Firialta Special Precautions

Hyperkalemia: Hyperkalemia has been observed in patients treated with Firialta.
Some patients are at a higher risk to develop hyperkalemia. Risk factors include low eGFR, higher serum potassium and previous episodes of hyperkalemia. Consider more frequent monitoring in these patients.
Initiation of Firialta treatment is not recommended if serum potassium >5.0 mmol/L. If serum potassium >4.8 to 5.0 mmol/L, initiation of Firialta treatment may be considered with additional serum potassium monitoring within the first 4 weeks based on patient characteristics and serum potassium levels (see Dosage & Administration).
Withhold Firialta in treated patients if serum potassium >5.5 mmol/L. Follow local guidelines for the management of hyperkalemia. Restart Firialta at 10 mg once daily if serum potassium ≤5.0 mmol/L (see Dosage & Administration).
Remeasure serum potassium and eGFR in all patients 4 weeks after initiation or re-start or up-titration of Firialta treatment. Thereafter, remeasure serum potassium periodically and as needed based on patient characteristics and serum potassium levels (see Dosage & Administration).
Concomitant medications: The risk of hyperkalemia also may increase with the intake of concomitant medications that may increase serum potassium (see Interactions). See also 'Concomitant use of substances that affect finerenone exposure' as follows.
Avoid concomitant use of Firialta with the following medications: potassium-sparing diuretics (e.g., amiloride, triamterene), other mineralocorticoid receptor antagonists (MRAs) (e.g., eplerenone, esaxerenone, spironolactone, canrenone).
Use Firialta with caution and monitor serum potassium when taken concomitantly with the following medications: potassium supplements, trimethoprim, or trimethoprim-sulfamethoxazole. Temporary discontinuation of Firialta may be necessary.
Renal impairment: The risk of hyperkalemia increases with decreasing renal function. Ongoing monitoring of renal function should be performed as needed according to standard practice (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Initiation of Firialta treatment is not recommended in patients with eGFR <25 mL/min/1.73 m² as clinical experience is limited (see Dosage & Administration).
Continue Firialta treatment with caution regarding serum potassium levels in patients with end-stage renal disease (eGFR <15 mL/min/1.73 m²) as clinical experience is limited (see Dosage & Administration).
Hepatic impairment: Patients with severe hepatic impairment (Child-Pugh C) have not been studied (see Pharmacology: Pharmacokinetics under Actions). Due to an expected significant increase in finerenone exposure, avoid use of Firialta in patients with severe hepatic impairment (see Dosage & Administration).
Due to an increase in finerenone exposure, consider additional serum potassium monitoring and adapt monitoring according to patient characteristics in patients with moderate hepatic impairment (Child-Pugh B) (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Concomitant use of substances that affect finerenone exposure: Moderate and weak CYP3A4 inhibitors: The concomitant use of Firialta with moderate CYP3A4 inhibitors (e.g., erythromycin and verapamil) and weak CYP3A4 inhibitors (e.g., amiodarone and fluvoxamine) is expected to increase finerenone exposure (see Interactions). Monitor serum potassium especially during initiation of or changes to dosing of Firialta or the CYP3A4 inhibitor (see Dosage & Administration).
Strong and moderate CYP3A4 inducers: Avoid concomitant use of Firialta with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital, St John's Wort) or moderate CYP3A4 inducers (e.g., efavirenz), which are expected to markedly decrease finerenone plasma concentrations and result in reduced therapeutic effect (see Interactions).
Consider selection of an alternate concomitant medicinal product with no or weak potential to induce CYP3A4.
Grapefruit: Avoid concomitant intake of grapefruit or grapefruit juice as it is expected to increase the plasma concentration of finerenone (see Dosage & Administration and Interactions).
Embryo-fetal toxicity: Animal data have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The relevance for humans is unknown. Firialta should not be used during pregnancy unless there has been careful consideration of the benefit for the mother and the risk to the fetus. If the patient becomes pregnant while taking Firialta, the patient should be informed of potential risks to the fetus. Advise women of childbearing potential to use effective contraception during treatment with Firialta. Advise women not to breastfeed during treatment with Firialta (see Use in Pregnancy & Lactation).
Effects on ability to drive or use machines: No effects on ability to drive and use machines have been observed.