"The U.S. Food and Drug Administration today expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.
- Patient Information:
Details with Side Effects
Read the Patient Information that comes with FOLOTYN before you start treatment and each time you get treated with FOLOTYN. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about FOLOTYN.
What is FOLOTYN?
FOLOTYN is a prescription anti-cancer (chemotherapy) medicine. FOLOTYN is used to treat people with a type of cancer called Peripheral T-cell Lymphoma (PTCL) that does not go away, gets worse, or comes back after use of another cancer treatment.
What should I tell my doctor before receiving FOLOTYN?
Before you receive FOLOTYN, tell your doctor if you:
- have liver problems.
- have kidney problems.
- have any other medical conditions.
- are pregnant or plan to become pregnant. FOLOTYN can harm your unborn baby. Talk to your doctor about the best way to prevent pregnancy while taking FOLOTYN. Tell your doctor right away if you become pregnant while taking FOLOTYN.
- are breast-feeding or plan to breast-feed. It is not known if FOLOTYN passes into breast milk. You and your doctor should decide if you will take FOLOTYN or breast-feed. You should not do both. Talk to your doctor about the best way to feed your baby while you are being treated with FOLOTYN.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how FOLOTYN works, and FOLOTYN may affect how other medicines works. Especially tell your doctor if you take:
- sulfamethoxazole trimethoprim (Bactrim®, Septra®, Septra DS, Sulfatrim Pediatric, Sulfamethoprim, Sulfamethoprim-DS)
- non-steroidal anti-inflammatory drugs (NSAIDs)
- probenecid (Probalan, Col-Probenecid)
Ask your doctor or pharmacist if you are not sure if your medicine is listed above.
Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist each time you start a new medicine.
How will I receive FOLOTYN?
- FOLOTYN will be given to you as directed by your doctor, as an intravenous (IV) injection into your vein over 3 to 5 minutes.
- FOLOTYN is usually given in cycles, one time each week for 6 weeks, with no treatment on the 7th week. Treatment with FOLOTYN may be continued as long as it is helpful to you.
To lower your chances of harmful side effects, it is important that you take folic acid and vitamin B12 during your treatment with FOLOTYN. Your doctor will give you specific instructions for vitamin supplementation.
- You will take folic acid by mouth for 10 days before your first dose of FOLOTYN. Do not take more or less folic acid than your doctor tells you to take. Continue taking folic acid every day until your doctor tells you to stop.
- Your doctor will give you a vitamin B12 injection into your muscle (intramuscular) before your first dose of FOLOTYN and about every 8 to 10 weeks during treatment with FOLOTYN.
You should have regular blood tests before and during your treatment with FOLOTYN. Your doctor may change your dose of FOLOTYN or delay treatment based on the results of your blood tests and on your general condition.
What are the possible side effects of FOLOTYN?
FOLOTYN may cause serious side effects, including:
- Low Blood Cell Counts: FOLOTYN can affect your bone marrow and cause you to have low blood cell counts. Your doctor will do blood tests as needed to check your blood cell counts.
- Low Platelet Count (thrombocytopenia): Tell your doctor right away if you have any unusual bleeding, such as nosebleeds, or bruising under your skin.
- Low White Blood Cell Count (neutropenia): A low white blood cell count can cause you to get infections, which may be serious. Serious illness or death can happen if an infection is not treated right away when white blood cell counts are very low. Tell your doctor right away if you have any of the following signs or symptoms of an infection:
- Low Red Blood Cell Count (anemia): Tell your doctor
if you have any of these symptoms of anemia during treatment with FOLOTYN:
- feeling weak, tired, or you get tired easily
- you look pale
- you feel short of breath
- Redness and sores of the mucous membrane lining of the mouth, lips, throat, digestive tract, and genitals (mucositis). Discomfort or pain due to mucositis may happen as early as a few days after treatment with FOLOTYN. Your doctor should tell you about ways to reduce your risk of getting mucositis, and how to maintain nutrition and control the discomfort from mucositis.
- Severe skin reactions. Severe skin reactions may
happen after treatment with FOLOTYN, especially if you have lymphoma in or
under your skin. If your skin reactions are severe, they may lead to serious illness
or death. Tell your doctor right away if you have of any of the following skin
- peeling and loss of skin
- Tumor Lysis Syndrome (TLS). FOLOTYN can cause the fast breakdown of certain types of cancer cells. This can lead to TLS. Your doctor may do blood tests to check you for TLS and treat you for TLS if needed.
- Harm to an unborn baby. Females should avoid becoming pregnant while being treated with FOLOTYN. Talk to your doctor about how to avoid pregnancy while taking FOLOTYN.
- Fever. Fever is often one of the most common and earliest signs of infection. Follow your doctor's instructions about how often to take your temperature, especially during the days after treatment with FOLOTYN. If you have a fever, tell your doctor or nurse right away.
- Loss of too much fluid from the body (dehydration). If you feel tired and weak this could be a sign of dehydration. Follow your doctor's instructions for what to do to help prevent or treat dehydration.
- Shortness of breath. Tell your doctor if this is a problem for you.
Common side effects of FOLOTYN include:
Tell your doctor about any side effect that bothers you or that does not go away.
These are not all the possible side effects of FOLOTYN. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.
General information about FOLOTYN
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. This patient information leaflet summarizes the most important information about FOLOTYN. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about FOLOTYN that is written for health professionals. For more information, go to www.FOLOTYN.com or call 1-888-255-6788.
What are the ingredients in FOLOTYN?
Active ingredient: pralatrexate
Inactive ingredients: sodium chloride, sodium hydroxide, and hydrochloric acid
What is PTCL?
PTCL is a rare type of non-Hodgkin's lymphoma, a cancer of the lymphatic system. It happens when a type of T-cell (a kind of white blood cell) grows too much. PTCL may be found in different parts of the body, such as the lymph nodes, skin, bone marrow, liver, or spleen.
Last reviewed on RxList: 6/7/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Folotyn Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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