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.[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, 12.5 mL vial, 1 count, NDC 61703-0343-65
  • 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
  • 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

• • All marketed presentations are available.

• • 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

• • 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]

• • 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

• 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, August 16, September 19 and 27, October 18, and November 8, 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, August 16, September 25, October 21, and November 13, 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, August 19, September 23, October 18, and November 14, 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.