pralatrexate

Generic Name: pralatrexate (PRAL a TREX ate)
Brand Names: Folotyn

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

Before you receive pralatrexate, tell your doctor if you have kidney disease.

Do not use pralatrexate if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

You should not breast-feed a baby while you are being treated with pralatrexate.

You may be required to take oral folic acid supplements and receive vitamin B12 injections to help prevent some of the side effects of pralatrexate. Follow your doctor's medication instructions very closely.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Call your doctor at once if you have a serious side effect such as fever, flu symptoms, mouth ulcers, easy bruising or bleeding, pale skin, rapid heart rate, trouble breathing, weakness, or feeling like you might pass out.

What is pralatrexate?

Pralatrexate is a cancer medication.

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

Pralatrexate is given for relapsed T-cell lymphoma, or after other medications have been tried without successful treatment.

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

What should I discuss with my health care provider before receiving pralatrexate?

You should not receive this medication if you are allergic to it.

If you have kidney disease, you may need a dose adjustment or special tests to safely use this medication.

FDA pregnancy category D. Do not use pralatrexate if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether pralatrexate passes into breast milk or if it could harm a nursing baby. You should not breast-feed a baby while you are being treated with pralatrexate.

How is pralatrexate given?

Pralatrexate is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.

Pralatrexate is usually given once per week for up to 6 weeks at a time. Follow your doctor's instructions.

You may be required to take daily folic acid supplements starting 10 days before your first dose of pralatrexate and ending 30 days after your last dose. Your doctor may also give you injections of vitamin B12 every 8 to 10 weeks while you are being treated with pralatrexate.

Using vitamin B12 and folic acid can help protect your blood cells from some of the side effects of pralatrexate. Follow your doctor's medication instructions very closely.

To be sure this medication is not causing harmful effects, your blood cells, kidney function, and liver function will need to be tested on a regular basis. Your cancer treatments may be delayed based on the results of these tests. Do not miss any scheduled visits to your doctor.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your pralatrexate injection.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a pralatrexate overdose are not known but may include some of the side effects listed in this medication guide.

What should I avoid while receiving pralatrexate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of pralatrexate?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

taste loss, mouth pain, redness or ulcers, or white-yellow mouth sores;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
fever, chills, body aches, flu symptoms, rapid heart rate, rapid and shallow breathing, fainting;
pale skin, feeling light-headed or short of breath, trouble concentrating;
weakness, decreased sweating, hot or dry skin; or
confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

Less serious side effects may include:

nausea, vomiting, loss of appetite;
diarrhea, constipation;
tired feeling;
cough;
swelling; or
mild rash or itching.

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 other medications you use, especially:

probenecid (Benemid);
trimethoprim (Bactrim, Proloprim, Septra, SMX-TMP); or
aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), nabumetone (Relafen), naproxen (Aleve, Naprosyn), meloxicam (Mobic), piroxicam (Feldene), and others.

This list is not complete and there may be other drugs that can interact with pralatrexate. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about pralatrexate.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.