Pralatrexate

Generic Name: pralatrexate (PRAL-a-TREX-ate)
Brand Name: Folotyn

Pralatrexate is used for:

Treating a type of cancer called peripheral T-cell lymphoma (PTCL) in certain patients.

Pralatrexate is a folate analog metabolic inhibitor. It works by killing certain types of cancer cells.

Do NOT use pralatrexate if:

  • you are allergic to any ingredient in pralatrexate
  • you have taken or will be taking palifermin within 24 hours before or after using pralatrexate

Contact your doctor or health care provider right away if any of these apply to you.

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Before using pralatrexate:

Some medical conditions may interact with pralatrexate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver or kidney problems
  • if you are on dialysis

Some MEDICINES MAY INTERACT with pralatrexate. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Palifermin because if mouth or tongue sores develop, they may be more severe or last longer
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), probenecid, or sulfamethoxazole/trimethoprim because they may increase the risk of pralatrexate's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if pralatrexate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use pralatrexate:

Use pralatrexate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with pralatrexate. Talk to your pharmacist if you have questions about this information.
  • Pralatrexate is usually given as an injection at your doctor's office, hospital, or clinic.
  • Pralatrexate is a clear, yellow solution. Do not use pralatrexate if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of pralatrexate, contact your doctor right away.

Ask your health care provider any questions you may have about how to use pralatrexate.

Important safety information:

  • You will need to take folic acid and receive vitamin B12 injections before using pralatrexate as well as while you are using it. This may help to decrease the risk of certain serious side effects (eg, blood problems, mouth sores or inflammation). Follow your doctor's instructions and continue taking these medicines until your doctor tells you to stop. Discuss any questions or concerns with your doctor.
  • Pralatrexate may cause you to become dehydrated. Check with your doctor about how to avoid becoming dehydrated while you use pralatrexate.
  • Pralatrexate may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Pralatrexate may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Patients who take pralatrexate have a risk of developing a serious and possibly fatal condition called tumor lysis syndrome (TLS). Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; severe nausea, vomiting, diarrhea, or loss of appetite; or sluggishness.
  • Severe and sometimes fatal skin reactions have been reported with the use of pralatrexate, especially in patients with lymphoma in or under the skin. Contact your doctor right away if you develop symptoms such as rash; sores; or red, swollen, blistered, or peeling skin.
  • Tell your doctor or dentist that you use pralatrexate before you receive any medical or dental care, emergency care, or surgery.
  • Women who are able to become pregnant should use an effective form of birth control while they are using pralatrexate. Talk with your doctor if you have questions about effective birth control.
  • If pralatrexate comes into contact with your skin, wash well with soap and water right away. If it gets in your eyes, nose, or mouth, rinse well with water right away.
  • Lab tests, including complete blood cell counts and liver and kidney function, may be performed while you use pralatrexate. These tests may be used to monitor your condition or check for side effects. Your doctor will also monitor you for pain, redness, sores, or inflammation of the mouth, lips, throat, or on the genitals. Be sure to keep all doctor and lab appointments.
  • Use pralatrexate with caution in the ELDERLY; they may be more sensitive to its effects.
  • Pralatrexate should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Pralatrexate may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using pralatrexate while you are pregnant. It is not known if pralatrexate is found in breast milk. Do not breast-feed while you are using pralatrexate.

Possible side effects of pralatrexate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; loss of appetite; mild cough or sore throat; mild stomach pain; mild swelling (eg, of the hands or feet); nausea; night sweats; pain in the hands, feet, or back; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast heartbeat; fever, chills, or persistent cough or sore throat; loss of skin; nosebleed; pain or burning during urination; pain, redness, sores, or inflammation of the mouth, lips, throat, or on the genitals; red, swollen, blistered, or peeling skin; severe or persistent tiredness or weakness; shortness of breath; symptoms of dehydration (eg, decreased urination, increased thirst, very dry mouth); symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, severe stomach pain, yellowing of the skin or eyes); symptoms of low blood potassium levels (eg, irregular heartbeat; muscle pain, weakness, or cramping); ulcers or sores on your skin; unusual bruising or bleeding; unusually pale skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of pralatrexate:

Pralatrexate is usually handled and stored by a health care provider. If you are using pralatrexate at home, store pralatrexate as directed by your pharmacist or health care provider. Keep pralatrexate out of the reach of children and away from pets.

General information:

  • If you have any questions about pralatrexate, please talk with your doctor, pharmacist, or other health care provider.
  • Pralatrexate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take pralatrexate or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about pralatrexate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to pralatrexate. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using pralatrexate.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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