News

FDA approves first ready-to-use oral solution of methotrexate


 

Photo by Bill Branson

Child with leukemia

The US Food and Drug Administration (FDA) has approved a ready-to-use oral solution of methotrexate (Xatmep) for use in certain pediatric patients.

The drug is approved as part of a multi-phase, combination chemotherapy maintenance regimen to treat pediatric patients with acute lymphoblastic leukemia.

Xatmep is also approved for use in pediatric patients with active polyarticular juvenile idiopathic arthritis who have had an insufficient response to, or cannot tolerate, an adequate trial of first-line therapy, including full-dose non-steroidal anti-inflammatory agents.

Xatmep is the first ready-to-use oral solution of methotrexate to be approved by the FDA.

There was previously no such formulation of the drug approved for use in pediatric patients requiring body surface area dosing (mg/m2), patients who have difficulty swallowing or cannot consume tablets, or those with needle-phobia.

Xatmep (methotrexate) Oral Solution, 2.5 mg/mL, requires no preparation. It eliminates the need for needles, crushing or splitting tablets, or for compounding tablets into a liquid formulation.

Xatmep requires refrigeration but may be stored at room temperature for 60 days after dispensing.

For more on Xatmep, see the prescribing information, which includes a boxed warning detailing the risk of severe toxic reactions, including embryo-fetal toxicity.

Xatmep is available through pharmacies and a qualified mail-order service. For information on how to obtain the drug, call 1-855-379-0382.

Xatmep is a product of Silvergate Pharmaceuticals, Inc.

Recommended Reading

FDA approves midostaurin for adult patients with FLT3+ AML
MDedge Hematology and Oncology
Treatment-related hypertension, kidney injury are undertreated in kids with leukemia
MDedge Hematology and Oncology
FDA boxed warning leads to drop off in use of ESAs
MDedge Hematology and Oncology
Longer course of idarubicin consolidation increases leukemia-free survival
MDedge Hematology and Oncology
Drug receives orphan designation for AML
MDedge Hematology and Oncology
FDA approves midostaurin to treat FLT3+ AML, advanced SM
MDedge Hematology and Oncology
FDA approves test to detect FLT3 mutations
MDedge Hematology and Oncology
Scientists create online database to aid CML research
MDedge Hematology and Oncology
Fertility treatments linked to risk of pediatric cancers
MDedge Hematology and Oncology
Role of TET2 in hematologic malignancies
MDedge Hematology and Oncology