Firialta Special Precautions

Hyperkalemia: Firialta can cause hyperkalemia [see Clinical Trials Experience under Adverse Reactions].
The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with Firialta and dose accordingly [see Prior to Initiation of Firialta under Dosage & Administration]. Do not initiate Firialta if serum potassium is > 5.0 mEq/L.
Measure serum potassium periodically during treatment with Firialta and adjust dose accordingly [see Monitoring and Dose Adjustment under Dosage & Administration]. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium [see CYP3A4 Inhibitors and Inducers and Drugs That Affect Serum Potassium under Interactions].
Hepatic Impairment: Avoid use of Firialta in patients with severe hepatic impairment (Child Pugh C).
No dosage adjustment is recommended in patients with mild or moderate hepatic impairment (Child Pugh A or B).
Consider additional serum potassium monitoring in patients with moderate hepatic impairment (Child Pugh B) [see Monitoring and Dose Adjustment under Dosage & Administration and PHARMACOLOGY: Pharmacokinetics under Actions].
Use in Children: The safety and efficacy of Firialta have not been established in patients below 18 years of age.
Use in the Elderly: Of the 2827 patients who received Firialta in the FIDELIO-DKD study, 58% of patients were 65 years and older, and 15% were 75 years and older. No overall differences in safety or efficacy were observed between these patients and younger patients. No dose adjustment is required.