Qulipta (atogepant) belongs to a class of medications called calcitonin gene-related peptide receptor (CGRP) antagonists. CGRP is a protein found in the brain and nervous system that is thought to contribute to the pain, inflammation, and vasodilation associated with migraine attacks.

Qulipta is a prescription medicine used in adults to help prevent migraine headache (severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound or light).

Qulipta works by blocking the action of the CGRP protein in the body. This helps prevent migraine headaches.

You should not take Qulipta if you are allergic to atogepant.

Take Qulipta as directed. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: carbamazepine (Carbatrol, Equetro, Tegretol, Teril, others), clarithromycin, cyclosporine (Gengraf, Neoral, Sandimmune), efavirenz (Sustiva, in Atripla, in Symfi), etravirine (Intelence), itraconazole (Sporanox, Tolsura), ketoconazole, phenytoin (Dilantin, Phenytek), and rifampin (Rifadin, Rimactane).

Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with atogepant, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

Also, tell your doctor what herbal products you are taking, especially St. John's wort.

Take Qulipta exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take Qulipta with or without food.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Migraine Prophylaxis:

• 10 mg, 30 mg, or 60 mg orally once a day .

Use: For the preventative treatment of episodic migraine.

To make sure Qulipta is safe for you, tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis); or

• liver disease.

In animal studies, atogepant caused pregnancy problems such as low birth weight or birth defects. It is not known if these effects could occur in humans. Ask your doctor about the risk.

Having migraine headaches during pregnancy may increase the risk of dangerously high blood pressure that can lead to medical problems in both mother and baby. The benefit of preventing migraines may outweigh any risk.

Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Qulipta is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Qulipta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common Qulipta side effects may include:

• nausea, constipation;

• feeling tired; or

• weight loss.

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.

Tell your doctor about all your current medicines. Many drugs can affect atogepant, especially:

• cyclosporine;

• St. John's wort;

• an antibiotic such as clarithromycin or rifampin;

• antifungal medicine such as itraconazole or ketoconazole;

• antiviral medicine to treat HIV, such as efavirenz or etravirine; or

• seizure medicine such as carbamazepine or phenytoin.

This list is not complete and many other drugs may affect atogepant. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.