Pralatrexate: uses, dosing, side effects & brands
Pralatrexate is a folate analog metabolic inhibitor sold in the U.S. under one brand, for peripheral t-cell lymphoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Folate Analog Metabolic Inhibitor
- Treats
- Peripheral T-Cell Lymphoma
- Available as
- Injectable
- Sold as
- Folotyn
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How pralatrexate is dosed
From the FDA label for Folotyn (application NDA022468). Other pralatrexate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Supplement patients with vitamin B 12 mg intramuscularly every 8-10 weeks starting 10 weeks before the first dose and folic acid 1 to 1.25 mg orally once daily starting 10 days before the first dose. ( 2.1 ) The recommended dosage of FOLOTYN is 30 mg/m 2 intravenously over 3 to 5 minutes once weekly for 6 weeks in 7-week cycles. ( 2.1 ) For patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m 2 ), reduce the FOLOTYN dose to 15 mg/m 2 ( 2.1 ). 2.1 Important Dosing Information Pretreatment Vitamin Supplementation Folic Acid Instruct patients to take folic acid 1 to 1.25 mg orally once daily beginning 10 days before the first dose of FOLOTYN. Continue folic acid during treatment with FOLOTYN and for 30 days after the last dose [ see Warnings and Precautions ( 5.1 , 5.2 )] . Vitamin B 12 Administer vitamin B 12 1 mg intramuscularly within 10 weeks prior to the first dose of FOLOTYN and every 8-10 weeks thereafter. Subsequent vitamin B 12 injections may be given the same day as treatment with FOLOTYN [ see Warnings and Precautions ( 5.1 , 5.2 )] . 2.2 Recommended Dosage The recommended dosage of FOLOTYN is 30 mg/m 2 intravenously over 3-5 minutes once weekly for 6 weeks in 7-week cycles until progressive disease or unacceptable toxicity. 2.3 Dosage Modifications for Renal Impairment and End Stage Renal Disease Severe renal impairment (eGFR 15 to 29 mL/min/1.73 m 2 by…
Pralatrexate side effects
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) ] Most common adverse reactions (>35%) are mucositis, thrombocytopenia, nausea, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc at 1-888-255-6788 or www.FOLOTYN.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Peripheral T-cell Lymphoma The safety of FOLOTYN was evaluated in Study PDX-008 [ see Clinical Studies (14) ] . Patients received FOLOTYN 30 mg/m 2 once weekly for 6 weeks in 7-week cycles. The median duration of treatment was 70 days (range: 1 day to 1.5 years). The majority of patients (69%, n = 77) remained at the target dose for the duration of treatment. Overall, 85% of scheduled doses were administered. Forty-four percent of patients (n = 49) experienced a…
Who shouldn’t take pralatrexate
None None.( 4 )
Pralatrexate drug interactions
Avoid coadministration with probenecid or nonsteroidal anti-inflammatory drugs. If coadministration is unavoidable, monitor for increased risk of adverse reactions. ( 7.1 ) 7.1 Effects of Other Drugs on FOLOTYN Coadministration of FOLOTYN with probenecid increased pralatrexate plasma concentrations [ see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions. Avoid coadministration with probenecid or nonsteroidal anti-inflammatory drugs. If coadministration is unavoidable, monitor for increased risk of adverse reactions.
Every pralatrexate product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Folotyn.
How long pralatrexate keeps
No pralatrexate label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does pralatrexate expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about pralatrexate
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 277 reports naming pralatrexate, and the FDA flagged 96% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- malignant neoplasm progression36 reports
- mucosal inflammation31 reports
- stomatitis31 reports
- pyrexia28 reports
- anaemia24 reports
- neutropenia22 reports
- diarrhoea20 reports
- fatigue20 reports
Read these as a signal, not a rate. A report does not mean pralatrexate caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is pralatrexate?
Folotyn (Pralatrexate) is a folate analog metabolic inhibitor used to treat Peripheral T-Cell Lymphoma.
What kind of drug is pralatrexate?
The FDA classifies pralatrexate as a folate analog metabolic inhibitor. Folate analog metabolic inhibitors like methotrexate block the enzyme that converts folate into its usable form, starving fast-dividing cells of the building blocks for DNA. At low doses they also calm an overactive immune system and reduce inflammation. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take pralatrexate with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run pralatrexate against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does pralatrexate come in?
Across the brands we track, pralatrexate is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic pralatrexate?
We do not currently list a generic-labelled pralatrexate product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Pralatrexate: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/pralatrexate
- MLA
- “Pralatrexate: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/pralatrexate.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for pralatrexate on DailyMed (NIH) ↗.