In the U.S.—

Another commonly used name is cA2.

• Inflammatory bowel disease therapy agent
• antirheumatic agent

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.

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

• Injection (U.S.)

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. Tell you health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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

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

Dosing—

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:
  • 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.

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.

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

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:

• More common
  • Chest pain;  chills;  fever;  flushing of face;  hives;  itching;  troubled breathing 
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Abdominal pain;  cough;  dizziness;  fainting;  headache;  muscle pain;  nasal congestion;  nausea;  runny nose;  shortness of breath;  sneezing;  sore throat;  tightness in chest;  unusual tiredness or weakness ;  vomiting;  wheezing 
  
  

• Less common
  • Back pain;  bloody or cloudy urine;  cracks in skin at the corners of mouth;  diarrhea;  difficult or painful urination;  frequent urge to urinate;  high blood pressure;  low blood pressure;  pain;  pain or tenderness around eyes and cheekbones ;  skin rash;  soreness or irritation of mouth or tongue;  soreness or redness around fingernails or toenails;  vaginal burning or itching and discharge;  white patches in mouth and/or on tongue 
  
  

• Rare
  • Abscess (swollen, red, tender area of infection containing pus) ;  back or side pain;  black, tarry stools;  blood in urine or stools;  bone or joint pain;  constipation;  falls;  feeling of fullness;  general feeling of illness;  hernia (bulge of tissue through the wall of the abdomen);  infection ;  irregular or pounding heartbeat ;  pain in rectum;  pain spreading from the abdomen to the left shoulder;  pinpoint red spots on skin;  stomach pain (severe);  swollen or painful glands;  tendon injury;  unusual bleeding or bruising;  weight loss (unusual);  yellow skin and eyes 
  
  

• Incidence not known—occurred during clinical practice
  • Bloody nose;  burning, tingling, numbness or pain in the hands, arms, feet or legs;  change in mental status;  dark or bloody urine;  difficulty breathing;  difficulty speaking ;  heavier menstrual periods;  inability to move arms and legs;  lower back or side pain;  painful or difficult urination;  pale skin;  redness, soreness or itching skin;  seizures;  sensation of pins and needles;  severe abdominal pain;  severe muscle weakness, sudden and progressing;  sore throat;  sores, welting, or blisters ;  stabbing pain;  sudden numbness and weakness in the arms and legs;  ulcers, sore, or white spots in mouth 
  
  

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:

• Ankylosing spondylitis
• Psoriasis
• Psoriatic arthritis
• 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.