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Overview: Pralatrexate is used to treat certain kinds of lymphoma, which is a type of blood cancer. Common side effects include nausea, tiredness, and mouth sores, which can sometimes be severe. Other serious side effects may include severe skin rashes and liver problems. Pralatrexate is given as an infusion into your vein (IV) by a health care provider.

Uses

What is pralatrexate used for?

Pralatrexate is commonly used to treat certain kinds of peripheral T-cell lymphoma (PTCL), which is a type of blood cancer.

Pralatrexate may also be used for other conditions as determined by your health care provider.

How does pralatrexate work (mechanism of action)?

Pralatrexate is a type of chemotherapy. It targets certain enzymes, or proteins, to prevent RNA and DNA in cancer cells from working. This allows pralatrexate to stop the cancer cells from growing and multiplying, which can help slow or stop the spread of cancer.

How is pralatrexate supplied (dosage forms)?

Brands and other names

  • Folotyn

Dosage forms and strengths

Pralatrexate is available in an injectable form that is given by a health care provider.

How should I store pralatrexate?

Pralatrexate is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of pralatrexate?

The most common side effects of pralatrexate are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Mouth sores (see below)
  • Blood disorders (see below)
  • Nausea
  • Tiredness

There may be other side effects of pralatrexate that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of pralatrexate?

While less common, the most serious side effects of pralatrexate are described below, along with what to do if they happen.

Severe Allergic Reactions. Pralatrexate may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash 
  • Bumps on the skin called hivesthat can be red, pink, white, or brown, depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Blood Disorders. Pralatrexate can cause blood disorders, such as low red blood cell levels (anemia), low platelet levels (thrombocytopenia), and low neutrophil levels (neutropenia). It is important to go to all appointments for bloodwork to ensure pralatrexate is safe for you. Get help right away if you have any of the following symptoms of blood disorders.

  • Fever 
  • Shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

Mouth Sores. Pralatrexate can cause sores in the mouth, as well as the lips, throat, genitals, or digestive tract. This is a common side effect of pralatrexate, and it can sometimes be severe. Tell your health care provider if you have sores, redness, or any other symptoms in your mouth or throat, such as trouble eating, drinking, or speaking. Your health care provider may need to pause or change your pralatrexate doses if you have severe symptoms. They can also give you advice on how to help prevent this side effect or limit discomfort, if needed.

Severe Skin Reactions. Pralatrexate can cause severe skin reactions, including toxic epidermal necrolysis (TEN), that can lead to death if not treated. If you get a rash, call your health care provider right away. Get emergency help if you have any of the following symptoms.

  • Painful skin that looks burned and peels off
  • Flat rash, sores, or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes
  • Flu-like symptoms including fever, chills, and muscle aches

Tumor Lysis Syndrome. Pralatrexate can cause a fast breakdown of cancer cells. This can lead to a condition called tumor lysis syndrome, which can be serious. It is important to drink plenty of water while receiving pralatrexate and to keep all appointments for bloodwork so your health care provider can see how your body is responding to pralatrexate. Tell your health care provider right away if you have any of the following signs of tumor lysis syndrome while using pralatrexate.

  • Nausea and vomiting
  • Weakness
  • Swelling or fluid retention
  • Shortness of breath
  • Muscle cramps
  • Seizures

Liver Damage. Liver damage, also called hepatotoxicity, can happen when using pralatrexate. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Warnings & Precautions

Who should not use pralatrexate?

Allergies to Ingredients. People who are allergic to any of the following should not use pralatrexate.

  • Pralatrexate
  • Folotyn
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific pralatrexate products they stock.

What should I know about pralatrexate before using it?

Pralatrexate is usually given by a health care provider in a hospital or clinic. It is given as an infusion into your vein (IV).

It is important to go to all appointments for bloodwork with your health care provider. They will use these tests to make sure it is safe for you to start pralatrexate. They will also use the tests to monitor your body’s response to pralatrexate and make sure it is safe for you to continue using the medicine.

You will likely be prescribed certain vitamins to take before, during, and after your treatment with pralatrexate. These can help prevent serious side effects from pralatrexate. Take these vitamins exactly as your health care provider tells you to.

What should I tell my health care provider before using pralatrexate?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if pralatrexate is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Kidney problems
  • Liver problems
  • An infection or symptoms of an infection, such as a fever

Other Medicines and Supplements. Pralatrexate may interact with other medicines and supplements. Before using pralatrexate, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Pralatrexate may harm an unborn baby. You should not be pregnant before starting pralatrexate. If you can get pregnant, you should use effective birth control while using pralatrexate and for six months after your last dose. If you are able to get a partner pregnant, you should use effective birth control while using pralatrexate and for three months after your last dose. Tell your health care provider right away if you are pregnant, think you might be pregnant, or plan to become pregnant.

Breastfeeding. It is not known if pralatrexate passes into breast milk. Do not breastfeed while using pralatrexate and for one week after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

Vaccines. Talk with your health care provider about any vaccines that you may need. You may not be able to receive certain vaccines right before or while using pralatrexate. Tell your health care provider about any vaccines you have recently received or have scheduled.

Interactions

Does pralatrexate interact with foods or drinks?

There are no known interactions between pralatrexate and foods or drinks.

It is unknown if drinking alcohol will affect pralatrexate, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does pralatrexate interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using pralatrexate.

  • Sulfamethoxazole/trimethoprim, which is an antibiotic used to treat certain infections
  • A nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen, naproxen, and others, which is in many prescription and OTC products for pain, swelling, and fever
  • Probenecid, which is a medicine commonly used for gout

This may not be a complete list of medicines that can interact with pralatrexate. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much pralatrexate?

If you or someone else has used too much pralatrexate, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of pralatrexate?

Pralatrexate is usually given by a health care provider in a hospital or clinic. Your health care provider will make sure you are receiving pralatrexate as scheduled. If you miss an appointment to get your pralatrexate dose, call to make another appointment as soon as possible.