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Mitoxantrone Hydrochloride Injection

Last Updated: February 12, 2018
Status: Current

Mitoxantrone Hydrochloride Injection

Products Affected - Description
  • Mitoxantrone Hydrochloride injection, Fresenius Kabi

2 mg/mL, 10 mL vial, 1 count (NDC 63323-0132-10)
2 mg/mL, 15 mL vial, 1 count (NDC 63323-0132-15)
 
Mitoxantrone Hydrochloride injection, Pfizer
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)
Reason for the Shortage
    • Fresenius Kabi has mitoxantrone available.1
    • Pfizer has mitoxantrone injection on shortage due to manufacturing delays.2
    • Teva has mitoxantrone injection available except for the 10 mL vials which are temporarily discontinued.3
Available Products
  • Mitoxantrone Hydrochloride injection, Fresenius Kabi

2 mg/mL, 12.5 mL vial, 1 count (NDC 63323-0132-12)
 
Mitoxantrone Hydrochloride injection, Pfizer
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)
 
Mitoxantrone Hydrochloride injection, Teva
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)

Estimated Resupply Dates

    • Fresenius Kabi has mitoxantrone 2 mg/mL 15 mL vials available with an expiration date of <4 months. The mitoxantrone 2 mg/mL 10 mL vials are on back order and the company estimates a release date of mid- to late-February 2018.1
    • Pfizer has mitoxantrone 2 mg/mL 15 mL vials on back order and the company estimates a release date of March 2018.2
    • Teva has temporarily discontinued mitoxantrone 10 mL vials and the company cannot estimate a release date.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.4-6
    • 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.4-6
    • 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.

Safety

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

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.4-6
    • 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.

References

    1. Fresenius Kabi (personal communications). September 24, November 11, and December 9 and 15, 2015; February 3, March 2, April 5, May 12, June 8, August 3, September 2, November 7 and 21, 2016; January 28, February 10, March 5, April 28, July 6, September 15, October 27, November 10 and 30, 2017; January 12, and February 12, 2018.
    2. Pfizer (personal communications). September 24, November 11, and December 9 and 15, 2015; February 3, March 2, April 5, May 12, June 13, August 11, September 7, November 10 and 22, 2016; January 30, March 7, May 3, July 14, September 15, October 27, November 10, December 5, 2017; January 12, and February 9, 2018.
    3. Teva (personal communications). September 24, November 11, and December 9 and 15, 2015; February 3, March 2, April 5, May 12, August 10, November 10, 2016; January 13, March 6, June 13, September 4, October 17, 2017; January 4, and February 12, 2018.
    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

Updated February 12, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. Created September 24, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

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