Atogepant

Atogepant is a prescription medicine used for the preventive treatment of migraine in adults, including both episodic and chronic migraine. It belongs to a class of medicines called CGRP inhibitors, also known as gepants. Atogepant is taken as a tablet once a day and is sold under the brand name Qulipta.

Atogepant is taken every day to make migraine attacks happen less often. It is a preventive treatment, so it is not used to stop a migraine attack that has already started.

Atogepant is used to prevent migraine attacks in adults, including both episodic and chronic migraine. Atogepant tablets are taken once a day to help reduce how often migraine attacks happen over time. It is a preventive medicine, so it is not used to stop a migraine attack that has already started.

These two types of migraine are defined by how many headache days a person has each month, based on the International Classification of Headache Disorders (ICHD-3):

• Episodic migraine: fewer than 15 headache days a month.
• Chronic migraine: 15 or more headache days a month for more than 3 months, with the features of migraine on at least 8 of those days.

Atogepant is only approved for use in adults. Its safety and effectiveness in children under 18 years have not been established.

Atogepant works by blocking the calcitonin gene-related peptide (CGRP) receptor. CGRP is a protein released around the brain and its blood vessels during a migraine attack, where it is thought to contribute to pain, inflammation, and widening of the blood vessels (vasodilation). By stopping CGRP from attaching to its receptor, atogepant helps prevent migraine attacks.

Atogepant belongs to a class of small-molecule CGRP receptor antagonists often called gepants. After a dose, peak levels in the blood are reached in about 1 to 2 hours, and the medicine has an elimination half-life of about 11 hours. Atogepant is broken down mainly by the CYP3A4 enzyme in the liver, which is why some other medicines can change how much atogepant is in the body.

In clinical trials, atogepant reduced how often migraine attacks happened, lowering monthly migraine days more than placebo over a 12-week treatment period. People with episodic migraine taking atogepant had 3.6 to 4.2 fewer migraine days a month, and people with chronic migraine taking the 60 mg dose had 6.9 fewer.

Another way to measure migraine prevention is the share of people who have at least a 50% drop in their monthly migraine days, sometimes called responders. Atogepant produced more responders than placebo in both episodic and chronic migraine. The main results are shown below.

Figures are mean reductions in monthly migraine days from the pivotal 12-week trials, where the episodic range reflects results across doses and studies. Reductions in migraine days were seen within the first 4 weeks of treatment, and the full effect is measured over 12 weeks. Individual results vary.

Atogepant is taken by mouth once a day, with or without food, exactly as prescribed. The usual dose depends on the type of migraine and on any other medicines being taken.

• Episodic migraine: 10 mg, 30 mg, or 60 mg once a day.
• Chronic migraine: 60 mg once a day.

If a dose is missed, take it as soon as possible, but skip the missed dose if it is almost time for the next one. Do not take two doses at the same time.

Atogepant dose adjustments

The dose of atogepant may need to be lowered, or the medicine avoided, when it is taken with certain other drugs or in people with severe kidney problems. The following adjustments are based on the current prescribing information.

*Taking atogepant with these medicines lowers the amount of atogepant in the body. Watch for the medicine working less well.

Atogepant should not be taken by anyone who has had an allergic reaction to atogepant or to any of the ingredients in the tablets. Serious reactions to atogepant have included anaphylaxis and severe shortness of breath (dyspnea).

Before starting atogepant, tell a healthcare provider about all medical conditions, including if you:

• have high blood pressure
• have circulation problems in the fingers and toes
• have kidney problems or are on dialysis
• have liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Atogepant should be avoided in people with severe liver (hepatic) impairment. No dose change is needed for mild or moderate liver problems.

The most common side effects of atogepant are nausea, constipation, and tiredness or sleepiness (fatigue or somnolence). These were the side effects reported most often in clinical trials and were more common than with placebo. Decreased appetite and dizziness were also reported.

Serious side effects of atogepant

Atogepant can cause serious side effects. Contact a healthcare provider or get emergency help if any of the following occur.

• Allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen when taking atogepant or days after a dose. Stop taking atogepant and get emergency medical help right away for swelling of the face, lips, or tongue, trouble breathing, hives, rash, or itching.
• High blood pressure (hypertension). New high blood pressure, or worsening of existing high blood pressure, can happen with atogepant. In reported cases this was most often noticed within the first 7 days of treatment, and some cases needed blood pressure medicine or hospital care. Contact a healthcare provider if blood pressure goes up.
• Raynaud's phenomenon. A circulation problem in the fingers and toes can start or get worse with atogepant. It can make the fingers or toes feel numb, cool, or painful, or change color from pale to blue to red. In reported cases, symptoms began about 1.5 days after a dose on average. Contact a healthcare provider if these symptoms occur.

In clinical trials, a small number of people had a weight decrease of at least 7 percent, and a small number had short-lived rises in liver enzymes that were not associated with symptoms or lasting liver injury. This is not a complete list of side effects. Report side effects to the FDA at 1-800-FDA-1088.

Many medicines can change the amount of atogepant in the body, mainly because atogepant is broken down by the CYP3A4 enzyme and is moved by certain transporters (OATP). A healthcare provider may adjust the atogepant dose when it is taken with these medicines. Tell a healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal products, and especially about:

• cyclosporine
• St. John's wort
• antibiotics such as clarithromycin or rifampin
• antifungal medicines such as itraconazole or ketoconazole
• medicines for HIV such as efavirenz or etravirine
• seizure medicines such as carbamazepine or phenytoin

Patients should also avoid grapefruit juice unless a healthcare provider says it is okay, and should keep an up-to-date list of their medicines to show to their pharmacist or provider.

It is not known whether atogepant is safe to use during pregnancy. There are no adequate studies in pregnant women, and animal studies showed effects on the developing fetus, such as lower body weight and structural changes, at doses higher than those used in people. Anyone who is pregnant or planning a pregnancy should talk with their healthcare provider about the risks and benefits.

There is a pregnancy registry that follows the health of women who take atogepant during pregnancy and their babies. Patients can enroll by calling 1-833-277-0206 or visiting empresspregnancyregistry.com.

Atogepant passes into breast milk in low amounts. In a study of breastfeeding women, the estimated amount reaching a nursing infant was about 0.19 percent of the mother's weight-adjusted dose, with a milk-to-plasma ratio of 0.08. The benefits of breastfeeding should be weighed against the mother's need for the medicine and any possible effects on the infant.

No. Atogepant is a prescription-only medicine, but it is not a controlled substance in the United States and is not scheduled by the Drug Enforcement Administration (DEA).

Atogepant and Qulipta are the same medicine. Atogepant is the generic (active ingredient) name, and Qulipta is the US brand name from AbbVie. There is currently no generic version of the tablet available; the medicine is sold only as the brand Qulipta. For brand-specific information such as cost, savings programs, and patient reviews, see the Qulipta page.

Atogepant is one of several medicines that block calcitonin gene-related peptide (CGRP), a protein involved in migraine attacks. These medicines fall into two broad groups: oral gepants, which are small molecules, and injectable CGRP monoclonal antibodies, which are larger antibody molecules. Atogepant is an oral gepant used only for the prevention of migraine.

Four gepants are currently approved by the FDA. They differ mainly in whether they are used to treat a migraine attack that has already started (acute treatment), to prevent attacks, or both.

Atogepant is the only gepant approved to prevent chronic migraine, and rimegepant is the only gepant approved for both acute and preventive use.

Atogepant vs rimegepant

The main difference between atogepant and rimegepant is how they are used. Atogepant is taken once a day and only to prevent migraine attacks. Rimegepant can be used two ways: as needed to treat a migraine attack that has already started, and every other day to help prevent episodic migraine. Atogepant is also the only gepant approved to prevent chronic migraine, meaning 15 or more headache days a month. Both are oral medicines that block the CGRP receptor and share common side effects such as nausea.

Atogepant vs injectable CGRP treatments

Injectable CGRP treatments are monoclonal antibodies, which are larger molecules than the gepants. They include erenumab (Aimovig), fremanezumab (Ajovy), galcanezumab (Emgality), and eptinezumab (Vyepti), and they are used only for prevention. Most are given by injection under the skin once a month or every 3 months, while eptinezumab is given as an intravenous (IV) infusion every 3 months. Atogepant differs in that it is a tablet taken by mouth once a day rather than an injection. The choice between an oral gepant and an injectable antibody depends on patient preference, other health conditions, other medicines, and how a person responds to treatment. A healthcare provider can help compare the options.

Store atogepant at room temperature between 20°C and 25°C (68°F and 77°F). Brief exposure to temperatures between 15°C and 30°C (59°F and 86°F) is allowed. Keep atogepant and all medicines out of the reach of children.

Atogepant is made by AbbVie Inc., North Chicago, Illinois. It is sold under the brand name Qulipta in the United States.

Active ingredient: atogepant.

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

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