Jylamvo, an FDA-Approved Oral Solution Formulation of Methotrexate, Now Available

Jylamvo, a Food and Drug Administration (FDA)-approved oral solution formulation of methotrexate, is now available from Shorla Oncology and Eversana.

Jylamvo is approved for the following indications:

• Treatment of adults with acute lymphoblastic leukemia as part of a combination chemotherapy maintenance regimen.
• Treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen.
• Treatment of adults with relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen.
• Treatment of adults with rheumatoid arthritis.
• Treatment of adults with severe psoriasis.

Jylamvo contains 2mg of methotrexate per mL and is packaged in bottles containing 60mL of oral solution. Each pack contains 1 bottle and a dosing syringe to ensure proper dosing. The oral solution is stable at room temperature for 90 days and does not require refrigeration. According to results from 2 bioequivalence studies, the oral solution was shown to have a palatable, sweet taste.

“We are delighted to introduce Jylamvo as an alternative treatment option for patients who may have difficulty swallowing pills,” said Sharon Cunningham, Chief Executive Officer of Shorla Oncology.

As with other methotrexate products, the prescribing information for Jylamvo includes a Boxed Warning related to embryo-fetal toxicity, hypersensitivity reactions, and severe adverse reactions.

This article originally appeared on MPR