Pralatrexate
Pralatrexate is a folate analog metabolic inhibitor used to treat relapsed or refractory peripheral T-cell lymphoma (PTCL). It works by blocking enzymes involved in folate metabolism, which depletes cells of the building blocks needed for DNA synthesis and cell division. This medication is specifically indicated for patients who have not responded to or have relapsed after prior therapy.
Pralatrexate is a chemotherapy agent that targets folate metabolism to treat relapsed peripheral T-cell lymphoma.
Key facts at a glance
- ATC
- L01BA05
- RxNorm
- 662019
- Generic
- Pralatrexate
- Class
- atc-l01
- Brands
- Folotyn
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
9 groupspregnancy
generalavoid use
contraindicated during pregnancy due to potential for fetal harm and embryotoxicity
regular fetal monitoring and pregnancy testing before and during treatment
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
first trimesteravoid use
avoid use during first trimester as this is period of highest teratogenic risk
comprehensive fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
generaldiscontinue breastfeeding
breastfeeding should be discontinued during treatment and for at least 1 week after last dose
monitor infant for adverse effects if exposed
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
pediatric generalnot established
safety and efficacy not established in pediatric patients; use only in clinical trials
close monitoring for toxicity in any pediatric use
geriatric
elderlyno specific adjustment; monitor closely
use with caution due to potential increased sensitivity and comorbidities; no specific dose reduction required but monitor for adverse effects
increased monitoring for myelosuppression, mucositis, and organ function
Use with caution and monitor for adverse effects.
renal_impairment
mild moderatereduce starting dose to 15 mg/m2
reduce dose to 15 mg/m2 for patients with CrCl 30-90 mL/min; monitor renal function closely
frequent monitoring of renal function and serum electrolytes
Use with caution and monitor for adverse effects.
renal_impairment
severenot recommended
use not recommended in patients with severe renal impairment (CrCl <30 mL/min) due to limited safety data
avoid use or consider alternative therapy
Use of this medication in this population requires careful consideration of risks and benefits.
hepatic_impairment
mild moderateno specific adjustment; monitor closely
use with caution; no formal dose adjustment but close monitoring of hepatic function recommended
regular liver function tests and monitoring for hepatotoxicity
Use with caution and monitor for adverse effects.
hepatic_impairment
severeuse with extreme caution
use only if benefits outweigh risks; consider dose reduction; monitor hepatic function frequently
intensive hepatic function monitoring
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval for treatment of peripheral T-cell lymphoma
Drug class
Classification as antifolate chemotherapy agent
Common uses
Primary indication for relapsed or refractory PTCL
Pralatrexate is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy.
As a folate analog metabolic inhibitor, pralatrexate competitively inhibits dihydrofolate reductase and interferes with polyglutamylation by folylpolyglutamyl synthetase. This leads to depletion of thymidine and other essential substrates needed for DNA synthesis, ultimately inhibiting cell proliferation.
Pralatrexate is administered intravenously and requires vitamin supplementation (leucovorin) to reduce toxicity. It carries risks of severe adverse effects including mucositis, myelosuppression, and hepatotoxicity. Regular monitoring of blood counts and organ function is required during treatment.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy