FDA Approves First Methotrexate Oral Solution

The FDA has approved Xatmep (methotrexate) Oral Solution 2.5 mg/mL, the first FDA-approved methotrexate oral solution.

Xatmep is indicated for the treatment of acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen, and polyarticular juvenile idiopathic arthritis (PJIA) in patients who had insufficient therapeutic response to, or who were intolerant of, first-line therapy including full dose NSAIDs.
____________________________________________________________________________________________________________________________________________
RELATED CONTENT
FDA Approves New Options for Pediatric Patients With Hepatitis C
FDA: Spiriva Respimat Granted Pediatric Exclusivity
____________________________________________________________________________________________________________________________________________

Xatmep includes a boxed warning for severe toxic reactions, including embryo-fetal toxicity, and is contraindicated in patients who are hypersensitive to methotrexate, or patients who are pregnant or nursing.

The most common adverse reactions include ulcerative stomatitis, leukopenia, nausea, abdominal distress, and elevated liver function tests.

—Michael Potts

Reference:

FDA Approves XATMEP™, the first and only ready-to-use methotrexate oral solution [press release]. April 26, 2017. Denver, Colorado. http://silvergatepharma.com/index.php/2017/04/26/xatmep/.