Infliximab Injection (patient information)

IMPORTANT WARNING

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/cder) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using infliximab.

Why this medication is prescribed

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 this medication should be used

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 2-8 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

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.

Special precautions

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 taking 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 3-12 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.

Special dietary instructions

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

What to do if you forget a dose

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

Side effects

Minor side effects

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

Severe side effects

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 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].

Storage conditions needed for this medication

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.

Other information

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.

Brand names

• Remicade®

Other names

• Anti-tumor Necrosis Factor-alpha
• Anti-TNF-α
• cA2