Recommended dosage¹

• 800 mg administered intravesically once a week for 6 weeks
• Administration should be delayed at least 2 weeks after transurethral resection and/or fulguration
• Patients should retain the drug for 2 hours before voiding
• Not a vesicant

An administration kit is shipped separately with each order of VALSTAR.

Administration instructions

Important Points

• VALSTAR^TM (valrubicin) should be administered under the supervision of a physician experienced in the use of intravesical cancer chemotherapeutic agents
• The personnel preparing the instillation bottle should review and be familiar with the current VALSTAR product labeling, including the Dosage and Administration section. The sequence of preparation and dilution steps is important to ensure successful preparation of the intended 75 mL instillation volume and to avoid potential product compromise
• Use aseptic technique during dilution and administration
• Skin reactions may occur with accidental exposure, and the use of gloves during dose preparation and administration is recommended
• If the eye is exposed to VALSTAR, the eye should be flushed with water immediately

Preparation

1. For each instillation, four 5 mL vials (containing 200 mg valrubicin/5 mL vial) should be allowed to warm slowly to room temperature but should not be heated. For example, this may take 20 to 30 minutes; an external heat source should not be used.
2. Using a disposable sterile syringe and needle (NOT PROVIDED), remove 45 mL of the 0.9% sodium chloride solution from the large instillation bottle and discard. This will leave 55 mL of the sodium chloride solution in the instillation bottle before adding VALSTAR.
3. Using a disposable sterile syringe and needle (NOT PROVIDED), aseptically draw up 5 mL (entire volume) of the VALSTAR product solution from a single product vial (red solution). NOTE: Repeat this procedure for each of the remaining 3 VALSTAR vials for a total of 20 mL of VALSTAR product solution.
4. Introduce the VALSTAR product solution into the instillation bottle, which will result in a final instillation volume of 75 mL (55 mL of 0.9% Sodium Chloride, USP, plus 20 mL of VALSTAR product solution).
5. Gently shake the instillation bottle until an even mixture is obtained. NOTE: Inspect the solution prior to administration. Dispose of any solution that contains particulate matter or is discolored.
6. Place the instillation bottle through the large circular portion of the instillation bottle hanger. Attach the smaller, oval portion over the instillation bottle cap and secure in place.

Administration

1. Before administering VALSTAR, carefully insert the decanting spike into the instillation bottle using caution not to exert excessive force, in order to avoid pushing the stopper into the bottle. Then clamp the tubing.
2. Hang the instillation bottle of VALSTAR solution from the IV pole, or hold the instillation bottle above the patient by hand.
3. Squeeze the priming chamber, at the base of the decanting spike; unclamp the tubing, prime with VALSTAR solution, and reclamp.
4. Remove cap from the distal end of the tubing, and insert into the patient’s indwelling catheter.
5. Unclamp the tubing and slowly instill diluted VALSTAR intravesically by gravity flow over a period of several minutes.
6. Withdraw the catheter. The patient should be instructed to retain the VALSTAR solution for 2 hours. At the end of 2 hours, the patient should void.

Disposal and Clean-up

Use a sharps container for needles. All materials used for preparation and administration should be disposed of as biohazardous waste.

Any solution that leaks out of the bladder and onto the patient should be cleaned up immediately with soap and water.

VALSTAR will stain surfaces. Spills should be cleaned up with undiluted chlorine bleach.

How supplied

• VALSTAR^TM (valrubicin) is supplied in a carton of four 200 mg/5 mL single-use vials for each treatment
• Vials should be refrigerated prior to use; DO NOT FREEZE
• Before dilution, the vials should be allowed to warm slowly to room temperature
• When warming the vials, DO NOT HEAT
• Inspect the solution prior to administration. VALSTAR is a clear red solution. Dispose of any solution that contains particulate matter or is discolored

Intravesical Chemotherapy Administration Kit

Kit contains:

1 each—Preparation and Administration Guide
1 each—Administration Tubing With Decanting Spike
1 each—Instillation Bottle Hanger
2 each—Dosing Labels
1 each—Instillation Bottle Containing 100 mL of 0.9% Sodium Chloride, USP (Sterile, Preservative-Free), Diluent

Additional supplies required (not included):

2 sterile, disposable 60 cc syringes, needles, catheter, sterile latex gloves, and alcohol wipes.