Pralatrexate - Injection

Uses

Pralatrexate is used to treat a certain type of cancer (peripheral T-Cell lymphoma-PTCL). Pralatrexate works by slowing or stopping the growth of cancer cells.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using pralatrexate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by a health care professional in a clinic or hospital. It is injected into a vein as directed by your doctor, usually once a week for 6 weeks. Tell your doctor or nurse right away if you notice redness, pain, or swelling during your injection.

The dosage is based on your body size, medical condition, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when you need to receive the medication.

To help prevent mouth sores, your doctor may also direct you to take folic acid and give you vitamin B12 shots. Carefully follow your doctor's directions for all your medications.

Side Effects

Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods. Nausea may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Serious skin reactions can occur. Tell your doctor right away if you develop rash, peeling, sores or blisters on the skin.

Tell your doctor right away if you have any serious side effects, including:

• easy bleeding/bruising
• dehydration
• feeling weak
• looking pale
• shortness of breath

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

Pralatrexate sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as:

• low back/side pain (flank pain)
• signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine)
• muscle spasms/weakness

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using pralatrexate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease
• liver problems

Pralatrexate can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using pralatrexate before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor may order a pregnancy test before starting this medication. You should not become pregnant while using pralatrexate. Pralatrexate may harm an unborn baby. Women of childbearing age should ask about reliable forms of birth control while using this medication and for 6 months after the last dose. Men with female partners of childbearing age should use reliable forms of birth control while using this medication and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 1 week after the last dose is not recommended. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some of the products that may interact with this drug include:

• NSAIDs (such as ibuprofen, naproxen)
• probenecid
• sulfa antibiotics (such as trimethoprim/sulfamethoxazole)

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs) which can increase the risk of side effects when used with pralatrexate. Ask your pharmacist about the safe use of those products.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as complete blood counts, liver function, kidney function) should be done before you start treatment with this medication and while you are using it. Keep all medical and lab appointments.

Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Storage

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).