Products Affected - Description

TheraCys Intravesical Injection, Sanofi Pasteur
81 mg lyophilized powder (NDC 49281-0880-03)

Reason for the Shortage

• Sanofi Pasteur states the reason for the shortage is manufacturing delay.¹

Available Products

Tice BCG Intravesical Injection, Merck²
50 mg lyophilized powder (NDC 00052-0602-02)

Estimated Resupply Dates

• Sanofi Pasteur has TheraCys 81 mg vials for intravesical injection on back order and the company estimates a release date in late-2013.¹
• Merck has Tice BCG 50 mg vials for intravesical injection available. The diluent for Tice BCG, preservative-free 0.9% sodium chloride (NDC 00520-0601-01) is also now available.²

Implications for Patient Care

BCG live intravesical contains live attenuated mycobacteria and is labeled for the treatment and prophylaxis of carcinoma in situ of the urinary bladder.^3-5 BCG live intravesical is also labeled for prophylaxis of primary or recurring stage Ta or T1 papillary tumors following transurethral resection.^3-5

Safety

• BCG live is biohazardous as it contains live, attenuated mycobacteria. This poses additional safety risks both for patients and for healthcare workers handling these agents.^5,6
• Use additional caution when processing orders for chemotherapy drugs, especially when switching between chemotherapy agents or when processing orders for chemotherapy agents with which staff may be unfamiliar (eg, those not normally prescribed at a specific institution).^5,6
• Tice BCG vaccine intradermal for tuberculosis is not a substitute for BCG live intravesical.
• Use preservative-free 0.9% sodium chloride to dilute BCG live intravesical. Avoid bacteriostatic 0.9% sodium chloride solution.^3-5

Alternative Agents & Management

• The choice of an alternative agent must be patient-specific and based on renal function, liver function, and the neoplasm type and location. No single agent can be substituted for BCG live.^5-7
• Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations.
• Refer to the ASHP Guidelines on Managing Drug Product Shortages for more guidance on developing a multidisciplinary plan when the supply must be allocated. 
  
  

Related Shortages

• Hepatitis A Virus Vaccine Inactivated— Resolved
• Hepatitis B Vaccine Recombinant— Resolved
• Hepatitis B Vaccine Recombinant and Bivalent Haemophilus influenzae type B conjugate— Resolved
• Measles, Mumps, Rubella and Varicella Virus Vaccine Live Injection— Resolved
• Rabies Vaccine
• Typhoid Vi Polysaccharide Injectable Vaccine
• Yellow Fever Vaccine Injection— Resolved
• Zoster Vaccine Live— Resolved

1. Sanofi Pasteur (personal communications). May 8, 21 and 31, June 20, July 13, August 8, September 19, and November 7, 2012; January 28, March 18, and May 17, 2013.
2. Merck (personal communications). May 9, 21 and 31, June 20, July 13, August 8, September 19, and November 7, 2012; January 28, March 18, and May 17, 2013.
3. Sanofi Pasteur. TheraCys (BCG live intravesical) Injection, [product information]. Swiftwater, PA: Sanofi Pasteur; 2011.
4. Merck. Tice BCG (BCG live intravesical) Injection, [product information]. West Point, PA: Merck, 2009.
5. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2012.
6. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
7. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. May 2012.

Updated

Updated May 17, 2013 by Leslie Jensen, PharmD, Drug Information Specialist. Created May 9, 2012, by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.