remicade

Remicade (infliximab) reduces the effects of a substance in the body that can cause inflammation.

Remicade is used to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn"s disease, and ankylosing spondylitis. Remicade is also used to treat severe or disabling plaque psoriasis (raised, silvery flaking of the skin).

Remicade is often used when other medicines have not been effective.

Important information

You should not use Remicade if you are allergic to infliximab, or if you are also being treated with anakinra (Kineret) or abatacept (Orencia).

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

Using Remicade may increase your risk of developing certain types of cancer, including a rare fast-growing type of lymphoma that can be fatal. This risk is higher in teenagers and young adults using Remicade with other medicines to treat Crohn"s disease or ulcerative colitis. Ask your doctor about your specific risk.

Remicade can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Serious and sometimes fatal infections may occur during treatment with Remicade. Call your doctor right away if you have signs of infection such as: fever, chills, flu symptoms, or pain, warmth, or redness of your skin.

Before using Remicade

You should not use Remicade if you are allergic to infliximab, or if you are also being treated with anakinra (Kineret) or abatacept (Orencia).

Some people using Remicade have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using Remicade with other medicines to treat Crohn"s disease or ulcerative colitis.

However, people with autoimmune disorders (including rheumatoid arthritis, Crohn"s disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.

Using Remicade may increase your risk of developing other types of cancer, including skin cancer. Ask your doctor about your specific risk.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where certain infections are common (Ohio River Valley, Mississippi River Valley, and the Southwest).

To make sure you can safely take Remicade, tell your doctor if you have any of these other conditions:

• severe heart failure, or other heart problems;

• an active or recent infection, open sores or skin wounds;

• diabetes;

• liver disease (especially hepatitis B);

• epilepsy or other seizure disorder;

• chronic obstructive pulmonary disease (COPD);

• a history of cancer;

• a weak immune system;

• numbness or tingling anywhere in your body;

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

• if you have recently been vaccinated with BCG (Bacille Calmette-Guérin); or

• if you are scheduled to receive any vaccines.

It is not known whether Remicade will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether infliximab passes into breast milk. You should not breast-feed while you are receiving Remicade.

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

How should I use Remicade?

Use Remicade exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Before you start treatment with Remicade, your doctor may perform tests to make sure you do not have tuberculosis or other infections. Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Remicade is injected into a vein through an IV. A healthcare provider will give you this injection. You may be watched closely after receiving Remicade, to make sure the medicine has not caused any serious side effects.

While using this medicine, you may need frequent blood tests.

Remicade can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Serious and sometimes fatal infections may occur during treatment with Remicade. Call your doctor right away if you have signs of infection such as: fever, chills, flu symptoms, or pain, warmth, or redness of your skin.

If you need surgery, tell the surgeon ahead of time that you are using Remicade.

If you have ever had hepatitis B, Remicade can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Remicade injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Avoid activities that may increase your risk of bleeding injury.

Do not receive a "live" vaccine while using Remicade. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Make sure your child is current on all vaccines before he or she starts treatment with Remicade.

Remicade side effects

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy or tingly, swollen, short of breath, or have a headache, fever, chills, muscle or joint pain, pain or tightness in your throat, chest pain, or trouble swallowing during the injection. Infusion reactions may also occur within 1 or 2 hours after injection.

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

Stop using Remicade and call your doctor right away if you have any of these symptoms of lymphoma:

• fever, night sweats, weight loss, tiredness;

• feeling full after eating only a small amount;

• pain in your upper stomach that may spread to your shoulder;

• easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Call your doctor at once if you have:

• signs of infection (fever, chills, flu symptoms, confusion, or pain, warmth, or redness of your skin);

• signs of tuberculosis (fever, cough, night sweats, loss of appetite, weight loss, feeling constantly tired);

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

• shortness of breath with swelling of your ankles or feet, rapid weight gain;

• numbness or tingling;

• weak feeling in your arms or legs;

• problems with vision;

• neck stiffness, seizure (convulsions);

• pain or burning when you urinate; or

• red, purple, or scaly skin rash, hair loss, joint or muscle pain, mouth sores.

Common Remicade side effects may include:

• stuffy nose, sinus pain, headache;

• mild stomach pain;

• mild skin rash; or

• flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Remicade?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Remicade, especially:

• azathioprine, mercaptopurine;

• methotrexate;

• phototherapy for psoriasis; or

• if you are also using "biologic" medications to treat your condition--adalimumab, certolizumab, etanercept, golimumab, natalizumab, rituximab, tocilizumab, and others.

This list is not complete. Other drugs may interact with infliximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.