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Methotrexate Injection

Last Updated: December 11, 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
    • Methotrexate injection, Pfizer, 25 mg/mL, 2 mL (with preservative) vial, 5 count, NDC 61703-0350-38
    • 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
Reason for the Shortage
    • Accord has methotrexate injection available.[1]
    • Fresenius Kabi has methotrexate injection available.[2]
    • Mylan Institutional has methotrexate injection available. Mylan Institutional discontinued the 40 mg/mL 2 mL, 4 mL, and 8 mL vials in late-2017.[3]
    • Pfizer did not provide a reason for the shortage.[4]
    • Teva has methotrexate injection on shortage due to increased demand.[5]
    • Hikma 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, 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, 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, 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

Estimated Resupply Dates

    • Pfizer has methotrexate 25 mg/mL 2 mL vials on allocation.
    • Teva has methotrexate 25 mg/mL 40 mL preservative-free vials on allocation. Check wholesaler for inventory.

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; and July 3, 2018.
    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, and December 9, 2018.
    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.
    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, and December 7, 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, May 4, August 13, November 12, and December 10, 2018.
    6. Hikma (personal communications). May 2, August 15, November 14, and December 5, 2018.
    7. Antineoplastic agents. AHFS Drug Information online. Bethesda, MD: American Society of Health-Systems Pharmacists. Accessed May 18, 2017.

Updated

Updated December 11, 2018 by Leslie Jensen, 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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