Firialta Adverse Reactions

Summary of the safety profile: The safety of Firialta in patients with chronic kidney disease associated with type 2 diabetes was evaluated in two pivotal phase III studies, FIDELIO-DKD and FIGARO-DKD. In the FIDELIO-DKD study, 2,827 patients received Firialta (10 or 20 mg once daily) with a mean duration of treatment of 2.2 years. In the FIGARO-DKD study, 3683 patients received Firialta (10 or 20 mg once daily) with a mean duration of treatment of 2.9 years.
The most frequently reported (≥10%) adverse reaction was hyperkalemia. See 'Description of selected adverse reactions' as follows (see Precautions).
Tabulated list of adverse reactions: The adverse reactions reported with Firialta are summarized in Table 4 as follows by MedDRA system organ class and by frequency.
Adverse reactions are ranked by system organ class and then by frequency with the most frequent first, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness. (See Table 4.)

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Description of selected adverse reactions: Hyperkalemia: In the FIDELIO-DKD study including patients with CKD (mean eGFR 44.3 mL/min/1.73 m²) and T2D, hyperkalemia events were reported in 18.3% of Firialta-treated patients compared with 9.0% of placebo-treated patients. An increase from baseline in mean serum potassium in the first month of treatment of approximately 0.2 mmol/L was observed in the Firialta group compared to placebo, which remained stable thereafter. In the FIGARO-DKD study including patients with CKD (mean eGFR 67.8 mL/min/1.73 m²) and T2D, hyperkalemia events were reported in 10.8% of Firialta-treated patients compared with 5.3% of placebo-treated patients. An increase from baseline in mean serum potassium in the first month of treatment of approximately 0.15 mmol/L was observed in the Firialta group compared to placebo, which remained stable thereafter. In both studies, the majority of hyperkalemia events were mild to moderate in patients treated with Firialta. For specific recommendations, refer to Dosage & Administration and Precautions.