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|Remicade

INFLIXIMAB (Systemic)

Some commonly used brand names are:

In the U.S.—

• Remicade

In Canada—

• Remicade

Another commonly used name is cA2 .

Category

• Inflammatory bowel disease therapy agent
• antirheumatic agent

Description

Infliximab (in-FLIX-i-mab) is a monoclonal antibody. It is used to treat Crohn"s disease in patients who have not been helped by other medicines and also in patients who have a type of Crohn"s disease in which fistulas form. It is also used to treat rheumatoid arthritis and ankylosing spondylitis which is a type of arthritis that affects the joints in the spine. In addition, it is used to treat psoriatic arthritis which is a type of arthritis that causes pain and swelling of the joints and patches of scaly skin on some areas of the body. Psoriatic arthritis is related to the skin condition, psoriasis. Infliximab is also used to treat ulcerative colitis.

This medicine is available only with your doctor"s prescription, in the following dosage form:

• Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For infliximab, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to infliximab or to rodents (such as rats or mice). Mouse cells are used in the preparation of infliximab. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in either humans or animals. It is not known if infliximab causes harmful effects on the fetus. Before receiving this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether infliximab passes into breast milk. Because of the risk of harmful effects in the nursing baby, it may be necessary for you to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of infliximab in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of infliximab in the elderly with use in other age groups. However, older adults generally get more infections than do younger adults, and it is not known if infliximab may affect the number of infections that older people get.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking infliximab, it is especially important that your health care professional knows if you are taking any of the following:

• Anakinra (e.g., Kineret)—Serious infection may occur if infliximab is used together with this medicine.

• Immunosuppressive therapy (medicine that helps prevent your body from rejecting an organ transplant)—May cause you to have a greater risk of getting a serious infection or a lymphoma (a type of blood cancer)

Other medical problems—The presence of other medical problems may affect the use of infliximab. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood problems, ongoing or in the past—Caution should be used.

• Cancer, history—This medicine should be used with caution. If you have a history of cancer, you may be more susceptible to lymphoma (a type of blood cancer).

• Heart disease—Infliximab is not recommended for patients with a certain type of heart disease called congestive heart failure.

• Hepatitis B—Infliximab could cause your hepatitis B to become active again if you have a history of hepatitis B.

• Infection—Infliximab is not recommended for patients with an active infection. Caution should be used if you have a chronic infection or history of a recurring infection.

• Inactive tuberculosis infection—Should be treated before starting infliximab therapy.

• Nervous system problems or
• Seizures—Caution should be used; your doctor will consider discontinuing this medicine if you develop serious CNS reactions.

Proper Use of This Medicine

Dosing—You will be given a Patient Information Sheet prior to each treatment. Make sure you read it each time you are scheduled for an infliximab treatment.

The dose of infliximab will be different for different patients. Infliximab is usually given by a doctor or nurse. The following information includes only the average dose of infliximab.

• For treatment of Crohn"s disease. ankylosing spondylitis, psoriatic arthritis, or ulcerative colitis:
  • Adults—5 milligrams (mg) per kilogram (kg) (2.27 mg per pound) of body weight, injected into a vein.
  • Children—Use and dose must be determined by your doctor.
• For treatment of rheumatoid arthritis:
  • Adults—3 milligrams (mg) per kilogram (kg) (1.36 mg per pound) of body weight, injected into a vein
  • Children—Use and dose must be determined by your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Store in the refrigerator. However, keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Infliximab may cause chest pain, fever, chills, itching, hives, flushing of face, or troubled breathing within a few hours after you receive it. Check with your doctor or nurse immediately if you have any of these symptoms.

Check with your doctor immediately if you have any symptoms of liver problems including skin and eyes turning yellow, dark brown-colored urine, right sided abdominal pain, fever or severe tiredness.

It is important to have a tuberculin skin test to make sure that you do not have an inactive tuberculosis infection, which could worsen while you are on infliximab therapy.

It is important to have your heart closely checked if you take infliximab, and have existing heart disease, which could worsen while you are on infliximab therapy

Your doctor will check you for active infections before each infliximab treatment. Tell your doctor if you are not feeling well or if you have symptoms of a cold or other type of infection.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in the product labeling, infliximab is used in certain patients with the following medical conditions:

• Psoriasis
• Reactive arthritis
• Inflammatory bowel disease arthritis

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.

Developed: 05/05/1999
Revised: 10/04/2005

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