Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most frequently reported adverse reactions ( > 5%) after administration of valrubicin intravesical solution are urinary frequency, dysuria, urinary urgency, bladder spasm, hematuria, bladder pain, urinary incontinence, cystitis, urinary tract infection, nocturia, local burning symptoms, abdominal pain, and nausea.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma at us.hikma@primevigilance.com or call 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trial 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 valrubicin intravesical solution was assessed in 230 patients with transitional cell carcinoma of the bladder, including 205 patients who received multiple weekly doses.
One hundred seventy-nine of the 205 patients received the approved dose and schedule of 800 mg weekly for multiple weeks.
Approximately 84% of patients who received intravesical valrubicin intravesical solution in clinical studies experienced local adverse reactions.
The local adverse reactions associated with valrubicin intravesical solution usually occur during or shortly after instillation and resolve within 1 to 7 days after the instillate is removed from the bladder.
Seven out of 143 patients (5%) who were scheduled to receive six doses of valrubicin intravesical solution failed to receive all of the planned doses because of the occurrence of local bladder symptoms.
TABLE 1 displays the frequency of the local adverse reactions at baseline and during treatment among 179 patients who received 800 mg doses of valrubicin intravesical solution in a multiple-cycle treatment regimen.
TABLE 1 Local Adverse Reactions Before and During Treatment with Valrubicin Intravesical Solution (N=179) Adverse 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% TABLE 2 displays the adverse reactions other than local bladder symptoms that occurred in 1% or more of the 230 patients who received at least one dose of valrubicin intravesical solution in a clinical trial.
5 WARNINGS AND PRECAUTIONS • Delaying cystectomy can lead to development of metastatic bladder cancer, which is lethal.
( 5.1 ) • Do not administer valrubicin intravesical solution to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised.
( 5.2 , 12.3 ) • Evaluate the status of the bladder before the intravesical instillation of valrubicin intravesical solution.
( 5.3 ) • Use with caution in patients with severe irritable bladder symptoms.
( 5.4 ) • Embryo-Fetal Toxicity: Valrubicin intravesical solution can cause fetal harm.
Like all medications, Valrubicin Intravesical Solution can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: