Pralatrexate (Folotyn)
General information
Class/mechanism: Folate analog, antimetabolite, competitive inhibitor of dihydrofolate reductase. Also competitively inhibits polyglutamylation by folylpolyglutamyl synthetase and causes depletion of thymidine.[1][2]
Route: IV
Extravasation: no information
Supportive care examples:[1]
- Patients should take daily folic acid (example dose: 1 to 1.25 mg PO once per day) starting in the 10-day period before starting therapy, during therapy, and for 30 days after the last dose of Pralatrexate (Folotyn).
- Vitamin B12 1000mcg should be given no less than 10 weeks before the first dose of Pralatrexate (Folotyn) and then every 8 to 10 weeks thereafter.
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is established
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 2009-09-24: Accelerated approval for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). (Based on PROPEL)
History of changes in Health Canada indication
- 2018-10-26: Initial notice of compliance with conditions for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
History of changes in PMDA indication
- 2017-07-03: New approval for the treatment of relapsed or refractory peripheral T-cell lymphoma.
Also known as
- Brand names: Difolta, Folotyn