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Atogepant

Also known as: Qulipta

Calcitonin Gene-related Peptide Receptor AntagonistCalcitonin Gene-related Peptide Receptor Antagonists

Route: Oral

3 interactions on record

Atogepant has 3 known drug interactions based on U.S. FDA drug labeling data. Notable interactions include combinations with Itraconazole, Rifampin, Topiramate. Patients taking Atogepant should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 3
Moderate: 3

Moderate (3)

Atogepant + Itraconazole— Strong CYP3A4 inhibitor resulting in significant increase in atogepant exposure; dosage adjustment to 10 mg once daily r…
Atogepant + Rifampin— Strong CYP3A4 inducer and OATP1B1/OATP1B3 inhibitor resulting in significant decrease in atogepant exposure; dosage adju…
Atogepant + Topiramate— Weak CYP3A4 inducer resulting in decreased atogepant exposure; dosage adjustment may be needed with monitoring for reduc…

Atogepant + Itraconazole🟡Moderate

Strong CYP3A4 inhibitor resulting in significant increase in atogepant exposure; dosage adjustment to 10 mg once daily recommended.

Atogepant + Rifampin🟡Moderate

Strong CYP3A4 inducer and OATP1B1/OATP1B3 inhibitor resulting in significant decrease in atogepant exposure; dosage adjustment and monitoring for reduced efficacy recommended.

Atogepant + Topiramate🟡Moderate

Weak CYP3A4 inducer resulting in decreased atogepant exposure; dosage adjustment may be needed with monitoring for reduced efficacy.

Contraindications

4 CONTRAINDICATIONS 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 )] . Patients with a history of hypersensitivity to atogepant or to any of the components of QULIPTA. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while taking QULIPTA. Patients should be encouraged to enroll by calling 1-833-277-0206 or visiting http://empresspregnancyregistry.com . Risk Summary There are no adequate data on the developmental risk associated with the use of QULIPTA in pregnant women. In animal studies, oral administration of atogepant during the period of organogenesis (rats and rabbits) or throughout pregnancy and lactation (rats) resulted in adverse developmental effects (decreased fetal and offspring body weight in rats; increased incidence of fetal structural variations in rabbits) at exposures greater than those used clinically [see Data ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The estimated rate of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Data Animal Data Oral administration of atogepant (0, 5, 15, 125, or 750 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreases in fetal body weight and in skeletal ossification at the two highest doses tested (125 and 750 mg/kg), which were not associated with maternal toxicity. At the no-effect dose (15 mg/kg/day) for adverse effects on embryofetal development, plasma exposure (AUC) was approximately 4 times that in humans at the maximum recommended human dose (MRHD) of 60 mg/day. Oral administration of atogepant (0, 30, 90, or 130 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in an increase in fetal visc

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.