Aquipta Adverse Reactions

Clinical trials experience: The safety of AQUIPTA was evaluated in 2657 patients with migraine who received at least one dose of AQUIPTA. Of these, 1225 patients were exposed to AQUIPTA daily for at least 6 months, and 826 patients were exposed for 12 months.
In 12-week, placebo-controlled clinical studies, 314 patients received at least one dose of AQUIPTA 10 mg once daily, 411 patients received at least one dose of AQUIPTA 30 mg once daily, 343 patients received at least one dose of AQUIPTA 30 mg twice daily, 678 patients received at least one dose of AQUIPTA 60 mg once daily, 91 patients received at least one dose of AQUIPTA 60 mg twice daily, and 663 patients received placebo.
Table 6 summarizes the adverse reactions that occurred during placebo-controlled studies. (See Table 6.)

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The adverse reaction that most commonly led to discontinuation was nausea (0.6%).
Liver Enzyme Elevations: In placebo-controlled studies, the rate of transaminase elevations over 3 times the upper limit of normal was similar between patients treated with AQUIPTA (0.9%) and those treated with placebo (1.2%). There were cases with transaminase elevations over 3 times the upper limit of normal that were temporally associated with AQUIPTA 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 placebo-controlled studies, the proportion of patients with a weight decrease of at least 7% at any point was 3.8% for patients treated with AQUIPTA 10 mg QD, 3.2% for AQUIPTA 30 mg QD, 5.3% for AQUIPTA 30 mg BID, 5.3% for AQUIPTA 60 mg QD, 6.8% for AQUIPTA 60 mg BID, and 2.5% for placebo.
Post marketing experience: The following adverse reactions have been identified during post-approval use of AQUIPTA. 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).