Skip to Content

Methotrexate Injection

Last Updated: May 4, 2018
Status: Current

Products Affected - Description
    • Methotrexate injection, Mylan Institutional, 25 mg/mL, 2 mL preservative-free vial, 5 count, NDC 67457-0467-99
    • Methotrexate injection, Mylan Institutional, 25 mg/mL, 4 mL preservative-free vial, 10 count, NDC 67457-0486-99
    • Methotrexate injection, Mylan Institutional, 25 mg/mL, 8 mL preservative-free vial, 10 count, NDC 67457-0485-99
Reason for the Shortage
    • Accord did not provide a reason for the shortage.[1]
    • Fresenius Kabi has methotrexate injection available.[2]
    • Mylan Institutional did not provide a reason for the shortage. Mylan Institutional discontinued the 40 mg/mL 2 mL, 4 mL, and 8 mL vials in late-2017.[3]
    • Pfizer has methotrexate injection available.[4]
    • Teva had methotrexate injection on shortage due to increased demand.[5]
    • West-Ward has methotrexate injection available.[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, Mylan Institutional, 25 mg/mL, 10 mL preservative-free vial, 1 count, NDC 67457-0466-10
    • Methotrexate injection, Mylan Institutional, 25 mg/mL, 40 mL preservative-free vial, 1 count, NDC 67457-0480-40
    • 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, 10 count, NDC 00703-3671-03
    • Methotrexate injection, Teva, 25 mg/mL, 40 mL preservative-free vial, 1 count, NDC 00703-3678-01
    • Methotrexate, West-Ward, 1 gram, vial, 1 count, NDC 00143-9830-01

Estimated Resupply Dates

    • All marketed presentations are available.

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 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.

References

    1. Accord (personal communications). October 27, November 14, December 15, 2016; February 3 and 17, April 24, May 18, June 9, July 18, and April 11, 2017.
    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, and May 2, 2018.
    3. Mylan Institutional (personal communications). October 27, 2016; February 17, May 18, August 15, and December 19, 2017; April 12, 2018.
    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, and May 4, 2018.
    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, and May 4, 2018.
    6. West-Ward (personal communications). May 2, 2018.
    7. Antineoplastic agents. AHFS Drug Information online. Bethesda, MD: American Society of Health-Systems Pharmacists. Accessed May 18, 2017.

Updated

Updated May 4, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. Created December 16, 2016 by Michelle Wheeler, PharmD, Drug Information Specialist. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

Hide