Remicade

You should not use this medication if you have heart failure, or if you are also being treated with anakinra (Kineret).

Before using infliximab, tell your doctor if you are allergic to any drugs, or if you have:

• an active or recent infection;

• a history of tuberculosis;

• hepatitis B;

• congestive heart failure;

• epilepsy or other seizure disorder;

• chronic obstructive pulmonary disease (COPD);

• a history of cancer; or

• a disease that affects the nerves or muscles, such as multiple sclerosis, myasthenia gravis, Guillain-Barre syndrome.

If you have any of these conditions, you may not be able to use infliximab, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether infliximab passes into breast milk. Do not use infliximab without first talking to your doctor if you are breast-feeding a baby.

Infliximab is not for use in children younger than 6 years old.

Using this medication may increase your risk of certain types of cancer, such as breast, colon, or skin cancer. Talk with your doctor about your specific risk.

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.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with infliximab. Contact your doctor right away if you have signs of infection such as:

• fever, chills, sore throat, flu symptoms weight loss;

• chest pain, ongoing cough, coughing up blood; or

• easy bruising or bleeding, pale skin, unusual weakness.

Call your doctor at once if you have any of these other serious side effects:

• 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.

Before you start treatment with infliximab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Treatment with infliximab may increase your risk of developing certain types of cancer or autoimmune disorders (such as a lupus-like syndrome). Talk with your doctor about your individual risk.

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.

Serious and sometimes fatal infections may occur during treatment with infliximab. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, flu symptoms, easy bruising or bleeding, pale skin, or unusual weakness.

Do not receive a "live” vaccine while you are being treated with infliximab.

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.

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.

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.