Pralatrexate

Pralatrexate is a prescription medication is used to treat people with a type of cancer called Peripheral T-cell Lymphoma (PTCL). Pralatrexate belongs to a group of drugs called folate analog metabolic blockers. It works by killing cancer cells.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of pralatrexate include sores and inflammation in the mouth, nausea, and tiredness.

Pralatrexate is a prescription medication used to treat peripheral T-cell lymphoma (PTCL). PTCL is a form of cancer that begins in a certain type of cells in the immune system. Pralatrexate has not been shown to help people who have lymphoma live longer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Pralatrexate may be found in some form under the following brand names:

• Folotyn

Common side effects of pralatrexate include the following:

• sores or inflammation of the mouth 
• low platelet count
• nausea
• fatigue
• fever
• dehydration
• difficulty breathing

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• sulfamethoxazole-trimethoprim (Bactrim, Septra, Septra DS, Sulfatrim Pediatric, Sulfamethoprim, Sulfamethoprim-DS)
• aspirin and other NSAIDs (nonsteroidal anti-inflammatory drugs) such as
  • celecoxib (Celebrex)
  • diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others)
  • etodolac (Lodine)
  • ibuprofen (Advil, Motrin, Nuprin)
  • indomethacin (Indocin, Indocin SR)
  • ketoprofen (Orudis, Actron, Oruvail)
  • ketorolac (Toradol)
  • meloxicam (Mobic)
  • nabumetone (Relafen)
  • naproxen (Naprosyn)
  • naproxen sodium (Aleve, Anaprox, Naprelan)
  • oxaprozin (Daypro)
  • piroxicam (Feldene)
• probenecid (Probalan, Col-Probenecid)

This is not a complete list of pralatrexate drug interactions. Ask your doctor or pharmacist for more information.

Serious adverse reactions can occur with use of pralatrexate including:

• low blood cell counts. This medication can affect your bone marrow and cause you to have low blood cell counts. Your doctor will do blood tests as needed to check your blood cell counts.
• low platelet count (thrombocytopenia). Tell your doctor right away if you have any unusual bleeding, such as nosebleeds, or bruising under your skin.
• low white blood cell count (neutropenia). A low white blood cell count can cause you to get infections, which may be serious. Serious illness or death can happen if an infection is not treated right away when white blood cell counts are very low. Tell your doctor right away if you have any of the following signs or symptoms of an infection:
  • fever
  • shortness of breath
  • pain or burning during urination
  • chills
  • cough
• low red blood cell count (anemia). Tell your doctor if you have any of these symptoms of anemia during treatment with pralatrexate:
  • feeling weak, tired, or you get tired easily
  • you look pale
  • you feel short of breath
• Redness and sores of the mucous membrane lining of the mouth, lips, throat, digestive tract, and genitals (mucositis). Discomfort or pain due to mucositis may happen as early as a few days after treatment with this medication. Your doctor should tell you about ways to reduce your risk of getting mucositis, and how to maintain nutrition and control the discomfort from mucositis.
• Severe skin reactions. Severe skin reactions may happen after treatment with pralatrexate, especially if you have lymphoma in or under your skin. If your skin reactions are severe, they may lead to serious illness or death. Tell your doctor right away if you have any of the following skin reactions:
  • rash
  • peeling and loss of skin
  • sores
  • blisters
• Tumor Lysis Syndrome (TLS). Pralatrexate can cause the fast breakdown of certain types of cancer cells. This can lead to TLS. Your doctor may do blood tests to check you for TLS and treat you for TLS if needed.
• Fever. Fever is often one of the most common and earliest signs of infection. Follow your doctor's instructions about how often to take your temperature, especially during the days after treatment with pralatrexate. If you have a fever, tell your doctor or nurse right away.
• Loss of too much fluid from the body (dehydration). If you feel tired and weak this could be a sign of dehydration. Follow your doctor's instructions for what to do to help prevent or treat dehydration.
• Shortness of breath. Tell your doctor if this is a problem for you.

Do not take this medication if you are allergic to pralatrexate or to any of its inactive ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of pralatrexate, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking pralatrexate, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to pralatrexate or to any of its ingredients
• have liver problems
• have kidney problems
• have heart problems
• if you are having surgery, including dental surgery
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if pralatrexate crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using pralatrexate.

• Pralatrexate will be given to you as directed by your doctor, as an intravenous (into the vein) injection into your vein over 3 to 5 minutes.
• Pralatrexate is usually given in cycles, one time each week for 6 weeks, with no treatment on the 7th week. Treatment with pralatrexate may be continued as long as it is helpful to you.

To lower your chances of harmful side effects, it is important that you take folic acid and vitamin B12 during your treatment with pralatrexate. Your doctor will give you specific instructions for vitamin supplementation.

• You will take folic acid by mouth for 10 days before your first dose of pralatrexate. Do not take more or less folic acid than your doctor tells you to take. Continue taking folic acid every day until your doctor tells you to stop.
• Your doctor will give you a vitamin B12 injection into your muscle (intramuscular) before your first dose of pralatrexate and about every 8 to 10 weeks during treatment with pralatrexate.

You should have regular blood tests before and during your treatment with pralatrexate. Your doctor may change your dose of pralatrexate or delay treatment based on the results of your blood tests and on your general condition.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Pralatrexed vials should be refrigerated at 2-8°C (36-46°F) until use.
• Pralatrexed vials should be stored in original carton to protect from light until use.
• Pralatrexed vials contain no preservatives and are intended for single use only.
• After first use, discard vial including any unused portion.
• Unopened vial(s) of pralatrexate are stable if stored in the original carton at room temperature for 72 hours.
  • Any vials left at room temperature for greater than 72 hours should be discarded.