Vyepti is an IV infusion treatment used to prevent migraine attacks. Migraine is a debilitating condition that causes a severe throbbing and pulsating headache on one side of the head. Migraine can cause other symptoms, such as sensitivity to light or sound, nausea, vomiting, and fatigue.
According to the American Migraine Foundation, migraine affects over 37 million people living in the U.S. and is the third most common disease in the world.
Vyepti was approved in 2020 as the first IV preventive treatment option for migraine. Vyepti contains the active ingredient eptinezumab. Vyepti is a monoclonal antibody that targets the calcitonin gene-related peptide (CGRP).
According to studies, Vyepti reduced headache and migraine days and improved quality of life. Below are common questions and answers about Vyepti and whether it may be a good treatment option for you.
How Does It Work?
Vyepti is a calcitonin gene-related peptide (CGRP) inhibitor. It works by blocking the effect of CGRP. CGRP causes pain, dilation of blood vessels, and inflammation. CGRP levels are increased during migraine episodes and in those who have chronic migraine. By blocking the effect of CGRP, migraine attacks are decreased.
How Was Vyepti Studied for Episodic Migraine?
Vyepti was studied in people with episodic migraine. The people in the study with episodic migraine have 4 to 14 headache days per month, with 4 of those being migraines. People in the study had an average of 8.6 migraine days per month. The study mostly looked at the average change in monthly migraine headache days over 3 months.
People in these studies were 18 to 71 years old, with an average age of 40. Most were female (84%), and 16% were male. Of the people in this study, 84% were White, 12% were Black, and 4% were other races.
People in the study were given either 100 milligrams of Vyepti, 300 milligrams of Vyepti, or a placebo (an IV that contains no medicine). Both the people in the study and the people helping with the study did not know who received which medicine. Hormone therapy and acute medicine such as triptans, opioids, and barbiturates were allowed. Preventive medicine was not allowed, except for menstrual migraine.
What Are the Main Benefits Based on Studies for Episodic Migraine?
- Quick results. Starting as soon as 1 day after treatment, people reported fewer headaches. Before starting treatment, almost 31% of people reported headaches on any given day. On the first day after treatment, only 14% to 15% of people on Vyepti reported a headache.
- Fewer migraine episodes. Before starting treatment, people in the studies reported about nine migraine attacks per month. After one treatment with Vyepti, they decreased by about four migraine attacks per month.
- Lasting results. The decrease in headaches lasted the entire treatment cycle of 3 months.
How Was Vyepti Studied for Chronic Migraine?
Vyepti was also studied in people with chronic migraine. To be in the study, people with chronic migraine needed to have at least 15 headache days per month, with at least 8 of those being migraine attacks. They also needed a migraine diagnosis before age 50 for at least 1 year.
The study mostly looked at the average change in monthly migraine days per month. The study also tracked how often people had to use a short-acting relief medicine for their migraine.
People in the study were 18 to 65 years old, with an average age of 41. Most were female (88%), and 12% were male. Of the people in this study, 91% were White, 7% were Black, and 2% were other races. People in these studies had an average of 21 headache days per month, with about 16 of those days being migraine days.
People in these studies were given either 100 milligrams of Vyepti, 300 milligrams of Vyepti, or a placebo. Acute, preventive, and hormonal medicines were allowed as long as they had been stable for at least 3 months.
In both the episodic and chronic migraine studies, people were required to complete a daily electronic diary. Every evening, they would record information about their headaches, including how severe they were, how long they lasted, their location, and if they used an acute medicine. They also completed several surveys about their health, headaches, and quality of life at scheduled visits.
What Are the Main Benefits Based on Studies for Chronic Migraine?
- Fewer migraines. People taking Vyepti had about 8 fewer migraine days per month. Before treatment, people averaged about 16 migraine days per month. After one treatment, those taking Vyepti decreased their migraine days by about 50%.
- Decrease in acute medicine use. People taking Vyepti were able to use less acute medicine to treat their migraine episodes. They used acute medicine about 3 fewer days per month.
- Quick results. As seen in the study for episodic migraine, Vyepti started to prevent headaches the day after treatment. Before treatment, about 58% of people had a headache on any given day. On the first day after treatment, only 28% to 29% of those people treated with Vyepti had a headache.
Other Benefits
A 2-year study on the safety and efficacy of Vyepti showed that the decrease in migraines was maintained throughout the study. And people taking Vyepti reported an improvement in their quality of life. Before treatment, 92.2% of people reported their migraine episodes had a severe impact on their life. After 2 years of treatment, that number decreased to 38.5%.
For migraine symptoms, at week 4 of the study, 61% of people reported improvement. As the study continued, 81% of people reported improvement at week 48. These results were maintained during the rest of the study.
Your results may be different from what was seen in studies.
How Long Does It Take to Decrease the Amount of Migraine Episodes?
In studies, some people saw a benefit the day after treatment with Vyepti. Most people saw a decrease in headaches and migraine attacks during the first month of treatment. Decreases in headaches were maintained throughout treatment.
Speak with your health care provider if you do not notice an improvement in 3 months.
What Can I Do to Prevent and Manage Side Effects?
The most common side effects from Vyepti include symptoms of the common cold, such as a stuffy nose and scratchy throat. Be sure you are getting plenty of rest, drinking enough water, and eating healthy foods. Sleeping with a humidifier may help relieve a stuffy nose. A warm compress applied to the nose or a nasal saline spray can also help with congestion.
To relieve a sore or scratchy throat, you can try gargling with salt water or sipping on tea with honey. Over-the-counter (OTC) throat lozenges may also provide relief.
Although rare, Vyepti can cause hypersensitivity or allergic reactions during or after your IV. Notify your health care provider if you have any side effects during your IV. Go to the closest emergency room if you have signs of a severe allergic reaction after you have left the IV center.
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 Do I Use It?
Vyepti is given by a health care provider as an IV that will take about 30 minutes. You will need an IV every 3 months. The recommended dosing is 100 milligrams every 3 months. Some people may require a higher dose of 300 milligrams every 3 months.
What Type of Drug Interactions Can Happen?
There are no known drug interactions with Vyepti. Tell your health care provider about all medicines and supplements you take.
How Long Does It Stay in My System?
It takes about 4 to 5 months for Vyepti to leave your system. It is not known if Vyepti could affect pregnancy. Notify your health care provider if you are pregnant or planning on becoming pregnant.
What Do I Need to Do to Get It?
Vyepti requires a prescription from a health care provider. A headache specialist or neurologist can prescribe Vyepti, and it may require a prior authorization from your insurance. Your health care provider will work with your insurance to get the medicine approved.
Vyepti is an IV that must be given by a health care provider. Depending on your insurance, you can get it at an IV center, your doctor’s office, or your home. Talk with your doctor for more information.
Is There Any Cost Assistance Available?
Eligibility depends on your current medical and prescription insurance coverage. A copay assistance program is available for eligible people. You may pay as little as $0 for Vyepti and receive help with the IV cost. Visit www.vyepti.com/financial-assistance or call 833-489-3784 for more information and help finding an IV center.
