Migraine, episodic, prevention (alternative agent):
Note: Avoid use in patients with recent cardiovascular or cerebrovascular ischemic events. Limit use to patients with <15 headache days per month, and those with significant disability from frequent migraines who are unable to tolerate or do not respond to adequate trials of other preventive therapies (IHS 2018; Loder 2018; Schwedt 2022). An adequate trial for assessment of effect is considered to be at least 8 weeks at a therapeutic dose (AHS [Ailani 2021a]).
Oral: 10 mg, 30 mg, or 60 mg once daily; maximum: 60 mg/day (Ailani 2021b; manufacturer’s labeling).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: 10 mg once daily.
End-stage renal disease on dialysis: 10 mg once daily; administer after dialysis on dialysis days.
Mild to moderate impairment (Child-Pugh class A, B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): Use is not recommended.
Refer to adult dosing; start at low end of dosing range and use with caution.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Qulipta: 10 mg, 30 mg, 60 mg
No
Oral: May be administered without regard to meals.
Migraine, episodic, prevention: Preventive treatment of episodic migraine in adults.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
1% to 10%:
Endocrine & metabolic: Weight loss (4% to 5%)
Gastrointestinal: Constipation (6%), decreased appetite (1% to 2%), nausea (5% to 9%)
Nervous system: Drowsiness (≤6%), fatigue (≤6%)
Frequency not defined: Hepatic: Increased serum transaminases (>3 x ULN)
There are no contraindications listed in the manufacturer's labeling.
Disease-related concerns:
• Hepatic impairment: Use is not recommended in patients with severe hepatic impairment.
• Renal impairment: Dose reduction required in severe and end-stage renal impairment.
Substrate of BCRP/ABCG2, CYP3A4 (major), OAT1/3, OATP1B1/1B3 (SLCO1B1/1B3), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CYP3A4 Inducers (Moderate): May decrease the serum concentration of Atogepant. Management: The recommended dose of atogepant is 30 mg once daily or 60 mg once daily when combined with strong or moderate CYP3A4 inducers. Risk D: Consider therapy modification
CYP3A4 Inducers (Strong): May decrease the serum concentration of Atogepant. Management: The recommended dose of atogepant is 30 mg once daily or 60 mg once daily when combined with strong or moderate CYP3A4 inducers. Risk D: Consider therapy modification
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Atogepant. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Atogepant. Management: The recommended dose of atogepant is 10 mg once daily when coadministered with strong CYP3A4 inhibitors. Risk D: Consider therapy modification
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors: May increase the serum concentration of Atogepant. Management: The recommended dose of atogepant when coadministered with OATP1B1/1B3 inhibitors is 10 mg once daily or 30 mg once daily. Risk D: Consider therapy modification
RifAMPin: May decrease the serum concentration of Atogepant. Specifically, atogepant concentrations may be reduced with daily dosing of rifampin. RifAMPin may increase the serum concentration of Atogepant. Specifically, increases in atogepant exposure may occur with single dose of rifampin or at the initiation of rifampin therapy. Management: When administered with single dose rifampin, or at rifampin initiation, the atogepant dose should be 10 mg once daily or 30 mg once daily. When administered with daily dosing of rifampin, the atogepant dose should be 30 mg once daily or 60 mg once daily. Risk D: Consider therapy modification
Voclosporin: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
In general, preventive treatment for migraine in patients trying to become pregnant should be avoided; treatment should be individualized considering the available safety data and needs of the patient should pregnancy occur (AHS [Ailani 2021a]).
Adverse events were observed in animal reproduction studies following oral administration of atogepant in doses greater than the recommended human dose.
In general, preventive treatment for migraine in pregnant patients should be avoided; treatment during pregnancy should be individualized considering the available safety data, the potential for adverse maternal and fetal events, and needs of the patient (AHS [Ailani 2021a]). Based on available data, other agents may be preferred for the prevention of migraine in pregnant patients (Burch 2019).
It is not known if atogepant is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. In general, preventive treatment for migraine in lactating patients should be avoided; when treatment is needed, therapy should be individualized considering the available safety data and needs of the patient (AHS [Ailani 2021a]).
Kidney and liver function (baseline and as clinically indicated).
Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist.
Distribution: Vd: 292 L.
Protein binding: ~98% (Boinpally 2021).
Metabolism: Primarily hepatic via CYP3A4.
Half-life elimination: ~11 hours.
Time to peak: ~1 to 2 hours.
Excretion: Feces (~42% as unchanged drug); urine (~5% as unchanged drug).
Tablets (Qulipta Oral)
10 mg (per each): $39.64
30 mg (per each): $39.64
60 mg (per each): $39.64
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