(in flix’ i mab)
IMPORTANT WARNING:
| Infliximab may decrease your ability to fight infection and increase the risk that you will get a serious or life-threatening infection. Stay away from people who are sick and wash your hands often while you are taking this medication. Tell your doctor if you have any type of infection now, including 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 have or have ever had any disease that affects your immune system, such as cancer, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or severe combined immunodeficiency syndrome (SCID). 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, so tell your doctor all the places you previously lived and all the places you recently visited or plan to visit while using infliximab. The risk for getting a serious or life-threatening infection while using infliximab may be greater for people who are also taking medications that suppress the immune system. 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; 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: chest pain; shortness of breath; fast, shallow breathing; sore throat; cough; fever; chills; flu-like symptoms; extreme tiredness; night sweats; weight loss; swelling of your neck or under your arm;and other signs of infection.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.Talk to your doctor about the risks of taking infliximab. |
Why is this medication prescribed?
Infliximab is used with methotrexate (a medication) to relieve the symptoms of rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function) in patients who did not get better when they took methotrexate alone. Infliximab is also used to relieve the symptoms of Crohn’s disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) in patients who have taken other medications and not gotten better. Infliximab is also used to decrease the number of fistulas (abnormal tunnels between two organs or an organ and the skin) and to prevent closed fistulas from reopening in patients with Crohn’s disease who have or have had fistulas. Infliximab is also used to relieve the symptoms of ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage).Infliximab is also used with or without methotrexate to relieve the symptoms of psoriatic arthritis (joint pain and swelling and scales on the skin). Infliximab is in a class of medications called tumor necrosis factor (TNF) inhibitors. It works by blocking the action of TNF, a substance in the body that causes inflammation.
How should this medicine be used?
Infliximab comes as a powder to be mixed with sterile water and infused (injected slowly) intravenously (into a vein) by a doctor or nurse. It is usually given in a doctor’s office every 2-8 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; headache; upset stomach; blurred vision; fever; chills; seizures; and chest pain.
Infliximab may control rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, and psoriatic arthritis, but it does not cure these conditions. 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 your dose or give you infliximab more often (up to once every 4 weeks) 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.
Your doctor will give you the manufacturer’s patient information sheet to read before you receive each dose of infliximab. Read the information carefully and ask your doctor any questions you have.
Other uses for this medicine
Infliximab is also sometimes used to treat ulcerative colitis (inflammation and sores in the large intestine), juvenile arthritis (joint pain and swelling in children), 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 drug 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?
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. Be sure to mention the medications listed in the IMPORTANT WARNING section and anakinra (Kineret).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 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; lupus (a condition in which the body attacks its own tissues and organs); lymphoma (cancer that begins in the cells that fight infection); congestive heart failure (a condition in which the heart cannot pump blood normally) or other heart disease; or liver, blood, or kidney 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 taking infliximab.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant whileusing infliximab, call your doctor.You should not breastfeed 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 (e.g., measles or flu shots) without talking to your doctor. Tell your doctor if you have recently received a vaccine.
- if you have Crohn’s disease, 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 3-12 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?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
If you miss an appointment to receive an infliximab infusion, call your doctor as soon as possible.
What side effects can this medication cause?
Infliximab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- upset stomach
- heartburn
- headache
- runny nose
- back pain
- white patches in mouth
- vaginal itching, burning, and pain or other signs of a yeast infection
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
- swelling of the feet, ankles, stomach, or lower legs
- dizziness or lightheadedness
- 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
- pale colored stools
- severe itching
- loss of appetite
- vomiting
- pain in the upper right part of your stomach
- unusual bruising or bleeding
- 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 patients who do not take these medications. Patients who have Crohn’s disease or rheumatoid arthritis are more likely to develop certain types of cancer than people who do not have these conditions. This is especially true if they have taken medications that suppress their immune systems for a long time. Using infliximab may increase this risk. 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 taking 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/MedWatch/report.htm] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Your doctor will store the medication in his or her office.
In case of emergency/overdose
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?
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.
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Last Revised - 07/01/2005