Pralatrexate

What it is used for

FOLOTYN 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 FOLOTYN is safe and effective in children.

Before you receive FOLOTYN, 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. FOLOTYN can harm your unborn baby. Females who are able to become pregnant: Males with female partners who are able to become pregnant should use effective birth control during treatment with FOLOTYN and for 3 months after the last dose of FOLOTYN.
  • Your healthcare provider may do a pregnancy test before you start treatment with FOLOTYN.
  • You should use effective birth control (contraception) during treatment with FOLOTYN 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 may be pregnant during treatment with FOLOTYN.

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

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 FOLOTYN works.

Especially tell your healthcare provider if you take:

• sulfamethoxazole trimethoprim
• non-steroidal anti-inflammatory drugs (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.

Side effects, and when to stop

FOLOTYN 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 FOLOTYN. Tell your healthcare provider right away if you develop any signs of infection, fever, bleeding or tiredness during treatment with FOLOTYN.
• Redness and sores of the mucous membrane lining of the mouth, lips, throat, digestive tract, and genitals (mucositis). Mucositis is common with FOLOTYN 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. FOLOTYN 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 f 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 FOLOTYN.
• 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 FOLOTYN.

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

These are not all of the possible side effects of FOLOTYN. 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 FOLOTYN. 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 FOLOTYN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about FOLOTYN that is written for health professionals.

How will I receive FOLOTYN?

• FOLOTYN will be given to you by your healthcare provider as an intravenous (IV) injection into your vein over 3 to 5 minutes.
• FOLOTYN 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 FOLOTYN to help reduce the risk of possible side effects.
  • You will take folic acid by mouth for 10 days before your first dose of FOLOTYN. Continue taking folic acid during treatment with FOLOTYN 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 FOLOTYN and every 8 to 10 weeks during treatment with FOLOTYN.

• Your healthcare provider will do blood tests before and during treatment with FOLOTYN.

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