Firialta Adverse Reactions

The following serious adverse reactions are discussed elsewhere in the monograph: Hyperkalemia [see Hyperkalemia under Precautions].
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 Firialta was evaluated in the randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 study FIDELIO-DKD. In this study, 2827 patients received Firialta (10 or 20 mg once daily) and 2831 received placebo. For patients in the Firialta group, the mean duration of treatment was 2.2 years.
Overall, serious adverse reactions occurred in 32% of patients receiving Firialta and in 34% of patients receiving placebo. Permanent discontinuation due to adverse reactions occurred in 7% of patients receiving Firialta and in 6% of patients receiving placebo. Hyperkalemia led to permanent discontinuation of treatment in 2.3% of patients receiving Firialta versus 0.9% of patients receiving placebo.
The most frequently reported (≥ 10%) adverse reaction was hyperkalemia [see Hyperkalemia under Precautions]. Hospitalization due to hyperkalemia for the Firialta group was 1.4% versus 0.3% in the placebo group.
Table 4 shows adverse reactions in FIDELIO-DKD that occurred more commonly on Firialta than on placebo, and in at least 1% of patients treated with Firialta. (See Table 4.)

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Laboratory Test: Initiation of Firialta may cause an initial small decrease in estimated GFR that occurs within the first 4 weeks of starting therapy, and then stabilizes. In a study that included patients with chronic kidney disease associated with type 2 diabetes, this decrease was reversible after treatment discontinuation.