Qulipta

Migraine Prevention

Qulipta is used to help prevent migraine attacks in adults. It is intended for individuals who experience either episodic migraines or chronic migraines. By taking the medication daily, the goal is to reduce the frequency, severity, and duration of migraine headaches over time.

Conditions Treated

Healthcare providers may prescribe Qulipta for the following conditions:

• Episodic Migraine: This is defined as having migraine headaches on fewer than 15 days per month.
• Chronic Migraine: This is defined as having 15 or more headache days per month, with at least 8 of those days being migraines.

Limitations of Use

It is important to understand that Qulipta is not used for the acute treatment of a migraine. This means:

• It will not stop a migraine attack that has already begun.
• It should be taken every day as a preventive measure, even on days when you do not have a headache.
• If a migraine attack occurs while you are using Qulipta, you should use your separate rescue or acute migraine medication as directed by your doctor.

Understanding CGRP

Qulipta belongs to a class of medications called calcitonin gene-related peptide (CGRP) receptor antagonists. CGRP is a protein that occurs naturally in the brain and nervous system. Research has shown that levels of this protein often increase during a migraine attack.

How Qulipta Blocks Migraines

When CGRP levels rise, the protein binds to specific receptors in the brain. This process can lead to several effects associated with migraines, including:

• Inflammation: Increased sensitivity and swelling in the brain's protective layers.
• Vasodilation: The widening of blood vessels.
• Pain signaling: The transmission of pain messages through the nervous system.

Qulipta works by attaching itself to these CGRP receptors. By occupying the receptor, it prevents the CGRP protein from binding to it. This action helps stop the chain reaction that leads to migraine symptoms, effectively reducing the frequency of migraine attacks.

Common Side Effects

The most frequently reported side effects of Qulipta are typically mild and may improve as your body adjusts to the medication. These include:

• Nausea
• Constipation
• Fatigue or sleepiness
• Decreased appetite
• Weight loss

Serious Side Effects

Serious side effects are less common but require immediate medical attention. The primary concern is a severe allergic reaction (hypersensitivity). Seek emergency medical help if you experience symptoms such as:

• Swelling of the face, lips, tongue, or throat
• Severe skin rash or hives
• Intense itching
• Difficulty breathing or swallowing

If you notice any signs of a serious allergic reaction, you should stop taking the medication and contact a healthcare provider immediately. It is important to discuss any persistent or worsening side effects with your doctor.

Hypersensitivity Reactions

Serious allergic reactions have been reported in patients using Qulipta. These reactions include anaphylaxis, rash, hives, and angioedema (swelling of the face, lips, tongue, or throat). Such reactions can occur within minutes or several days after taking the medication. If a serious allergic reaction is suspected, the medication should be stopped immediately and medical attention sought.

Liver and Kidney Impairment

The way the body processes Qulipta is affected by liver and kidney function. Precautions include:

• Severe Hepatic Impairment: Use of this medication is generally avoided in individuals with severe liver disease.
• Severe Renal Impairment: For patients with severe kidney disease or those on dialysis, healthcare providers typically recommend a lower dosage.

Pregnancy and Breastfeeding

There is limited data on the use of Qulipta in pregnant individuals to inform a drug-associated risk of adverse developmental outcomes. It is also unknown if the medication passes into human breast milk or how it affects a breastfed infant. Healthcare providers usually discuss the potential risks and benefits before prescribing this medication to those who are pregnant, planning to become pregnant, or breastfeeding.

Pregnancy

There are no adequate studies on the use of Qulipta in pregnant individuals to determine if there is a drug-associated risk for birth defects, miscarriage, or other adverse outcomes. In animal studies, high doses of atogepant were associated with decreased fetal body weight and variations in bone development; however, these effects occurred at exposures much higher than the typical human dose.

If you are pregnant or planning to become pregnant, consult your doctor to weigh the benefits of treatment against potential risks. There is a pregnancy exposure registry that monitors health outcomes in individuals who take Qulipta during pregnancy.

Breastfeeding

It is not known if Qulipta passes into human breast milk, how it affects a nursing infant, or if it impacts milk production. While animal studies have shown that atogepant is present in the milk of lactating rats, human data are currently unavailable.

The decision to breastfeed while taking Qulipta should be made in consultation with a healthcare provider, considering the mother's clinical need for the medication and any potential adverse effects on the breastfed child.

Dosage Forms

Qulipta is available as a tablet to be taken by mouth. It is typically administered once daily and can be taken with or without food.

FDA Approval History

Qulipta (atogepant) received its initial approval from the U.S. Food and Drug Administration (FDA) in September 2021. Originally approved for the preventive treatment of episodic migraine, its indication was expanded in April 2023 to include the preventive treatment of chronic migraine in adults.

Regulatory Status

Qulipta is classified as a calcitonin gene-related peptide (CGRP) receptor antagonist. It is available only by prescription and is not a scheduled or controlled substance. There are currently no boxed warnings or Risk Evaluation and Mitigation Strategy (REMS) requirements associated with this medication.

Approved Use

The FDA-approved labeling specifies that Qulipta is for preventive use only. It is not indicated for the acute treatment of a migraine attack that has already started.

Insurance and Out-of-Pocket Costs

The amount you pay for Qulipta is largely determined by your health insurance plan. Many insurance providers require prior authorization, which means your healthcare provider must submit documentation to the insurance company to justify the medical necessity of the drug before it is covered. Your specific out-of-pocket cost will depend on your plan's formulary tier for brand-name medications, as well as your deductible and copay requirements.

Generic Availability

Qulipta is a brand-name medication containing the active ingredient atogepant. There is currently no generic version of atogepant available. Generic drugs typically cost significantly less than brand-name drugs, but they only become available after the patent for the original medication expires.

Financial Assistance Programs

Because Qulipta can be expensive, there are several options that may help reduce the cost:

• Manufacturer Savings Card: Patients with commercial or private insurance may be eligible for a copay savings card provided by the manufacturer, which can significantly lower monthly out-of-pocket expenses.
• Patient Assistance Programs: For individuals who are uninsured or underinsured, the manufacturer may offer programs that provide the medication at a reduced cost or for free, based on financial need and eligibility criteria.
• Pharmacy Selection: Prices can vary between different retail pharmacies. Some patients find that using a mail-order pharmacy through their insurance provider offers a more cost-effective way to obtain a 90-day supply.