Kerendia Adverse Reactions

Summary of the safety profile: The safety of KERENDIA in patients with chronic kidney disease and 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 KERENDIA (10 or 20 mg once daily) with a mean duration of treatment of 2.2 years. In the FIGARO-DKD study, 3683 patients received KERENDIA (10 or 20 mg once daily) with a mean duration of treatment of 2.9 years.
The most frequently reported (≥10%) adverse reaction was hyperkalaemia. See Description of selected adverse reactions as follows (see Precautions).
Tabulated list of adverse reactions: The adverse reactions reported with KERENDIA are summarised in Table 4 as follows by MedDRA system organ class and by frequency. (See Table 4.)
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); very rare (<1/10,000).
Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

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The data in Table 5 and Table 6 as follows reflect updated frequencies of KERENDIA-ADRs from the pool of two Phase III studies FIGARO-DKD and FIDELIO-DKD with safety population of a total of 6510 subjects who were exposed to KERENDIA and 6489 subjects on placebo. (See Tables 5 and 6.)

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Description of selected adverse reactions: Hyperkalaemia: In the FIDELIO-DKD study including patients with CKD (mean eGFR 44.3 mL/min/1.73 m²) and Type 2 diabetes, hyperkalaemia events were reported in 18.3% of KERENDIA-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 KERENDIA 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 Type 2 diabetes, hyperkalaemia events were reported in 10.8% of KERENDIA-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 KERENDIA group compared to placebo, which remained stable thereafter. In both studies, the majority of hyperkalaemia events were mild to moderate in patients treated with KERENDIA. For specific recommendations, refer to Dosage & Administration and Precautions.
Reporting Suspected Adverse Effects: Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product.