Pronunciation:

pral-a-TREX-ate

Brand Names:

• Folotyn

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Antimetabolite

Uses of This Medicine:

Pralatrexate injection is used to treat peripheral T-cell lymphoma (PTCL) in patients who have already been treated with other medicines that did not work well. Peripheral T-cell lymphoma is a rare type of cancer that affects certain white blood cells and causes enlarged and swollen lymph nodes in the neck, armpits, and groin.

Pralatrexate belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other unwanted effects may also occur. Some of these may be serious and must be reported to your doctor.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of pralatrexate injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pralatrexate injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving pralatrexate injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Probenecid

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia (low red blood cells) or
• Bone marrow problems or
• Liver disease or
• Neutropenia (low white blood cells) or
• Thrombocytopenia (low platelets)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine 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.

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

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Make sure your doctor knows if you are pregnant before you receive this medicine. If you are a woman of childbearing potential, you should use two forms of birth control together to avoid getting pregnant while you are receiving this medicine. If you have become pregnant during your treatment, tell your doctor right away.

Pralatrexate can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor right away if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

This medicine may cause mucositis, which is redness or sores on the inside of the mouth or tongue. Check with your doctor right away if you have cracked lips, diarrhea, difficulty with swallowing, or sores, ulcers, or white spots on the lips, tongue, or inside of the mouth while you are receiving this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are receiving this medicine.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

blood in the urine or stools

body aches or pain

chills

convulsions

cough

cracked lips

decreased urine

diarrhea

difficult or labored breathing

difficulty with swallowing

dry mouth

ear congestion

fast, pounding, or irregular heartbeat or pulse

fever

headache

increased thirst

loss of appetite

loss of voice

lower back or side pain

mood changes

muscle pain or cramps

nasal congestion

nausea or vomiting

numbness or tingling in the hands, feet, or lips

painful or difficult urination

pale skin

pinpoint red spots on the skin

runny nose

shortness of breath

sneezing

sore throat

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

swelling

tightness in the chest

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach pain

back pain

bloody nose

constipation

itching skin

lack or loss of strength

night sweats

pain in the arms or legs

rash

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.