Valstar Side Effects
Generic Name: valrubicin
Please note - some side effects for Valstar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Valstar - for the Consumer
Valstar
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Valstar:
Seek medical attention right away if any of these SEVERE side effects occur when using Valstar:Bladder pain or spasm; burning or discomfort of the urethra; headache; irritable bladder symptoms (eg, frequent or painful urination, urgent need to urinate); loss of bladder control; mild dizziness, weakness, or tiredness; nausea; stomach pain.
Severe allergic reactions (difficulty breathing; hives; itching; rash; swelling of the mouth, face, lips, or tongue; tightness in the chest); blood in the urine; chest pain; fever; inability to urinate; persistent red discoloration of the urine; severe or persistent bladder pain or spasms; severe or persistent painful urination, trouble urinating, or urinary urgency.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopValstar Side Effects - for the Professional
Valstar
Approximately 84% of patients who received intravesical Valstar in clinical studies experienced local adverse events, but approximately half of the patients reported irritable bladder symptoms prior to treatment. The local adverse reactions associated with Valstar usually occur during or shortly after instillation and resolve within 1 to 7 days after the instillate is removed from the bladder.
TABLE 1 displays the frequency of the local adverse experiences at baseline and during treatment among 170 patients who received 800 mg doses of Valstar® (valrubicin) Sterile Solution for Intravesical Instillation in a multiple-cycle treatment regimen. Only 7 of 143 patients who were scheduled to receive six doses failed to receive all of the planned doses because of the occurrence of local bladder symptoms.
| TABLE 1 Occurrence of Local Adverse Reactions Before and During Treatment with Intravesical Valstar (% of Patients) |
||
|---|---|---|
| Patients Who Received Multiple-Cycle Treatment Regimen at 800 mg/dose (N=170) |
||
| Reaction | Before Treatment |
During 6-week Course of Treatment |
| ANY LOCAL BLADDER SYMPTOM |
45% | 88% |
| Urinary Frequency | 30% | 61% |
| Dysuria | 11% | 56% |
| Urinary Urgency | 27% | 57% |
| Bladder Spasm | 3% | 31% |
| Hematuria | 11% | 29% |
| Bladder Pain | 6% | 28% |
| Urinary Incontinence | 7% | 22% |
| Cystitis | 4% | 15% |
| Nocturia | 2% | 7% |
| Local Burning Symptoms – Procedure Related |
0% | 5% |
| Urethral Pain | 0% | 3% |
| Pelvic Pain | 1% | 1% |
| Hematuria (Gross) | 0% | 1% |
Most systemic adverse events associated with use of Valstar have been mild in nature and self-limited, resolving within 24 hours after drug administration. TABLE 2 displays the adverse events other than local bladder symptoms that occurred in 1% or more of the 230 patients who received at least one dose of Valstar (200 to 900 mg) in a clinical trial. It cannot be determined whether these events are drug-related.
| TABLE 2 Most Commonly Reported Systemic Adverse Reactions Following Intravesical Administration of Valstar (% of Patients) |
|
|---|---|
| Body System Preferred Term |
All Patients Who Received Valstar (N = 230) |
| Body as a Whole | |
| Abdominal Pain | 5% |
| Asthenia | 4% |
| Back Pain | 3% |
| Chest Pain | 3% |
| Fever | 2% |
| Headache | 4% |
| Malaise | 4% |
| Cardiovascular | |
| Vasodilation | 2% |
| Digestive | |
| Diarrhea | 3% |
| Flatulence | 1% |
| Nausea | 5% |
| Vomiting | 2% |
| Hemic and Lymphatic | |
| Anemia | 2% |
| Metabolic and Nutritional | |
| Hyperglycemia | 1% |
| Peripheral Edema | 1% |
| Musculoskeletal | |
| Myalgia | 1% |
| Nervous | |
| Dizziness | 3% |
| Respiratory | |
| Pneumonia | 1% |
| Skin and Appendages | |
| Rash | 3% |
| Urogenital | |
| Hematuria (miscroscopic) | 3% |
| Urinary Retention | 4% |
| Urinary Tract Infection | 15% |
Adverse reactions other than local reactions that occurred in less than 1% of the patients who received Valstar intravesically in clinical trials are listed below. This list includes only adverse reactions that were suspected of being related to treatment.
Digestive System: Tenesmus.
Metabolic and Nutritional: Nonprotein nitrogen increased.
Skin and Appendages: Pruritus.
Special Senses: Taste loss.
Urogenital System: Local skin irritation, poor urine flow, and urethritis.
Inadvertent paravenous extravasation of Valstar was not associated with skin ulceration or necrosis.
TopSide Effects by Body System - for Healthcare Professionals
Local
Local adverse reactions associated with valrubicin usually occurred during or shortly after instillate and resolve within one to seven days after the instillation is removed from the bladder.
Local side effects including any local bladder symptom (88%) and procedure related burning symptoms (5%) have been reported.
Genitourinary
Genitourinary side effects including urinary frequency (61%), urinary urgency (57%), dysuria (56%), bladder spasm (31%), hematuria (29%), bladder pain (28%), urinary incontinence (22%), urinary tract infection (15%), cystitis (15%), nocturia (7%), urinary retention (4%), microscopic hematuria (3%), urethral pain (3%), pelvic pain (1%), and gross hematuria (1%) have been reported.
General
General side effects including abdominal pain (5%), asthenia (4%), headache (4%), malaise (4%), back pain (3%), chest pain (3%), and fever (2%) have been reported.
Gastrointestinal
Gastrointestinal side effects including nausea (5%), diarrhea (3%), vomiting (2%), and flatulence (1%) have been reported.
Nervous system
Nervous system side effects including dizziness (3%) have been reported.
Dermatologic
Dermatologic side effects including rash (3%) have been reported.
Cardiovascular
Cardiovascular side effects including vasodilation (2%) have been reported.
Hematologic
Hematologic side effects including anemia (2%) have been reported.
Metabolic
Metabolic side effects including hyperglycemia (1%) and peripheral edema (1%) have been reported.
Musculoskeletal
Musculoskeletal side effects including myalgia (1%) have been reported.
Respiratory
Respiratory side effects including pneumonia (1%) have been reported.
TopMore Valstar resources
- Valstar Prescribing Information (FDA)
- Valstar MedFacts Consumer Leaflet (Wolters Kluwer)
- Valstar Concise Consumer Information (Cerner Multum)
- Valstar Advanced Consumer (Micromedex) - Includes Dosage Information
- Valrubicin Professional Patient Advice (Wolters Kluwer)
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