From the Guidelines
Qulipta (atogepant) is contraindicated in patients with a known hypersensitivity to atogepant or any of its components. The medication should not be used concurrently with strong CYP3A4 inhibitors like ketoconazole or itraconazole, as these medications can significantly increase atogepant levels in the blood, potentially leading to increased side effects 1. Patients with severe renal impairment (creatinine clearance less than 30 mL/min) or end-stage renal disease should use Qulipta with caution and at reduced doses, as kidney function affects how the medication is cleared from the body. Similarly, those with severe hepatic impairment should exercise caution when using this medication. Pregnant women should discuss the risks and benefits with their healthcare provider before taking Qulipta, as there is limited data on its safety during pregnancy. Some key points to consider when prescribing Qulipta include:
- The medication works by blocking calcitonin gene-related peptide (CGRP) receptors to prevent migraine attacks, but blocking this pathway could potentially affect physiological processes in which CGRP is involved, which is why these contraindications and precautions are important to consider.
- The 2023 VA/DoD headache guidelines provide a broad scope of recommendations for the management of headache, including the use of CGRP-acting agents like atogepant 1.
- Atogepant has a “weak for” recommendation for the prevention of episodic migraine (EM) according to the 2023 guideline 1. It is essential to carefully evaluate the patient's medical history, current medications, and potential risks before prescribing Qulipta, and to monitor them closely while they are taking the medication.
From the FDA Drug Label
QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA. Reactions have included anaphylaxis and dyspnea [see Warnings and Precautions (5.1)]. The contraindication for QULIPTA is a history of hypersensitivity to atogepant or any of the components of QULIPTA, which can cause severe reactions such as anaphylaxis and dyspnea 2.
From the Research
Qulipta Contraindications
- There are no direct studies on Qulipta contraindications in the provided evidence.
Hepatic Impairment and Drug Interactions
- Hepatic impairment can alter drug disposition, leading to increased concentrations and reduced plasma clearance of drugs 3.
- The pharmacokinetics of certain drugs, such as opioids, can be affected in patients with hepatic impairment, requiring dose adjustments to avoid accumulation and adverse effects 3.
- Atogepant, a drug related to Qulipta, has been studied in patients with hepatic impairment, and its pharmacokinetics were not substantially different in those with mild and moderate hepatic disease compared to healthy volunteers 4.
Drug Safety and Efficacy
- Atogepant has been shown to be effective in reducing the number of migraine days and headache days over a period of 12 weeks, with common adverse events including constipation and nausea 5.
- The safety and efficacy of Qulipta, however, cannot be directly determined from the provided evidence, as there are no studies specifically on Qulipta contraindications.