Qulipta

Qulipta is used to help prevent episodic and chronic migraine headaches in adults. These are severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound or light. Qulipta is an oral tablet taken once a day.

Qulipta (atogepant) belongs to a class of medications called CGRP inhibitors.

Qulipta gained FDA approval on September 28, 2021. There is no Qulipta generic available.

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

• Qulipta is usually taken 1 time daily.
• You may take Qulipta with or without food.
• The dosage of Qulipta depends on what other medications you are currently taking.

Do not take Qulipta if you are allergic to atogepant, Qulipta, or any of the inactive ingredients in the tablets (see the end of this guide for a list).

Before you take Qulipta, tell your healthcare provider about all of your medical conditions, including if you:

• Have high blood pressure
• Have circulation problems in your fingers and toes
• Have kidney problems or are on dialysis
• Have liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or intend to breastfeed.

Qulipta is not approved for patients younger than 18 years.

Pregnancy

It is not known if Qulipta will harm your unborn baby.

Pregnancy Registry: There is a pregnancy registry for women who take Qulipta during pregnancy. The purpose of this registry is to collect information about your health and that of your baby. Talk to your healthcare provider or call 1-833-277-0206 to enroll in this registry. You can also visit http://empresspregnancyregistry.com.

Breastfeeding

Very small amounts of Qulipta pass into breast milk. Talk to your healthcare provider if you plan to breastfeed.

Common Side Effects

The most common side effects of Qulipta are:

• Nausea
• Constipation
• Fatigue and sleepiness.

Serious Side Effects

Qulipta can cause the following serious side effects:

• Severe Allergic Reactions, including anaphylaxis. Serious allergic reactions can happen when you take Qulipta or days after. Stop taking Qulipta and get emergency help right away if you get any of the following symptoms, which may be part of a serious allergic reaction: Swelling of the face, lips, or tongue Itching Trouble breathing Hives Rash.

Warning: Serious allergic reactions can occur within hours or days after taking Qulipta.

• High Blood Pressure. High blood pressure or worsening of high blood pressure can happen when you take Qulipta. Contact your healthcare provider if you have an increase in blood pressure
• Raynaud's Phenomenon. A type of circulation problem can worsen or happen when you take Qulipta. Raynaud’s phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale to blue to red. Contact your healthcare provider if these symptoms occur

These are not all of the possible side effects of Qulipta. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Qulipta (atogepant) works to prevent migraines by blocking CGRP (calcitonin gene-related peptide), a protein that triggers migraine attacks. By binding to CGRP receptors, it stops blood vessel dilation and inflammation in the brain. Qulipta is taken daily as a preventive treatment, and is not for active migraines.

Clinical trials have shown that Qulipta starts working within the first week of treatment. Research also shows a 54% reduction in monthly migraine days in patients with episodic migraine and a 36% reduction in patients with chronic migraine headaches (see How well does Qulipta work for migraine?).

Qulipta (atogepant) belongs to the drug class called calcitonin gene-related peptide receptor antagonists, or CGRPs.

Dose of Qulipta for Episodic Migraine

• 10 mg, 30 mg, or 60 mg orally once a day
• The specific dosage depends on how often you get migraines.
• Your doctor will adjust your dosage if you have severe kidney disease or take interacting medicines. You should avoid taking Qulipta if you have severe liver disease.

Dose of Qulipta for Chronic Migraine

• 60 mg orally once a day.

Qulipta dosage adjustments

Dosage adjustments are needed when Qulipta is taken with certain other medications and for people with severe kidney disease.

* Coadministration reduces Qulipta exposure. Monitor for reduced effectiveness.

The cost of Qulipta depends on your insurance and the pharmacy where you obtain it. With the Qulipta Complete Savings Card, eligible commercially insured patients may pay as little as $0.

This Qulipta co-pay assistance program is not available to patients receiving prescription reimbursement under Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs, or where prohibited by law. Call 1-855-QULIPTA for additional information.

For more information, see Qulipta Prices, Coupons, Copay Cards & Patient Assistance.

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.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and if you drink grapefruit juice. Qulipta may affect the way other medicines work, and other medicines may affect how Qulipta works. Your healthcare provider may need to change the dose of Quliptawhen taken with certain other medicines. Especially tell your doctor if you take:

• 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.

Keep a list of medicines you take to show to your healthcare provider or pharmacist when you get a new medicine. See the Qulipta Prescribing Information for more information.

Store Qulipta at room temperature away from moisture and heat.

Qulipta (atogepant) is made by AbbVie, headquartered in North Chicago, Illinois.

Key medications in AbbVie's portfolio include:

• Humira (arthritis, psoriasis)
• Botox (cosmetic and therapeutic uses)
• Vraylar (schizophrenia, bipolar)
• Rinvoq (arthritis)
• Skyrizi (psoriasis)
• Ubrelvy (migraine).

Note that AbbVie acquired many of these medications through its 2020 acquisition of Allergan.

Active ingredient: atogepantInactive ingredients: colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.

Qulipta is available as 10 mg, 30 mg, and 60 mg tablets.