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Safety

12-WEEK SAFETY PROFILE

QULIPTA® 12-week safety

Safe and well tolerated across patients

ADVERSE REACTIONS
≥ 2% for QULIPTA and greater than placebo¹*

	Placebo (n=663)	QULIPTA 10 mg QD (n=314)	QULIPTA 30 mg QD (n=411)	QULIPTA 60 mg QD (n=678)
Nausea	3%	5%	6%	9%
Constipation	2%	6%	6%	8%
Fatigue/ Somnolence	4%	4%	4%	5%
Decreased appetite	<1%	2%	1%	3%
Dizziness	2%	2%	2%	3%

*QULIPTA 10 mg and QULIPTA 30 mg data are specific to two EM trials; QULIPTA 60 mg data are pooled from one CM trial and two EM trials.

Studies included patients with a history of³:

Gastrointestinal disorders (31%)
Psychiatric disorders (41%)

In all studies, a decrease in weight was observed¹:

The proportion of patients with a weight decrease of at least 7% at any point was 5.3% for QULIPTA 60 mg QD, 3.2% for QULIPTA 30 mg QD, 3.8% for QULIPTA 10 mg QD, and 2.5% for placebo.¹

Discontinuation³:

3.1% of patients (21/663) on placebo discontinued due to adverse events vs patients on QULIPTA 10 mg 4.1% (13/314), QULIPTA 30 mg 3.6% (15/411), or QULIPTA 60 mg 3.1% (21/678).

CM=chronic migraine; EM=episodic migraine.

52-WEEK SAFETY PROFILE

Open-label, long-term safety study

Well tolerated across 52 weeks

ADVERSE EVENTS ≥5%³	QULIPTA 60 mg QD (n=543)
Upper respiratory tract infection	10%
Constipation	7%
Nausea	6%
Urinary tract infection	5%

Patient demographics³:

Mean age: 42.5 years (range 18-78)
88.3% Female
76.8% White
15.7% Hispanic or Latino

A decrease in weight was observed³:

The proportion of patients with a weight decrease of at least 7% at any point was 24.1% for QULIPTA 60 mg QD.

Discontinuation³:

5.7% of patients (31/543) discontinued QULIPTA 60 mg due to adverse events.

LIMITATIONS: These are observations from the 52-week, open-label safety study. Data from this open-label safety study have limitations as the study was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. Results should be interpreted with these factors in mind.

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INDICATION

QULIPTA^® (atogepant) is indicated for the preventive treatment of migraine in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: Cases, including anaphylaxis, dyspnea, rash, pruritus, urticaria, and facial edema, have been reported with use of QULIPTA. Hypersensitivity reactions can occur days after administration. If a hypersensitivity reaction occurs, discontinue QULIPTA and institute appropriate therapy.

Hypertension (HTN): Development or worsening of pre-existing HTN has been reported following the use of CGRP antagonists, including QULIPTA. 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. QULIPTA was discontinued in many of the cases. Monitor patients for new-onset or worsening of pre-existing HTN, and consider whether discontinuation of QULIPTA 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 QULIPTA. 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. QULIPTA 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 (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence.

Dosage form and strengths: QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets.

US-QLP-250104

Please see full Prescribing Information.

This site is intended for U.S. healthcare professionals only.

INDICATION AND IMPORTANT SAFETY INFORMATION

QULIPTA^® (atogepant) is indicated for the preventive treatment of migraine in adults.

CONTRAINDICATIONS

QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA.

INDICATION AND IMPORTANT SAFETY INFORMATION

QULIPTA^® (atogepant) is indicated for the preventive treatment of migraine in adults.

CONTRAINDICATIONS

QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA.

INDICATION AND IMPORTANT SAFETY INFORMATION

QULIPTA^® (atogepant) is indicated for the preventive treatment of migraine in adults.

CONTRAINDICATIONS

QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA.

INDICATION AND IMPORTANT SAFETY INFORMATION

QULIPTA^® (atogepant) is indicated for the preventive treatment of migraine in adults.

CONTRAINDICATIONS

QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA.

INDICATION

QULIPTA^® (atogepant) is indicated for the preventive treatment of migraine in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: Cases, including anaphylaxis, dyspnea, rash, pruritus, urticaria, and facial edema, have been reported with use of QULIPTA. Hypersensitivity reactions can occur days after administration. If a hypersensitivity reaction occurs, discontinue QULIPTA and institute appropriate therapy.

Hypertension (HTN): Development or worsening of pre-existing HTN has been reported following the use of CGRP antagonists, including QULIPTA. 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. QULIPTA was discontinued in many of the cases. Monitor patients for new-onset or worsening of pre-existing HTN, and consider whether discontinuation of QULIPTA 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 QULIPTA. 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. QULIPTA 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 (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence.

Dosage form and strengths: QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets.

US-QLP-250104