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TOVIAZ®Dosage and Administration (fesoterodine fumarate)

2 DOSAGE AND ADMINISTRATION

2.1 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).

2.2 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).

2.3 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/min8 mg
CLcr 15 to 29 mL/min4 mg
CLcr <15 mL/min 4 mg

2.4 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/1.73m4 mg
eGFR 15 to 29 mL/min/1.73mUse is Not Recommended
eGFR <15 mL/min/1.73m or requiring dialysisUse 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)
Estimated 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.
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.
eGFR 30 to 89 mL/min/1.73m8 mg
eGFR15 to 29 mL/min/1.73m4 mg
eGFR <15 mL/min/1.73m or requiring dialysisUse is Not Recommended

2.5 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).

2.6 Administration Instructions

Swallow Toviaz whole with liquid. Do not chew, divide, or crush. Take with or without food [see Clinical Pharmacology (12.3)].

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