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Methotrexate Injection

Last Updated: January 16, 2018
Status: Resolved

Methotrexate Injection

Products Affected - Description
  • Methotrexate injection, Accord
    25 mg/mL, 2 mL preservative-free vial, 1 count (NDC 16729-0277-30)

25 mg/mL, 10 mL vial, 1 count (NDC 16729-0277-03)
25 mg/mL, 40 mL preservative-free vial, 1 count (NDC 16729-0277-35)
 
Methotrexate injection, Mylan Institutional
25 mg/mL, 2 mL preservative-free vial, 5 count (NDC 67457-0467-99) - discontinued
25 mg/mL, 4 mL preservative-free vial, 10 count (NDC 67457-0486-99) - discontinued
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 and 4 mL vials in late-2017.3
    • Pfizer has methotrexate injection available.4
    • Teva had methotrexate injection on shortage due to increased demand.5
Available Products
  • 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)
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)
25 mg/mL, 40 mL preservative-free vial, 1 count (NDC 61703-0408-41)
 
Methotrexate injection, Teva
25 mg/mL, 2 mL preservative-free vial, 10 count (NDC 00703-3671-03)
25 mg/mL, 10 mL preservative-free vial, 1 count (NDC 00703-3675-01)
25 mg/mL, 40 mL preservative-free vial, 1 count (NDC 00703-3678-01)

Estimated Resupply Dates

  • Accord has methotrexate 25 mg/mL 2 mL, 10 mL, and 40 mL vials on back order and the company cannot estimate a release date.1

     

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.6
    • 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.

References

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

Updated

Updated January 16, 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.

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