Pralatrexate (2 brand names, 2 dosage forms, 2 routes)
Available dosage forms: SOLUTION, INJECTABLE.
Routes of administration: INTRAVENOUS, INJECTION.
Brand Names
- FOLOTYN
- PRALATREXATE
Indications and Usage
Pralatrexate injection is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Contraindications
None
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1)] Mucositis [see Warnings and Precautions (5.2)] Dermatologic Reactions [see Warnings and Precautions (5.3)] Tumor Lysis Syndrome [see Warnings and Precautions (5.4)] Hepatic Toxicity [see Warnings and Precautions (5.5)]
Mechanism of Action
Pralatrexate is a folate analog metabolic inhibitor that competitively inhibits dihydrofolate reductase. It is also a competitive inhibitor for polyglutamylation by the enzyme folylpolyglutamyl synthetase. This inhibition results in the depletion of thymidine and other biological molecules the synthesis of which depends on single carbon transfer.
Overdosage
No specific information is available on the treatment of overdosage of pralatrexate injection. If an overdose occurs, general supportive measures should be instituted as deemed necessary by the treating healthcare provider. Based on pralatrexate injection’s mechanism of action, consider the prompt administration of leucovorin.