Qulipta (Atogepant)
Dosage & administration
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Qulipta prescribing information
Dosage and Administration (2.2 Dosage Modification s Dosage modifications and usage recommendations for episodic and chronic migraine with concomitant use of specific drugs and for patients with renal impairment are provided in Table 1. Table 1 : Dos age Modifications for Drug Interactions and for Specific Populations
a Coadministration decreases atogepant exposure. Monitor for reduced efficacy. | 9/2025 | |||||||||||||||||||||||||||
Warnings and Precautions (5.000000000000000e+00 2 Hyper tension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including QULIPTA, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. QULIPTA was discontinued in many of the reported cases. Monitor patients treated with QULIPTA for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of QULIPTA is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled. 5.000000000000000e+00 3 Raynaud’s Phenomenon Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including QULIPTA. In reported cases with small molecule CGRP antagonists, symptom onset occurred a median of 1.5 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. QULIPTA should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms. |
3/2025 | |||||||||||||||||||||||||||
QULIPTA is indicated for the preventive treatment of migraine in adults.
- QULIPTA is taken orally with or without food. ()2.1Recommended Dosage
QULIPTA is taken orally with or without food.
Episodic MigraineThe recommended dosage of QULIPTA for episodic migraine is 10 mg, 30 mg, or 60 mg taken once daily.
Chronic MigraineThe recommended dosage of QULIPTA for chronic migraine is 60 mg taken once daily.
- For episodic migraine, the recommended dosage is 10 mg, 30 mg, or 60 mg taken once daily. ()2.1Recommended Dosage
QULIPTA is taken orally with or without food.
Episodic MigraineThe recommended dosage of QULIPTA for episodic migraine is 10 mg, 30 mg, or 60 mg taken once daily.
Chronic MigraineThe recommended dosage of QULIPTA for chronic migraine is 60 mg taken once daily.
- For chronic migraine, the recommended dosage is 60 mg taken once daily. ()2.1Recommended Dosage
QULIPTA is taken orally with or without food.
Episodic MigraineThe recommended dosage of QULIPTA for episodic migraine is 10 mg, 30 mg, or 60 mg taken once daily.
Chronic MigraineThe recommended dosage of QULIPTA for chronic migraine is 60 mg taken once daily.
- Severe Renal Impairment or End-Stage Renal Disease (,2.2DosageModifications
Dosage modifications and usage recommendations for episodic and chronic migraine with concomitant use of specific drugs and for patients with renal impairment are provided in Table 1.
Table1: DosageModifications for Drug Interactions and for Specific PopulationsDosage ModificationsRecommended Once DailyDosage forEpisodic MigraineUsage andRecommendedOnce DailyDosage forChronic MigraineConcomitant Drug[see Drug Interactions (7)]Strong CYP3A4 Inhibitors(7.1)10 mg10 mgStrong CYP3A4 Inducers(7.2)60 mgaNot recommendedModerate CYP3A4 Inducers(7.2)60 mgNot recommendedWeak CYP3A4 Inducers(7.2)30 mg or 60 mg60 mgaOATP Inhibitors(7.3)10 mg or 30 mg30 mgRenal Impairment[see Use in Specific Populations (8)]Severe Renal Impairment and End-Stage Renal Disease (CLcr <30 mL/min)(8.6)10 mgNot recommendeda Coadministration decreases atogepant exposure. Monitor for reduced efficacy.):8.000000000000000e+006Renal ImpairmentThe renal route of elimination plays a minor role in the clearance of atogepant
[see Clinical Pharmacology(12.3)]. For episodic migraine, in patients with severe renal impairment (CLcr 15-29 mL/min) and in patients with end-stage renal disease (ESRD) (CLcr <15 mL/min), the recommended dosage of QULIPTA is 10 mg once daily; in patients with ESRD undergoing intermittent dialysis, QULIPTA should preferably be taken after dialysis[see Dosage and Administration(2.2)]. For chronic migraine, use of QULIPTA in patients with severe renal impairment and in patients with ESRD is not recommended. No dose adjustment is recommended for patients with mild or moderate renal impairment.- Episodic migraine: 10 mg once daily.
- Chronic migraine: Not recommended.
- Episodic migraine: 10 mg once daily.
QULIPTA 10 mg is supplied as white to off-white, round biconvex tablets debossed with “A” and “10” on one side.
QULIPTA 30 mg is supplied as white to off-white, oval biconvex tablets debossed with “A30” on one side.
QULIPTA 60 mg is supplied as white to off-white, oval biconvex tablets debossed with “A60” on one side.
- Pregnancy: Based on animal data, may cause fetal harm. ()8.1PregnancyPregnancy 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 SummaryThere 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
[seeData].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 ConsiderationsDisease-Associated Maternal and/or Embryo/Fetal RiskPublished data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.
DataAnimalDataOral 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 visceral and skeletal variations at the highest dose tested (130 mg/kg/day), which was associated with minimal maternal toxicity. At the no-effect dose (90 mg/kg/day) for adverse effects on embryofetal development, plasma exposure (AUC) was approximately 3 times that in humans at the MRHD.
Oral administration of atogepant (0, 15, 45, or 125 mg/kg/day) to rats throughout gestation and lactation resulted in decreased pup body weight at the highest dose tested (125 mg/kg/day), which persisted into adulthood. At the no-effect dose (45 mg/kg/day) for adverse effects on pre- and postnatal development, plasma exposure (AUC) was approximately 5 times that in humans at the MRHD.
- Avoid use in patients with severe hepatic impairment. ()8.000000000000000e+007Hepatic Impairment
No dose adjustment of QULIPTA is recommended for patients with mild or moderate hepatic impairment. Avoid use of QULIPTA in patients with severe hepatic impairment
[seeAdverse Reactions (6.1) andClinical Pharmacology (12.3)].
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
Hypersensitivity reactions, including anaphylaxis, dyspnea, rash, pruritus, urticaria, and facial edema, have been reported with use of QULIPTA