TOVIAZ- fesoterodine fumarate tablet, film coated, extended release

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

FESOTERODINE FUMARATE (UNII: EOS72165S7) (FESOTERODINE - UNII:621G617227)

제공처:

Pfizer Laboratories Div Pfizer Inc

INN (국제 이름):

FESOTERODINE FUMARATE

구성:

FESOTERODINE FUMARATE 4 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Toviaz is indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. Toviaz is indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older with a body weight greater than 25 kg. Toviaz is contraindicated in patients with any of the following: Risk Summary There are no available data with the use of Toviaz in pregnant women and adolescents to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times respectively the maximum recommended human dose (MRHD) of 8 mg/day, based on AUC (see Data) . The background risk of major birth defects and miscarriage for the indicated population are unknown. However, in the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Animal Data No dose-related teratogenicity was observed in reproduction studies performed in mice and rabbits. In mice at 6 to 27 times the expected exposure at the maximum recommended human dose (MRHD) of 8 mg based on AUC (75 mg/kg/day, oral), increased resorptions and decreased live fetuses were observed. One fetus with cleft palate was observed at each dose (15, 45, and 75 mg/kg/day), at an incidence within the background historical range. In rabbits treated at 3 to 11 times the MRHD (27 mg/kg/day, oral), incompletely ossified sternebrae (retardation of bone development) and reduced survival were observed in fetuses. In rabbits at 9 to 11 times the MRHD (4.5 mg/kg/day, subcutaneous), maternal toxicity and incompletely ossified sternebrae were observed in fetuses (at an incidence within the background historical range). In rabbits at 3 times the MRHD (1.5 mg/kg/day, subcutaneous), decreased maternal food consumption in the absence of any fetal effects was observed. Oral administration of 30 mg/kg/day fesoterodine to mice in a pre- and post-natal development study resulted in decreased body weight of the dams and delayed ear opening of the pups. No effects were noted on mating and reproduction of the F1 dams or on the F2 offspring. Risk Summary There is no information on the presence of fesoterodine in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Toviaz and any potential adverse effects on the breastfed child from Toviaz or from the underlying maternal condition. The safety and effectiveness of Toviaz have been established for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 6 years and older and weighing greater than 25 kg. The information on this use is discussed throughout labeling. Use of Toviaz for treatment of NDO is supported by evidence from a randomized, open-label trial with an initial 12-week efficacy phase followed by a 12-week safety extension phase in pediatric patients from 6 years to 17 years of age (Study 3) [see Adverse Reactions (6.1) and Clinical Studies (14.2)]. Study results demonstrated that treatment with Toviaz 4 mg and 8 mg daily resulted in improvements from baseline to Week 12 in maximum cystometric bladder capacity (MCBC) for patients weighing greater than 25 kg [see Clinical Studies (14.2) and Clinical Pharmacology (12.3)] . The most commonly reported adverse reactions in patients who received Toviaz 4 mg or 8 mg in Study 3 (≥2%) were diarrhea, UTI, dry mouth, constipation, abdominal pain, nausea, weight increase and headache [see Adverse Reactions (6.1)]. Mean increases from baseline in heart rate were reported with both the 4 mg and 8 mg daily doses of Toviaz, with larger mean increases reported in pediatric patients who received the 8 mg daily dose [see Adverse Reactions (6.1)]. The safety and effectiveness of Toviaz have not been established in pediatric patients younger than 6 years of age or weighing 25 kg or less. No dose adjustment is recommended for the elderly. The pharmacokinetics of fesoterodine are not significantly influenced by age. Of the 1,567 patients who received Toviaz 4 mg or 8 mg orally once daily in Phase 2 and 3, placebo-controlled, efficacy and safety studies for OAB, 515 (33%) were 65 years of age or older, and 140 (9%) were 75 years of age or older. No overall difference in effectiveness was observed between patients younger than 65 years of age and those 65 years of age or older in these studies. However, the incidence of antimuscarinic adverse reactions, including dry mouth, constipation, dyspepsia, increase in residual urine, dizziness (8 mg only) and urinary tract infection, was higher in patients 75 years of age and older as compared to younger patients [see Clinical Studies (14.1) and Adverse Reactions (6)]. In adult patients with severe renal impairment (CLCR <30 mL/min), Cmax and AUC are increased 2.0- and 2.3-fold, respectively. Doses of Toviaz greater than 4 mg are not recommended in adult patients with severe renal impairment. In patients with mild or moderate renal impairment (CLCR ranging from 30–80 mL/min), Cmax and AUC of the active metabolite are increased up to 1.5- and 1.8-fold, respectively, as compared to healthy subjects. No dose adjustment is recommended in patients with mild or moderate renal impairment [see Clinical Pharmacology (12.3) and Dosage and Administration (2.2, 2.3 )] . The recommended dosage of Toviaz in pediatric patients weighing greater than 25 kg and up to 35 kg with mild-to-moderate renal impairment (eGFR 30 to 89 mL/min/1.73m2 ) is 4 mg once daily and Toviaz is not recommend in those with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2 ). In pediatric patients weighing greater than 35 kg with mild-to-moderate renal impairment (eGFR 30 to 89 mL/min/1.73m2 ), the recommended starting dosage of Toviaz is 4 mg orally once daily, with increase to the recommended dosage of Toviaz 8 mg orally once daily, and in those with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2 ) the recommended dose is 4 mg once daily [see Dosage and Administration (2.2, 2.4)] . Patients with severe hepatic impairment (Child-Pugh C) have not been studied; therefore Toviaz is not recommended for use in these patients. In patients with moderate (Child-Pugh B) hepatic impairment, Cmax and AUC of the active metabolite are increased 1.4- and 2.1-fold, respectively, as compared to healthy subjects. No dose adjustment is recommended in patients with mild or moderate hepatic impairment [see Clinical Pharmacology (12.3)] .

제품 요약:

Toviaz (fesoterodine fumarate) extended-release tablets 4 mg are light blue, oval, biconvex, film-coated, and engraved with "FS" on one side. They are supplied as follows: Bottles of 30 NDC 0069-0242-30 Toviaz (fesoterodine fumarate) extended-release tablets 8 mg are blue, oval, biconvex, film-coated, and engraved with "FT" on one side. They are supplied as follows: Bottles of 30 NDC 0069-0244-30 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

승인 상태:

New Drug Application

제품 특성 요약

TOVIAZ- FESOTERODINE FUMARATE TABLET, FILM COATED, EXTENDED RELEASE
PFIZER LABORATORIES DIV PFIZER INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOVIAZ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOVIAZ.
TOVIAZ (FESOTERODINE FUMARATE) EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
Toviaz is indicated for the treatment of:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 4 mg and 8 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Overactive bladder (OAB) in adults with symptoms of urge urinary
incontinence, urgency, and
frequency. (1.1)
Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years
of age and older and weighing
greater than 25 kg. (1.2)
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. (2.1)
NDO in Pediatric Patients 6 Years and Older:
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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. (2.2)
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. (2.2)
Adult or Pediatric Patients with Renal Impairment: Refer to the full
prescribing information for
recommended dosage. (2.3, 2.4)
Dosage Modifications Due to Strong CYP3A4 Inhibitors: Refer to the
full prescribing information for
recommended dosage. (2.5)
Administration: Swallow whole with liquid. Do not chew, divide, or
crush. Take with or without food.
(2.6)
Known or suspected hypersensitivity to Toviaz or any of its
ingredients or to tolterodine tartrate
tablets or tolterodine tartrate extended-release capsules. (4)
Urinary retention (4)
Gastric retention (4)