INFLIXIMAB (Systemic)
Some commonly used brand names are:
In the U.S.?
In Canada?
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 children6 years of age and older and adults who have not been helped by other medicinesand also in patients who have a type of Crohn's disease in which fistulasform. It is also used to treat rheumatoid arthritis and ankylosing spondylitiswhich 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 thatcauses pain and swelling of the joints and patches of scaly skin on some areasof 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 thefollowing 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 followingshould be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to infliximab or to rodents (such as rats or mice). Mousecells are used in the preparation of infliximab. Also tell your health careprofessional 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. Beforereceiving this medicine, make sure your doctor knows if you are pregnant orif you may become pregnant.
Breast-feeding?It is not known whether infliximab passes intobreast milk. Because of the risk of harmful effects in the nursing baby, itmay be necessary for you to stop breast-feeding during treatment. Be sureyou have discussed the risks and benefits of the medicine with your doctor.
Children?Studies of this medicine for treatment of Crohn'swith fistulas, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis,and ulcerative colitis have been done only in adult patients, and there isno specific information comparing use of infliximab in children for theseconditions with use in other age groups.
Appropriate studies performed to date have not demonstrated pediatrics-specificproblems that would limit the usefulness of infliximab for the treatment ofCrohn's disease in children 6 years of age and older.
Your child's vaccinations need to be current before he/she begins takinginfliximab. Be sure to ask your child's doctor if you have any questions aboutthis.
A very serious kind of cancer called hepatosplenic T-cell lymphomas hasbeen reported in some teenagers and young adults who were taking this medicine.They were also taking azathioprine or 6-mercaptopurine. The connection betweeninfliximab and this cancer is unclear.
Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof infliximab in the elderly with use in other age groups. However, olderadults generally get more infections than do younger adults, and it is notknown if infliximab may affect the number of infections that older peopleget.
Other medicines?Although certain medicines should not be used togetherat all, in other cases two different medicines may be used together even ifan interaction might occur. In these cases, your doctor may want to changethe dose, or other precautions may be necessary. When you are taking infliximab,it is especially important that your health care professional knows if youare taking any of the following:
- Anakinra (e.g., Kineret)?Serious infection may occur if infliximabis used together with this medicine.
- Immunosuppressive therapy (medicine that helps prevent your bodyfrom rejecting an organ transplant)?May cause you to have a greaterrisk of getting a serious infection or a lymphoma (a type of blood cancer)
Other medical problems?The presence of other medical problemsmay affect the use of infliximab. Make sure you tell your doctor if you haveany 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 (atype of blood cancer).
- Heart disease?Infliximab is not recommended for patients witha certain type of heart disease called congestive heart failure.
- Hepatitis B?Infliximab could cause your hepatitis B to becomeactive again if you have a history of hepatitis B.
- Infection?Infliximab is not recommended for patients with anactive infection. Caution should be used if you have a chronic infection orhistory of a recurring infection.
- Inactive tuberculosis infection?Should be treated before startinginfliximab therapy.
- Nervous system problems or
- Seizures?Caution should be used; your doctor will considerdiscontinuing this medicine if you develop serious CNS reactions.
Proper Use of This Medicine
Dosing?You will be given a Patient Information Sheetprior to each treatment. Make sure you read it each time you are scheduledfor an infliximab treatment.
The dose of infliximab will be different for different patients. Infliximabis usually given by a doctor or nurse. The following information includesonly the average dose of infliximab.
- For treatment of Crohn's with fistulas, ankylosing spondylitis, psoriaticarthritis, 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.
- 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?5 mg per kg (2.27 mg per pound) of body weight, injectedinto a vein.
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 otherdamp 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 surethat any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
Infliximabmay cause chest pain, fever, chills, itching, hives, flushing of face, ortroubled breathing within a few hours after you receive it. Check with your doctor or nurse immediately if you have any of thesesymptoms.
Check with your doctor immediately if you have any symptoms of liver problemsincluding skin and eyes turning yellow, dark brown-colored urine, right sidedabdominal pain, fever or severe tiredness.
It is important to have a tuberculin skin test to make sure that you donot have an inactive tuberculosis infection, which could worsen while youare 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 infliximabtherapy.
Your doctor will check you for active infections before each infliximabtreatment. Tell your doctor if you are not feeling well or if you have symptomsof a cold or other type of infection.
Side Effects of This Medicine
Along with its needed effects, a medicine maycause 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 ofthe following side effects occur:
Checkwith your doctor as soon as possible if any of the following side effectsoccur:
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 (bulgeof tissue through the wall of the abdomen); infection; irregular or pounding heartbeat ; pain in rectum; pain spreading fromthe abdomen to the left shoulder; pinpoint red spotson skin; stomach pain (severe); swollen or painful glands; tendon injury; unusual bleeding or bruising; weightloss (unusual); yellow skin and eyes
Incidence not known?occurred during clinical practice
Area rash; bloody nose; burning, tingling, numbness or pain in the hands, arms, feetor legs; change in mental status; clay-colored stools; continuing vomiting; convulsions; dark or bloody urine; difficulty breathing; difficulty speaking; difficulty swallowing; fast heartbeat; fatigue; general feeling of tiredness or weakness; heaviermenstrual periods; hives; hoarseness; inability to move arms and legs; itching, puffiness, or swelling of the eyelids or around theeyes, face, lips or tongue; light-colored stools; loss of appetite; lossof bladder control; lower back or side pain; muscle spasm or jerking of all extremities; noisy breathing; painful or difficult urination; painless swelling in neck, armpits or groin; pale skin; redness, soreness or itching skin; seizures; sensation of pins and needles; severe abdominal pain; severe muscle weakness, sudden and progressing; slow or irregular breathing; sore throat; sores, welting, or blisters; stabbingpain; stomach pain; suddenloss of consciousness; sudden numbness and weaknessin the arms and legs; ulcers, sore, or white spotsin mouth; unpleasant breath odor; upper right abdominal pain; vomiting of blood
Additional Information
Once a medicine has been approved for marketing for a certain use, experiencemay show that it is also useful for other medical problems. Although thisuse is not included in the product labeling, infliximab is used in certainpatients with the following medical conditions:
- Psoriasis
- Reactive arthritis
- Inflammatory bowel disease arthritis
Other than the above information, there is no additionalinformation relating to proper use, precautions, or side effects for thisuse.
Developed: 05/05/1999
Revised: 05/31/2006
