Products Affected - Description

• • Cytarabine solution for injection, Mylan Institutional, 100 mg/mL, 20 mL preservative-free vial, 1 count, NDC 67457-0452-20
  • Cytarabine solution for injection, Mylan Institutional, 20 mg/mL, 5 mL preservative-free vial, 10 count, NDC 00069-0152-02
  • Cytarabine solution for injection, Mylan Institutional, 20 mg/mL, 50 mL preservative-free vial, 1 count, NDC 67457-0454-50

Reason for the Shortage

• • Fresenius Kabi has cytarabine available.[1]
  • Mylan Institutional cannot provide a reason for the shortage. Their presentations are on long-term back order.[2]
  • West-Ward discontinued cytarabine injection in September 2014.[3]
  • Hospira has all cytarabine injection available.[4]

Available Products

• • Cytarabine solution for injection, Fresenius Kabi, 100 mg/mL, 20 mL preservative-free vial, 1 count, NDC 63323-0120-20
  • Cytarabine solution for injection, Pfizer, 100 mg/mL, 20 mL preservative-free vial, 1 count, NDC 61703-0319-22
  • Cytarabine solution for injection, Pfizer, 20 mg/mL, 25 mL multiple dose vial, 1 count, NDC 61703-0304-36
  • Cytarabine solution for injection, Pfizer, 20 mg/mL, 5 mL preservative-free vial, 5 count, NDC 61703-0305-38
  • Cytarabine solution for injection, Pfizer, 20 mg/mL, 50 mL preservative-free vial, 1 count, NDC 61703-0303-46

• • Mylan Institutional has cytarabine 20 mg/mL 5 mL and 50 mL vials and 100 mg/mL 20 mL vials on back order and the company cannot estimate a release date.[2]
  • All other marketed presentations are available.

• • Cytarabine is a pyrimidine antimetabolite. It is labeled for use as a single agent or in combination with other antineoplastic agents for a variety of leukemias including acute and chronic myelocytic leukemia, acute lymphocytic leukemia, and meningeal leukemia. These regimens are labeled for use in both adult and pediatric patients.[5,6,7]
  • Cytarabine is used off-label in adults with Hodgkin disease or undergoing hematopoietic stem cell transplantation. Cytarabine is also used in non-Hodgkin lymphoma.[5,6,7]
  • 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 cytarabine, pose additional safety risks both for patients and for healthcare workers handling these agents.[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).[5,6]

• • 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 cytarabine.[5,6,7]
  • Consider evaluating the health-care system's total supply of cytarabine before beginning patients on combination chemotherapy regimens containing cytarabine. 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). March 11 and 30, May 6, July 23, August 5, September 23, December 2, 2015; January 20, April 11, July 7, and October 17, 2016.
  2. Mylan Institutional (personal communications). March 11, May 8, July 24, August 11, September 28, December 7, 2015; January 25, April 12, July 11, and October 11, 2016.
  3. West-Ward (personal communications). March 4, 2015.
  4. Hospira (personal communications and website). March 12 and 30, May 8, July 23, August 12, September 28, December 9, 2015; January 25, April 12, July 14, and October 19, 2016.
  5. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2015 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2015: 839-1281.
  6. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. (http://online.factsandcomparisons.com/index.aspx). March 2015.
  7. Lexi-Drugs Online. Lexi-Comp, Inc.; 2015.