Adverse reactions : תופעות לוואי

6      ADVERSE REACTIONS

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 3.
Table 2: Adverse Reactions Occurring with an Incidence of At Least 2% for QULIPTA and Greater than Placebo in Studies 1, 2 and 3*
Placebo       QULIPTA          QULIPTA         QULIPTA
10 mg             30 mg          60 mg
(N= 663)        (N=314)           (N=411)        (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 * 10 mg and 30 mg incidence from Studies 1 and 2; 60 mg pooled incidence from Studies 1, 2, and 3.

The adverse reactions that most commonly led to discontinuation of QULIPTA in these studies were nausea (0.6%), constipation (0.5%), and fatigue/somnolence (0.2%).
Liver Enzyme Elevations
In Study 1, Study 2, and Study 3, the rate of transaminase elevations over 3 times the upper limit of normal was similar between patients treated with QULIPTA (0.9%) and those treated with placebo (1.2%). However, there were cases with transaminase elevations over 3 times the upper limit of normal that were temporally associated with QULIPTA treatment; these were asymptomatic and resolved within 8 weeks of discontinuation. There were no cases of severe liver injury or jaundice.
Decreases in Body Weight
In Study 1, Study 2, and Study 3, the proportion of patients with a weight decrease of at least 7% at any point was 2.5% for placebo, 3.8% for QULIPTA 10 mg, 3.2% for QULIPTA 30 mg, and 5.3% for QULIPTA 60 mg.

6.2     Postmarketing Experience
The following adverse reactions have been identified during post approval use of QULIPTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Hypersensitivity (e.g., anaphylaxis, dyspnea, rash, pruritus, urticaria, facial edema) [see Contraindications (4) and Warnings and Precautions (5.1)]

Effects on ability to drive and use machines

QULIPTA has no or negligible influence on the ability to drive and use machines.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il