Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypertension [see Warnings and Precautions ( 5.2 )] Raynaud’s Phenomenon [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of QULIPTA was evaluated in 2657 patients with migraine who received at least one dose of QULIPTA.
Of these, 1225 patients were exposed to QULIPTA for at least 6 months, and 826 patients were exposed for 12 months.
In the 12-week, placebo-controlled clinical studies (Studies 1, 2, and 3), 314 patients received at least one dose of QULIPTA 10 mg once daily, 411 patients received at least one dose of QULIPTA 30 mg once daily, 678 patients received at least one dose of QULIPTA 60 mg once daily, and 663 patients received placebo [see Clinical Studies ( 14 ) ] .
Approximately 88% were female, 75% were White, 13% were Black, 10% were Asian, and 10% were of Hispanic or Latino ethnicity.
The mean age at study entry was 41 years (range 18 to 74 years).
The most common adverse reactions (incidence at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence.
Table 2 summarizes the adverse reactions that occurred during Studies 1, 2, and
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: If a hypersensitivity reaction occurs, discontinue QULIPTA and initiate appropriate therapy.
Severe hypersensitivity reactions have included anaphylaxis and dyspnea.
These reactions can occur days after administration.
( 5.1 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur.
( 5.2 ) Raynaud’s phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur.
Like all medications, Qulipta can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: