When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive this medicine if you have had an allergic reaction to pralatrexate or if you are pregnant.

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 dose and schedule. This medicine is given through a needle placed in a vein.
• You will take a folic acid supplement and receive vitamin B12 shots to help prevent some side effects. Your doctor will tell you how much and how often you need these supplements.
• Read and follow the patient instructions that come with this medicine. Talk to 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.

• Some foods and medicines can affect how pralatrexate works. Tell your doctor if you also use any of the following:
  
  • Probenecid
  • Trimethoprim/sulfamethoxazole
  • NSAID pain or arthritis medicine (such as aspirin, diclofenac, ibuprofen, naproxen, celecoxib)

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease or liver disease.
• This medicine may cause the following problems:
  
  • Sores and redness in your mouth, throat, or genital areas
  • Severe skin problems, which could be life-threatening
  • Tumor lysis syndrome
  • Liver problems
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. 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
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, and body aches
• Sores or white patches on your lips, mouth, or throat
• Swelling in your hands, ankles, or feet, rapid weight gain
• Trouble swallowing or eating
• Unusual bleeding, bruising, or weakness

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

• Mild nausea, constipation, diarrhea, vomiting
• Tiredness

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