Toviaz Dosage

Generic name: FESOTERODINE FUMARATE 4mg
Dosage form: tablet, film coated, extended release
Drug class: Urinary antispasmodics

Medically reviewed by Drugs.com. Last updated on Mar 4, 2024.

Recommended Dosage for Adult Patients With OAB

The recommended starting dosage of Toviaz in adults is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of Toviaz 8 mg once daily. For administration instructions, see Dosage and Administration (2.6).

Recommended Dosage for Pediatric Patients Aged 6 Years and Older With NDO

Pediatric Patients Weighing Greater than 25 kg and up to 35 kg

The recommended dosage of Toviaz is 4 mg orally once daily. If needed, dosage may be increased to Toviaz 8 mg orally once daily. For administration instructions, see Dosage and Administration (2.6).

Pediatric Patients Weighing Greater than 35 kg

The recommended starting dosage of Toviaz is 4 mg orally once daily. After one week, increase to Toviaz 8 mg orally once daily. For administration instructions, see Dosage and Administration (2.6).

Recommended Dosage in Adult Patients With Renal Impairment

The recommended dosage of Toviaz in adult patients with renal impairment is described in Table 1 [see Use in Specific Populations (8.6)]. For administration instructions, see Dosage and Administration (2.6).

Table 1: Toviaz Recommended Dose in Adult Patients With Renal Impairment (Administered Orally Once Daily)
Estimated Creatinine Clearance*	Recommended Dose
* Calculate CLcr using the Cockcroft-Gault formula
CLcr 30 to 89 mL/min	8 mg
CLcr 15 to 29 mL/min	4 mg
CLcr <15 mL/min	4 mg

Recommended Dosage in Pediatric Patients With Renal Impairment

Pediatric Patients Weighing Greater than 25 kg and up to 35 kg

The recommended dosage of Toviaz in pediatric patients with renal impairment weighing greater than 25 kg and up to 35 kg is described in Table 2 [see Use in Specific Populations (8.6)]. For administration instructions, see Dosage and Administration (2.6).

Table 2: Toviaz Recommended Dose in Pediatric Patients Aged 6 Years and Older Weighing Greater Than 25 kg and up to 35 kg With Renal Impairment (Administered Orally Once Daily)
Estimated Glomerular Filtration Rate (GFR)*	Recommended Dose†
* Estimate GFR using a validated GFR estimating equation for the pediatric age range of the approved indication. † Dosing was derived assuming similar proportional effects of renal impairment in adults and pediatric patients 6 years and older.
eGFR 30 to 89 mL/min/1.73m†	4 mg
eGFR 15 to 29 mL/min/1.73m†	Use is Not Recommended
eGFR <15 mL/min/1.73m2 or requiring dialysis	Use is Not Recommended

Pediatric Patients weighing greater than 35 kg

The recommended dosage of Toviaz in pediatric patients with renal impairment weighing greater than 35 kg is described in Table 3 [see Use in Specific Populations (8.6)]. For administration instructions, see Dosage and Administration (2.6).

Table 3: Toviaz Recommended Dose in Pediatric Patients Aged 6 Years and Older Weighing Greater Than 35 kg With Renal Impairment (Administered Orally Once Daily)

* Estimate GFR using a validated GFR estimating equation for the pediatric age range of the approved indication. † Dosing was derived assuming similar proportional effects of renal impairment in adults and pediatric patients 6 years and older. ‡ The recommended starting dosage of Toviaz is 4 mg orally once daily. After one week, increase to the recommended dosage of Toviaz 8 mg orally once daily.
Estimated GFR*	Recommended Dose†
eGFR 30 to 89 mL/min/1.73m‡	8 mg‡
eGFR15 to 29 mL/min/1.73m‡	4 mg
eGFR <15 mL/min/1.73m2 or requiring dialysis	Use is Not Recommended

Toviaz Dosage Modifications Due to Strong CYP3A4 Inhibitors

Adult Patients with OAB

The maximum recommended dosage is Toviaz 4 mg orally once daily in adult patients taking strong CYP3A4 inhibitors [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)]. For administration instructions, see Dosage and Administration (2.6).

Pediatric Patients with NDO

Pediatric Patients Weighing Greater than 25 kg and up to 35 kg

The use of Toviaz in pediatric patients weighing greater than 25 kg and up to 35 kg and taking strong CYP3A4 inhibitors is not recommended [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)]. For administration instructions, see Dosage and Administration (2.6).

Pediatric Patients Weighing Greater than 35 kg

The maximum recommended dosage is Toviaz 4 mg orally once daily in pediatric patients weighing greater than 35 kg and taking strong CYP3A4 inhibitors [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)]. For administration instructions, see Dosage and Administration (2.6).