Folotyn is a cancer medication.

Folotyn is used to treat T-cell lymphoma that has spread throughout the body.

Folotyn is given for relapsed T-cell lymphoma, or after other medications have been tried without successful treatment.

Before you receive Folotyn, tell your doctor if you have kidney disease.

Folotyn can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

Do not use pralatrexate if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. You should not breast-feed a baby while you are being treated with Folotyn. You may be required to take oral folic acid supplements and receive vitamin B12 injections to help prevent some of the side effects of Folotyn. Follow your doctor's medication instructions very closely.

Folotyn is given as an infusion into a vein. A healthcare provider will give you this injection.

Folotyn is usually given once per week for up to 6 weeks at a time.

Your doctor may have you take folic acid supplements before, during, and after your treatment with Folotyn. You may also receive vitamin B12 injections every 8 to 10 weeks. This can help protect your blood cells from certain side effects of pralatrexate.

Follow your doctor's dosing instructions very carefully.

Folotyn can increase your risk of bleeding or infection. You will need frequent medical tests. Your cancer treatments may be delayed based on the results.

Usual Adult Dose for Lymphoma:

Usual Adult Dose: 30 mg/m2 via intravenous push over 3 to 5 minutes once weekly for 6 weeks in 7 week cycles.

Duration: Until disease progression or unacceptable toxicity.

Comments:
-Patients should take low dose (1 mg to 1.25 mg) oral folic acid daily.
-Folic acid should start 10 days before the first dose of pralatrexate and continue for 30 days after the last dose.
-Patients should also receive a B12 (1 mg) injection within 10 weeks before the first dose of pralatrexate and every 8 to 10 weeks thereafter.
-Subsequent B12 injections may be given the same day as treatment with pralatrexate.

Use: The treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

Tell your doctor if you have ever had liver or kidney problems.

You may need to have a negative pregnancy test before starting treatment with Folotyn.

Pralatrexate can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use Folotyn if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Folotyn.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using Folotyn, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Get emergency medical help if you have signs of an allergic reaction to Folotyn (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of tumor cell breakdown - tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth;

• low white blood cell counts - fever, skin sores, sore throat, cough, trouble breathing;

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;

• low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or

• dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Common Folotyn side effects may include:

• sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;

• easy bruising, unusual bleeding, purple or red spots under your skin;

• nausea; or

• feeling tired.

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.

Tell your doctor about all your other medicines, especially:

• trimethoprim;

• sulfamethoxazole;

• probenecid; or

• NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with pralatrexate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.