Infliximab

What it is used for

INFLECTRA is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.

Pediatric Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy. Ulcerative Colitis: reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Pediatric Ulcerative Colitis: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy. Rheumatoid Arthritis in combination with methotrexate: reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active disease.

Ankylosing Spondylitis: reducing signs and symptoms in adult patients with active disease. Psoriatic Arthritis: reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients. Plaque Psoriasis: treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

1.1 Crohn's Disease INFLECTRA is indicated for: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy. reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD.

1.2 Pediatric Crohn's Disease INFLECTRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active CD who have had an inadequate response to conventional therapy. 1.3 Ulcerative Colitis INFLECTRA is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

1.4 Pediatric Ulcerative Colitis INFLECTRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy. 1.5 Rheumatoid Arthritis INFLECTRA, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA).

1.6 Ankylosing Spondylitis INFLECTRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). 1.7 Psoriatic Arthritis INFLECTRA is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (PsA).

1.8 Plaque Psoriasis INFLECTRA is indicated for the treatment of adult patients with chronic severe (i.e., extensiv

The most important thing to know

REMICADE may cause serious side effects, including: 1. Risk of infection REMICADE is a medicine that affects your immune system. REMICADE can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving REMICADE. These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body.

Some patients have died from these infections. Your doctor should test you for TB before starting REMICADE. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE. Before starting REMICADE, tell your doctor if you: think you have an infection. You should not start receiving REMICADE if you have any kind of infection.

are being treated for an infection. have signs of an infection, such as a fever, cough, flu-like symptoms. have any open cuts or sores on your body. get a lot of infections or have infections that keep coming back. have diabetes or an immune system problem. People with these conditions have a higher chance for infections.

have TB, or have been in close contact with someone with TB. live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may develop or become more severe if you receive REMICADE.

If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor. have or have had hepatitis B. use the medicines KINERET (anakinra), ORENCIA (abatacept), ACTEMRA (tocilizumab), or other medicines called biologics used to treat the same conditions as REMICADE.

After starting REMICADE, if you have an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your doctor right away. REMICADE can make you more likely to get infections or make any infection that you have worse. 2. Risk of Cancer There have been cases of unusual cancers in children and teenage patients using tumor necrosis factor (TNF) blocker medicines.

For children and adults receiving TNF blocker medicines, including REMICADE, the chances of getting lymphoma or other cancers may increase. Some people receiving TNF blockers, including REMICADE, developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men.

Also, most people were being treated for Crohn's disease or ulcerative colitis with a TNF blocker and another medicine called azathioprine or 6-mercaptopurine. People who have been treated for rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis for a long time may be more likely to develop lymphoma.

This is especially true for people with very active disease. Some people treated with REMICADE have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with REMICADE, tell your doctor. Patients with Chronic Obstructive Pulmonary Disease (COPD), a specific type of lung disease, may have an increased risk for getting cancer while being treated with REMICADE.

Some women being treated for rheumatoid arthritis with REMICADE have developed cervical cancer. For women receiving REMICADE, including those over 60 years of age, your doctor may recommend that you continue to be regularly screened for cervical cancer. Tell your doctor if you have ever had any type of cancer. Discuss with your doctor any need to adjust medicines you may be taking.

See the section "

Side effects, and when to stop

" below for more information. What is REMICADE? REMICADE is a prescription medicine that is approved for patients with: Rheumatoid Arthritis - adults with moderately to severely active rheumatoid arthritis, along with the medicine methotrexate. Crohn's Disease - children 6 years and older and adults with Crohn's disease who have not responded well to other medicines.

Ankylosing Spondylitis in adults Psoriatic Arthritis in adults Plaque Psoriasis - adult patients with plaque psoriasis that is chronic (does not go away), severe, extensive, and/or disabling. Ulcerative Colitis - children 6 years and older and adults with moderately to severely active ulcerative colitis who have not responded well to other medicines.

REMICADE blocks the action of a protein in your body called tumor necrosis factor-alpha (TNF-alpha). TNF-alpha is made by your body's immune system. People with certain diseases have too much TNF-alpha that can cause the immune system to attack normal healthy parts of the body. REMICADE can block the damage caused by too much TNF-alpha.

It is not known if REMICADE is safe and effective in children under 6 years of age. Who should not receive REMICADE? You should not receive REMICADE if you have: heart failure, unless your doctor has examined you and decided that you are able to receive REMICADE. Talk to your doctor about your heart failure. had an allergic reaction to REMICADE, or any of the other ingredients in REMICADE.

See the end of this Medication Guide for a complete list of ingredients in REMICADE.

Who should not take it

Do not take REMICADE together with medicines such as KINERET (anakinra), ORENCIA (abatacept), ACTEMRA (tocilizumab), or other medicines called biologics that are used to treat the same conditions as REMICADE. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

These include any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis. Know the medicines you take. Keep a list of your medicines and show them to your doctor and pharmacist when you get a new medicine. What are the possible side effects of REMICADE?

REMICADE can cause serious side effects, including: Serious Infections Some patients, especially those 65 years and older have had serious infections while receiving REMICADE. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body or cause infections in certain areas (such as skin).

Some patients die from these infections. If you get an infection while receiving treatment with REMICADE your doctor will treat your infection and may need to stop your REMICADE treatment. Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving REMICADE: a fever feel very tired have a cough have flu-like symptoms warm, red, or painful skin Your doctor will examine you for TB and perform a test to see if you have TB.

If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with REMICADE and during treatment with REMICADE. Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving REMICADE. Patients who had a negative TB skin test before receiving REMICADE have developed active TB.

If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with REMICADE. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment with REMICADE and occasionally while you are being treated.

Tell your doctor if you have any of the following symptoms: feel unwell poor appetite tiredness (fatigue) fever, skin rash, or joint pain Heart Failure If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving REMICADE. Your congestive heart failure may get worse while you are receiving REMICADE.

Be sure to tell your doctor of any new or worse symptoms including: shortness of breath swelling of ankles or feet sudden weight gain Treatment with REMICADE may need to be stopped if you get new or worse congestive heart failure. Other Heart Problems Some patients have experienced a heart attack (some of which led to death), low blood flow to the heart, or abnormal heart rhythm within 24 hours of beginning their infusion of REMICADE.

Symptoms may include chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat. Tell your doctor right away if you have any of these symptoms. Liver Injury Some patients receiving REMICADE have developed serious liver problems.

Tell your doctor if you have: jaundice (skin and eyes turning yellow) dark brown-colored urine pain on the right side of your stomach area (right-sided abdominal pain) fever extreme tiredness (severe fatigue) Blood Problems In some patients receiving REMICADE, the body may not make enough of the blood cells that help fight infections or help stop bleeding.

Tell your doctor if you: have a fever that does not go away bruise or bleed very easily look very pale Ner

What to say before you start

Your doctor will assess your health before each treatment. Tell your doctor about all of your medical conditions, including if you: have an infection (). have other liver problems including liver failure. have heart failure or other heart conditions. If you have heart failure, it may get worse while you receive REMICADE.

have or have had any type of cancer. have had phototherapy (treatment with ultraviolet light or sunlight along with a medicine to make your skin sensitive to light) for psoriasis. You may have a higher chance of getting skin cancer while receiving REMICADE. have COPD, a specific type of lung disease. Patients with COPD may have an increased risk of getting cancer while receiving REMICADE.

have or have had a condition that affects your nervous system such as: multiple sclerosis, or Guillain-Barré syndrome, or if you experience any numbness or tingling, or if you have had a seizure. have recently received or are scheduled to receive a vaccine. Adults and children receiving REMICADE should not receive live vaccines (for example, the Bacille Calmette-Guérin [BCG] vaccine) or treatment with a weakened bacteria (such as BCG for bladder cancer).

Adults and children should have all of their vaccines brought up to date before starting treatment with REMICADE. are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed. You and your doctor should decide if you should receive REMICADE while you are pregnant or breastfeeding. If you have a baby and you were receiving REMICADE during your pregnancy, it is important to tell your baby's doctor and other health care professionals about your REMICADE use so they can decide when your baby should receive any vaccine.

Certain vaccinations can cause infections. If you received REMICADE while you were pregnant, your baby may be at higher risk for getting an infection. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death. This includes live vaccines such as the BCG, rotavirus, or any other live vaccines.

For other types of vaccines, talk with your doctor. How should I receive REMICADE? You will be given REMICADE through a needle placed in a vein (IV or intravenous infusion) in your arm. Your doctor may decide to give you medicine before starting the REMICADE infusion to prevent or lessen side effects. Only a healthcare professional should prepare the medicine and administer it to you.

REMICADE will be given to you over a period of about 2 hours. If you have side effects from REMICADE, the infusion may need to be adjusted or stopped. In addition, your healthcare professional may decide to treat your symptoms. A healthcare professional will monitor you during the REMICADE infusion and for a period of time afterward for side effects.

Your doctor may do certain tests while you are receiving REMICADE to monitor you for side effects and to see how well you respond to the treatment. Your doctor will determine the right dose of REMICADE for you and how often you should receive it. Make sure to discuss with your doctor when you will receive infusions and to come in for all your infusions and follow-up appointments.