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 reactions:
rash
peeling and loss of skin
sores
blisters
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:
nausea
vomiting
tiredness
constipation
swelling
cough
nosebleed
diarrhea
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. Youcanask 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.
ALLOS®
THERAPEUTICS
Allos Therapeutics, Inc.
Westminster, CO 80020
Issued: May 2010
Revised: January 2011
FOLOTYN®
(pralatrexate injection)
FOLOTYN, ALLOS, the mobius triangle symbol, and the flower