Valstar

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Contraindications

Hypersensitivity to valrubicin, anthracyclines or other ingredients

Perforated bladder mucosa

Active UTI

Small bladder capacity; unable to tolerate a 75 mL instillation

Cautions

Complete response in only 20%

Delaying cystectomy can lead to development of metastatic bladder cancer, which is lethal

Not for administration to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised

Evaluate status of bladder before intravesical instillation of therapy

Use with caution in patients with severe irritable bladder symptoms

Advise females of reproductive potential of potential risk to fetus and to use effective contraception

Delay valrubicin therapy for 2 weeks after transurethral resection or fulguration

Urine may be red-tinged for 24 hr post-instillation

Was unavailable since 2002 due to manufacturing problems; reintroduced 2009

Contact your doctor if you miss a dose of valrubicin.

Valstar is part of the drug class:

• Anthracyclines and related substances

Before receiving Valstar,

• tell your doctor and pharmacist if you are allergic to Valstar, daunorubicin, doxorubicin, epirubicin, or idarubicin; any other medications; or any of the ingredients in Valstar solution. Ask your doctor for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have a urinary tract infection, or if you urinate frequently because you have small bladder. Your doctor will not want you to receive Valstar solution.
• your doctor will look at your bladder before giving vsolution to see if you have a hole in your bladder or a weak bladder wall. If you have these problems, your treatment will need to wait until your bladder has healed.
• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are using Valstar. You should use birth control to prevent pregnancy in yourself or your partner during your treatment with Valstar. Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while using Valstar, call your doctor.
• tell your doctor if you are breastfeeding

Valrubicin commonly causes the urine to turn red for about 24 hours after it is given. This is normal and is no cause for concern. However, tell your doctor if you continue to pass red urine for longer than 24 hours.

• It is used to treat bladder cancer.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

200 mg/5 mL sterile, clear red, solution in single-use vials for intravesical instillation upon dilution. 

  Risk of Metastatic Bladder Cancer with Delayed Cystectomy

Inform patients that Valstar has been shown to induce complete response in only about 1 in 5 patients with BCG-refractory CIS, and that delaying cystectomy could lead to development of metastatic bladder cancer, which is lethal. The exact risk of developing metastatic bladder cancer from such a delay may be difficult to assess [see Clinical Studies (14)] but increases the longer cystectomy is delayed in the presence of persisting CIS. If there is not a complete response of CIS to treatment after 3 months or if CIS recurs, reconsider cystectomy.

  Risks in Patients with Perforated Bladder

Evaluate the bladder before the intravesical instillation of drug and do not administer Valstar to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised [see Contraindications (4)]. In case of bladder perforation, delay the administration of Valstar until bladder integrity has been restored.  One patient with a perforated bladder who received 800 mg of Valstar intravesically developed severe leukopenia and neutropenia approximately two weeks after drug administration [see Clinical Pharmacology (12.3)].

  Risk in Patients Undergoing Transurethral Resection of the Bladder (TURB)

To avoid systemic exposure to Valstar for the patients undergoing TURB, evaluate the status of the bladder before the intravesical instillation of drug. Delay administration at least two weeks after transurethral resection and/or fulguration.

  Risk in Patients with Irritable Bladder Symptoms

Use Valstar with caution in patients with severe irritable bladder symptoms. Bladder spasm and spontaneous discharge of the intravesical instillate may occur; clamping of the urinary catheter is not advised.

  Embryo-Fetal Toxicity

Based on findings in animal studies and its mechanism of action, Valstar can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1 and 12.3)].  In animal reproduction studies, intravenous administration of valrubicin to pregnant rats during the period of organogenesis at a dose about 0.2 times the recommended human intravesical dose caused embryo-fetal malformations and increased resorptions.  Advise females who might become pregnant of the potential risk to a fetus.

Advise females of reproductive potential to use effective contraception during treatment with Valstar and for 6 months following the final dose [see Use in Specific Populations (8.1 and 8.3)].

  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 Valstar 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 Valstar in clinical studies experienced local adverse reactions. 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. Seven out of 143 patients (5%) who were scheduled to receive six doses of Valstar 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 Valstar in a multiple-cycle treatment regimen.                                                                               

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 Valstar in a clinical trial.                                                                                                                                      

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.

    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