"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
DOSAGE AND ADMINISTRATION
VALSTAR (valrubicin) is recommended at a dose of 800 mg administered intravesically once a week for six weeks. Administration should be delayed at least two weeks after transurethral resection and/or fulguration. For each instillation, four 5 mL vials (200 mg valrubicin/5 mL vial) should be allowed to warm slowly to room temperature, but should not be heated. Twenty milliliters of VALSTAR (valrubicin) should then be withdrawn from the four vials and diluted with 55 mL 0.9% Sodium Chloride Injection, USP providing 75 mL of a diluted VALSTAR (valrubicin) solution. A urethral catheter should then be inserted into the patient's bladder under aseptic conditions, the bladder drained, and the diluted 75 mL VALSTAR (valrubicin) solution instilled slowly via gravity flow over a period of several minutes. The catheter should then be withdrawn. The patient should retain the drug for two hours before voiding. At the end of two hours, all patients should void. (Some patients will be unable to retain the drug for the full two hours.) Patients should be instructed to maintain adequate hydration following treatment.
Patients receiving VALSTAR (valrubicin) for refractory carcinoma in situ must be monitored closely for disease recurrence or progression. Recommended evaluations include cystoscopy, biop-sy, and urine cytology every 3 months.
Administration Precautions: As recommended with other cytotoxic agents, caution should be exercised in handling and preparing the solution of VALSTAR (valrubicin) . Contact toxicity, common and severe with other anthracyclines, is not typical with VALSTAR (valrubicin) and, when observed, has been mild. Skin reactions may occur with accidental exposure, and the use of gloves during dose preparation and administration is recommended. Irritation of the eye has also been reported with accidental exposure. If this happens, the eye should be flushed with water immediately and thoroughly.
VALSTAR (valrubicin) sterile 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. VALSTAR (valrubicin) solutions 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.
Procedures for proper handling and disposal of anticancer drugs should be used.1-7 Spills should be cleaned up with undiluted chlorine bleach.
Preparation for Administration: VALSTAR (valrubicin) Sterile Solution for Intravesical Instillation is a clear red solution. It should be visually inspected for particulate matter and discoloration prior to administration. At temperatures below 4°C, 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, VALSTAR (valrubicin) should not be administered.
Stability: Unopened vials of VALSTAR (valrubicin) are stable until the date indicated on the package when stored under refrigerated conditions at 2°-8°C (36°-46°F). Vials should not be heated. VALSTAR (valrubicin) 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, VALSTAR (valrubicin) should not be mixed with other drugs.
VALSTAR (valrubicin) Sterile Solution for Intravesical Instillation is a clear red solution in polyoxyl castor oil/dehydrated alcohol, USP, containing 40 mg valrubicin per mL. VALSTAR (valrubicin) Sterile Solution for Intravesical Instillation is available in single-use, clear glass vials, individually packaged in the following sizes:
NDC 67979-001-01Carton of 4, 5 mL Single-Use Vials
(200 mg/5 mL)
NDC 67979-001-02Carton of 24, 5 mL Single-Use Vials (200 mg/5 mL)
Store vials under refrigeration at 2°-8°C (36°-46°F) in the carton. DO NOT FREEZE.
For more information, call 1-888-282-5372.
1.Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.
2. “AMA Council Report, Guidelines for Handing Parenteral Antineoplastics.” JAMA, 1985; 2.53(11): 1590-1592.
3.National Study Commission on Cytotoxic Exposure-Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
4. “Clinical Oncological Society of Australia, Guidelines and Recommendations for Safe Handling of Antineoplastic Agents.” Med J Australia, 1983; 1:426-428.
5.Jones R.B., et al. “Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center.” CA-A Cancer Journal for Clinicians, 1983; (Sept/Oct):258-263.
6. “American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs.” Am J. Hosp Pharm, 1990; 47:1033-1049.
7. “Controlling Occupational Exposure to Hazardous Drugs.” (OSHA Work-Practice Guidelines), Am J Health-Syst Pharm, 1996; 53:1669-1685.
Marketed by: Indevus Pharmaceuticals, Inc., Lexington, MA 02421. Manufactured by: PrimaPharm, Inc. San Diego, CA 92121 USA. For: Indevus Pharmaceuticals, Inc., Lexington, MA 02421 USA. Rev.01 April 2007. FDA revision date: 4/24/2001
Last reviewed on RxList: 11/24/2008
This monograph has been modified to include the generic and brand name in many instances.
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