Pralatrexate

What is Pralatrexate?

• Pralatrexate (Folotyn) is a folate analog metabolic inhibitor used in the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL).

Pralatrexate

Pralatrexate ball-and-stick

What are the uses of this medicine?

• Pralatrexate (Folotyn) is a prescription anti-cancer (chemotherapy) medicine. Folotyn is used to treat people with a type of cancer called Peripheral T-cell Lymphoma (PTCL) that does not go away, gets worse, or comes back after use of another cancer treatment.

PTCL:

• PTCL is a rare type of non-Hodgkin's lymphoma, a cancer of the lymphatic system.
• It happens when a type of T-cell (a kind of white blood cell) grows too much.
• PTCL may be found in different parts of the body, such as the lymph nodes, skin, bone marrow, liver, or spleen.

How does this medicine work?

• Pralatrexate (pral" a trex' ate) is a folate analogue which acts as an antagonist to the enzymes involved in folate dependent synthetic pathways such as thymidine synthase, dihydrofolate reductase and glycinamide ribonucleotide formyltransferase.
• Inhibition of these enzymes leads to decrease in intracellular concentrations of thymidine and purine which blocks RNA and DNA synthesis and leads to apoptotic cell death in rapidly dividing cells.
• In vitro and in vivo studies have shown that pralatrexate has activity against peripheral T cell lymphomas.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Some medicines may affect how Folotyn works, and Folotyn may affect how other medicines work.

Especially tell your doctor if you take:

• sulfamethoxazole trimethoprim (Bactrim®, Septra®, Septra DS, Sulfatrim Pediatric, Sulfamethoprim, Sulfamethoprim-DS)
• non-steroidal anti-inflammatory drugs (NSAIDs)
• probenecid (Probalan, Col-Probenecid)

Is this medicine FDA approved?

• Pralatrexate was approved for medical use in the United States in September 2009, as the first treatment for Peripheral T-cell Lymphoma (PTCL), an often aggressive type of non-Hodgkins lymphoma.

How should this medicine be used?

• Prior to initiating Folotyn, supplement patients with vitamin B12 1 mg intramuscularly every 8-10 weeks and folic acid 1.0-1.25 mg orally on a daily basis.

Recommended dosage:

• The recommended dose of Folotyn is 30 mg/m2 administered as an intravenous push over 3 to 5 minutes once weekly for 6 weeks in 7-week cycles.
• For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73 m2), the recommended dose of Folotyn is 15 mg/m2.

• Management of severe or intolerable adverse reactions may require dose omission, reduction, or discontinuation of Folotyn therapy.

Administration:

• Folotyn will be given to you as directed by your doctor, as an intravenous (IV) injection into your vein over 3 to 5 minutes.
• Folotyn is usually given in cycles, one time each week for 6 weeks, with no treatment on the 7th week. Treatment with Folotyn 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 Folotyn. 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 Folotyn. 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 Folotyn and about every 8 to 10 weeks during treatment with Folotyn.
• You should have regular blood tests before and during your treatment with Folotyn. Your doctor may change your dose of Folotyn or delay treatment based on the results of your blood tests and on your general condition.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Sterile, single-dose vials containing pralatrexate at a concentration of 20 mg/mL in the following presentations:
• 20 mg of pralatrexate in 1 mL solution in a vial (20 mg / 1 mL)
• 40 mg of pralatrexate in 2 mL solution in a vial (40 mg / 2 mL)

This medicine is available in fallowing brand namesː

• Folotyn

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• vomiting
• tiredness
• constipation
• swelling
• cough
• nosebleed
• diarrhea

Folotyn may cause serious side effects, including:

• Low Blood Cell Counts
• thrombocytopenia
• neutropenia
• anemia
• mucositis
• Severe skin reactions
• Tumor Lysis Syndrome (TLS)
• Harm to an unborn baby
• Fever
• dehydration
• Shortness of breath

What special precautions should I follow?

• Folotyn can cause bone marrow suppression, manifested by thrombocytopenia, neutropenia, and/or anemia. Monitor blood counts and omit and/or reduce dose for hematologic toxicities.
• Folotyn can cause mucositis. Monitor at least weekly. If ≥ Grade 2 mucositis is observed, omit and/or reduce dose.
• Folotyn can cause severe dermatologic reactions, which may result in death. Reactions, including fatal reactions, have occurred and may be progressive and increase in severity with further treatment. Monitor closely, and omit and/or reduce dose or discontinue Folotyn.
• Folotyn can cause tumor lysis syndrome (TLS). Monitor patients who are at increased risk of TLS and treat promptly.
• Folotyn can cause hepatic toxicity and liver function test abnormalities. Monitor for toxicity. For liver function test abnormalities Grade 3 or greater, omit until recovery then reduce dose or discontinue therapy as required.
• 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. Avoid Folotyn use in patients with end stage renal disease including those undergoing dialysis unless the potential benefit justifies the potential risk.
• Folotyn can cause fetal harm when administered to a pregnant woman. Women should avoid becoming pregnant while being treated with Folotyn. Inform pregnant women of the potential harm to the fetus.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• No specific information is available on overdosage of Folotyn.

Management of overdosage:

• If an overdose occurs, general supportive measures should be instituted as deemed necessary by the treating physician.
• Based on Folotyn's mechanism of action, consider the prompt administration of leucovorin.

Can this medicine be used in pregnancy?

• Folotyn can cause fetal harm when administered to a pregnant woman.
• 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.

Can this medicine be used in children?

• The safety and effectiveness of Folotyn in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: pralatrexate
• Inactive ingredients: sodium chloride, sodium hydroxide, and hydrochloric acid

Who manufactures and distributes this medicine?

Manufactured for:

• Spectrum Pharmaceuticals, Inc. and its wholly-owned subsidiary Allos Therapeutics, Inc.
• Westminster, CO

What should I know about storage and disposal of this medication?

• Vials must be stored refrigerated at 2-8°C (36-46°F) in original carton to protect from light.
• Handle and dispose of Folotyn according to guidelines issued for cytotoxic drugs, including the use of gloves and other protective clothing to prevent skin contact.
• Each vial of Folotyn is intended for single use only. Any unused drug remaining after injection must be discarded.

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• Dailymed label info on Pralatrexate
• FDA Pralatrexate

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