July 28, 2016
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Side Effects


Approximately 84% of patients who received intravesical VALSTAR (valrubicin) 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 (valrubicin) 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 (valrubicin) (% of Patients)

Reaction Patients Who Received Multiple-Cycle Treatment Regimen at 800 mg/dose
(N = 170)
Before Treatment During 6-week Course of Treatment
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 (valrubicin) 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 (valrubicin) (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 (valrubicin) (% 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%
  Vasodilation 2%
  Diarrhea 3%
  Flatulence 1%
  Nausea 5%
  Vomiting 2%
Hemic and Lymphatic
  Anemia 2%
Metabolic and Nutritional
  Hyperglycemia 1%
  Peripheral Edema 1%
  Myalgia 1%
  Dizziness 3%
  Pneumonia 1%
Skin and Appendages
  Rash 3%
  Hematuria (microscopic) 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 (valrubicin) 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 (valrubicin) was not associated with skin ulceration or necrosis.

Read the Valstar (valrubicin) Side Effects Center for a complete guide to possible side effects


Because systemic exposure to VALSTAR (valrubicin) is negligible following intravesical administration, the potential for drug interactions is low. No drug interaction studies were conducted.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/24/2008

Side Effects

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