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QULIPTA®
Dosing

QULIPTA DOSING

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Simple once-daily dosing

SIMPLE FOR YOU. SIMPLE FOR YOUR PATIENTS.

No titration or loading dose1

No refrigeration1

No self-injections1

RECOMMENDED DOSES

Episodic Migraine

10 mg, 30 mg, or 60 mg taken once daily

Chronic Migraine

60 mg taken once daily

In a 2024 survey of current QULIPTA users (n=129)2*

96%

said they like having a migraine preventive that is available in a pill rather than an injection2†

*Source: Online survey conducted by Ipsos Healthcare on behalf of AbbVie Inc, between June 16, 2024, and July 16, 2024, among 425 adults aged 18-64, of which 129 were using QULIPTA at the time of the survey.

†Survey respondents could choose from the following to indicate their agreement with the provided statement: strongly disagree, disagree, somewhat disagree, neither disagree nor agree, somewhat agree, agree, or strongly agree. The percentage represents those who answered strongly agree, agree, and somewhat agree.

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QULIPTA DRUG INTERACTIONS 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: 10 mg once daily
  • 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

CYP3A4=Cytochrome P450 3A4; OATP=organic anion transporting polypeptide.

Pharmacological onset and offset

Daily dosing with QULIPTA offers the opportunity to rapidly reach and maintain steady state1,9,10

  • 1 to 2 hours time to peak plasma concentrations (Tmax)1
  • Reaches steady state in 2 to 3 days1,9,10*

Elimination from the body in days, in case of pregnancy or other life events1,10

The effect of QULIPTA on pregnancy has not been clinically evaluated.1

  • 11-hour elimination half-life1
  • Leaves the body in 2 to 3 days after discontinuation1,10

The clinical significance of these data is not known.

*Steady state occurs after 4 to 5 half-lives.10

†Elimination of a drug by 94% to 97% occurs after 4 to 5 half-lives and the concentration in the body is considered no longer clinically relevant in patients with normal hepatic and renal function.10

 

The half-life of a drug is the time it takes for 50% of the drug to be eliminated from the body.10

Coadministration with UBRELVY® (ubrogepant)

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.1,11 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

UBRELVY is contraindicated:

  • With concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin).
  • In patients with a history of serious hypersensitivity to ubrogepant or any ingredient of the product.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: 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.

Hypertension (HTN): Development or worsening of pre-existing HTN has been reported following the use of CGRP antagonists, including UBRELVY. Some patients who developed new onset HTN had risk factors. There were cases requiring initiation of HTN treatment and, in some cases, hospitalization. HTN may occur at any time but was most frequently reported within 7 days of initiation. The CGRP antagonist was discontinued in many of the cases. Monitor patients for new-onset or worsening of pre-existing HTN and consider whether discontinuation of UBRELVY is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.

Raynaud’s phenomenon (RP): Development, recurrence, or worsening of pre-existing RP has been reported following the use of CGRP antagonists, including UBRELVY. In cases with small molecule CGRP antagonists, symptom onset occurred a median of 1.5 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. UBRELVY should be discontinued if signs or symptoms of RP develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of RP should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

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

Please see full Prescribing Information.

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