Valrubicin

Valrubicin Intravesical solution is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.

Valrubicin is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Valrubicin is used to treat bladder cancer that has not spread to other parts of the body.

Valrubicin is usually given after BCG (Bacillus Calmette and Guérin) has been tried without success.

Valrubicin may also be used for purposes not listed in this medication guide.

Recommended Dosing

For Intravesical Use Only. Do NOT administer by intravenous or intramuscular routes.

Valrubicin Intravesical solution is recommended at a dose of 800 mg administered intravesically once a week for six weeks. Delay administration at least two weeks after transurethral resection and/or fulguration [ see Warnings and Precautions ( 5.2, 5.3)].

Preparation, Handling, and Administration

Handle and dispose of Valrubicin Intravesical solution in a manner consistent with other cytotoxic drugs. 1 The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug.

Valrubicin Intravesical solution contains polyoxyl castor oil, which has been known to cause leaching of di(2-ethylhexyl) phthalate (DEHP) a hepatotoxic plasticizer, from polyvinyl chloride (PVC) bags and intravenous tubing. Valrubicin Intravesical solution should be prepared and stored in glass, polypropylene, or polyolefin containers and tubing. It is recommended that non-DEHP containing administration sets, such as those that are polyethylene-lined, be used.

Valrubicin Intravesical solution is a sterile, clear red solution. Visually inspect for particulate matter and discoloration prior to administration. At temperatures below 4°C (39°F), polyoxyl castor oil may begin to form a waxy precipitate. If this happens, the vial should be warmed in the hand until the solution is clear. If particulate matter is still seen, do not administer Valrubicin Intravesical solution.

For each instillation, slowly allow four 5 mL vials (200 mg Valrubicin/5 mL vial) to warm to room temperature, but do not heat. Withdraw 20 mL of Valrubicin Intravesical solution from the four vials and dilute with 55 mL of 0.9% Sodium Chloride Injection, USP to provide 75 mL of a diluted Valrubicin Intravesical solution. Valrubicin Intravesical solution diluted in 0.9% Sodium Chloride Injection, USP for administration is stable for 12 hours at temperatures up to 25°C (77°F). Since compatibility data are not available, do not mix Valrubicin Intravesical solution with other drugs.

Insert a urethral catheter into the patient's bladder under aseptic conditions, drain the bladder, and instill the diluted 75 mL Valrubicin Intravesical solution slowly via gravity flow over a period of several minutes. Withdraw the catheter and retain Valrubicin Intravesical solution in the bladder for two hours before voiding. At the end of two hours, all patients should void. Some patients may be unable to retain the drug for the full two hours. Instruct patients to maintain adequate hydration following Valrubicin Intravesical solution treatment.

See also:
What is the most important information I should know about Valrubicin?

Valrubicin (Valrubicin) is contraindicated in patients with known hypersensitivity to anthracyclines or polyoxyl castor oil.

Patients with concurrent urinary tract infections should not receive Valrubicin (Valrubicin).

Valrubicin (Valrubicin) should not be administered to patients with a small bladder capacity, i.e., unable to tolerate a 75 mL instillation.

Use Valrubicin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Valrubicin is usually administered at your doctor's office, hospital, or clinic.
• If Valrubicin contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Drinking extra fluids while you are taking Valrubicin is recommended. Check with your doctor for instructions.
• If you miss a dose of Valrubicin, contact your doctor as soon as possible.

Ask your health care provider any questions you may have about how to use Valrubicin.

Valrubicin is used to treat bladder cancer. The usual treatment for bladder cancer is surgery. However, if you and your doctor decide that the risk of surgery is greater than its benefit or that surgery may be delayed, this medication may be used as part of your treatment.

This medication belongs to a class of drugs known as anthracyclines and works by slowing or stopping the growth of cancer cells.

This medication may not cure your cancer. Delaying surgery could lead to a more serious illness (metastatic cancer). Discuss the risks and benefits of this medication with your doctor.

How to use Valrubicin intravesical

This medication is given by placement into the bladder as directed by your doctor. Do not give by injection into a vein or muscle or under the skin. After this medication is placed through a tube (catheter), it is usually left in the bladder for 2 hours, then released by urinating. This drug is usually used once weekly for 6 weeks or as directed by your doctor.

Drink plenty of fluids after each treatment with this medication unless otherwise directed by your doctor. Doing so helps clear it from your body and decrease side effects.

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What other drugs will affect Valrubicin?

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

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What are the possible side effects of Valrubicin?

Approximately 84% of patients who received intravesical Valrubicin (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 Valrubicin (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 Valrubicin®(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 Valrubicin (Valrubicin) (% of Patients)

Most systemic adverse events associated with use of Valrubicin (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 Valrubicin (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 Valrubicin (Valrubicin) (% of Patients)

Adverse reactions other than local reactions that occurred in less than 1% of the patients who received Valrubicin (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 Valrubicin (Valrubicin) was not associated with skin ulceration or necrosis.

Valrubicin (N-trifluoroacetyladriamycin-14-valerate, Valrubicin®) is a chemotherapy drug used to treat bladder cancer. Valrubicin is a semisynthetic analog of the anthracycline doxorubicin, and is administered by infusion directly into the bladder.