Products Affected - Description
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)
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
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)
2 mg/mL, 15 mL vial, 1 count (NDC 63323-0132-15)
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
- Hospira has all mitoxantrone injection on long-term back order and the company estimates a release date of February 2017.2
- Teva has mitoxantrone 10 mL vials on back order and the company estimates a release date of October 2016.3
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.
- 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, and September 2, 2016.
- Hospira (personal communications). September 24, November 11, and December 9 and 15, 2015; February 3, March 2, April 5, May 12, June 13, August 11, and September 7, 2016.
- Teva (personal communications). September 24, November 11, and December 9 and 15, 2015; February 3, March 2, April 5, May 12, and August 10, 2016.
- Antineoplastic agents. In: McEvoy GK, ed. AHFS 2015 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2015: 839-1281.
- Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. March 2015.
- Lexi-Drugs Online. Lexi-Comp, Inc.; 2015.
Updated September 7, 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.
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