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METHOTREXATE How Supplied/Storage and Handling (Methotrexate Preservative-Free Vial)

HOW SUPPLIED

Parenteral:

Methotrexate Injection, USP, Isotonic Liquid, Preservative Free, for Single Use Only. Each 25 mg/mL, 40 mL vial contains methotrexate sodium equivalent to 1 g methotrexate.

      1 g, 40 mL Vial               NDC 61703-408-41

Store at controlled room temperature, 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]; excursions permitted to 15° to 30°C (59° to 86°F). PROTECT FROM LIGHT.

‡LEUCOVORIN RESCUE SCHEDULES FOLLOWING TREATMENT WITH HIGHER DOSES OF METHOTREXATE

Clinical Situation

Laboratory Findings

Leucovorin Dosage and

Duration

Normal Methotrexate

Elimination

Serum methotrexate level approximately 10 micromolar at 24 hours after administration, 1 micromolar at 48 hours, and less than 0.2 micromolar at 72 hours.

15 mg PO, IM, or IV q 6 hours for 60 hours (10 doses starting at 24 hours after start of methotrexate infusion).

Delayed Late Methotrexate Elimination

Serum methotrexate level remaining above 0.2 micromolar at 72 hours, and more than 0.05 micromolar at 96 hours after administration.

Continue 15 mg PO, IM, or IV q six hours, until methotrexate level is less than 0.05 micromolar.

Delayed Early Methotrexate Elimination and/or Evidence of Acute Renal Injury

Serum methotrexate level of 50 micromolar or more at 24 hours, or 5 micromolar or more at 48 hours after administration, OR; a 100% or greater increase in serum creatinine level at 24 hours after methotrexate administration, (e.g., an increase from 0.5 mg/dL to a level of 1 mg/dL or more).

150 mg IV q three hours, until methotrexate level is less than 1 micromolar; then 15 mg IV q three hours until methotrexate level is less than 0.05 micromolar.

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