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Pralatrexate (Folotyn): Uses, Side Effects and Dosage

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Prescription (Rx)
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20 mg/mL, 40 mg/2 mL
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Pralatrexate

What is Pralatrexate injection?

Pralatrexate injection is a prescription used to treat people with a type of cancer called peripheral T-cell lymphoma (PTCL) that does not go away, gets worse, or comes back after use of another cancer treatment.

It is not known if Pralatrexate injection is safe and effective in children.

Before you receive Pralatrexate injection, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney problems, including end-stage renal disease (ESRD)

  • are pregnant or plan to become pregnant. Pralatrexate injection can harm your unborn baby.

    Females who are able to become pregnant:

    • Your healthcare provider may do a pregnancy test before you start treatment with Pralatrexate injection.
    • You should use effective birth control (contraception) during treatment with Pralatrexate injection and for 6 months after the last dose. Talk to your healthcare provider about the best birth control methods you can use during this time.
    • Tell your healthcare provider if you become pregnant or think you maybe pregnant during treatment with Pralatrexate injection.

    Males with female partners who are able to become pregnant should use effective birth control during treatment with Pralatrexate injection and for 3 months after the last dose of Pralatrexate injection.

  • are breastfeeding or plan to breastfeed. It is not known if Pralatrexate injection passes into your breast milk. Do not breastfeed during treatment with Pralatrexate injection and for 1 week after the last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Pralatrexate injection.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how Pralatrexate injection works.

Especially tell your healthcare provider if you take:

  • sulfamethoxazole trimethoprim
  • non-steroidal anti-inflammatory (NSAIDs) medicines
  • probenecid

Know the medicines you take. Keep a list of them and show it to your healthcare provider or pharmacist each time you start a new medicine.

How will I receive Pralatrexate injection?

  • Pralatrexate injection will be given to you by your healthcare provider as an intravenous (IV) injection into your vein over 3 to 5 minutes.
  • Pralatrexate injection is usually given in cycles, one time each week for 6 weeks, with no treatment on the 7th week.

  • Your healthcare provider will treat you with folic acid and vitamin B12 before and during your treatment with Pralatrexate injection to help reduce the risk of possible side effects.

    • You will take folic acid by mouth for 10 days before your first dose of Pralatrexate injection. Continue taking folic acid during treatment with Pralatrexate injection and for 30 days after the last dose.
    • Your healthcare provider will give you a vitamin B12 injection into your muscle (intramuscular). You will get your first vitamin B12 injection 10 weeks before your first dose of Pralatrexate injection and every 8 to 10 weeks during treatment with Pralatrexate injection.
  • Your healthcare provider will do blood tests before and during treatment with Pralatrexate injection.

Your healthcare provider may stop treatment, delay treatment, or change your dose of Pralatrexate injection based on results of your blood tests and if you have certain side effects.

What are the possible side effects of Pralatrexate injection?

Pralatrexate injection may cause serious side effects, including:

  • Low blood cell counts: Your healthcare provider will do blood tests to check your blood cell counts before and during treatment with Pralatrexate injection. Tell your healthcare provider right away if you develop any signs of infection, fever, bleeding or tiredness during treatment with Pralatrexate injection.
  • Redness and sores of the mucous membrane lining of the mouth, lips,throat, digestive tract, and genitals (mucositis). Mucositis is common with Pralatrexate injection and can be severe. Tell your healthcare provider if you develop redness or painful sores in your mouth or throat, or have trouble speaking, eating or drinking. Your healthcare provider will tell you about ways to reduce your risk of getting mucositis, and how to maintain nutrition and help control the discomfort from mucositis.

  • Severe skin reactions. Pralatrexate injection can cause severe skin reactions that may lead to death. In people with lymphoma, severe skin reactions may happen on and under your skin. Tell your healthcare provider right away if you develop any of the following skin reactions:

    • rash
    • peeling and loss of skin
    • sores
    • blisters
  • Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of certain types of cancer cells. Your healthcare provider may do blood tests to check you for TLS and treat you if needed.
  • Liver problems. Your healthcare provider will monitor you for liver problems during treatment with Pralatrexate injection.
  • Increased risk of serious reactions in people with kidney problems. People with severe kidney problems may have a greater risk for increased serious reactions during treatment with Pralatrexate injection.

The most common side effects of Pralatrexate injection include: low platelet blood counts, nausea, and tiredness.

These are not all of the possible side effects of Pralatrexate injection.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Pralatrexate injection.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. This Patient Information leaflet summarizes the most important information about Pralatrexate injection. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Pralatrexate injection that is written for health professionals.

What are the ingredients in Pralatrexate injection?

Active ingredient: pralatrexate

Inactive ingredients: sodium chloride, sodium hydroxide, and hydrochloric acid.

Manufactured for:

Lake Zurich, IL 60047

www.fresenius-kabi.com/us

Made in Germany

451757

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA AUTHORIZED GENERIC 022468 · View the label on DailyMed

Revision date stated in the text: September 2022

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Pralatrexate

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Folate Analog Metabolic Inhibitor
Active ingredient Pralatrexate
Dosage form Injection
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) ACROTECH BIOPHARMA
FDA approval NDA AUTHORIZED GENERIC 022468NDA authorized generic Approved September 24, 2009
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code APCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Folotyn with the same TE code
Manufacturers 2 labelers list this drug on DailyMed
Packages (NDC)
Package
20 mg/mL – 1 ml in 1 vial, single-dose / 1 in 1 carton
40 mg/2 mL – 2 ml in 1 vial, single-dose / 1 in 1 carton

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.