If you have spent any time on the Cluster Headache Support Group (“CHSG”) Facebook page, then you probably have noticed many comments and questions about Eli Lilly and Company’s (“Lilly”) breakthrough episodic cluster headache treatment called Emgality®. Drawing on our members’ experiences as well as information received from The Lilly Answers Center, we have assembled some practical information and tips regarding Emgality® dosing and administration.
What Is Emgality®?
Emgality® (galcanequmab-gnlm) is a preventive treatment for migraine and episodic cluster headache. Emgality® first received FDA approval in September 2018 for the preventive treatment of migraine in adults. FDA approval for the treatment of episodic cluster headache followed in June 2019. To date, it is the only treatment of its kind that is FDA-approved for the prevention of episodic cluster headache. Some physicians are also prescribing Emgality® for off-label use by chronic cluster headache patients.
How Does Emgality® Prevent Cluster Attacks?
A substance in the brain called “calcitonin gene related peptide” (“CGRP”) is believed to play a key role in migraine and cluster headache. Emgality® is a CGRP antibody treatment. This means that Emgality® was specifically developed to block CGRP from binding to its receptor in the brain. The exact mechanism by which this prevents migraine and episodic cluster attacks is beyond the scope of this article, but it is important to understand that this treatment works as a long-term preventive. It is not designed to stop an attack that has already started, and it is not a type of “pain medication”.
How Effective is Emgality®?
Lilly studied Emgality® in a phase 3 randomized, double-blind, placebo-controlled study of episodic cluster headache patients. The study showed that Emgality® was effective in reducing average weekly cluster headache attack frequency throughout a cluster period for adult patients with episodic cluster headache. Emgality® was not studied in chronic cluster headache patients.
Anecdotally, some CHSG members report complete remission of cluster headache symptoms while using Emgality®. Others report shorter cycles, fewer attacks, and/or decreased intensity of attacks. Members using Emgality® who still experience cluster attacks relate that they continue to use other treatments to stop an attack (such as high-flow oxygen or sumatriptan), but share that they need such treatments less frequently or in lower doses.
A frequent question seen in our group is whether other preventive treatments should be continued while using Emgality®. This is a question that can only be answered after consulting with your physician.
How Is Emgality® Prescribed for Cluster Headache?
We often see comments in the group that reflect confusion about the correct dose of Emgality® for the treatment of cluster headache. There are important differences in the way Emgality® is prescribed and administered for migraine versus cluster headache.
For migraine prevention, Emgality® is dispensed in 120 mg auto-injectors. There is an initial loading dose of 240 mg (two auto-injectors) followed by one dose of 120 mg every month thereafter (one auto-injector every month). The migraine dose is also available in a prefilled syringe.
For the prevention of cluster headache, there is no initial loading dose of Emgality®. The cluster headache dose is a single dose of 300 mg, contained in three 100 mg prefilled syringes, every month. That means that you will administer three injections to yourself at the same time, and you will give yourself those three injections once per month for as long as your physician instructs.
Lilly has explained that the single dose of 300 mg once a month was selected for the phase 3 study in episodic cluster headache because it demonstrated efficacy in a prior phase 2 migraine prevention study in which patients received 150 mg every two weeks. Based on data obtained from the migraine study, Lilly’s researchers predicted that a once-monthly 300 mg dose would be effective in preventing episodic cluster headache. Lilly’s phase 3 study of Emgality® in episodic cluster headache patients proved that they were correct.
Are You Getting the Right Dose of Emgality®?
We see frequent reports from CHSG members that they are starting Emgality®, but they have been prescribed the migraine dose rather than the dose that Lilly developed in the episodic cluster headache study. There may be good reasons why a physician prescribes the migraine dose, but it is critically important to talk your physician so that you understand why you are not prescribed the cluster headache dose if that is the case. In some instances, CHSG members say that they were prescribed the migraine dose through sheer error by their physician’s office – perhaps because cluster headache is less common than migraine and staff are less familiar with the cluster headache dose.
This is an area where you must be your own best advocate. If you are not getting the dose that was proven effective for cluster headache, you may not be giving this exciting new treatment a fair chance at helping you. Speak up, and make sure you are receiving the dose that is correct for your condition.
When Do You Start Emgality® and What Should You Expect?
As to when you should start and stop Emgality® after it is prescribed, that will depend on a number of factors that also must be discussed with your physician. For episodic cluster headache, Lilly recommends that you take the first 300 mg dose at the start of a cluster period and continue every month until the end of the cluster period. Some chronic cluster headache CHSG members have shared that they use Emgality® every month and, with physician approval, do not plan to stop.
CHSG members who have been prescribed Emgality® relate varying results in the group comments. Some say that they experienced immediate and complete relief from attacks. Others say that they used Emgality® for several months before experiencing a significant change. Provided your doctor approves, these comments suggest that you should not give up too soon if you don’t experience an immediate benefit.
As with any medication, potential side effects must be considered carefully in consultation with your physician. Lilly explains that the most common side effects are injection site reactions. More information on warnings and side effects is available at https://www.emgality.com/cluster.
For cluster headache prevention, Emgality® injections are dispensed in three prefilled syringes with a fine needle and a wide thumb-pad for ease of injecting. Emgality® comes with clear instructions for use and you can view a video on injecting Emgality® at the company’s website: https://www.emgality.com/cluster/taking-emgality/how-to-inject. You should also discuss the injection process with your physician to ensure that you understand how to inject it correctly. Some CHSG members receive their first dose in their physician’s office so they learn how to inject from an expert.
CHSG members often ask why Emgality® is not dispensed in auto-injectors versus the prefilled syringes. Lilly has explained that at the time they began studying Emgality® for cluster headache, the auto-injector was not available. Lilly decided that in order to help cluster headache patients and address the unmet need for this treatment as quickly as possible, they would move forward with the prefilled syringe method. At this time, Lilly does not plan to make the 300 mg dose available in auto-injectors.
In addition to the instructions provided by Lilly, our CHSG members have offered several tips for easing the injection process:
- First and foremost – do not inject the medication while it is chilled! Emgality® is delivered refrigerated and must be stored in refrigeration, but you should allow it to come to room temperature before injecting. Injecting Emgality® straight from the refrigerator can result in a stinging or burning sensation. The package insert says to let it sit at room temperature for 30 minutes before injecting, but the company also explains that Emgality® can remain at temperatures up to 86ºF (30ºC) for up to 7 days (in its original packaging). Lilly cautions that you must not warm up the syringes by placing them in the microwave or running hot water over them, and do not place them in direct sunlight. Simply remove the box from the refrigerator at least 30 minutes before you inject.
- Choosing a site for injecting Emgality® depends whether you are injecting yourself or having someone else inject you. If you are injecting yourself, you may inject into your abdomen (staying a least 2 inches away from your navel), or in the front of your thighs (at least 2 inches above the knee and 2 inches below the groin). Another person can give you the injection in the back of your upper arm or buttocks.
- CHSG members often say that there is less discomfort if you select the site with the most fat. Many find that injecting in the abdomen results in very little discomfort for that reason.
- Be sure to clean each injection site with an alcohol wipe.
- Some CHSG members mark each of the three injection sites with a Sharpie and then hold an ice cube on each site for a few seconds to help numb it before injecting.
- The needle should be inserted at a 45º angle. The Emgality® package insert illustrates how to find the correct angle.
- Inject the medicine slowly – going too fast also can create a burning or stinging sensation.
- Make a note of where you injected so you can alternate the sites the following month, and use your calendar or a phone app to make a reminder about taking your Emgality® at the same time the following month.
Proper Syringe Disposal—Get a Free Sharps Container From Lilly!
As with all other injectable medications, it is important for safety and environmental reasons to properly dispose of the used syringes and needles. Do not put them in your household trash! An FDA-approved sharps container is the best way to safely dispose of them. If you do not already have one, Lilly will send Emgality® users an FDA-approved sharps container at no cost. You can order a free sharps container at https://www.emgality.com/sharps-container-registration.
Share Your Emgality® Experiences With CHSG
The development of Emgality® is a milestone for cluster headache sufferers. As Emgality® becomes available to more of our CHSG members, please continue to share your experiences and usage tips with the group.