Qulipta From AbbVie

Pharmacy Times, January 2022, Volume 88, Issue 1

The FDA has approved atogepant oral tablets (Qulipta; AbbVie) for the preventive treatment of episodic migraines in adults.

The FDA has approved atogepant oral tablets (Qulipta; AbbVie) for the preventive treatment of episodic migraines in adults.1 Migraines affect an estimated 39 million Americans and 1 billion individuals worldwide. The severe, throbbing headache pain associated with a migraine attack is often accompanied by symptoms such as extreme sensitivity to light or sound, as well as nausea. Qulipta is the only oral medication in its class specifically developed for preventive treatment of migraines.2

PHARMACOLOGY AND PHARMACOKINETICS

Qulipta is a calcitonin gene-related peptide receptor antagonist. It displays peak plasma concentrations 1 to 2 hours after oral administration. Qulipta is eliminated mainly through metabolism by cytochrome P450 3A4 (CYP3A4) and has an elimination half-life of about 11 hours. Age, body weight, gender, and race do not significantly affect the pharmacokinetics of Qulipta.1

DOSAGE AND ADMINISTRATION

The recommended dose of Qulipta is 10, 30, or 60 mg/d orally, with dose modifications depending on concurrent use of specific drugs and renal function. The dose for patients who are concomitantly using strong CYP3A4 inhibitors is 10 mg/d. Patients who are concomitantly using strong and moderate CYP3A4 inducers should use 30 or 60 mg/d. The dose for patients who are concomitantly using organic anion transporting polypeptide inhibitors is 10 or 30 mg/d. Patients with a creatinine clearance of less than 30 mL/min should use 10 mg/d. A dose adjustment is not required for patients with mild or moderate renal impairment.

The medication may be taken with or without food. Qulipta is supplied in 10-mg, 30-mg, and 60-mg tablets.1

CLINICAL TRIALS

The efficacy of Qulipta for the preventive treatment of episodic migraines in adult patients was evaluated in 2 double-blind, multicenter, placebo-controlled, randomized studies of participants with at least a 1-year history of migraine with or without aura. Study 1 (NCT03777059) randomized 910 patients 1:1:1:1 to receive Qulipta 10 mg, Qulipta 30 mg, Qulipta 60 mg, or a placebo once daily for 12 weeks. Study 2 (NCT02848326) randomized 652 patients 1:2:2:2 to receive Qulipta 10 mg, Qulipta 30 mg, Qulipta 60 mg, or a placebo once daily for 12 weeks. Both studies allowed patients to use acute headache treatments as needed, such as acetaminophen, ergotamine derivatives, nonsteroidal anti-inflammatory drugs, opioids, and triptans. Concomitant use of a medication that acts on the calcitonin gene-related peptide pathway for either acute or preventive treatment of migraines was not allowed. Patients with myocardial infarction, stroke, or transient ischemic attacks within 6 months prior to screening were excluded from the studies.

In both studies, the primary efficacy end point was the change from baseline in mean monthly migraine days over the 12-week treatment period. A significantly greater reduction in mean monthly headache days was demonstrated across all doses of Qulipta compared with the placebo. Additionally, a secondary end point in study 1 evaluated the proportion of patients who achieved a 50% or more reduction in monthly migraine days over the 12-week treatment period. The study found a statistically significant difference, with 56% of the 10-mg group, 59% of the 30-mg group, and 61% of the 60-mg group achieving a 50% to 100% reduction, compared with 29% in the placebo group.1,2

CONTRADICTIONS, WARNINGS, AND PRECAUTIONS

There are no contraindications to treatment with Qulipta. Based on animal data, the use of Qulipta during pregnancy may result in fetal harm. There are no data on the presence of Qulipta in human milk, the effects of the medication on the breastfed infant, or the effects of Qulipta on milk production. The effectiveness and safety of Qulipta in pediatric patients have not been established. Patients with severe hepatic impairment should avoid the use of Qulipta. Patients with mild or moderate hepatic impairment do not require a dose adjustment when using Qulipta.

The most common adverse reactions are constipation, fatigue, and nausea.1

Monica Holmberg, PharmD, BCPS, is a pharmacist and Pharmacy Times contributor.

REFERENCES

1. Qulipta. Prescribing information. AbbVie; 2021. Accessed November 2, 2021. https://www.rxabbvie.com/pdf/QULIPTA_pi.pdf

2. FDA approves Qulipta (atogepant), the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine. News release. AbbVie. Sept. 28, 2021. Accessed November 2, 2021. https://news.abbvie.com/news/press-releases/fda-approves-qulipta-atogepant-first-and-only-oral-cgrp-receptor-antagonist-specifically-developed-for-preventive-treatment-migraine.htm