IMPORTANT SAFETY INFORMATION ABOUT FOLOTYN
- Low Blood Cell Counts: Patients may experience low blood
cell counts. Your doctor will do weekly blood tests to check your blood counts.
- Low Platelet Count: Lower platelets may cause unusual
bleeding, such as nosebleeds, or abnormal bruising. Talk to your doctor right away
if this happens.
- Low White Blood Cell Count: Lower white blood cell counts
can reduce the body's defenses against infection. If you have any of the following
signs or symptoms of infection (fever, chills, cough, shortness of breath, pain
or burning on urination), tell your doctor right away. Serious illness or death
could result if such infections are not treated when white blood cell counts are
- Low Red Blood Cell Count: Lower red blood cell counts
may make you feel weak, feel tired, and get tired easily. You may appear pale and
be short of breath. Contact your doctor if you experience any of these symptoms
following treatment with FOLOTYN.
- Mucositis Patients may develop mucositis, which is redness
and/or sores in the mucous membranes including the mouth, lips, throat, and other
areas along the digestive tract and genitals. Discomfort or pain due to mucositis
may occur as early as a few days after treatment with FOLOTYN. Talk with your doctor
about ways to reduce your risk of developing mucositis, and/or ways to maintain
nutrition and control the discomfort if you develop it. It is important to take
folic acid and vitamin B12 during your treatment with FOLOTYN. Your doctor will
give you specific instructions for vitamin supplementation.
- Severe Skin Reactions: Severe skin reactions may happen
after treatment with FOLOTYN, which can be fatal. Tell your doctor right away if
you have any of the following skin reactions: rash, peeling and loss of skin,
sores, or 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.
- Pregnancy and Nursing: Tell your doctor if you are pregnant
or plan to become pregnant. FOLOTYN can harm your unborn baby. FOLOTYN has not been
studied in pregnant women. Tell your doctor if you are breastfeeding or plan to
breastfeed. It is not known if FOLOTYN will pass into your breast milk. Talk to
your doctor about whether you should discontinue breastfeeding.
- 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
- Nausea, Vomiting, Diarrhea and Constipation: Patients
may experience nausea, vomiting, abdominal pain, diarrhea, and/or constipation.
Medicines can be given that may help reduce these symptoms. If you experience any
of these symptoms, tell your doctor.
- Other side effects may include:
- Dizziness, lightheadedness, and fainting spells
- Fatigue, weakness, and lethargy
- Rash, itching or swelling
- Loss of appetite and weight loss
- Joint and muscle pain
These are not all of the potential side effects of FOLOTYN. If you have any side
effect that bothers you or that doesn't go away, be sure to talk with your healthcare
Tell your doctor about your medical conditions, including
liver and kidney problems.
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
work. 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.
Please see patient information within the full Prescribing Information