What are the adverse reactions of Aila Gokna?

The safety of ALAGONA was evaluated in 2 6-month, randomized, double-blind, placebo-controlled clinical trials [EM-1 (NCT01620528) and EM-2 (NCT01931670)], in which a total of 952 adult women with moderate to severe pain associated with endometriosis were treated with ALAGONA (475 at 150 mg once daily and 477 at 200 mg twice daily) and 734 patients received placebo. The age range of the population is 18-49 years old. Women who completed 6 months of treatment and met eligibility criteria continued treatment in two uncontrolled, blinded, 6-month extension trials [EM-3(NCT01760954) and EM-4(NCT02143713)] for a total treatment duration of up to 12 months.

serious adverse events

Overall, the most common serious adverse events reported by subjects treated in the two placebo-controlled clinical trials (Studies EM-1 and EM-2) included appendicitis (0.3%), abdominal pain (0.2%), and back pain (0.2%). In these trials, 0.2% of subjects treated with ALAGONA 150 mg once daily and 0.2% of subjects treated with ALAGONA 200 mg twice daily discontinued treatment due to serious adverse reactions, compared with 0.5% in the placebo group.

Adverse reactions leading to study discontinuation

In two placebo-controlled clinical trials (Studies EM-1 and EM-2), 5.5% of subjects in the Elagokna 150 mg once-daily group and 9.6% of patients in the Elagokna 200 mg twice-daily group discontinued treatment due to adverse reactions, while 6.0% of subjects in the placebo-treated group discontinued treatment due to adverse reactions. The most common reasons for discontinuation were hot flashes or night sweats (1.1% in the 150 mg once-daily group and 2.5% in the 200 mg twice-daily group) and nausea (0.8% in the 150 mg once-daily group and 1.5% in the 200 mg twice-daily group), and were dose-related. Most discontinuations due to hot flashes or night sweats (10/17, 59%) and nausea (7/11, 64%) occurred within the first 2 months of treatment.

In two extension trials (Studies EM-3 and EM-4), the most common reason for discontinuation was a decrease in BMD and was dose-related. In these trials, 0.3% of subjects in the Elagokana 150 mg once-daily group and 3.6% of patients in the Elagokana 200 mg twice-daily group discontinued treatment due to decreased BMD.

The most common adverse reactions in the Elagokna trial were hot flashes (24%), headache (17%), nausea (11%), insomnia (6%), mood changes, mood swings (6%), amenorrhea (4%), depressed mood, depression, depressive symptoms and/or tearing (3%), anxiety (3%), and joint pain (3%).

It is recommended that patients take medication according to the doctor's instructions, pay attention to physical reactions, and if they are intolerant, contact the doctor in time for symptomatic treatment.

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