QULIPTA SIDE EFFECTS
- Generic Name: atogepant tablets
- Brand Name: Qulipta
SIDE EFFECTS
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 1958 patients with migraine who received at least one dose of QULIPTA. Of these, 839 patients were exposed to QULIPTA once daily for at least 6 months, and 487 patients were exposed for 12 months.
In the 12-week, placebo-controlled clinical studies (Study 1 and Study 2), 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, 417 patients received at least one dose of QULIPTA 60 mg once daily, and 408 patients received placebo [see Clinical Studies]. Approximately 88% were female, 80% were White, 17% were Black, and 12% 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.
Table 1 summarizes the adverse reactions that occurred during Study 1 and Study 2.
Table 1: Adverse Reactions Occurring with an Incidence of At Least 2% for QULIPTA and Greater than Placebo in Studies 1 and 2
| Placebo (N= 408) % |
QULIPTA 10 mg (N=314) % |
QULIPTA 30 mg (N=411) % |
QULIPTA 60 mg (N=417) % |
|
| Nausea | 3 | 5 | 6 | 9 |
| Constipation | 1 | 6 | 6 | 6 |
| F atigue/ Somnolence | 3 | 4 | 4 | 6 |
| Decreased Appetite | <1 | 2 | 1 | 2 |
The adverse reactions that most commonly led to discontinuation in Studies 1 and 2 were constipation (0.5%), nausea (0.5%), and fatigue/somnolence (0.5%).
Liver Enzyme Elevations
In Study 1 and Study 2, the rate of transaminase elevations over 3 times the upper limit of normal was similar between patients treated with QULIPTA (1.0%) and those treated with placebo (1.8%). 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 Studies 1 and 2, the proportion of patients with a weight decrease of at least 7% at any point was 2.8% for placebo, 3.8% for QULIPTA 10 mg, 3.2% for QULIPTA 30 mg, and 4.9% for QULIPTA 60 mg.
SRC: NLM .