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8/19/2019

Mitoxantrone Hydrochloride Injection

Products Affected - Description

    • Mitoxantrone Hydrochloride injection, Pfizer, 2 mg/mL, 12.5 mL vial, 1 count, NDC 61703-0343-65
    • 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 had 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, 10 mL vial, 1 count, NDC 63323-0132-10
    • Mitoxantrone Hydrochloride injection, Fresenius Kabi, 2 mg/mL, 12.5 mL vial, 1 count, NDC 63323-0132-12
    • Mitoxantrone Hydrochloride injection, Fresenius Kabi, 2 mg/mL, 15 mL vial, 1 count, NDC 63323-0132-15
    • Mitoxantrone Hydrochloride injection, Pfizer, 2 mg/mL, 10 mL vial, 1 count, NDC 61703-0343-18
    • Mitoxantrone Hydrochloride injection, Pfizer, 2 mg/mL, 15 mL vial, 1 count, NDC 61703-0343-66
    • Mitoxantrone Hydrochloride injection, Teva, 2 mg/mL, 12.5 mL vial, 1 count, NDC 00703-4680-01
    • Mitoxantrone Hydrochloride injection, Teva, 2 mg/mL, 15 mL vial, 1 count, NDC 00703-4686-01

Estimated Resupply Dates

    • Pfizer has short-dated mitoxantrone 2 mg/mL 12.5 mL vials available with an expiration date of November 2019.[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 (www.nccn.org) or American Society of Clinical Oncology (www.asco.org) 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. http://www.ashp.org/DocLibrary/Policy/DrugShortages/ASHP_shortage_guide09.pdf

References

    1. Fresenius Kabi (personal communications). September 24, November 11, 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, February 12, March 2 and 16, April 6, May 19, July 18, August 13, September 21, December 14, 2018; February 15, March 15, April 26, May 30, July 26, and August 16, 2019.
    2. Pfizer (personal communications). September 24, November 11, 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, February 9, March 5 and 16, April 6, May 22, and July 20, August 15, September 25, December 12, 2018; February 15, March 14, April 24, May 31, July 30, and August 16, 2019.
    3. Teva (personal communications). September 24, November 11, 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, February 12, March 5 and 19, April 6, May 21, July 16, August 13, September 24, December 10, 2018; February 11, March 18, April 22, May 27, July 29, and August 19, 2019.
    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. (http://online.factsandcomparisons.com/index.aspx). March 2015.
    6. Lexi-Drugs Online. Lexi-Comp, Inc.; 2015.

Updated

Updated August 19, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created September 24, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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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