Preventing Migraines With Qulipta

7 min read

The approval of medicines called “CGRP antagonists” has led to big changes in how migraines are managed. These medicines work in a different way than older medicines to treat or prevent migraine. The first CGRP antagonists were only available as a shot, and they were only approved to prevent migraine. Qulipta (kew-LIP-tah) was approved in 2021 to prevent episodic migraine. In 2023, it was approved as the first CGRP antagonist to prevent all frequencies of migraine – including both episodic and chronic migraine. Episodic migraine is when you have up to 14 headache days per month. Chronic migraine is at least 15 headache days per month. 

Migraine is a condition where you have intense headaches, usually with throbbing pain on one side. The headache can come back again and again and may last for up to 72 hours. You may also have what is called an aura, where you have changes in your vision or other symptoms, such as numbness or trouble speaking.

The active ingredient in Qulipta is atogepant. You may also hear it called a “gepant.” It is a calcitonin gene-related peptide (CGRP) antagonist. CGRP is a protein that causes blood vessels to widen and can lead to pain and inflammation during a migraine. CGRP may also have a role in causing migraine. CGRP antagonists, like Qulipta, prevent CGRP from binding to its receptors and having its effects. Blocking CGRP can help prevent future migraine attacks.

Qulipta comes as a 10-milligram, 30-milligram, and 60-milligram tablet that you take by mouth, with or without food. The dosage differs, depending on whether you are taking it to prevent episodic or chronic migraine. For episodic migraine, the recommended dosage is 10 milligrams, 30 milligrams, or 60 milligrams once daily. For chronic migraine, the recommended dosage is 60 milligrams once daily. 

If you have severe liver or kidney problems or you are on dialysis, you may need to avoid Qulipta or your health care provider may prescribe a lower dose. You may also need a lower dose or to avoid Qulipta if you are taking certain other medicines. For more details, see the section about interactions below.

For preventing episodic migraine, two studies were done to see if Qulipta was effective, compared to a placebo containing no medicine. People in the studies did not know if they were getting Qulipta or the placebo. 

Both studies included people who had a history of migraine with or without aura for at least a year. People could take medicines to treat an acute headache (including acetaminophen, ibuprofen, or a triptan) as needed. They could not take other medicines that affected CGRP, and they could not take other medicines to prevent migraine (such as topiramate, propranolol, or amitriptyline).

In these studies, people took a placebo or Qulipta at a dose of 10 milligrams, 30 milligrams, or 60 milligrams once daily for 3 months. Efficacy was measured by the change in the average number of monthly migraine days during that time frame. 

People in these studies had an average of about 8 migraine days per month before the study started. Most people in the studies were female (over 85%) and White (over 76%). The average age of people in the studies was 40 to 42 years.

People in the studies who took Qulipta to prevent episodic migraine had fewer migraine days per month than people who took the placebo. The people who took Qulipta had 3.6 to 4.2 fewer migraine days per month over 3 months, depending on their daily dose of Qulipta. People who took the placebo had about 2.5 fewer migraine days per month.

For preventing chronic migraine, a study was done to see if 60 milligrams of Qulipta once daily was effective, compared to a placebo containing no medicine. Again, people in the studies did not know if they were getting Qulipta or the placebo. 

Everyone in the study had a history of chronic migraine for at least a year. People in the study could take medicines to treat an acute headache (including acetaminophen, ibuprofen, or a triptan) as needed. About 11% of people in the study were allowed to use one other medicine to prevent migraine (such as topiramate, propranolol, or amitriptyline). They could not take other medicines that affected CGRP.

People in this study had an average of about 19 migraine days per month before the study started. Most people in this study were female (87%) and White (60%). The average age of people in the study was 42 years.

Efficacy was measured by the change in the average number of monthly migraine days during the 3 months the study lasted. The people who took 60 milligrams of Qulipta once daily to prevent chronic migraine had about 7 fewer migraine days per month, while people who took the placebo had about 5 fewer migraine days per month. 

Your results may differ from what was seen in clinical studies.

Qulipta is meant to be taken once every day to prevent migraine. It should not be used to treat an acute migraine. Talk with your health care provider about the best way to treat an acute migraine. 

Qulipta should start working to prevent your migraines within a few weeks of starting it. Tell your health care provider if the number of headaches you have per month is not going down. Consider keeping a headache diary to keep track of when you have migraines and when you take your migraine medicines. This can help you and your health care provider find out how well your medicines are working for you.

If you have trouble remembering to take Qulipta, consider following a routine. For example, take it every day at the same time, such as after brushing your teeth. You can also use calendar or smartphone reminders to help. 

The most common side effects are nausea, constipation, tiredness, and drowsiness. 

Nausea is a common symptom that can happen with migraine in general. To help limit nausea, you can try simple steps, like eating bland foods, such as toast or crackers, and avoiding strong smells, such as from cooking, perfume, or smoke. Your health care provider may also prescribe medicine to help manage nausea if you commonly have nausea during a migraine.

If you have constipation, there are strategies you can use to help prevent and manage it. For example, you can drink more fluids, add high-fiber fruits and vegetables to your diet, and exercise most days of the week, if possible. You could also try adjusting how you sit on the toilet to make it easier to poop, such as by leaning back, raising your feet, or squatting.

Because Qulipta can cause tiredness and drowsiness, do not drive or do other activities that require alertness or coordination until you know how it affects you.

While not common, a severe allergic reaction may happen with Qulipta. Stop taking Qulipta and get medical help right away if you have symptoms of an allergic reaction, such as trouble breathing or a severe rash. An allergic reaction can happen right away or days after taking the medicine.

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.

Several medicines can affect the blood levels of Qulipta. Your body has enzymes and proteins that process and remove many types of medicines from the body. Other medicines can affect this process, which may slow down or speed up how Qulipta is broken down or cleared from your body. 

For example, taking Qulipta with medicines that inhibit certain enzymes or proteins could increase the amount of Qulipta in your body. This may lead to excessive or dangerous side effects. Grapefruit juice can also inhibit some of these enzymes. 

 On the other hand, taking Qulipta with medicines that induce certain enzymes could decrease the amount of Qulipta in your body. This may cause it to work less well or not work at all. 

If you are taking certain medicines that inhibit or induce these enzymes or proteins, you may not be able to take Qulipta at all, or your health care provider may need to prescribe a lower dose. Ask your pharmacist or other health care provider if any of your medicines interact with Qulipta. 

Tell your health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. Also tell them if you eat grapefruit or drink grapefruit juice. This will help them determine if there are any interactions with Qulipta, or if you need a dosage adjustment. Do not start or stop other medicines while taking Qulipta without talking to your health care provider.

You will need a prescription from a health care provider. Your primary care provider, neurologist, or a headache specialist may prescribe it, and you can get it at any pharmacy.

There is a copay card available from the drugmaker that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance, and what type of insurance you have. You can find out more at https://www.qulipta.com/savings-support/qulipta-complete-savings-program.