Pralatrexate Injection
Pralatrexate injection is a chemotherapy medicine used to treat peripheral T-cell lymphoma (a type of blood cancer) that has come back or stopped responding to other treatments.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Pralatrexate Injection: Patient Information Guide
A plain-language walkthrough of Pralatrexate Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Pralatrexate injection is approved to treat one specific blood cancer in adults.
- Relapsed or refractory peripheral T-cell lymphoma (PTCL): Pralatrexate injection (available as Folotyn and as Pralatrexate) is used when this T-cell cancer has come back after previous treatment or has stopped responding to it. This approval is based on overall tumor response rate under the FDA's accelerated approval program; continued approval may depend on confirmatory trial results.
⚙️How it works▾
Pralatrexate is designed to look like folate — a B-vitamin that rapidly dividing cells, including cancer cells, need to make DNA. It blocks an enzyme called dihydrofolate reductase, cutting off the supply of building blocks cancer cells need to copy their DNA and multiply. It also interferes with a process called polyglutamylation, which helps the drug accumulate and stay active inside cancer cells for longer.
By depleting thymidine and other molecules essential for DNA synthesis, pralatrexate disrupts cancer cell replication. This is also why the drug affects normal rapidly dividing cells — such as those lining the mouth and bone marrow — leading to mucositis and low blood counts as side effects.
💊How it's taken▾
Pralatrexate injection is given intravenously (IV) by a healthcare professional — not taken at home. It is infused once weekly for 6 weeks, followed by a 1-week rest, in repeating 7-week treatment cycles. It is given undiluted, directly into a vein over 3–5 minutes.
- Folic acid must be started by mouth daily, beginning 10 days before the first infusion, and continued throughout treatment and for 30 days after the last dose.
- Vitamin B12 must be given by injection within 10 weeks before the first dose and every 8–10 weeks during treatment — these can be given on the same day as pralatrexate infusions.
- Doses may be held, reduced, or stopped based on blood counts, mouth sore severity, kidney function, or other side effects — your care team will check these before each dose.
🤒Side effects — in detail▾
The most common side effects — occurring in more than one-third of patients — include mucositis (mouth or GI tract sores), low platelet counts, nausea, and fatigue. Other frequently reported effects include:
- Anemia (low red blood cell count)
- Constipation
- Fever
- Swelling (edema)
- Cough
- Nosebleeds (epistaxis)
- Vomiting
- Neutropenia (low infection-fighting white blood cells)
- Diarrhea
- Shortness of breath
- Rash or itching
- Abnormal liver function tests
Serious reactions — including life-threatening skin peeling (toxic epidermal necrolysis), severe infections, and fatal mucositis — have been reported. Contact your care team immediately if any side effect feels severe or is getting worse.
⚠️Warnings & precautions▾
- Myelosuppression (low blood counts): Pralatrexate can suppress the bone marrow, causing dangerously low platelets, white blood cells, and red blood cells. Blood counts are checked before every dose. Taking folic acid and vitamin B12 as directed helps reduce this risk.
- Mucositis (mouth and GI sores): Severe mouth sores are one of the most common reasons doses are held or stopped. Vitamin supplements help reduce the risk. Report worsening sores right away.
- Severe skin reactions: Toxic epidermal necrolysis (TEN) — a condition where large areas of skin blister and peel — has occurred and can be fatal. Skin reactions may worsen with each treatment. Seek urgent care for any severe or spreading skin changes.
- Tumor lysis syndrome: As cancer cells die rapidly, they can release substances that disrupt the body's chemistry. Patients at higher risk are monitored and treated promptly if this occurs.
- Liver toxicity: Abnormal liver tests can signal liver damage. Liver function is monitored regularly; doses may need to be adjusted.
- Kidney impairment: Patients with severe kidney disease need a lower dose. End-stage kidney disease (including those on dialysis) greatly increases the risk of serious side effects — pralatrexate should generally be avoided in these patients.
- Harm to unborn babies: Pralatrexate can cause fetal death and birth defects. Effective contraception is required during and after treatment (6 months for women, 3 months for men).
🔀What it interacts with▾
Pralatrexate has a few important drug interactions to be aware of:
- Probenecid (used for gout): Slows the body's ability to clear pralatrexate, increasing drug levels in the blood and the risk of serious side effects. Avoid using these together; if unavoidable, close monitoring is needed.
- NSAIDs (nonsteroidal anti-inflammatory drugs such as ibuprofen, naproxen): May increase the risk of adverse reactions. Avoid if possible; tell your doctor about any over-the-counter pain relievers you use.
- Pralatrexate may also affect how the body handles certain other chemotherapy drugs such as etoposide and teniposide, due to its effects on drug transport proteins — your oncology team will manage these interactions.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Kidney disease: Tell your doctor about any kidney problems. Severe kidney impairment requires a lower dose; end-stage kidney disease (on dialysis) is a reason to avoid this drug in most cases.
- Liver disease: The effect of liver impairment on this drug has not been well studied — inform your doctor of any liver conditions.
- Pregnancy: This drug can seriously harm or kill an unborn baby. Confirm you are not pregnant before starting, and use reliable birth control during treatment and for 6 months (women) or 3 months (men) after the last dose.
- Breastfeeding: Do not breastfeed during treatment or for 1 week after the last dose, due to the risk of serious harm to the nursing infant.
- Children: Safety and effectiveness in pediatric patients have not been established.
- Older adults (65+): Age-related decline in kidney function can raise pralatrexate levels in the body, increasing the risk of side effects. Older patients are monitored more closely.
- Other medications: Tell your doctor and pharmacist about all medications — prescription, over-the-counter, and supplements — especially probenecid and NSAIDs.
🚑If you take too much▾
There is no specific antidote for a pralatrexate overdose. If too much is given, supportive medical care will be provided based on what the treating team decides is appropriate. Because of how pralatrexate works — by blocking folate pathways — prompt administration of leucovorin (a form of folate) may be considered to help counteract the effects.
📡Pharmacodynamics — effects in the body▾
The precise relationship between pralatrexate blood levels and its effects on the body — and exactly how quickly those effects occur — has not been fully established. What is known is that by blocking folate-dependent processes in cancer cells, pralatrexate reduces the ability of those cells to replicate. This same mechanism also affects healthy rapidly dividing cells, which is why side effects like mouth sores and low blood counts occur.
🔬Pharmacokinetics — how your body processes it▾
Pralatrexate is given intravenously and spreads widely through the body. It is not significantly broken down by the liver's main enzyme system (CYP450), which means fewer metabolism-based drug interactions. It is primarily eliminated through the kidneys — about one-third of each dose is excreted unchanged in urine — which is why kidney function directly affects how the drug is cleared. The drug's half-life (the time for blood levels to fall by half) is roughly 12–18 hours, and it does not build up in the body with repeated weekly dosing.
📦How to store it▾
Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
📄 Written from Pralatrexate Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Pralatrexate Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is pralatrexate used for? ▾
Why do I have to take folic acid and vitamin B12 before my infusions? ▾
What side effects should I call my doctor about right away? ▾
Can I take ibuprofen or other over-the-counter pain relievers while on this treatment? ▾
Is it safe to get pregnant or father a child during treatment? ▾
What happens if my blood counts are too low on the day of my infusion? ▾
Is Pralatrexate Injection available over the counter? ▾
When was Pralatrexate Injection first available? ▾
Who makes Pralatrexate Injection? ▾
💬 Answers drafted from Pralatrexate Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Pralatrexate Injection comes
Pralatrexate Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Folotyn and Pralatrexate injection are used to treat relapsed or refractory peripheral T-cell lymphoma (PTCL) in adults
- Folotyn and Pralatrexate injection are given intravenously (into a vein) by a healthcare provider over 3–5 minutes, once weekly for 6 weeks in a 7-week cycle
- Pralatrexate injection is administered undiluted through the side port of a free-flowing sodium chloride (saline) IV line — it is not diluted before infusion
- Before starting Folotyn or Pralatrexate injection, patients must take folic acid by mouth daily (beginning 10 days before the first dose) and receive vitamin B12 injections every 8–10 weeks
- Pralatrexate injection is a hazardous drug — if it contacts skin, wash immediately with soap and water; if it contacts mucous membranes, flush thoroughly with water
📊 Pralatrexate Injection across the U.S. market
How Pralatrexate Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Pralatrexate Injection is used
A general measure of how commonly Pralatrexate Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Pralatrexate Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Pralatrexate Injection prescribed? Of the 1,596 medications we measure, Pralatrexate Injection ranks #1,513 by Medicaid prescriptions — more than 5% of them.
Utilization by Pralatrexate Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
1 ML pralatrexate 20 MG/ML Injection
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1796419
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Pralatrexate Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 4 listed Pralatrexate Injection NDCs with Medicaid activity.
🔍 Compare Pralatrexate Injection products
A representative set of FDA-listed product records for Pralatrexate Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 20 mg/mL | Intravenous | Acrotech Biopharma Inc × 4 listings | NDA | View NDC → |
| 40 mg/2 mL | Intravenous | Acrotech Biopharma Inc × 3 listings | NDA | View NDC → |
| 20 mg/mL | Intravenous | Acrotech Biopharma LLC | NDA | View NDC → |
| 20 mg/mL | Intravenous | Dr.Reddy's Laboratories Inc., | ANDA | View NDC → |
| 40 mg/2 mL | Intravenous | Dr.Reddy's Laboratories Inc., | ANDA | View NDC → |
| 20 mg/mL | Intravenous | Fresenius Kabi USA, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 40 mg/2 mL | Intravenous | Fresenius Kabi USA, LLC | NDA AUTHORIZED GENERIC | View NDC → |
Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Pralatrexate Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Pralatrexate Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Pralatrexate Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Pralatrexate Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 662019 1 dose form · 2 strengths
-
Dose form (SCDF) Injection RxCUI 1796418In current FDA listingsClinical drug / strength (SCD) 1 ML pralatrexate 20 MG/MLRxCUI 17964192 ML pralatrexate 20 MG/MLRxCUI 1796424
Look up RxCUI 662019 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Pralatrexate Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 3 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Fresenius Kabi USA, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.