Products Affected - Description

• • Methotrexate injection, Accord, 25 mg/mL, 10 mL preservative-free 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, 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

Reason for the Shortage

• • Accord has methotrexate injection on shortage due to manufacturing delays.
  • Fresenius Kabi has methotrexate injection available.
  • Pfizer has methotrexate injection on back order due to manufacturing delays.
  • Teva has methotrexate injection on back order due to increased demand.
  • Hikma has methotrexate injection on back order due to increased demand.

Available Products

• • 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, Fresenius Kabi, 1 gram, vial, 1 count, NDC 63323-0122-50
  • 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

• • Accord has methotrexate 25 mg/mL 2 mL preservative-free vials available in limited supply. The 10 mL preservative-free vials are on back order and the company cannot estimate a release date.
  • Hikma has methotrexate 25 mg/mL 2 mL preservative-free vials and 1 gram lyophilized powder vials on allocation.
  • Teva has methotrexate 25 mg/mL 40 mL preservative-free vials on back order and the company estimates a release date of December 2024.

• • 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.
  • 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.
  • Reserve preservative-free methotrexate for intrathecal doses.
  • Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations and other specialists for non-oncology uses.
  • Use oral methotrexate whenever possible for non-oncology indications.