Firialta Dosage/Direction for Use

Method of administration: Oral use.
Tablets may be taken with a glass of water and with or without food (see Pharmacology: Pharmacokinetics under Actions).
Avoid taking Firialta with grapefruit or grapefruit juice (see Precautions and Interactions).
For patients who are unable to swallow whole tablets, Firialta tablet may be crushed and mixed with water or soft foods, such as applesauce, immediately prior to use and administered orally (see Pharmacology: Pharmacokinetics under Actions).
Dosage regimen: The recommended target dose of Firialta is 20 mg once daily.
Initiation of treatment: Initiation of Firialta treatment is recommended when serum potassium ≤4.8 mmol/L. For monitoring of serum potassium, see 'Continuation of treatment' as follows.
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 Precautions).
If serum potassium >5.0 mmol/L, initiation of Firialta treatment is not recommended (see Precautions).
Measure estimated glomerular filtration rate (eGFR) to determine the starting dose. The starting dose of Firialta is: 20 mg once daily if eGFR ≥60 mL/min/1.73 m² or 10 mg once daily if eGFR ≥25 to <60 mL/min/1.73 m².
Initiation of Firialta treatment is not recommended in patients with eGFR <25 mL/min/1.73 m² as clinical experience is limited.
Continuation of treatment: Four weeks after initiation or re-start or up-titration of Firialta treatment, remeasure serum potassium and eGFR. See Table 3 to determine continuation of Firialta treatment and dose adjustment.
Thereafter, remeasure serum potassium periodically and as needed based on patient characteristics and serum potassium levels (see Precautions and Interactions). (See Table 3.)

Click on icon to see table/diagram/image

Missed doses: A missed dose should be taken as soon as possible after it is noticed, but only on the same day. If this is not possible, the dose should be skipped, and the next dose taken as prescribed. Two doses should not be taken to make up for a missed dose.
The maximum daily dose of Firialta is 20 mg.
Additional information on special populations: Patients with renal impairment: Initiation of Firialta treatment: In patients with eGFR >25 to <60 mL/min/1.73 m², the starting dose of Firialta is 10 mg once daily. See Initiation of treatment as previously mentioned.
In patients with eGFR <25 mL/min/1.73 m², initiation of Firialta treatment is not recommended as clinical experience is limited (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Continuation of Firialta treatment: In patients with mild, moderate or severe renal impairment, continue Firialta treatment and adjust dose based on serum potassium. Measure eGFR 4 weeks after initiation to determine up-titration. See Table 3 and Continuation of treatment as previously mentioned.
In patients with end-stage renal disease (eGFR <15 mL/min/1.73 m²), continue Firialta treatment with caution regarding serum potassium levels as clinical experience is limited (see Precautions).
Patients with hepatic impairment: In patients with severe hepatic impairment (Child-Pugh C), avoid treatment with Firialta (see Precautions and Pharmacology: Pharmacokinetics under Actions). In patients with mild or moderate hepatic impairment, no initial dose adjustment is required (Child-Pugh A or B) (see Pharmacology: Pharmacokinetics under Actions).
In patients with moderate hepatic impairment (Child-Pugh B), consider additional serum potassium monitoring and adapt monitoring according to patient characteristics (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Patients taking concomitant medications: In patients taking Firialta concomitantly with moderate or weak CYP3A4 inhibitors, potassium supplements, trimethoprim, or trimethoprim-sulfamethoxazole, consider additional serum potassium monitoring and adapt monitoring according to patient characteristics and make Firialta treatment decisions as directed in Table 3. Temporary discontinuation of Firialta when taking trimethoprim, or trimethoprim-sulfamethoxazole, may be necessary (see Precautions and Interactions).
Pediatric patients: The safety and efficacy of Firialta have not been established in patients under 18 years of age. Therefore, Firialta is not recommended for use in pediatric patients.
Geriatric patients: No dose adjustment is required in the elderly (see Pharmacology: Pharmacokinetics under Actions).
Gender: No dose adjustment is required based on gender (see Pharmacology: Pharmacokinetics under Actions).
Body weight: No dose adjustment is required based on body weight (see Pharmacology: Pharmacokinetics under Actions).
Ethnic differences: No dose adjustment is required based on ethnic differences (see Pharmacology: Pharmacokinetics under Actions).
Smoking status: No dose adjustment is required based on smoking status (see Pharmacology: Pharmacokinetics under Actions).