Products Affected - Description

• • Methotrexate injection, Mylan Institutional, 25 mg/mL, 10 mL preservative-free vial, 1 count, NDC 67457-0466-10 - discontinued
  • Methotrexate injection, Mylan Institutional, 25 mg/mL, 40 mL preservative-free vial, 1 count, NDC 67457-0480-40 - discontinued

Reason for the Shortage

• • Accord has methotrexate injection on back order due to increased demand.[1]
  • Fresenius Kabi has methotrexate injection available.[2]
  • Mylan Institutional did not provide a reason for the shortage. They discontinued the 25 mg/mL 10 mL vials in October 2020.[3]
  • Pfizer has methotrexate injection available.[4]
  • Teva has methotrexate injection available.[5]
  • Hikma did not provide a reason for the shortage.[6]

Available Products

• • Methotrexate injection, Accord, 25 mg/mL, 10 mL vial, 1 count, NDC 16729-0277-03
  • Methotrexate injection, Accord, 25 mg/mL, 2 mL preservative-free vial, 1 count, NDC 16729-0277-30
  • Methotrexate injection, Accord, 25 mg/mL, 40 mL preservative-free vial, 1 count, NDC 16729-0277-35
  • Methotrexate injection, Fresenius Kabi, 25 mg/mL, 10 mL (with preservative) vial, 1 count, NDC 63323-0123-10
  • Methotrexate lyophilized powder for solution for injection, Fresenius Kabi, 1 gram, vial, 1 count, NDC 63323-0122-50
  • Methotrexate injection, Hikma, 25 mg/mL, 2 mL preservative-free vial, 10 count, NDC 00143-9519-10
  • Methotrexate, Hikma, 1 gram, vial, 1 count, NDC 00143-9830-01
  • Methotrexate injection, Pfizer, 25 mg/mL, 2 mL (with preservative) vial, 5 count, NDC 61703-0350-38
  • Methotrexate injection, Pfizer, 25 mg/mL, 40 mL preservative-free vial, 1 count, NDC 61703-0408-41
  • Methotrexate injection, Teva, 25 mg/mL, 10 mL preservative-free vial, 1 count, NDC 00703-3675-01
  • Methotrexate injection, Teva, 25 mg/mL, 2 mL preservative-free vial, 1 count, NDC 00703-3671-01
  • Methotrexate injection, Teva, 25 mg/mL, 40 mL preservative-free vial, 1 count, NDC 00703-3678-01

• • All marketed presentations are available.

• • 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 methotrexate.[7]
  • Reserve preservative-free methotrexate for intrathecal doses.
  • Consider reserving methotrexate injection for oncology indications.
  • Use oral methotrexate whenever possible for non-oncology indications.
  • Consider evaluating the health-care system's total supply of methotrexate before beginning patients on combination chemotherapy regimens containing methotrexate. If adequate supplies are not available, select an alternative regimen.
  • Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations and other specialists for non-oncology uses.
  • Refer to the ASHP Guidelines on Managing Drug Product Shortages for more guidance on developing a multidisciplinary plan when the supply must be allocated. file:///C:/Users/u0032866/Downloads/guidelines-managing-drug-product-shortages.pdf.

• 1. Accord (personal communications). October 27, November 14, December 15, 2016; February 3 and 17, April 24, May 18, June 9, July 18, April 11, 2017; July 3, 2018; February 7, March 1, 12, and 26, April 23, May 31, August 16, November 6, 2019. January 14, August 28, 2020; and May 5, 2021.
  2. Fresenius Kabi, USA (personal communications). November 11, December 8, 2016; January 28, February 14, April 13, May 9 and 19, June 8, July 14, August 10, September 7 and 28, November 10, December 22, 2017; January 12, March 2, April 17, May 2, August 17, November 9, December 9, 2018; February 1 and 21, March 5, 8, and 21, April 19, June 21, and August 12, 16, and 30, September 6, October 3, November 8 and 22, 2019. January 17, 21, and 24, February 14, May 7, June 4, August 28, December 23, 2020; February 5, May 28, June 18, and November 19, 2021.
  3. Mylan Institutional (personal communications). October 27, 2016; February 17, May 18, August 15, and December 19, 2017; April 12, July 3, and November 16, 2018; March 12 and 26, May 13, November 20, 2019; January 17, 30, August 31, and December 16, 2020; February 10, and November 10, 2021.
  4. Pfizer (personal communications and website). November 11, December 16, 2016; February 17, April 21, May 5, 12, and 19, June 8, July 14, August 17, September 11 and 29, November 15, December 22, 2017; January 12, March 5, April 20, May 4, August 17, November 13, December 7, 2018; February 6 and 28, March 8 and 26, April 19, June 26, August 30, October 1, November 8, December 3, 2019; January 16 and 29, February 14, May 7, June 3, September 1, December 23, 2020; February 5, May 28, June 18, and November 30, 2021.
  5. Teva (personal communications). October 26, December 16, 2016; January 13, April 24, May 10, June 13, August 14, September 4, and November 13, 2017; March 5, April 13, April 20, May 4, August 13, November 12, December 10, 2018; February 4 and 25, March 7 and 25, April 22, June 24, August 19, September 2 and 6, October 1, November 8, 2019; January 17, February 14, May 4 and 29, August 28, December 18, 2020; February 5, May 28, June 18, and November 19, 2021.
  6. Hikma (personal communications). May 2, August 15, November 14, December 5, 2018; February 6 and 27, March 6 and 20, April 17, October 30, November 27, 2019; January 7 and 29, February 12, May 6, June 3, August 26, December 23, 2020; February 3, June 2 and 23, and November 24, 2021.
  7. Antineoplastic agents. AHFS Drug Information online. Bethesda, MD: American Society of Health-Systems Pharmacists. Accessed May 18, 2017.