Folotyn

Name: Folotyn

Uses of Folotyn

Folotyn 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. Folotyn 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.

Folotyn Dosage

  • This medication is available in an injectable form to be dosed by a healthcare professional.
  • The recommended dose of Folotyn is 30 mg/m2 given as an intravenous (into the vein) push over 3-5 minutes once weekly for 6 weeks in 7-week cycles. The dose may be adjusted due to response and/or toxicity.

 

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your pralatrexate injection.

Pralatrexate side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • bone marrow suppression--fever, chills, cold or flu symptoms, pale skin, easy bruising or bleeding, red or pink urine, painful mouth sores, cough, trouble breathing, feeling light-headed, rapid heart rate;

  • dehydration--feeling very thirsty or hot, are unable to urinate, and have heavy sweating or hot and dry skin;

  • low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • nausea, vomiting, loss of appetite, diarrhea, constipation;

  • tired feeling;

  • swelling; or

  • mild rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

PRALAtrexate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV use only

20 mg/mL

Folotyn (available in single-dose vials)

Allos

Commonly used brand name(s)

In the U.S.

  • Folotyn

Available Dosage Forms:

  • Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antimetabolite

Uses For Folotyn

Pralatrexate injection is used to treat peripheral T-cell lymphoma (PTCL) in patients who have already been treated with other medicines that did not work well. Peripheral T-cell lymphoma is a rare type of cancer that affects certain white blood cells and causes enlarged and swollen lymph nodes in the neck, armpits, and groin.

Pralatrexate belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other unwanted effects may also occur. Some of these may be serious and must be reported to your doctor.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Proper Use of Folotyn

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

It is very important to take folic acid tablets during your treatment with pralatrexate to lower your chances of harmful side effects. You must start taking 1 to 1.25 milligrams (mg) of folic acid every day for at least 10 days before your first dose. You must keep taking folic acid every day during therapy and for 30 days after your last pralatrexate dose. You can get folic acid as a nonprescription (over-the-counter [OTC]) product. Ask your doctor for help in choosing a folic acid product.

Your doctor will also give you vitamin B12 injections during your treatment with pralatrexate to lower your chances of harmful side effects. You will get your first injection about 10 weeks before your first dose, and additional injections about every 8 to 10 weeks during therapy.

This medicine usually comes with a patient information leaflet. Read the information carefully and make sure you understand it before receiving this medicine. If you have any questions, ask your doctor.

What are some things I need to know or do while I take Folotyn?

  • Tell all of your health care providers that you take Folotyn. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
  • Mouth irritation and mouth sores are common with this medicine. These side effects may happen as early as a few days after getting Folotyn. Do what your doctor or other health care provider tells you to prevent mouth irritation or mouth sores. Call your doctor if mouth irritation or mouth sores get very bad, bother you, or do not go away.
  • A very bad skin reaction (toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Patients with cancer who take this medicine may be at a greater risk of getting a bad health problem called tumor lysis syndrome (TLS). Sometimes, this has been deadly. Call your doctor right away if you have a fast heartbeat or a heartbeat that does not feel normal; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, loose stools, or not able to eat; or feel sluggish.
  • If you are 65 or older, use Folotyn with care. You could have more side effects.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • Use birth control that you can trust to prevent pregnancy while taking this medicine.
  • If you are pregnant or you get pregnant while taking Folotyn, call your doctor right away.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Folotyn (pralatrexate) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 Folotyn. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Indications and Usage for Folotyn

Folotyn is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is based on overall response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated.

Warnings and Precautions

Bone Marrow Suppression

Folotyn can cause bone marrow suppression, manifested by thrombocytopenia, neutropenia, and/or anemia. Monitor complete blood counts and omit and/or reduce the dose based on ANC and platelet count prior to each dose as outlined in Section 2.2 Table 2. Administer vitamin B12 and instruct patients to take folic acid to reduce the risk of treatment-related hematological toxicity [see Dosage and Administration (2.1, 2.2) and Adverse Reactions (6.1)].

Mucositis

Folotyn can cause mucositis. Monitor for mucositis weekly and if ≥ Grade 2 mucositis is observed, omit and/or reduce the dose as outlined in Section 2.2 Table 1. Administer vitamin B12 and instruct patients to take folic acid to reduce the risk of mucositis [see Dosage and Administration (2.1, 2.2) and Adverse Reactions (6.1)].

Dermatologic Reactions

Folotyn can cause severe dermatologic reactions, which may result in death. These dermatologic reactions have been reported in clinical studies (14/663 patients [2.1%]) and post marketing experience, and have included skin exfoliation, ulceration, and toxic epidermal necrolysis (TEN). They may be progressive and increase in severity with further treatment, and may involve skin and subcutaneous sites of known lymphoma. Monitor patients with dermatologic reactions closely, and if severe, withhold or discontinue Folotyn [see Adverse Reactions (6.2) and Use in Specific Populations (8.7)].

Tumor Lysis Syndrome

Folotyn can cause tumor lysis syndrome (TLS). Monitor patients who are at increased risk of TLS and treat promptly.

Hepatic Toxicity

Folotyn can cause hepatic toxicity and liver function test abnormalities. Persistent liver function test abnormalities may be indicators of hepatic toxicity and require dose modification or discontinuation. Monitor liver function tests. Omit dose until recovery, adjust or discontinue therapy based on the severity of the hepatic toxicity [see Dosage and Administration (2.2) and Use in Specific Populations (8.6)].

Risk of Increased Toxicity in the Presence of Impaired Renal Function

Patients with moderate to severe renal function impairment may be at greater risk for increased exposure and toxicity. Monitor patients for renal function and systemic toxicity and adjust dosing accordingly.

Serious adverse drug reactions including toxic epidermal necrolysis and mucositis were reported in patients with end stage renal disease (ESRD) undergoing dialysis who were administered Folotyn therapy. Avoid Folotyn use in patients with end stage renal disease including those undergoing dialysis unless the potential benefit justifies the potential risk [see Dosage and Administration (2.2), Adverse Reactions (6.2), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].

Embryo-Fetal Toxicity

Folotyn can cause fetal harm when administered to a pregnant woman. Folotyn was embryotoxic and fetotoxic in rats and rabbits. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1)].

Before receiving Folotyn

You should not receive Folotyn if you are allergic to pralatrexate.

To make sure you can safely use this medicine, tell your doctor if you have kidney disease.

Do not use Folotyn if you are pregnant. It could harm the unborn baby. Use effective birth control to avoid pregnancy during your treatment with Folotyn. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

It is not known whether pralatrexate passes into breast milk or if it could harm a nursing baby. You should not breast-feed a baby while you are being treated with Folotyn.

How is Folotyn given?

Folotyn is injected into a vein through an IV. A healthcare provider will give you this injection.

Folotyn is usually given once per week for up to 6 weeks at a time. Follow your doctor's instructions.

Your doctor may have you take folic acid supplements starting 10 days before your first dose of Folotyn and ending 30 days after your last dose. Your may also receive vitamin B12 injections every 8 to 10 weeks during treatment. This can help protect your blood cells from some of the side effects of pralatrexate. Follow your doctor's medication instructions very closely.

Folotyn can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

For the Consumer

Applies to pralatrexate: intravenous solution

Along with its needed effects, pralatrexate (the active ingredient contained in Folotyn) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking pralatrexate:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • body aches or pain
  • chills
  • convulsions
  • cough
  • cracked lips
  • decreased urine
  • diarrhea
  • difficult or labored breathing
  • difficulty with swallowing
  • dry mouth
  • ear congestion
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • headache
  • increased thirst
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • mood changes
  • muscle pain or cramps
  • nasal congestion
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • runny nose
  • shortness of breath
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • swelling
  • tightness in the chest
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Some side effects of pralatrexate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach pain
  • back pain
  • bloody nose
  • constipation
  • itching skin
  • lack or loss of strength
  • night sweats
  • pain in the arms or legs
  • rash
  • weight loss

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