Silvergate announced the launch of Xatmep (methotrexate) Oral Solution indicated to treat pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen, and for the management of polyarticular juvenile idiopathic arthritis (pJIA) in those who have had an insufficient response to, or are intolerant of, an adequate trial of first-line therapy including full-dose nonsteroidal anti-inflammatory drugs (NSAIDs).
Xatmep is the first ready-to-use (RTU) methotrexate oral solution formulation, eliminating the need for needles, tablet crushing, or liquid compounding for this patient population. Before Xatmep, there was no FDA-approved, RTU oral liquid methotrexate product for use in children requiring body surface area (BSA) dosing (mg/m2).
Methotrexate works by inhibiting dihydrofolic acid reductase, which interferes with DNA synthesis, repair, and cellular replication. Malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and urinary bladder cells are more sensitive to the effects of methotrexate. In pJIA, the mechanism is not fully known but it is presumed to affect immune function.
Xatmep is available as a 2.5mg/mL strength ready-to-use solution in 120mL bottles. It requires refrigeration but may be kept at room temperature for 60 days after dispensing.
For more information call (855) 379-0382 or visit Xatmep.com.