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Doxorubicin Liposomal Injection

[26 March 2015]

Products Affected - Description

Doxil 2 mg/mL, Janssen Products, LP
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
  • FDA approved a new manufacturer of Doxil in January 2015.
  • Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014.
  • Caraco launched generic doxorubicin liposomal injection in mid-March 2013 and can supply the market with their presentations.4
     

Available Products

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)
 
Doxil 2 mg/mL, Janssen Products, LP
2 mg/mL, 10 mL (20 mg) vial (NDC 59676-0960-01)

Estimated Resupply Dates

Janssen has Doxil 25 mL (50 mg) vials on long-term back order and the company cannot estimate a release date. Doxil 10 mL (20 mg) vials are available.3,5

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.6-10
  • Doxorubicin liposomal is used off-label in adults for treating refractory metastatic breast cancer. 6-10
  • Refer to national guidelines such as those from the National Comprehensive Cancer Network (www.nccn.org) or American Society of Clinical Oncology (www.asco.org) for additional information regarding therapeutic use.

Safety

  • Doxorubicin liposomal is not bioequivalent to conventional doxorubicin injection. Do not substitute these products on a mg per mg basis.6-10
  • Chemotherapy agents, such as doxorubicin, pose additional safety risks both for patients and for healthcare workers handling these agents.8-10
  • 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).8-10

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. 8-10
  • 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.
  • 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

References

  1. Centocor Ortho Biotech (personal communications). June 24, 2011.
  2. 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.
  3. 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; and February 24, March 25, May 7, July 14, August 27, October 16, November 26, 2014; January 28, February 23, and March 26, 2015.
  4. Caraco (personal communication). February 7, March 4 and 19, April 9, June 13, August 8, September 26, October 15, and December 10, 2013; and February 24, March 25, July 17, August 27, October 16, and December 1, 2014; January 20 and 30, and February 23, 2015.
  5. Janssen Products, LP. Dear Healthcare Professional Letter: Important Update- Additional Release of Newly Manufactured Doxil. Accessed March 26, 2015.
  6. Doxil® (doxorubicin HCl liposome injection) for intravenous injection, [product information]. Horsham, PA: Janssen Products, LP; 2015.
  7. Doxorubicin hydrochloride liposomal injection [product information]. Cranbury, NJ: Sun Pharmaceutical Industries, 2015.
  8. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. March 2015.
  9. Lexi-Drugs Online. Lexi-Comp, Inc.; 2015.
  10. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2015 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2015: 839-1281.

Updated

Updated March 26, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. Created June 27, 2011, by Ginny Jones, RPh, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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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