FDA approved Methotrexate Preservative Free for Multiple Neoplastic and Inflammatory IndicationsFDA approved Preservative-Free Methotrexate for Cancer, Arthritis, and Psoriasis

Methotrexate is a folate analog metabolic inhibitor. The label states that it is a folate analog metabolic inhibitor but does not provide further mechanistic details.

Methotrexate Injection is indicated for: - Neoplastic diseases: treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen; prophylaxis and treatment of meningeal leukemia in adult and pediatric patients; treatment of adult and pediatric patients with non-Hodgkin lymphoma; treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen; treatment of adults with breast cancer as part of a combination chemotherapy regimen; treatment of adults with squamous cell carcinoma of the head and neck as a single agent; treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen. - Treatment of adults with rheumatoid arthritis (RA). - Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). - Treatment of adults with severe psoriasis.

Important: Verify pregnancy status in females of reproductive potential before starting. Use only preservative-free methotrexate for neonates or low birth weight infants and for intrathecal use. Do not use benzyl alcohol-containing formulations for high-dose regimens unless immediate treatment is required and preservative-free formulations are not available. Consider potential differences in bioavailability when switching between oral and injectable methotrexate.

Neoplastic diseases: Refer to prescribing information for disease-specific dosing. For intermediate- and high-dose regimens (500 mg/m2 or greater), administer leucovorin rescue. For doses between 100 mg/m2 and less than 500 mg/m2, consider leucovorin rescue. For high-dose regimens, monitor serum creatinine, electrolytes at baseline and at least daily; administer intravenous fluids and alkalinize urine to maintain urinary pH 7 or higher; monitor methotrexate concentrations at least daily. Administer glucarpidase for toxic plasma methotrexate concentrations (>1 micromole per liter) and delayed clearance due to impaired renal function.

RA: Recommended starting dosage 7.5 mg once weekly intramuscularly; adjust to optimal response. pJIA: Recommended starting dosage 10 mg/m2 once weekly subcutaneously or intramuscularly; adjust to optimal response. Psoriasis: Recommended dosage 10 mg to 25 mg once weekly intramuscularly or intravenously; adjust to optimal response, then reduce to lowest possible dosage.

Trial data not available in label.

The label includes warnings and precautions referenced in sections 5.1 (pregnancy), 5.3 (benzyl alcohol), and 8.4 (use in specific populations). Contraindications are referenced in section 4 but not detailed in the provided text. The label emphasizes verifying pregnancy status before starting and using preservative-free formulations for neonates, low birth weight infants, and intrathecal use.

Methotrexate Injection is a folate analog metabolic inhibitor indicated for multiple neoplastic diseases, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and severe psoriasis. The preservative-free formulation is specifically required for intrathecal use and for neonates or low birth weight infants, and should be used for high-dose regimens unless immediate treatment is required and preservative-free formulations are not available. The label does not provide information on comparative efficacy or placement in treatment algorithms.