Pralatrexate (pral-a-TREX-ate)

Treats T-cell lymphoma.

Brand Name(s):

Folotyn

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
• You will take a folic acid supplement with this medicine. You will also receive vitamin B12 injections (shots). These medicines will help prevent some side effects. Your doctor will tell you how much folic acid to take and when to take it.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you also use probenecid (Benemid), trimethoprim/sulfamethoxazole (Bactrim, Cotrim, Septra), or an NSAID pain or arthritis medicine (such as aspirin, diclofenac, ibuprofen, naproxen, Advil, Aleve, Celebrex, Voltaren).

Warnings While Using This Medicine:

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding or if you have kidney disease, liver disease, or bone marrow problems (such as anemia, neutropenia, or thrombocytopenia).
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• Check with your doctor right away if you have blistering or peeling skin, sores or ulcers on the skin, trouble swallowing, or fever or chills while you are receiving this medicine. This medicine may cause serious skin reactions or mucositis (swelling or sores in the mouth).
• This medicine may cause a serious reaction called tumor lysis syndrome. Call your doctor right away if you have changes in how often you urinate, rapid weight gain, swelling of the feet or lower legs, uneven heartbeat, or seizures.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Change in how much or how often you urinate
• Fever, chills, cough, and body aches
• Seizures
• Sores or white patches on your lips, mouth, or throat
• Swelling in your hands, ankles, or feet, rapid weight gain
• Tiny red dots on the skin, especially on the lower legs
• Trouble breathing or swallowing
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea
• Mild skin rash
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088