pralatrexate

What is the most important information I should know about pralatrexate?

What is pralatrexate?

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

Pralatrexate is usually given after other treatments have failed.

Pralatrexate may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving pralatrexate?

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

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

• If you are a woman, do not use pralatrexate 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 pralatrexate.

How is pralatrexate given?

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

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

Follow your doctor's dosing instructions very carefully.

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

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving pralatrexate?

Do not receive a "live" vaccine while using pralatrexate, 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.

What are the possible side effects of pralatrexate?

• 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 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.

What other drugs will affect pralatrexate?

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 affect pralatrexate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about pralatrexate.