Version May 2024
Note: Avoid use in patients with recent cardiovascular or cerebrovascular ischemic events. Limit use to patients with significant disability from frequent migraines who are unable to tolerate or do not respond to adequate trials of at least 2 other preventive therapies (Ref). An adequate trial for assessment of effect is considered to be at least 8 weeks at a therapeutic dose (Ref).
Migraine, chronic, prevention (alternative agent): Oral: 60 mg once daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Migraine, chronic, prevention:
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: Avoid use.
Migraine, episodic, prevention:
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: 10 mg once daily.
Hemodialysis, intermittent (thrice weekly): 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.
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% to 8%), decreased appetite (1% to 3%), nausea (5% to 9%)
Nervous system: Dizziness (3%), drowsiness (≤5%), fatigue (≤5%)
Frequency not defined: Hepatic: Increased serum transaminases (>3 x ULN)
Postmarketing: Hypersensitivity: Hypersensitivity reaction (including anaphylaxis)
Hypersensitivity (eg, anaphylaxis, dyspnea) to atogepant or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity reactions: Anaphylaxis, dyspnea, facial edema, pruritus, rash, and/or urticaria may occur. Hypersensitivity reactions may occur days after administration. If a hypersensitivity reaction occurs, discontinue therapy and administer appropriate therapy.
Disease-related concerns:
• Hepatic impairment: Use is not recommended in patients with severe hepatic impairment.
• Renal impairment: Dose reduction or avoidance of use required in severe and end-stage renal impairment.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Qulipta: 10 mg, 30 mg, 60 mg
No
Tablets (Qulipta Oral)
10 mg (per each): $43.70
30 mg (per each): $43.70
60 mg (per each): $43.70
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Qulipta: 10 mg, 30 mg, 60 mg
Oral: May be administered without regard to meals.
Migraine, episodic or chronic, prevention: Preventive treatment of episodic or chronic migraine in adults.
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.
Adalimumab: May decrease the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
Asciminib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
Bimekizumab: May decrease the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
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: For treatment of episodic migraine, the recommended dose of atogepant is 30 mg once daily or 60 mg once daily when combined with CYP3A4 inducers. When used for treatment of chronic migraine, use of atogepant with CYP3A4 inducers should be avoided. Risk D: Consider therapy modification
CYP3A4 Inducers (Strong): May decrease the serum concentration of Atogepant. Management: For treatment of episodic migraine, the recommended dose of atogepant is 30 mg once daily or 60 mg once daily when combined with CYP3A4 inducers. When used for treatment of chronic migraine, use of atogepant with CYP3A4 inducers should be avoided. Risk D: Consider therapy modification
CYP3A4 Inducers (Weak): May decrease the serum concentration of Atogepant. Management: For treatment of episodic migraine, the recommended dose of atogepant is 30 mg once daily or 60 mg once daily when combined with CYP3A4 inducers. When used for treatment of chronic migraine, use of atogepant with CYP3A4 inducers should be avoided. 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: For treatment of episodic migraine, the recommended atogepant dose is 10 mg once daily with a concurrent strong CYP3A4 inhibitor. If used for treatment of chronic migraine, concurrent use of atogepant with strong CYP3A4 inhibitors should be avoided. Risk D: Consider therapy modification
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
Enasidenib: May increase the serum concentration of Atogepant. Enasidenib may decrease the serum concentration of Atogepant. Management: Consider avoiding this combination if possible, as enasidenib is both an OATP1B1/1B3 inhibitor and weak CYP3A4 inducer, with unknown net effects on atogepant exposure. Risk D: Consider therapy modification
Encorafenib: May increase the serum concentration of Atogepant. Encorafenib may decrease the serum concentration of Atogepant. Management: Consider avoiding this combination if possible, as encorafenib is both a strong CYP3A4 inducer and an OATP1B1/1B3 inhibitor, with unknown net effects on atogepant exposure. Risk D: Consider therapy modification
Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk X: Avoid combination
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
Interleukin-6 (IL-6) Inhibiting Therapies: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
Interleukin-6 (IL-6) Inhibiting Therapies: May decrease the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Management: Consider alternatives to this combination when possible. If combined, monitor for decreased effectiveness of these CYP3A4 substrates if combined with ivosidenib. Risk D: Consider therapy modification
Leniolisib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination
Mavacamten: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors: May increase the serum concentration of Atogepant. Management: For episodic migraine, the recommended atogepant dose is 10 mg or 30 mg once daily if given with OATP1B1/1B3 inhibitors. For chronic migraine, the recommended atogepant dose is 30 mg once daily with OATP1B1/1B3 inhibitors. Risk D: Consider therapy modification
Olutasidenib: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Management: Avoid use of olutasidenib with sensitive or narrow therapeutic index CYP3A4 substrates when possible. If concurrent use with olutasidenib is unavoidable, monitor closely for evidence of decreased concentrations of the CYP3A4 substrates. Risk D: Consider therapy modification
Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
Pretomanid: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
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: Episodic migraine: atogepant dose should be 10 mg or 30 mg once daily with single dose rifampin, or 30 mg or 60 mg once daily with daily rifampin. Chronic migraine: avoid atogepant with daily rifampin; with single dose rifampin, use atogepant 30 mg daily. Risk D: Consider therapy modification
Sotagliflozin: May decrease the serum concentration of Atogepant. Sotagliflozin may increase the serum concentration of Atogepant. Management: For treatment of episodic migraine, the recommended dose of atogepant is 30 mg once daily or 60 mg once daily when combined with sotagliflozin. When used for treatment of chronic migraine, use of atogepant with sotagliflozin should be avoided. Risk D: Consider therapy modification
Taurursodiol: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk X: Avoid combination
Trofinetide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Management: Avoid concurrent use with OATP1B1/1B3 substrates for which small changes in exposure may be associated with serious toxicities. Monitor for evidence of an altered response to any OATP1B1/1B3 substrate if used together with trofinetide. Risk D: Consider therapy modification
Ustekinumab: May decrease the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
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. Options for patients planning a pregnancy should be considered as part of a shared decision-making process. Nonpharmacologic interventions should be considered initially. When needed, preventive treatment should be individualized considering the available safety data and needs of the patient should pregnancy occur. A gradual discontinuation of preventive medications is generally preferred when the decision is made to stop treatment prior to conception (ACOG 2022; AHS [Ailani 2021a]).
Adverse events were observed in animal reproduction studies following oral administration of atogepant in doses greater than the recommended human dose.
Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. Based on animal data, CGRP may help regulate placental blood flow, uterine relaxation, and maintain BP; CGRP antagonists could potentially increase the risk of gestational hypertension and preeclampsia (Dodick 2019). The risk of hypertensive disorders, including preeclampsia and eclampsia, are also increased in pregnant patients with migraine (ACOG 2022; Dodick 2019).
In general, preventive treatment for migraine should be avoided during pregnancy. Options for pregnant patients should be considered as part of a shared decision-making process. Nonpharmacologic interventions should be considered initially. When needed, preventive treatment should be individualized considering the available safety data, the potential for adverse maternal and fetal events, and needs of the patient (ACOG 2022; AHS [Ailani 2021a]). Oral CGRP receptor antagonists are not currently recommended for the prevention of migraine in pregnant patients due to lack of data (ACOG 2022).
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 needed, therapy should be individualized considering the available safety data and needs of the patient (AHS [Ailani 2021a]). Oral calcitonin gene-related peptide receptor antagonists are not currently recommended for the prevention of migraine in lactating patients due to lack of data (ACOG 2022).
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).
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