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Dosing

 

 

QULIPTA® dosing

One pill, once a day.1
No titration needed.

RECOMMENDED DOSES

Episodic Migraine 10 mg, 30 mg, or 60 mg taken once daily.

Chronic Migraine 60 mg taken once daily.

USAGE AND DOSE MODIFICATIONS

Episodic Migraine

DRUG INTERACTIONS

  • Strong CYP3A4 Inhibitors: 10 mg once daily
  • CYP3A4 Inducers: 30 mg or 60 mg once daily
  • OATP Inhibitors: 10 mg or 30 mg once daily

USE IN SPECIFIC POPULATIONS

  • Severe Renal Impairment or End-Stage Renal Disease: 10 mg once daily

Severe Hepatic Impairment: Avoid use

Chronic Migraine

DRUG INTERACTIONS

  • Strong CYP3A4 Inhibitors: Avoid use
  • CYP3A4 Inducers: Avoid use
  • OATP Inhibitors: 30 mg once daily

USE IN SPECIFIC POPULATIONS

  • Severe Renal Impairment or End-Stage Renal Disease: Avoid use

Severe Hepatic Impairment: Avoid use

CM=chronic migraine; CYP3A4=Cytochrome P450 3A4; EM=episodic migraine; OATP=organic anion transporting polypeptide.

QULIPTA PHARMACOKINETIC PROFILE

1 to 2 hours:
time to peak plasma concentrations (Tmax)1 11 hours:
elimination half-life1

The clinical significance of these data is not known.

Coadministration of QULIPTA with UBRELVY did not result in significant pharmacokinetic interactions

The Phase 3 studies for UBRELVY and QULIPTA that supported product approval had no patients on concomitant medication that acted on the CGRP pathway.1,7 Clinical conclusions of safety and efficacy should not be drawn from pharmacokinetic studies.

INDICATION

UBRELVY® (ubrogepant) is indicated for the acute treatment of migraine with or without aura in adults. UBRELVY is not indicated for the preventive treatment of migraine.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Drug Interactions: UBRELVY is contraindicated with concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin).

Hypersensitivity Reactions: UBRELVY is contraindicated in patients with a history of serious hypersensitivity to ubrogepant or any ingredient of the product. Cases, including anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus, have been reported. Hypersensitivity reactions can occur minutes, hours, or days after administration. Most reactions were not serious, and some led to discontinuation. If a serious or severe reaction occurs, discontinue UBRELVY and institute appropriate therapy.

ADVERSE REACTIONS

The most common adverse reactions were nausea (4% vs 2% placebo) and somnolence (3% vs 1% placebo).

DRUG INTERACTIONS

  • Strong CYP3A4 Inducers: Should be avoided as concomitant use will result in reduction of ubrogepant exposure.
  • Dose modifications are recommended when using the following:
    • Moderate or weak CYP3A4 inhibitors and inducers
    • BCRP and/or P-gp only inhibitors

DOSAGE AND ADMINISTRATION

  • The recommended dose is 50 mg or 100 mg taken orally, as needed.    
  • If needed, a second dose may be administered at least 2 hours after the initial dose.
  • The maximum dose in a 24-hour period is 200 mg. The safety of treating more than 8 migraines in a 30-day period has not been established.
  • Severe hepatic or severe renal impairment: Recommended dose is 50 mg; if needed, a second 50 mg dose may be taken at least 2 hours after the initial dose.
  • Avoid use in patients with end-stage renal disease.

Please see full Prescribing Information.

 

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