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12/4/2019

Methotrexate Injection

Products Affected - Description

    • 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, Teva, 25 mg/mL, 2 mL preservative-free vial, 10 count, NDC 00703-3671-03 - discontinued
    • 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 on back order due to increased demand.[1]
    • Fresenius Kabi has methotrexate injection available.[2]
    • Mylan Institutional has methotrexate injection available.[3]
    • Pfizer did not provide a reason for the shortage.[4]
    • Teva did not provide a reason for the shortage.[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 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

    • Hikma has methotrexate 1 gram vials available with short expiration dating (October 2020).[6]
    • Pfizer has methotrexate 25 mg/mL 2 mL vials available in limited supply.[4]
    • Teva has methotrexate 25 mg/mL 40 mL vials on allocation. Please check with your wholesaler.[5]

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, April 11, 2017; July 3, 2018; February 7, March 1, 12, and 26, April 23, May 31, August 16, and November 6, 2019.
    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, and November 8 and 22, 2019.
    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, and November 20, 2019.
    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, and November 8, and December 3, 2019.
    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, and November 8, 2019.
    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, and November 27, 2019.
    7. Antineoplastic agents. AHFS Drug Information online. Bethesda, MD: American Society of Health-Systems Pharmacists. Accessed May 18, 2017.

Updated

Updated December 4, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. Created December 16, 2016 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Vizient, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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