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Pralatrexate

(pra luh treks ate)

Trade/other name(s): Folotyn, PDX

Why would this drug be used?

Pralatrexate is used to treat peripheral T-cell lymphoma, a type of non-Hodgkin lymphoma. It is also being studied for use against other types of cancer.

How does this drug work?

Pralatrexate belongs to a group of chemotherapy drugs called anti-metabolites. More specifically, it is an anti-folate. It prevents cells from using folate to make DNA and RNA. Because cancer cells need these substances to make new cells, pralatrexate may slow or stop the growth of cancer cells.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have any type of liver disease (including hepatitis). This drug may affect the function of your liver. Reduced liver function might result in more drug than expected staying in the body, which could lead to serious side effects. Your doctor may need to adjust your dose accordingly.
  • If you have any type of kidney disease. This drug is removed from the body in part by the kidneys. Lowered kidney function might result in more drug than expected staying in the body, which could lead to serious side effects. Your doctor may need to adjust your dose accordingly.
  • If you have any other medical conditions such as heart disease, congestive heart failure, diabetes, gout, or infections. These conditions may require that your medicine dose, regimen, or timing be changed.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. This drug may cause birth defects if it is taken at the time of conception or during pregnancy. If you're sexually active while taking this drug, you should use some kind of birth control. It is important to check with your doctor about what kinds of birth control can be used with this medicine.
  • If you are breast-feeding. Although no studies have been done, this drug may pass into breast milk and affect the baby. Breast-feeding is not recommended during treatment with this drug.
  • If you think you might want to have children in the future. It is not known if this drug affects fertility. Talk with your doctor about the possible risk with this drug and the options that may preserve your ability to have children.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Probenecid, a drug used to treat gout, can cause pralatrexate to stay in your system longer, which may worsen its side effects.

The antibiotic trimethoprim-sulfa (Bactrim, Septra) can cause the same problem.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are a group of medicines that include aspirin, ibuprofen, naproxen, diclofenac, indomethacin, tolmetin, meclofenamate, and others. These drugs can cause pralatrexate to stay in your system longer, which may worsen its side effects. Since there are many types of NSAIDs, check with your doctor, nurse, or pharmacist to find out if any of the medicines you are taking are in this group.

Check with your doctor, nurse, or pharmacist about other medicines, vitamins, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Pralatrexate is given as an injection in the vein (intravenously; IV) over 3 to 5 minutes, usually once a week for 6 weeks. This is followed by a week off, after which the cycle may be repeated. The dose depends on your body size. The dose may be adjusted or delayed depending upon your blood counts and whether you have mouth sores or other side effects.

You will need to take folic acid (a vitamin pill) each day, starting within 10 days before your first dose of pralatrexate and continuing for 30 days after the last dose. You can buy folic acid over the counter (without a prescription). You will need only 1 mg to 1.25 mg per day. If you have any questions, or need help in deciding which folic acid product to use, ask your nurse, pharmacist, or doctor.

Your doctor or nurse will also give you vitamin B12 as an injection into a muscle during treatment. The first shot is given within 10 weeks before starting pralatrexate, and other shots will be given every 8 to 10 weeks after that.

These vitamins help protect your body's normal cells from the effects of the chemotherapy.

Precautions

This drug may cause sores in the mouth or on the lips, often within the first few weeks after starting treatment. This can cause mouth pain, bleeding, or even trouble eating. Your doctor or nurse can suggest ways to reduce this, such as changing the way you eat or how you brush your teeth. If needed, your doctor can prescribe medicine to help with the pain. Your doctor may also need to reduce or delay your next dose of this drug.

You may have nausea and vomiting on the day you receive this drug or in the first few days afterward. Your doctor may give you medicine before your treatment to help prevent nausea and vomiting. You may also get a prescription for an anti-nausea medicine that you can take at home. It is important to have these medicines on hand and to take them as prescribed by your doctor.

Pralatrexate can make you feel tired. You may feel tired and weak for a few days after your treatment. Tell your doctor or nurse if you have severe weakness or tiredness.

Your doctor will test your blood throughout your treatment, looking for possible effects of the drug on blood counts (described below) or on other body organs. Based on the test results, you may be given medicines to help treat any effects. Your doctor may also need to reduce or delay your next dose of this drug, or even stop it altogether.

This drug can lower your white blood cell count, especially in the weeks after the drug is given. This can increase your chance of getting an infection. Be sure to let your doctor or nurse know right away if you have any signs of infection, such as fever (100.5o F or higher), chills, diarrhea, mouth sores, pain when passing urine, a new cough, or bringing up sputum.

This drug may lower your platelet count in the weeks after it is given, which can increase your risk of bleeding. Talk with your doctor before taking any drugs or supplements that might affect your body's ability to stop bleeding, such as aspirin or aspirin-containing medicines, warfarin (Coumadin), or vitamin E. Tell your doctor right away if you have unusual bruising, or bleeding such as nosebleeds, bleeding gums when you brush your teeth, or black, tarry stools.

This drug may lower your red blood cell count. If this occurs, it is usually a month or two after starting treatment. A low red blood cell count (known as anemia) can cause shortness of breath, or make you feel weak or tired all the time. Your doctor may give you medicines to help prevent or treat this condition, or you may need to get blood transfusions.

Do not get any immunizations (vaccinations), either during or after treatment with this drug, without your doctor's OK. This drug may affect your immune system, which could make vaccines ineffective, or could even lead to serious infections. Try to avoid contact with people who have recently received a live virus vaccine, such as the oral polio vaccine or smallpox vaccine. Check with your doctor about this.

While taking this drug, and for a few days afterward, there is a slight chance of a serious skin reaction. It can start as a skin rash with redness or blistering in the mouth, nose, or eyes, along with fever and body aches. If this happens, it must be treated right away to reduce the risk of more serious complications.

Possible side effects

If you have any of the following side effects, talk to your doctor or nurse. They can help you understand these side effects and help you deal with them.

Common

  • Sores in the mouth or on the lips*
  • Low white blood cell count with increased risk of infection*
  • Low platelet count with increased risk of bleeding*
  • Low red blood cell count (anemia) which can cause fatigue and shortness of breath*
  • Nausea*
  • Vomiting*
  • Diarrhea
  • Constipation
  • Feeling tired (fatigue)
  • Fever
  • Cough
  • Nosebleeds
  • Swelling in the hands or feet

Less common

  • Trouble breathing
  • Feeling weak
  • Loss of appetite
  • Skin rash or itching
  • Abnormal blood tests which suggest that the drug is affecting the liver or kidneys (Your doctor will discuss the importance of this finding, if any.)
  • Sore throat
  • Rapid heart rate
  • Pain in the abdomen
  • Night sweats

Rare

  • Serious rash with fever and blistering*
  • Low blood pressure, which can cause you to feel dizzy or faint
  • Death from severe infection or blistering skin rash

*See the "Precautions" section for more detailed information.

Side effects not listed above can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2009.

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.

Last Medical Review: 03/07/2011
Last Revised: 03/07/2011