Pralatrexate Injection

WHY is this medicine prescribed?

Pralatrexate injection is used to treat peripheral T-cell lymphoma (PTCL; a form of cancer that begins in a certain type of cells in the immune system) that has not improved or that has come back after treatment with other medications. Pralatrexate injection has not been shown to help people who have lymphoma live longer. Pralatrexate injection is in a class of medications called folate analogue metabolic inhibitors. It works by killing cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Pralatrexate injection comes as a solution (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a hospital or clinic. It is usually given over a period of 3 to 5 minutes once a week for 6 weeks as part of a 7-week cycle. Your treatment will probably continue until your condition worsens or you develop serious side effects.

Your doctor may need to adjust your dose, skip a dose, or stop your treatment if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with pralatrexate injection.

You will need to take folic acid and vitamin B₁₂ during your treatment with pralatrexate injection to help prevent certain side effects. Your doctor will probably tell you to take folic acid by mouth every day beginning 10 days before you start your treatment and for 30 days after your final dose of pralatrexate injection. Your doctor will also probably tell you that you will need to receive a vitamin B₁₂ injection no more than 10 weeks before your first dose of pralatrexate injection and every 8 to 10 weeks for as long as your treatment continues.

What SPECIAL PRECAUTIONS should I follow?

Before receiving pralatrexate injection,

• tell your doctor and pharmacist if you are allergic to pralatrexate injection, or any other medications, or any of the ingredients in pralatrexate injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aspirin and other nonsteroidal anti-inflammatory medications (NSAIDS) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); probenecid (Probalan), and trimethoprim/sulfamethoxazole (Bactrim). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had kidney or liver disease.

• tell your doctor if you are pregnant, could be pregnant, or plan to become pregnant. You should not become pregnant while you are receiving pralatrexate injection. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while receiving pralatrexate injection, call your doctor immediately. Pralatrexate injection may harm the fetus.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Pralatrexate injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• constipation
• decreased appetite
• tiredness
• weakness
• rash
• itching
• night sweats
• stomach, back, arm, or leg pain
• swelling of the hands, feet, ankles, or lower legs

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• white patches or sores on the lips or in the mouth and throat
• fever, sore throat, cough, chills, or other signs of infection
• unusual bleeding or bruising
• bleeding gums
• nosebleeds
• small red or purple dots on the skin
• blood in the urine or stool
• shortness of breath
• chest pain
• fast or irregular heartbeat
• pale skin
• cold hands and feet
• extreme thirst
• dry, sticky mouth
• sunken eyes
• decreased urination
• dizziness or lightheadedness

Pralatrexate injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to pralatrexate injection.

Ask your doctor any questions you have about your medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.