Infliximab Injection
(in flix' i mab)
(in flix' i mab)
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- Our information about drug and safety, off-label uses, side effects and interactions is based on the best available clinical evidence -- the same information used by hospital pharmacists
Remicade Anti-tumor Necrosis Factor-alpha, Anti-TNF-α, cA2
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 abatacept (Orencia), anakinra (Kineret), 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.
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.
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.
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
Some adults who used infliximab during clinical trials and some children 18 years of age or younger who used infliximab and
similar medications developed lymphoma (cancer that begins in the cells of the immune system), skin cancer, and other types
of cancer. There is not enough information to tell whether adults or children who use infliximab are more likely to develop
cancer than people who do not use the medication. Patients who have certain autoimmune diseases may be more likely to develop
certain types of cancer than people who do not have these conditions, especially if their disease is very active or they have
taken immunosuppressants for a long time.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. People who have psoriasis may be at higher risk of developing skin
cancer while they are using infliximab, especially if they have been treated with phototherapy for a long time. Talk to your
doctor about the risks 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/MedWatch/index.html] or by phone [1-800-332-1088].
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. 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.
- 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 treated with infliximab injection, talk to his or her doctor about vaccinations that should be given before the start of treatment. If possible, your child should be given all vaccinations needed for children of his or her age before beginning treatment.
- 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.
Unless your doctor tells you otherwise, continue your normal diet.
If you miss an appointment to receive an infliximab infusion, call your doctor as soon as possible.
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.
Your doctor will store the medication in his or her office.
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.
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.











