Infliximab Injection: MedlinePlus Drug Information

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Other drug names:	A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Infliximab Injection

(in flix' i mab)

Contents of this page:
Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow? What should I do if I forget a dose? What side effects can this medication cause?	What storage conditions are needed for this medicine? In case of emergency/overdose What other information should I know? Brand names Other names

IMPORTANT WARNING: Return to top

[UPDATED 08/31/2009] Supplemental Q&As added

[Posted 08/04/2009] FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia. FDA is also requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy.

TNF blockers are approved for the treatment of one or more of a number of immune system diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis.

[Posted 09/04/2008] FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dyspnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses. For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the pathogen(s) are identified.

[Posted 06/03/2008] FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients.

For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch, http://www.fda.gov/Drugs, and http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements.

IMPORTANT WARNING: Return to top

Infliximab may decrease your ability to fight infection and increase the risk that you will get a serious or life-threatening infection. Tell your doctor if you have any type of infection now, including minor infections (such as open cuts or sores), infections that come and go (such as cold sores) and chronic infections that do not go away, or if you often get any type of infection such as bladder infections. Also tell your doctor if you are taking medications that suppress the immune system such as azathioprine (Imuran), cancer chemotherapy medications, cyclosporine (Neoral, Sandimmune), oral corticosteroids; 6-mercaptopurine (Purinethol); methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf). If you experience any of the following symptoms during or shortly after your treatment with infliximab, call your doctor immediately: sore throat; cough; fever; extreme tiredness; flu-like symptoms; warm, red, or painful skin; or other signs of infection.

Infliximab increases the risk that you will get some types of infections that are most common in certain parts of the United States and the world. Tell your doctor all the places you previously lived and all the places you recently visited or plan to visit while using infliximab.

You may be infected with tuberculosis (TB, a type of lung infection) but not have any symptoms of the disease. In this case, infliximab may increase the risk that your infection will become more serious and you will develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medication to treat this infection before you start using infliximab. Tell your doctor if you have or have ever had TB, or if you have been around someone who has TB.

Keep all appointments with your doctor. Your doctor will monitor your health carefully to be sure you do not develop a serious infection.

Some children and young adults with Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) who used infliximab developed a rare type of cancer called hepatosplenic T-cell lymphoma. These patients were also taking azathioprine (Imuran) or 6-mercaptopurine (Purinethol) when they developed this cancer.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with infliximab and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using infliximab.

Why is this medication prescribed? Return to top

Infliximab is used to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including:

rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function) that is also being treated with methotrexate (Rheumatrex, Trexall).
Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) that has not improved when treated with other medications.
ulcerative colitis (condition that causes swelling and sores in the lining of the large intestine) that has not improved when treated with other medications.
ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage).
psoriasis (a skin disease in which red, scaly patches form on some areas of the body).
psoriatic arthritis (joint pain and swelling and scales on the skin).

Infliximab is in a class of medications called tumor necrosis factor-alpha (TNF-alpha) inhibitors. It works by blocking the action of TNF-alpha, a substance in the body that causes inflammation.

How should this medicine be used? Return to top

Infliximab comes as a powder to be mixed with sterile water and administered intravenously (into a vein) by a doctor or nurse. It is usually given in a doctor's office every 2 to 8 weeks. It will take about 2 hours for you to receive your entire dose of infliximab.

Infliximab may cause serious allergic reactions during an infusion and for 2 hours afterward. A doctor or nurse will monitor you during this time to be sure you are not having a serious reaction to the medication. You may be given other medications to treat or prevent reactions to infliximab. Tell your doctor or nurse immediately if you experience any of the following symptoms during or shortly after your infusion: hives; rash; itching; swelling of the face, eyes, mouth, throat, tongue, lips, hands, feet, ankles, or lower legs; difficulty breathing or swallowing; flushing dizziness; fainting; fever; chills; seizures; and chest pain.

Infliximab may help control your symptoms, but it will not cure your condition. Your doctor will watch you carefully to see how well infliximab works for you. If you have rheumatoid arthritis or Crohn's disease, your doctor may increase the amount of medication you receive, if needed. If you have Crohn's disease and your condition has not improved after 14 weeks, your doctor may stop treating you with infliximab. It is important to tell your doctor how you are feeling during your treatment.

Other uses for this medicine Return to top

Infliximab is also sometimes used to treat juvenile arthritis (joint pain and swelling that begins in childhood) and Behcet's syndrome (ulcers in the mouth and on the genitals and inflammation of various parts of the body). Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow? Return to top

Before using infliximab,

tell your doctor and pharmacist if you are allergic to infliximab, any medications made from murine (mouse) proteins, or any other medications. Ask your doctor or pharmacist if you don't know whether a medication you are allergic to is made from murine proteins.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section, anakinra (Kineret), and etanercept (Enbrel). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had congestive heart failure (condition in which the heart cannot pump enough blood to other parts of the body). Your doctor may tell you not to use infliximab.
tell your doctor if you have ever been treated with phototherapy (a treatment for psoriasis that involves exposing the skin to ultraviolet light) and if you have or have ever had a disease that affects your nervous system, such as multiple sclerosis (MS; loss of coordination, weakness, and numbness due to nerve damage), Guillain-Barre syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage) or optic neuritis (inflammation of the nerve that sends messages from the eye to the brain); numbness, burning or tingling in any part of your body; seizures; chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways); any type of cancer; bleeding problems or diseases that affect your blood; or heart disease.
tell your doctor if you have or have ever had hepatitis B (a viral liver infection), have been told that you are a carrier (you are not sick, but the virus is still in your blood) of hepatitis B, or have been in close contact with someone who has hepatitis B. If you are a carrier of hepatitis B, your doctor will watch you carefully to be sure you do not develop an active infection while you are using infliximab.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using infliximab, call your doctor. You should not breast-feed while using infliximab.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are using infliximab.
do not have any vaccinations without talking to your doctor.Tell your doctor if you have recently received a vaccine. If your child will be using infliximab, be sure that your child has received all the shots that are required for children of his or her age before he or she begins treatment with infliximab.
if you were treated with infliximab in the past and you are now starting a second course of treatment, you may have a delayed allergic reaction 3 to 12 days after you receive infliximab. Tell your doctor if you experience any of the following symptoms several days or longer after your treatment: muscle or joint pain; fever; rash; hives; itching; swelling of the hands, face, or lips; difficulty swallowing; sore throat; and headache.

What special dietary instructions should I follow? Return to top

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose? Return to top

If you miss an appointment to receive an infliximab infusion, call your doctor as soon as possible.

What side effects can this medication cause? Return to top

Infliximab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

stomach pain
nausea
heartburn
headache
runny nose
back pain
white patches in the mouth
vaginal itching, burning, and pain or other signs of a yeast infection
flushing

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, or those listed in the IMPORTANT WARNING section, call your doctor immediately:

any type of rash, including a rash on the cheeks or arms that gets worse in the sun
chest pain
swelling of the feet, ankles, stomach, or lower legs
sudden weight gain
shortness of breath
blurred vision or vision changes
weakness in arms or legs
muscle or joint pain
numbness or tingling in any part of the body
seizures
yellowing of the skin or eyes
dark colored urine
loss of appetite
pain in the upper right part of the stomach
unusual bruising or bleeding
blood in stool
pale skin

Studies have shown that people who use infliximab or similar medications may be more likely to develop lymphoma (cancer that begins in the cells that fight infection) than people who do not take these medications. Patients who have autoimmune diseases are more likely to develop certain types of cancer than people who do not have these conditions.This is especially true if their disease is very active. Using infliximab may increase this risk. People who have COPD may have a higher risk of developing cancer while they are using infliximab than people who do not have this condition. Talk to your doctor about the risk of using infliximab.

Infliximab may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine? Return to top

Your doctor will store the medication in his or her office.

In case of emergency/overdose Return to top

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know? Return to top

Be sure to schedule appointments with your doctor well in advance so that you will be able to receive infliximab on schedule and at times that are convenient for you.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names Return to top

Remicade®

Other names Return to top

Anti-tumor Necrosis Factor-alpha

Anti-TNF-α

Last Revised - 09/01/2009

American Society of Health-System Pharmacists, Inc. Disclaimer

AHFS^® Consumer Medication Information. © Copyright, 2009. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.