Atogepant
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Calcitonin Gene-related Peptide Receptor Antagonist
Dosing in kidney impairment
2 DOSAGE AND ADMINISTRATION QULIPTA is taken orally with or without food. For episodic migraine, the recommended dosage is 10 mg, 30 mg, or 60 mg taken once daily. For chronic migraine, the recommended dosage is 60 mg taken once daily. Severe Renal Impairment or End-Stage Renal Disease ( 2.2 , 8.6 ): Episodic migraine: 10 mg once daily.
Chronic migraine: Not recommended. 2.1 Recommended Dosage QULIPTA is taken orally with or without food. Episodic Migraine The recommended dosage of QULIPTA for episodic migraine is 10 mg, 30 mg, or 60 mg taken once daily. Chronic Migraine The recommended dosage of QULIPTA for chronic migraine is 60 mg taken once daily. 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 [See table below.] Moderate CYP3A4 Inducers 60 mg Not recommended Weak CYP3A4 Inducers 30 mg or 60 mg 60 mg a OATP Inhibitors 10 mg or 30 mg 30 mg Renal Impairment [see Use in Specific Populations] Severe Renal Impairment and End-Stage Renal Disease (CLcr <30 mL/min) 10 mg Not recommended a Coadministration decreases atogepant exposure.
| Dosage Modifications | Recommended Once Daily Dosage for Episodic Migraine | Usage and Recommended Once Daily Dosage for Chronic Migraine |
| Concomitant Drug [see Drug Interactions (7)] | ||
| Strong CYP3A4 Inhibitors (7.1) | 10 mg | 10 mg |
| Strong CYP3A4 Inducers (7.2) | 60 mga | Not recommended |
| Moderate CYP3A4 Inducers (7.2) | 60 mg | Not recommended |
| Weak CYP3A4 Inducers (7.2) | 30 mg or 60 mg | 60 mga |
| OATP Inhibitors (7.3) | 10 mg or 30 mg | 30 mg |
| Renal Impairment [see Use in Specific Populations (8)] | ||
| Severe Renal Impairment and End-Stage Renal Disease (CLcr <30 mL/min) (8.6) | 10 mg | Not recommended |
Drug interactions
Check atogepant against a medication listLabel text (5 paragraphs)
Recommended dosage modifications: Strong CYP3A4 Inhibitors ( 2.2 , 7.1 ): Episodic or chronic migraine: 10 mg once daily Strong CYP3A4 Inducers ( 2.2 , 7.2 ): Episodic migraine: 60 mg once daily (monitor for reduced efficacy). Chronic migraine: Not recommended. Moderate CYP3A4 Inducers ( 2.2 , 7.2 ): Episodic migraine: 60 mg once daily. Chronic migraine: Not recommended. Weak CYP3A4 Inducers ( 2.2 , 7.2 ): Episodic migraine: 30 mg or 60 mg once daily. Chronic migraine: 60 mg once daily. OATP Inhibitors ( 2.2 , 7.3 ): Episodic migraine: 10 mg or 30 mg once daily. Chronic migraine: 30 mg once daily.
7.1 CYP3A4 Inhibitors Coadministration of QULIPTA with itraconazole, a strong CYP3A4 inhibitor, resulted in a significant increase in exposure of atogepant in healthy subjects [see Clinical Pharmacology ( 12.3 )] . The recommended dosage of QULIPTA with concomitant use of strong CYP3A4 inhibitors is 10 mg once daily [see Dosage and Administration ( 2.2 ) ] . No dosage adjustment of QULIPTA is needed with concomitant use of moderate or weak CYP3A4 inhibitors.
7.2 CYP3A4 Inducers Coadministration of QULIPTA with steady-state rifampin, a strong CYP3A4 inducer and OATP1B1 and OATP1B3 inhibitor, resulted in a significant decrease in exposure of atogepant in healthy subjects [see Clinical Pharmacology ( 12.3 )] . Concomitant administration of QULIPTA with moderate inducers of CYP3A4 can also result in decreased exposure of atogepant. Coadministration of QULIPTA with steady-state topiramate, a weak CYP3A4 inducer, resulted in decreased exposure of atogepant in healthy subjects [see Clinical Phar macology ( 12.3 )] . For episodic migraine, the recommended dosage of QULIPTA with concomitant use of strong or moderate CYP3A4 inducers is 60 mg once daily.
During concomitant use of QULIPTA with strong CYP3A4 inducers, monitor monthly for signs of reduced efficacy, and consider alternative therapies if a reduction in efficacy is observed. The recommended dosage of QULIPTA with concomitant use of weak CYP3A4 inducers is 30 mg or 60 mg once daily [see Dosage and Administration ( 2.2 ) ] . For chronic migraine, concomitant use of strong or moderate CYP3A4 inducers with QULIPTA is not recommended. The recommended dosage of QULIPTA with concomitant use of weak CYP3A4 inducers is 60 mg once daily.
Monitor monthly for signs of reduced efficacy, and consider alternative therapies if a reduction in efficacy is observed [see Dosage and Administration ( 2.2 ) ] . 7 .3 OATP Inhibitors Coadministration of QULIPTA with single dose rifampin, an OATP inhibitor, resulted in a significant increase in exposure of atogepant in healthy subjects [see Clinical Pharmacology ( 12.3 )] . For episodic migraine, the recommended dosage of QULIPTA with concomitant use of OATP inhibitors is 10 mg or 30 mg once daily. For chronic migraine, the recommended dosage of QULIPTA with concomitant use of OATP inhibitors is 30 mg once daily [see Dosage and Administration ( 2.2 ) ] .
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 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
E*Likelihood score E*: Unproven but possibly rate cause of clinically apparent acute liver injury.
Atogepant is a small molecule inhibitor of the calcitonin gene-related peptide (CGRP) receptor that blocks the action of CGRP, a potent vasodilator believed to play a role in migraine headaches. Atogepant is approved for prevention of acute migraine attacks. In clinical trials, atogepant was generally well tolerated with only rare instances of transient serum aminotransferase elevations during therapy and with no reported instances of clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
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 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,…
Breastfeeding (LactMed)
No information is available on the clinical use of atogepant during breastfeeding. However, amounts in breastmilk are low and virtually absent from milk 16 hours after a dose. Atogepant would not be expected to cause any adverse effects in breastfed infants. If atogepant is required by the mother of an older infant, it is not a reason to discontinue breastfeeding, but until more data become available, an alternate drug may be preferred while nursing a newborn or preterm infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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