Mitoxantrone Hydrochloride Injection

[13 June 2016]

Products Affected - Description

Mitoxantrone Hydrochloride injection, Fresenius Kabi
2 mg/mL, 15 mL vial, 1 count (NDC 63323-0132-15)
Mitoxantrone Hydrochloride injection, Hospira
2 mg/mL, 10 mL vial, 1 count (NDC 61703-0343-18)
2 mg/mL, 12.5 mL vial, 1 count (NDC 61703-0343-65)
2 mg/mL, 15 mL vial, 1 count (NDC 61703-0343-66)
Mitoxantrone Hydrochloride injection, Teva
2 mg/mL, 10 mL vial, 1 count (NDC 00703-4685-01)
2 mg/mL, 12.5 mL vial, 1 count (NDC 00703-4680-01)
2 mg/mL, 15 mL vial, 1 count (NDC 00703-4686-01)

Reason for the Shortage

  • Fresenius Kabi has mitoxantrone available for direct order.1
  • Hospira has mitoxantrone injection on shortage due to manufacturing delay.2
  • Teva has mitoxantrone injection on allocation due to current market conditions.3

Available Products

Mitoxantrone Hydrochloride injection, Fresenius Kabi
2 mg/mL, 10 mL vial, 1 count (NDC 63323-0132-10)
2 mg/mL, 12.5 mL vial, 1 count (NDC 63323-0132-12)

Estimated Resupply Dates

  • Fresenius Kabi has mitoxantrone 15 mL vials available for direct order with an expiration date of < 5 months.1
  • Hospira has all mitoxantrone injection on long-term back order and the company estimates a release date of February 2017.2
  • Teva has all mitoxantrone presentations on allocation.3

Implications for Patient Care

  • Mitoxantrone is an antineoplastic anthracenedione and a topoisomerase II inhibitor. It is labeled for use for the treatment of acute nonlymphocytic leukemia, multiple sclerosis, and prostate cancer.4,5,6
  • Mitoxantrone is used off-label for the treatment of breast cancer, non-Hodgkin lymphoma, and autologous bone marrow transplantation. It has also been used off-label in children for the treatment of acute nonlymphocytic leukemia or solid tumors. 4,5,6
  • Refer to national guidelines such as those from the National Comprehensive Cancer Network or American Society of Clinical Oncology for additional information regarding therapeutic use.


  • Chemotherapy agents, such as mitoxantrone, pose additional safety risks both for patients and for healthcare workers handling these agents.4,5,6
  • 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).4,5,6

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 mitoxantrone.4,5,6
  • Consider evaluating the health-care system's total supply of mitoxantrone before beginning patients on combination chemotherapy regimens containing mitoxatnrone. 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


  1. Fresenius Kabi (personal communications). September 24, November 11, and December 9 and 15, 2015; February 3, March 2, April 5, May 12, and June 8, 2016.
  2. Hospira (personal communications). September 24, November 11, and December 9 and 15, 2015; February 3, March 2, April 5, May 12, and June 13, 2016.
  3. Teva (personal communications). September 24, November 11, and December 9 and 15, 2015; February 3, March 2, April 5, and May 12, 2016.
  4. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2015 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2015: 839-1281.
  5. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. March 2015.
  6. Lexi-Drugs Online. Lexi-Comp, Inc.; 2015.


Updated June 13, 2016 by Michelle Wheeler, PharmD, Drug Information Specialist. Created September 24, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.


This information is provided through the support of Vizient 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. Vizient, 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 Vizient, 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 Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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