New Injectable Form of Methotrexate Approved

November 25, 2019 – The U.S. FDA has approved RediTrexTM (methotrexate) injection, manufactured by Cumberland Pharmaceuticals. The product is indicated to manage severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA) in patients who are intolerant of or have had an inadequate response to first-line therapy, and to provide symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are do not have an adequate response to other forms of therapy.

RediTrex joins multiple other FDA-approved brand name and generic methotrexate products on the U.S. market. These include oral tablets, an oral solution, and a powder approved for use in autoinjectors. For some patients, injectable methotrexate can reduce discomfort and provide more effective treatment.

Recommended dosing with RediTrex is based on the condition being treated. The product is administered via subcutaneous injection in the abdomen or thigh once per week. RediTrex should not be used in patients who require oral, intramuscular, intravenous, intra-arterial, or intrathecal dosing. It should also not be used in patients who require doses of less than 7.5mg per week or more than 25mg per week, high-dose regimens, or dose adjustments at increments of less than 2.5mg.

A black box warning cautions that methotrexate products carry a risk of severe toxic reactions, death, and embryo-fetal toxicity. These products should only be prescribed by physicians who have knowledge and experience in the use of antimetabolite therapy.

Cumberland Pharmaceuticals has not yet announced launch or pricing plans.