Fesoterodinedosage

OAB in Adults: The recommended starting dosage is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of 8 mg once daily.

NDO in Pediatric Patients 6 Years and Older:

Pediatric Patients Weighing Greater than 25 kg and up to 35 kg: The recommended dosage is 4 mg orally once daily. If needed, dosage may be increased to 8 mg orally once daily.

Pediatric Patients Weighing Greater than 35 kg: The recommended starting dosage is 4 mg orally once daily. After one week, increase to 8 mg orally once daily.

Adult or Pediatric Patients with Renal Impairment: Refer to the full prescribing information for recommended dosage.

Dosage Modifications Due to Strong CYP3A4 Inhibitors: Refer to the full prescribing information for recommended dosage.

Administration: Swallow whole with liquid. Do not chew, divide, or crush. Take with or without food.

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.

2.2 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. 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.

2.3 Recommended

Dosage in Adult Patients With Renal Impairment The recommended dosage of Toviaz in adult patients with renal impairment is described in Table 1. For administration instructions, see Dosage and Administration.

Table 1: Toviaz Recommended Dose in Adult Patients With Renal Impairment (Administered Orally Once Daily) Estimated Creatinine Clearance Calculate CLcr using the Cockcroft-Gault formula Recommended Dose CLcr 30 to 89 mL/min 8 mg CLcr 15 to 29 mL/min 4 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. For administration instructions, see Dosage and Administration.

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) Estimate GFR using a validated GFR estimating equation for the pediatric age range of the approved indication. Recommended Dose 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/1.73m 2 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. For administration instructions, see Dosage and Administration.

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 Estimate GFR using a validated GFR estimating equation for the pediatric age range of the approved indication. Recommended Dose 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 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. 8 mg eGFR15 to 29 mL/min/1.73m 4 mg eGFR <15 mL/min/1.73m 2 or requiring dialysis Use 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. For administration instructions, see Dosage and Administration. 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. For administration instructions, see Dosage and Administration. 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. For administration instructions, see Dosage and Administration.

2.6 Administration

Instructions Swallow Toviaz whole with liquid. Do not chew, divide, or crush. Take with or without food.