Pralatrexate Intravenous

In the U.S.

• Folotyn

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antimetabolite

A nurse or other trained health professional will give you pralatrexate in a hospital or cancer treatment center. pralatrexate is given through a needle placed in one of your veins.

It is very important to take folic acid tablets during your treatment with pralatrexate to lower your chances of harmful side effects. You must start taking 1 to 1.25 milligrams (mg) of folic acid every day for at least 10 days before your first dose. You must keep taking folic acid every day during therapy and for 30 days after your last pralatrexate dose. You can get folic acid as a nonprescription (over-the-counter [OTC]) product. Ask your doctor for help in choosing a folic acid product.

Your doctor will also give you vitamin B12 injections during your treatment with pralatrexate to lower your chances of harmful side effects. You will get your first injection about 10 weeks before your first dose, and additional injections about every 8 to 10 weeks during therapy.

pralatrexate usually comes with a patient information leaflet. Read the information carefully and make sure you understand it before receiving pralatrexate. If you have any questions, ask your doctor.

Redness or sores of the mouth/lips/throat, or nausea, may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do 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 any of these unlikely but serious side effects occur: signs of infection (such as fever, cough, sore throat, chills), easy bleeding/bruising, dehydration, feeling weak, looking pale, shortness of breath.

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.

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.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. 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

Laboratory and/or medical tests (such as complete blood counts, liver function tests, kidney function tests) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.