Special Alerts:
[Posted 06/03/2008] FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF and http://www.fda.gov/cder/drug/early_comm/TNF_blockers.htm.
Before you start treatment with infliximab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.
Infliximab is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. This medicine is usually given at intervals of 2 to 8 weeks.
Infliximab must be injected slowly, over about 2 hours. Your doctor may wish to observe you after the injection to make sure the medicine has not caused any serious side effects.
You may be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.
Infliximab can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.
If you store infliximab at home, keep it in the refrigerator. Do not allow the medicine to freeze and do not use it beyond the expiration date.Contact your doctor if you miss a dose of infliximab.
Seek emergency medical attention if you think you have used too much of this medicine. An overdose of infliximab is not expected to produce life-threatening symptoms.
Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.
Do not receive a "live" vaccine while you are being treated with infliximab.
fever, chills, sore throat, flu symptoms weight loss;
chest pain, ongoing cough, coughing up blood; or
easy bruising or bleeding, pale skin, unusual weakness.
feeling short of breath, even with mild exertion;
swelling of your ankles or feet;
red, purple, or scaly skin rash, hair loss, joint or muscle pain, mouth sores;
numbness or tingling;
weak feeling in your arms or legs; or
problems with vision;
seizure (convulsions);
pain or burning when you urinate; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Other less serious side effects are more likely to occur, such as:
stuffy nose, sinus pain;
stomach pain;
mild skin rash; or
headache.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
There may be other drugs that can affect infliximab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
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