Migraine, moderate to severe, acute treatment (alternative agent):
Note: Consider use if triptans are contraindicated (eg, cardiovascular risk factors), ineffective, or poorly tolerated. Administration early in the course of a migraine attack, at the first sign of pain, may improve response to treatment (AHS [Ailani 2021]).
Oral: 50 to 100 mg as a single dose; if symptoms persist or return, may repeat dose after ≥2 hours. Maximum: 200 mg per 24 hours (Dodick 2019; 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 15 to 29 mL/minute: 50 mg as a single dose; if symptoms persist or return, may repeat dose after ≥2 hours. Maximum dose: 100 mg per 24 hours.
CrCl <15 mL/minute: Avoid use (has not been studied).
Mild to moderate impairment (Child-Pugh class A, B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): 50 mg as a single dose; if symptoms persist or return, may repeat dose after ≥2 hours. Maximum dose: 100 mg per 24 hours.
Refer to adult dosing; initiate at lower end of the dosing range.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Ubrelvy: 50 mg, 100 mg
No
Oral: Administer with or without food.
Migraine, moderate to severe, acute treatment: Treatment of migraine with or without aura in adults.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Central nervous system: Drowsiness (2% to 3%)
Gastrointestinal: Nausea (4%), xerostomia (2%)
Concomitant use of strong CYP3A4 inhibitors.
Disease-related concerns:
• Hepatic impairment: Dose reduction required in severe hepatic impairment.
• Renal impairment: Use is not recommended in patients with end-stage renal impairment; dose reduction required in severe renal impairment.
Other warnings/precautions:
• Appropriate use: Only indicated for treatment of acute migraine; not indicated for prevention of migraine.
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.
BCRP/ABCG2 Inhibitors: May increase the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with a BCRP inhibitor. Risk D: Consider therapy modification
Ciprofloxacin (Systemic): May increase the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and consider avoiding a second dose for 24 hours when used with ciprofloxacin. Risk D: Consider therapy modification
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CycloSPORINE (Systemic): May increase the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and consider avoiding a second dose for 24 hours when used with cyclosporine. Risk D: Consider therapy modification
CYP3A4 Inducers (Moderate): May decrease the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 100 mg and second dose (if needed) of 100 mg when used with a moderate CYP3A4 inducer. Risk D: Consider therapy modification
CYP3A4 Inducers (Strong): May decrease the serum concentration of Ubrogepant. Risk X: Avoid combination
CYP3A4 Inducers (Weak): May decrease the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 100 mg and second dose (if needed) of 100 mg when used with a weak CYP3A4 inducer. Risk D: Consider therapy modification
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and avoid a second dose for 24 hours when used with moderate CYP3A4 inhibitors. Risk D: Consider therapy modification
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Ubrogepant. Risk X: Avoid combination
CYP3A4 Inhibitors (Weak): May increase the serum concentration of Ubrogepant. Management: In patients taking weak CYP3A4 inhibitors, the initial and second dose (given at least 2 hours later if needed) of ubrogepant should be limited to 50 mg. Risk D: Consider therapy modification
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk X: Avoid combination
Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
FluvoxaMINE: May increase the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and consider avoiding a second dose for 24 hours when used with fluvoxamine. Risk D: Consider therapy modification
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Futibatinib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy
Futibatinib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
Gilteritinib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
Gilteritinib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy
Interleukin-6 (IL-6) Inhibiting Therapies: May decrease the serum concentration of CYP3A4 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
Lasmiditan: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive 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
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
Pacritinib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination
Pacritinib: May increase the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination
Pacritinib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination
P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with a P-gp inhibitor. Risk D: Consider therapy modification
Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
Spironolactone: May increase the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy
St John's Wort: May decrease the serum concentration of Ubrogepant. Risk X: Avoid combination
Taurursodiol: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination
Taurursodiol: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination
Taurursodiol: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk X: Avoid combination
Treosulfan: May increase the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination
Voxilaprevir: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination
Based on data from animal reproduction studies, in utero exposure to ubrogepant may cause fetal harm.
Treatment of migraine 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 2021]). Based on available data, other agents may be preferred for the management of acute migraine in pregnant patients (Burch 2019).
It is not known if ubrogepant 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. Treatment of migraine in lactating patients should be individualized considering the available safety data and needs of the patient (AHS [Ailani 2021]).
Ubrogepant is a calcitonin gene-related peptide receptor antagonist.
Absorption: Administration with a high-fat meal delays Tmax by 2 hours and reduces Cmax by 22%.
Distribution: Vd: 350 L.
Protein binding: Plasma: 87%.
Metabolism: Primarily hepatic via CYP3A4.
Half-life elimination: ~5 to 7 hours.
Time to peak: ~1.5 hours.
Excretion: Feces (42% as unchanged drug); urine (6% as unchanged drug).
Altered kidney function: Absorption, distribution, metabolism, and excretion information and a conservative assumption suggest severe renal impairment is unlikely to cause more than a 2-fold increase in exposure of ubrogepant; however, ubrogepant has not been studied in patients with CrCl <30 mL/minute.
Hepatic function impairment: Ubrogepant exposure increased by 115% in patients with severe hepatic impairment (Child-Pugh class C).
Tablets (Ubrelvy Oral)
50 mg (per each): $112.45
100 mg (per each): $112.46
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