Xatmep, First Ready-to-Use Methotrexate Oral Solution, Wins FDA Nod

Product indicated for leukemia and arthritis in children

The FDA has cleared Xatmep (Silvergate Pharmaceuticals), the first approved methotrexate oral solution, for use in pediatric patients with acute lymphoblastic leukemia (ALL) or polyarticular juvenile idiopathic arthritis (pJIA). The product, which consists of 2.5 mg/mL of methotrexate, requires no preparation, eliminating the need for needles, crushing or splitting tablets, or compounding tablets into a liquid formulation.

Xatmep is indicated for the:

  • Management of pediatric patients with active pJIA who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy, including full-dose nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Treatment of pediatric patients with ALL as part of a multiphase, combination chemotherapy maintenance regimen

Methotrexate inhibits dihydrofolic acid reductase, thereby interfering with DNA synthesis, repair, and cellular replication. Actively proliferating tissues, such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder, are generally more sensitive to this effect of methotrexate. The drug’s mechanism of action in pJIA is unknown.

The labelling for Xatmep includes a boxed warning regarding the potential for severe toxic reactions, include embryo-fetal toxicity.

Sources: Silvergate Pharmaceuticals; April 26, 2016; and Xatmep Prescribing Information; April 2017.