FDA Approves Jylamvo (methotrexate) for Multiple Neoplastic and Inflammatory Indications

Jylamvo is a folate analog metabolic inhibitor. It inhibits dihydrofolate reductase, thereby interfering with DNA synthesis, repair, and cellular replication.

Jylamvo is indicated for: (1) treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen; (2) treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen; (3) treatment of adults with relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen; (4) treatment of adults with rheumatoid arthritis; (5) treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA); (6) treatment of adults with severe psoriasis.

Verify pregnancy status in females of reproductive potential before starting Jylamvo. Instruct patients and caregivers to use the copackaged syringe and bottle adaptor to measure the dose, as medication errors have led to deaths. Jylamvo contains 2 mg methotrexate per mL. For ALL: 20 mg/m2 orally once weekly. For mycosis fungoides: 25-75 mg orally once weekly as monotherapy or 10 mg/m2 orally twice weekly as part of combination chemotherapy. For relapsed/refractory non-Hodgkin lymphoma: 2.5 mg orally 2-4 times per week (max 10 mg/week). For rheumatoid arthritis: starting dose 7.5 mg orally once weekly, adjust to optimal response; doses >20 mg weekly increase risk of serious adverse reactions. For pJIA: starting dose 10 mg/m2 orally once weekly, adjust to optimal response; doses >30 mg/m2 weekly increase risk of serious adverse reactions. For psoriasis: 10-25 mg orally once weekly until adequate response. Administer folic acid or folinic acid to reduce methotrexate adverse reactions.

Trial data not available in label.

Contraindicated in pregnancy. Verify pregnancy status before starting. Medication errors have led to deaths; instruct patients on proper dosing. Jylamvo is a hazardous drug; follow special handling and disposal procedures. For rheumatoid arthritis and pJIA, administer folic acid or folinic acid to reduce risk of adverse reactions.

Jylamvo provides an oral liquid formulation of methotrexate for multiple indications. It may be used in patients who cannot swallow tablets or require flexible dosing. Clinicians should be aware of the risk of medication errors and ensure proper dosing instructions are given.