VESIcare LS
Generic: SOLIFENACIN SUCCINATE
Basic Information
Manufacturer
Astellas Pharma US, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
e0300384-e980-45d5-8ed4-48a2618671ae
Indications & Usage
1 INDICATIONS AND USAGE VESIcare LS ® is indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older.
VESIcare LS is a muscarinic antagonist indicated for the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 years and older.
( 1 )
VESIcare LS is a muscarinic antagonist indicated for the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 years and older.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS • Angioedema and Anaphylactic Reactions [see Warnings and Precautions ( 5.1 )] • Urinary Retention [see Warnings and Precautions ( 5.2 )] • Gastrointestinal Disorders [see Warnings and Precautions ( 5.3 )] • Central Nervous System Effects [see Warnings and Precautions ( 5.4 )] • QT Prolongation in Patients at High Risk of QT Prolongation [see Warnings and Precautions ( 5.6 )] The most common adverse reactions (> 2%) were constipation, dry mouth and urinary tract infection.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc.
at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of VESIcare LS oral suspension was evaluated in two open-label trials (Studies 1 and 2) [see Clinical Studies ( 14 )] .
The two studies included 95 pediatric patients aged 2 to 17 years with neurogenic detrusor overactivity (NDO) who were 53% female, 58% White, 34% Asian and 2% Black.
Treatment was initiated at the weight-based starting recommended dose and was titrated up or down in 2.5 mg increments over 12 weeks to the lowest effective dose (not to exceed the maximum recommended dose).
Subsequent to the dose titration period, patients continued their optimized dose for a 40-week maintenance period (mean exposure duration 301 days, range 1 to 413 days).
The most commonly reported adverse reactions were constipation, dry mouth, urinary tract infection, abdominal pain, urinalysis bacterial test positive, and somnolence.
The incidence of adverse reactions was similar between patients taking the starting recommended dose and patients taking the maximum recommended dose with the exception of constipation, which was reported, in 8.5% of patients taking the maximum recommended dose compared to 0% of patients taking the starting recommended dose.
Table 2 lists the adverse reactions reported in Studies 1 and 2 at an incidence equal to or greater than 1%.
Table 2: Adverse Reactions Reported in ≥ 1% of Neurogenic Detrusor Overactivity (NDO) Patients Aged 2 to 17 Years Taking VESIcare LS Oral Suspension in Studies 1 and 2 Adverse Reaction Percentage (%) of Patients Reporting Adverse Reactions N=95 Constipation 7.4 Dry mouth 3.2 Urinary tract infection 2.1 Abdominal pain 1.1 Urinalysis bacterial test positive 1.1 Somnolence 1.1 Adverse reactions reported in ≥ 1% of solifenacin succinate-treated adult patients and at an incidence greater than in placebo-treated adult patients in clinical adult trials were: Gastrointestinal disorders : dry mouth, constipation, nausea, dyspepsia, upper abdominal pain, vomiting Infections and infestations : urinary tract infection, influenza, pharyngitis Nervous system disorders : dizziness Eye disorders : blurred vision, dry eyes Renal and urinary disorders : urinary retention General disorders and administration site conditions : lower limb edema, fatigue Psychiatric disorders : depression Respiratory, thoracic and mediastinal disorders : cough Vascular disorders : hypertension 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of solifenacin succinate.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General disorders and administration site conditions : peripheral edema, hypersensitivity reactions (including angioedema with airway obstruction, rash, pruritus, urticaria, anaphylactic reaction); Nervous system disorders : dizziness, headache, confusion, hallucinations, delirium, somnolence; Cardiac disorders : QT prolongation, Torsade de Pointes, atrial fibrillation, tachycardia, palpitations; Hepatobiliary disorders : liver disorders mostly characterized by abnormal liver function tests, AST (aspartate aminotransferase), ALT (alanine aminotransferase), GGT (gamma-glutamyl transferase); Renal and urinary disorders : renal impairment, urinary retention; Metabolism and nutrition disorders : decreased appetite, hyperkalemia; Skin and subcutaneous tissue disorders : exfoliative dermatitis, erythema multiforme, dry skin; Eye disorders : glaucoma; Gastrointestinal disorders : gastroesophageal reflux disease, ileus, vomiting, abdominal pain, dysgeusia, sialadenitis; Respiratory, thoracic and mediastinal disorders : dysphonia, nasal dryness; Musculoskeletal and connective tissue disorders : muscular weakness.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc.
at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of VESIcare LS oral suspension was evaluated in two open-label trials (Studies 1 and 2) [see Clinical Studies ( 14 )] .
The two studies included 95 pediatric patients aged 2 to 17 years with neurogenic detrusor overactivity (NDO) who were 53% female, 58% White, 34% Asian and 2% Black.
Treatment was initiated at the weight-based starting recommended dose and was titrated up or down in 2.5 mg increments over 12 weeks to the lowest effective dose (not to exceed the maximum recommended dose).
Subsequent to the dose titration period, patients continued their optimized dose for a 40-week maintenance period (mean exposure duration 301 days, range 1 to 413 days).
The most commonly reported adverse reactions were constipation, dry mouth, urinary tract infection, abdominal pain, urinalysis bacterial test positive, and somnolence.
The incidence of adverse reactions was similar between patients taking the starting recommended dose and patients taking the maximum recommended dose with the exception of constipation, which was reported, in 8.5% of patients taking the maximum recommended dose compared to 0% of patients taking the starting recommended dose.
Table 2 lists the adverse reactions reported in Studies 1 and 2 at an incidence equal to or greater than 1%.
Table 2: Adverse Reactions Reported in ≥ 1% of Neurogenic Detrusor Overactivity (NDO) Patients Aged 2 to 17 Years Taking VESIcare LS Oral Suspension in Studies 1 and 2 Adverse Reaction Percentage (%) of Patients Reporting Adverse Reactions N=95 Constipation 7.4 Dry mouth 3.2 Urinary tract infection 2.1 Abdominal pain 1.1 Urinalysis bacterial test positive 1.1 Somnolence 1.1 Adverse reactions reported in ≥ 1% of solifenacin succinate-treated adult patients and at an incidence greater than in placebo-treated adult patients in clinical adult trials were: Gastrointestinal disorders : dry mouth, constipation, nausea, dyspepsia, upper abdominal pain, vomiting Infections and infestations : urinary tract infection, influenza, pharyngitis Nervous system disorders : dizziness Eye disorders : blurred vision, dry eyes Renal and urinary disorders : urinary retention General disorders and administration site conditions : lower limb edema, fatigue Psychiatric disorders : depression Respiratory, thoracic and mediastinal disorders : cough Vascular disorders : hypertension 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of solifenacin succinate.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General disorders and administration site conditions : peripheral edema, hypersensitivity reactions (including angioedema with airway obstruction, rash, pruritus, urticaria, anaphylactic reaction); Nervous system disorders : dizziness, headache, confusion, hallucinations, delirium, somnolence; Cardiac disorders : QT prolongation, Torsade de Pointes, atrial fibrillation, tachycardia, palpitations; Hepatobiliary disorders : liver disorders mostly characterized by abnormal liver function tests, AST (aspartate aminotransferase), ALT (alanine aminotransferase), GGT (gamma-glutamyl transferase); Renal and urinary disorders : renal impairment, urinary retention; Metabolism and nutrition disorders : decreased appetite, hyperkalemia; Skin and subcutaneous tissue disorders : exfoliative dermatitis, erythema multiforme, dry skin; Eye disorders : glaucoma; Gastrointestinal disorders : gastroesophageal reflux disease, ileus, vomiting, abdominal pain, dysgeusia, sialadenitis; Respiratory, thoracic and mediastinal disorders : dysphonia, nasal dryness; Musculoskeletal and connective tissue disorders : muscular weakness.