Qulipta (Atogepant) for preventive treatment of migraine in adults

Qulipta is an oral medication approved for the preventive treatment of migraine in adults. Its active ingredient, atogepant, works by blocking the receptor for calcitonin gene-related peptide (CGRP), a molecule involved in migraine development.

Qulipta is indicated for the preventive treatment of migraine in adults, including both episodic and chronic migraine:

• Episodic migraine: Recommended doses are 10 mg, 30 mg, or 60 mg once daily.
• Chronic migraine: Recommended dose is 60 mg once daily.

Dosage adjustments are necessary for patients with severe renal impairment or end-stage renal disease, and when used with certain interacting medications.

Atogepant

Atogepant in Qulipta blocks receptors for CGRP, a neuropeptide involved in the signaling pathways that cause migraine headaches. By antagonizing CGRP receptors, Qulipta helps reduce migraine frequency.

Qulipta is taken orally once daily, with or without food.

Episodic migraine:

• 10 mg, 30 mg, or 60 mg once daily.

Chronic migraine:

• 60 mg once daily.

Dosage modifications for special populations and with interacting drugs:

In patients with ESRD on dialysis, Qulipta should preferably be taken after dialysis.

Qulipta is contraindicated in patients with known hypersensitivity to atogepant or any components of the product. Hypersensitivity reactions have included anaphylaxis and respiratory distress.

Hypersensitivity reactions

If signs of hypersensitivity occur (including anaphylaxis, dyspnea, rash, urticaria, facial edema), discontinue Qulipta and initiate appropriate treatment. Reactions may occur days after dosing.

Hypertension

New or worsened hypertension has been reported postmarketing, sometimes requiring medical treatment or hospitalization. Monitor blood pressure, especially within the first week of treatment, and consider discontinuation if blood pressure is uncontrolled or no other cause is found.

Raynaud’s phenomenon

New or worsening Raynaud’s phenomenon has been reported, often with serious consequences. If symptoms develop, discontinue Qulipta and evaluate the patient. Patients with a history of Raynaud’s should be monitored and informed about this risk.

The most common side effects reported in clinical trials (occurring in 4% or more of patients and more than placebo) include nausea, constipation, and fatigue or somnolence.

Other adverse reactions include decreased appetite and dizziness.

Elevations in liver enzymes greater than three times the upper limit of normal occurred at similar rates as placebo and were asymptomatic and resolved after stopping treatment.

Some patients had weight loss of 7% or more during treatment.

Postmarketing reports include hypersensitivity reactions, hypertension, and Raynaud’s phenomenon.

Qulipta’s exposure can be increased or decreased by drugs affecting CYP3A4 or OATP transporters, requiring dosage adjustments:

• Strong CYP3A4 inhibitors: Increase atogepant levels. Dose: 10 mg once daily.
• Strong or moderate CYP3A4 inducers: Decrease atogepant levels. Episodic migraine dose: 60 mg once daily with monitoring; chronic migraine use not recommended.
• Weak CYP3A4 inducers: Episodic: 30 mg or 60 mg once daily; Chronic: 60 mg once daily; monitor efficacy.
• OATP inhibitors: Increase atogepant levels. Episodic: 10 mg or 30 mg once daily; Chronic: 30 mg once daily.

Monitor for reduced efficacy during coadministration with CYP3A4 inducers.

Pregnancy

Animal studies have shown developmental toxicity at exposures several times higher than clinical doses, including decreased fetal body weight and increased fetal variations. There are no adequate human data. A pregnancy exposure registry is available to monitor outcomes.

Lactation

Atogepant is excreted in breast milk in low amounts. The estimated infant exposure is very low. The effects on nursing infants are unknown, so weigh benefits of breastfeeding and maternal treatment needs carefully.