Remicade (Centocor Inc)
Remicade (Centocor Inc) - General Information
Tumor necrosis factor (TNF-alpha) binding antibody (chimeric IgG1). It is composed of human constant and murine variable regions. Remicade (Centocor Inc) is produced by a recombinant cell line cultured by continuous perfusion
Pharmacology of Remicade (Centocor Inc)
Used in the treatment of auto-immune disorders such as Crohn's disease and rheumatoid arthritis. Remicade (Centocor Inc) binds to tumor necrosis factor alpha (TNFa) and inhibits binding of TNFa with its receptors. This reduces production of pro-inflammatory cytokines such as interleukins (IL) 1 and 6. This also limits leukocyte migration and expression of adhesion molecules by endothelial cells and leukocytes. Remicade (Centocor Inc) also limits the activation of neutrophil and eosinophil functional activity, reduces production of tissue degrading enzymes produced by synoviocytes and/or chondrocytes. Remicade (Centocor Inc) decreases synovitis and joint erosions in collagen-induced arthritis and allows eroded joints to heal.
Remicade (Centocor Inc) for patients
REMICADE® (infliximab)
You should read this information sheet before you start using REMICADE® (pronounced rem-eh-kaid) and before each time you are scheduled to receive REMICADE. This information sheet does not take the place of talking with your doctor. You and your doctor should talk about your health and how you are feeling before you start taking REMICADE, while you are taking it and at regular checkups. If you do not understand any of the information in this sheet, you should ask your doctor to explain what it means.
What is REMICADE?
REMICADE is a medicine that is used to treat adults with moderately to severely active rheumatoid arthritis, Crohn�s disease and ulcerative colitis. In Crohn�s disease and ulcerative colitis, REMICADE is for people who have not responded well enough to other medicines. REMICADE is also used to treat active ankylosing spondylitis and psoriatic arthritis.
How does REMICADE work?
The medicine REMICADE is a type of protein that recognizes, attaches to and blocks the action of a substance in your body called tumor necrosis factor. Tumor necrosis factor (TNF) is made by certain blood cells in your body. REMICADE will not cure rheumatoid arthritis, Crohn�s disease, ulcerative colitis, ankylosing spondylitis or psoriatic arthritis, but blocking TNF with REMICADE may reduce the inflammation caused by TNF in your body. You should also know that REMICADE may help you feel better but can also cause serious side effects and can reduce your body�s ability to fight infections.
What should I know about the immune system, and taking REMICADE for Rheumatoid Arthritis, Crohn�s Disease, Ulcerative Colitis, Ankylosing Spondylitis or Psoriatic Arthritis?
The immune system protects the body by responding to �invaders� like bacteria, viruses and other foreign matter that enter your body by producing antibodies and putting them into action to fight off the �invaders.� In diseases like rheumatoid arthritis, Crohn�s disease, ulcerative colitis, ankylosing spondylitis and psoriatic arthritis, TNF can cause your immune system to attack healthy tissues in your body and cause inflammation and damage. If these diseases are untreated, it can cause permanent damage to the body�s bones, cartilage and tissue.
While taking REMICADE can block the TNF that causes inflammation, it can also lower your body�s ability to fight infections. So, taking REMICADE can make you more prone to getting infections or it can make an infection that you already have worse. You should call your doctor right away if you think you have an infection.
What important information should I know about treatment with REMICADE?
REMICADE, like other medicines that affect your immune system, is a strong medicine that can cause serious side effects. Possible serious side effects include:
Serious Infections:
� Some patients have had serious infections while receiving REMICADE. Some of the patients have died from these infections. Serious infections include TB (tuberculosis), and infections caused by viruses, fungi or bacteria that have spread throughout the body. If you develop a fever, feel very tired, have a cough, or have flu-like symptoms, these could be signs that you may be getting an infection. If you have any of these symptoms while you are taking or after you have taken REMICADE, you should tell your doctor right away.
Heart Failure:
� If you have been told that you have a heart problem called congestive heart failure and you are currently being treated with REMICADE, you will need to be closely monitored by your doctor. If you develop new or worse symptoms that are related to your heart condition, such as shortness of breath or swelling of your ankles or feet, you must contact your doctor immediately.
Blood Problems:
� In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you stop bleeding. Some of the patients have died from this failure to produce blood cells. If you develop a fever that doesn't go away, bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may decide to stop your treatment.
Allergic Reactions:
� Some patients have had severe allergic reactions to REMICADE. These reactions can happen while you are getting your REMICADE infusion or shortly afterwards. The symptoms of an allergic reaction may include hives (red, raised, itchy patches of skin), difficulty breathing, chest pain and high or low blood pressure. Your doctor may decide to stop REMICADE treatment and give you medicines to treat the allergic reaction.
� Some patients who have been taking REMICADE for Crohn�s disease have had allergic reactions 3 to 12 days after receiving their REMICADE treatment. The symptoms of this type of delayed reaction may include fever, rash, headache and muscle or joint pain. Call your doctor right away if you develop any of these symptoms or any other unusual symptoms such as difficulty swallowing.
Nervous System Disorders:
� There have been rare cases where people taking REMICADE or other TNF blockers have developed disorders that affected their nervous system. Signs that you could be having a problem include: changes in your vision, weakness in your arms and/or legs, and numbness or tingling in any part of your body.
Cancer:
� Reports of a type of blood cancer called lymphoma in patients on REMICADE or other TNF blockers are rare but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn�s disease, ankylosing spondylitis or psoriatic arthritis for a long time, particularly those with highly active disease may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. If you take REMICADE or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should also tell your doctor if you have had or develop lymphoma or other cancers while you are taking REMICADE.
Liver Injury:
� There have been rare cases where people taking REMICADE have developed serious liver problems, some fatal. Signs that you could be having a problem include: jaundice (skin and eyes turning yellow), dark brown-colored urine, right sided abdominal pain, fever, and severe fatigue (tiredness). You should contact your doctor immediately if you develop any of these symptoms.
Other Important Information
Some patients have developed symptoms that can resemble a disease called lupus. Lupus-like symptoms may include chest discomfort or pain that doesn�t go away, shortness of breath, joint pain, or a rash on the cheeks or arms that gets worse in the sun. If you develop any of these symptoms your doctor may decide to stop your treatment with REMICADE.
What are the more common side effects of REMICADE?
The more common side effects with REMICADE are respiratory infections (that may include sinus infections and sore throat), coughing and stomach pain.
Who should not take REMICADE?
YOU SHOULD NOT take REMICADE if you have:
� Heart failure, unless your doctor has talked to you and decided that you are able to take REMICADE.
� Had an allergic reaction to REMICADE or any other product that was made with murine (mouse) proteins.
What health concerns should I talk to my doctor about?
Before receiving your first treatment with REMICADE you should tell your doctor if you:
� Have or think you may have any kind of infection. The infection could be in only one place in your body (such as an open cut or sore), or an infection that affects your whole body (such as the flu). Having an infection could put you at risk for serious side effects from REMICADE.
� Have an infection that won�t go away or a history of infection that keeps coming back.
� Have had TB (tuberculosis), or if you have recently been with anyone who might have TB. Your doctor will examine you for TB and perform a skin test. If your doctor feels that you are at risk for TB, he or she may start treating you for TB before you begin REMICADE therapy.
� Have lived in or visited an area of the country where an infection called histoplasmosis or coccidioidomycosis (an infection caused by a fungus that affects the lungs) is common. If you don�t know if the area you live in is one where histoplasmosis or coccidioidomycosis is common, ask your doctor.
� Have or have previously had heart failure or other heart conditions.
� Have or have had a condition that affects your nervous system, like multiple sclerosis, or Guillain-Barr� syndrome, or if you experience any numbness, or tingling, or have had a seizure.
� Are pregnant or nursing.
� Have recently received or are scheduled to receive a vaccine.
Can I take REMICADE while I am on other medicines?
Tell your doctor if you are taking any other medicines including over the counter medicines, supplements or herbal products before you are treated with REMICADE. If you start taking or plan to start taking any new medicine while you are taking REMICADE, tell your doctor.
REMICADE and KINERET should not be taken together.
How will REMICADE be given to me?
REMICADE will be given to you by a healthcare professional. REMICADE will be given to you by an IV. This means that the medicine will be given to you through a needle placed in a vein in your arm. It will take about 2 hours to give you the full dose of medicine. During that time and for a period after you receive REMICADE, you will be monitored by a healthcare professional. Your doctor may ask you to take other medicines along with REMICADE.
Only a health care professional should prepare the medicine and administer it to you.
How often will I receive REMICADE?
Rheumatoid Arthritis
If you are receiving REMICADE for rheumatoid arthritis you will receive your first dose followed by additional doses at 2 and 6 weeks after the first dose. You will then receive a dose every 8 weeks. Your doctor will monitor your response to REMICADE and may change your dose or treat you more frequently (as often as every 4 weeks).
Crohn�s Disease or Fistulizing Crohn�s Disease
If you are receiving REMICADE for active Crohn's disease or fistulizing Crohn�s disease, you will receive your first dose followed by additional doses at 2 and 6 weeks after the first dose. You will then receive a dose every 8 weeks. Your doctor will monitor your response to REMICADE and may change your dose.
Ulcerative Colitis
If you are receiving REMICADE for ulcerative colitis, you will receive your first dose followed by additional doses at 2 and 6 weeks after the first dose. You will then receive a dose every 8 weeks and your doctor will monitor your response to REMICADE.
Ankylosing Spondylitis
If you are receiving REMICADE for ankylosing spondylitis you will receive your first dose followed by additional doses at 2 and 6 weeks after the first dose. You will then receive a dose every 6 weeks.
Psoriatic Arthritis
If you are receiving REMICADE for psoriatic arthritis you will receive your first dose followed by additional doses at 2 and 6 weeks after the first dose. You will then receive a dose every 8 weeks.
What if I still have questions?
If you have any questions, or problems, always talk first with your doctor. You can also visit the REMICADE internet site at www.remicade.com.
Remicade (Centocor Inc) Interactions
Concurrent administration of etanercept (another TNFα-blocking agent) and anakinra (an interleukin-1 antagonist) has been associated with an increased risk of serious infections, and increased risk of neutropenia and no additional benefit compared to these medicinal products alone. Other TNFa-blocking agents (including REMICADE) used in combination with anakinra may also result in similar toxicities.
Specific drug interaction studies, including interactions with MTX, have not been conducted. The majority of patients in rheumatoid arthritis or Crohn�s disease clinical studies received one or more concomitant medications. In rheumatoid arthritis, concomitant medications besides MTX were nonsteroidal anti-inflammatory agents, folic acid, corticosteroids and/or narcotics. Concomitant Crohn�s disease medications were antibiotics, antivirals, corticosteroids, 6-MP/AZA and aminosalicylates. In psoriatic arthritis clinical trials, concomitant medications included MTX in approximately half of the patients as well as nonsteroidal anti-inflammatory agents, folic acid and corticosteroids.
Patients with Crohn�s disease who received immunosuppressants tended to experience fewer infusion reactions compared to patients on no immunosuppressants. Serum infliximab concentrations appeared to be unaffected by baseline use of medications for the treatment of Crohn�s disease including corticosteroids, antibiotics (metronidazole or ciprofloxacin) and aminosalicylates.
Remicade (Centocor Inc) Contraindications
REMICADE at doses >5 mg/kg should not be administered to patients with moderate to severe heart failure. In a randomized study evaluating REMICADE in patients with moderate to severe heart failure (New York Heart Association [NYHA] Functional Class III/IV), REMICADE treatment at 10 mg/kg was associated with an increased incidence of death and hospitalization due to worsening heart failure.
REMICADE should not be administered to patients with known hypersensitivity to any murine proteins or other component of the product.
Additional information about Remicade (Centocor Inc)
Remicade (Centocor Inc) Indication: For treatment of Crohn's disease, psoriasis, rheumatoid arthitis and ankylosing spondylitis
Mechanism Of Action: Remicade (Centocor Inc) neutralizes the biological activity of TNFa by binding with high affinity to the soluble and transmembrane forms of TNFa and inhibits binding of TNFa with its receptors. Remicade (Centocor Inc) does not neutralize TNFb (lymphotoxin a), a related cytokine that utilizes the same receptors as TNFa
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Infliximab
Synonyms: Ig gamma-1 chain C region
Drug Category: Immunomodulatory Agents; Immunosuppressive Agents
Drug Type: Biotech; Approved
Other Brand Names containing Infliximab: Remicade (Centocor Inc);
Absorption: Not Available
Toxicity (Overdose): Not Available
Protein Binding: Not Available
Biotransformation: Most likely removed by opsonization via the reticuloendothelial system when bound to T lymphocytes, or by human antimurine antibody production
Half Life: 9.5 days
Dosage Forms of Remicade (Centocor Inc): Powder, for solution Intravenous
Chemical IUPAC Name: Chimeric mouse/human anti-TNF-alpha antibody (cA2)
Chemical Formula: C6428H9912N1694O1987S46
Infliximab on Wikipedia: https://en.wikipedia.org/wiki/Infliximab
Organisms Affected: Humans and other mammals