An FDA-Approved Oral Methotrexate SolutionThe FDA is reinforcing the importance of prescribing an FDA-approved product such as Xatmep methotrexate oral solution for pediatric patients. According to the FDA:
“When a drug is FDA-approved, patients are assured that the FDA has reviewed the safety and efficacy of the drug and the adequacy of the manufacturing process to produce a quality product….compounded drugs do not provide such assurance and, therefore, should only be used when an FDA-approved product is not available to meet the medical needs of an individual patient.”1The FDA approval process helps ensure safety and effectiveness for your pediatric patients.
Xatmep Oral Solution
|Meets FDA standards for potency and purity1,2|
|Required compliance with FDA’s CGMPs1,2*|
|Source of active ingredient approved by FDA2|
|Crushing tablets or compounding tablets into a liquid formulation||NO|
|Methotrexate injections necessary||NO|
|Dosing based on body surface area||YES|
|Covered by Medicaid||YES|
Assured efficacy delivered with consistent potencyWell established efficacy: The efficacy of methotrexate is well established for the treatment ALL in pediatric patients.3
Dosing based on body surface area: With Xatmep (methotrexate) Oral Solution, 2.5 mg/mL, you can provide body surface area-based dosing for the treatment of ALL in pediatric patients.
Consistent potency: When you choose to prescribe or dispense Xatmep, it provides consistent potency from first to last dose in every prescription, to help ensure consistency from hospital to home.
Oral solution prevents incidental inhalation of a hazardous substance due to methotrexate dust from cutting or crushing tablets.