Silvergate Pharmaceuticals announces Xatmep availability

DENVER — The first methotrexate oral solution approved by the Food and Drug Administration, Xatmep, is now available, manufacturer Silvergate Pharmaceuticals announced Monday. The drug, approved by the FDA in April, is indicated to treat acute lymphoblastic leukemia and manage polyarticular juvenile idiopathic arthritis in pediatric patients.

"Xatmep is an exciting product in that it provides an FDA-approved, ready-to-use oral solution of methotrexate for children without the need for needles, crushing of tablets, or compounding into a liquid formulation," Silvergate president and CEO Frank Segrave said. "As a company, we continue to focus on pediatric medications that are safe, effective, and readily available."

The oral solution requires no preparation, the company said, noting that it requires refrigeration but can be stored at room temperature for up to 60 days after dispensing to the patient. The drug comes with a boxed warning about the risk of severe toxic reactions, including embryo-fetal toxicity, bone marrow suppression, serious infections, hepatic toxicity and pulmonary toxicity, among others.