[10 December 2013]
Products Affected - Description
Doxil 2 mg/mL, Janssen Products, LP
2 mg/mL, 10 mL (20 mg) vial (NDC 59676-0960-01)
2 mg/mL, 25 mL (50 mg) vial (NDC 59676-0960-02)
Reason for the Shortage
- Janssen Products, LP states the shortage is due to manufacturing issues. Janssen Products, LP has updates with information about the shortage on the Doxil website that is updated regularly.1-3
- Janssen is working to transition Doxil manufacturing to additional suppliers. The recent solution was to use areas of the Ben Venue Laboratories facility available for production and other partners to complete the manufacturing process. FDA exercised regulatory discretion and approved several lots of 2 mg/mL 10 mL (20 mg) vials but no more lots using this process will be released.
- Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure.
Caraco launched generic doxorubicin liposomal injection in mid-March 2013 and can supply the market with their presentations.6
Doxorubicin liposomal, Caraco
2 mg/mL, 10 mL (20 mg) vial (NDC 47335-0049-40)
2 mg/mL, 25 mL (50 mg) vial (NDC 47335-0050-40)
Estimated Resupply Dates
Janssen has Doxil 2 mg/mL 10 mL (20 mg) and 25 mL (50 mg) vials on long-term back order and the company will not resume production until a new manufacturing site is located.3,7
Implications for Patient Care
- Doxorubicin liposomal is an anthracycline glycoside agent encapsulated in liposomes. Doxorubicin liposomal is labeled for use in adults with refractory multiple myeloma, refractory ovarian cancer, and AIDS-related Kaposi sarcoma.8,9
- Doxorubicin liposomal is used off-label in adults for treating refractory metastatic breast cancer. 8,9
- Doxorubicin liposomal is not bioequivalent to conventional doxorubicin injection. Do not substitute these products on a mg per mg basis.9-12
- Chemotherapy agents, such as doxorubicin, pose additional safety risks both for patients and for healthcare workers handling these agents.11,12
- 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).11,12
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 doxorubicin liposomal.9-12
- Evaluate the health-care system’s total supply of doxorubicin liposomal before beginning patients on combination chemotherapy regimens containing doxorubicin liposomal. If adequate supplies are not available, select an alternative regimen. The manufacturer currently recommends against initiating doxorubicin liposomal therapy.1
- 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.
- Centocor Ortho Biotech (personal communications). June 24, 2011.
- Johnson and Johnson Distribution Center (personal communications). June 27, and July 12, 18, and 22, 2011; February 28 and December 19, 2012; January 3, February 8, and March 5, 2013.
- Janssen Products, LP (personal communication). July 28 and 29, August 4, 5, 15, 18, and 19, September 6, 9, and 27, October 11 and 17, November 21, December 9, 12, and 23, 2011; January 19, February 9 and 28, March 22, April 5, May 9, June 29, August 2, October 15 and 25, November 27, 2012; January 7, March 13, April 9 and 11, May 20, June 13, August 13, September 26, October 14, November 11, and December 10, 2013.
- FDA (written communication). URGENT – Doxil® (Doxorubicin Hydrochloride Liposome Injection) Shortage Update. Available online. Accessed March 22, 2012.
- FDA (written communication). Lipodox Importation Frequently Asked Questions. Available online. Accessed March 22, 2012.
- Caraco (personal communication). February 7, March 4 and 19, April 9, June 13, August 8, September 26, October 15, and December 10, 2013.
- Janssen Products, LP. Dear Healthcare Professional Letter: Important Update- Additional Release of Newly Manufactured Doxil.
- Doxil® (doxorubicin HCl liposome injection) for intravenous injection, [product information]. Raritan, NJ: Centocor Ortho Biotech Products, LP; 2010.
- Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. June 2011.
- Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2011.
- Lipodox and Lipodox 50 (doxorubicin hydrochloride liposome injection) [product information]. Andheri, Mumbai, India: Sun Pharmaceutical; 2010. Accessed March 22, 2012.
- Antineoplastic agents. In: McEvoy GK, ed. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2011: 905-1276.
Updated December 10, 2013 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 27, 2011, by Ginny Jones, RPh, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.
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