Xatmep (methotrexate), the first and only oral methotrexate solution, has gained US Food and Drug Administration (FDA) approval in the treatment of acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis in pediatric patients. For those pediatric patients with needle phobia or difficulty swallowing pills, this is a great option.1
This folate analog metabolic inhibitor is a ready-to-use 2.5 mg/mL solution and is indicated as part of a combination chemotherapy maintenance regimen for those pediatric patients with ALL.
Xatmep is contraindicated in those with a hypersensitivity to methotrexate and to those who are pregnant or nursing. Additionally, live virus immunizations are not recommended during treatment.
“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.” said Frank Segrave, President and CEO, Silvergate Pharmaceuticals, Inc.
As with other chemotherapy drugs, patients taking this medication may experience bone marrow suppression, infection, renal, gastrointestinal, hepatic, pulmonary, and dermatologic toxicities. Pregnancy should be avoided during and after treatment with the use of effective contraceptive methods. Current recommendations are for post-treatment birth control includes 3 months in men and 6 months in women.
Xatmep can additionally carry the risk for developing a secondary malignancy, impaired fertility, ineffective immunizations, and risk of soft tissue necrosis and osteonecrosis when radiation is received concomitantly.
Drug interactions do exist and include actual potential interactions with oral antibiotics, hepatotoxins, probenecid, and theophylline.
Would this be a better option for your pediatric ALL patients over intravenous administration?
- Silvergate Pharmaceuticals, Inc. FDA Approves XATMEP™, the First and Only Ready-To-Use Methotrexate Oral Solution. 2017 Apr 26.