can I Prevent and Manage Side Effects?
The most common side effect seen in clinical studies is injection site reactions. These include pain, itching, redness, and swelling at the site where the injection was given. You can apply a cool compress or ice pack to help reduce swelling. Your pharmacist may recommend an OTC pain reliever or an antihistamine like Benadryl for itching. Injection sites should be rotated to help reduce irritation. This means that every time you inject the medicine, you should use a different injection site to avoid repeated use of the same area.
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
How Long Does It Stay in My System?
It takes about 4 to 5 months for Emgality to leave your body. It is not known if Emgality could affect pregnancy. Notify your health care provider If you are pregnant or planning on becoming pregnant. If you become pregnant while taking Emgality, you can join the pregnancy registry by visiting www.migrainepregnancyregistry.com or calling 833-464-4724.
What Do I Need to Do to Get It?
Emgality requires a prescription from a health care provider. A neurologist or migraine specialist can prescribe Emgality. Your insurance may require a prior authorization, which means your health care provider must provide information to the insurance company about why you need the medicine so that it will be covered. Your health care provider will work with your insurance to get Emgality covered for you. It is available at retail and mail-order pharmacies.
Is There Any Cost Assistance Available?
Eligibility depends on your current medical and prescription coverage.
There is a savings program that can help with out-of-pocket costs for commercially insured people or those without insurance. You may pay as little as $0 for each dose for up to 12 months. Visit www.Emgality.com/savings or call 833-364-2548.
If you have questions about cost, insurance, or any other questions about Emgality, contact the manufacturer at 833-364-2548.
