RemicadeInfliximab

What is Remicade• Remicade is the brand name for

Infliximab• An injectable prescription drug which is

usually prescribed when other medicines or treatments have failed

• Manufactured and sold by Johnson & Johnson subsidiary Janssen Biotech

• The FDA first approved Remicade for adult Crohn's disease in 1998, and extended approvals to other immune system diseases, including rheumatoid arthritis in 2004, ulcerative colitis in 2005, pediatric Crohn's in 2006, and pediatric ulcerative colitis in 2011.

Production mechanism Infliximab is a human medicine but

it was developed originally in mice as a mouse antibody.

The mouse common amino acid sequences were replaced with similar human antibody domain as human has immune reactions to mouse proteins.

For the combination of mouse and human antibody amino acid sequences, it is called a monoclonal antibody.

Formulation

• Formulation : 100mg/vial powder for solution to be administrated as an IV infusion

• The active ingredient is Infliximab.

• The inactive ingredients in REMICADE include: sucrose, polysorbate 80, monobasic sodium phosphate monohydrate, and dibasic sodium phosphate dyhydrate.

Usage• Rheumatoid Arthritis• Crohn's disease•Ulcerative Colitis• Psoriatic Arthritis• Plaque Psoriasis• Ankylosing spondylitis

Mechanisms Delivers TNF-α which is a TNFα is a pro-

inflammatory and immune regulatory cytokine Produces too much TNF-α which results in

inflammation & other symptoms. But Remicade has the ability to bind with this

TNF-α and block the action of it. By doing so it block the damage also having

too much TNF in the body.No medicine can do this but remicade a target specific medicine can do this to recover from inflammatory related disease

Remicade binds to Tumore Necrosis Factor Alpha and blocks its inflammatory effect.

Admisintration

• Remicade (infliximab) is administered directly into a vein (intravenous infusion).

• This is done in a hospital or clinic.

• It cannot be taken orally because the drug's active ingredient would be destroyed.

Dosage Remicade is dosed in milligrams (mg) per

kilogram (kg) of the patient’s body weight. Recommended dosage is generally 5 mg/kg at

0, two, and six weeks, followed by a maintenance regimen of 5 mg/kg every eight weeks after that.

Rheumatoid arthritis: The recommended dosage is 3 mg/kg, used in combination with methotrexate.

Crohn's disease: Some adult patients may benefit from increasing the regimen dosage to 10 mg/kg.

Ankylosing spondylitis: The maintenance regimen is treatment every six weeks, not every eight weeks.

Side Effects Common Side Effects of Remicade (Infliximab):-Stomach and chest pain-Cough, runny nose, sneezing-Respiratory infections, such as sinus infections and sore throat-Fatigue or weakness-Difficulty breathing Serious Side Effects of Remicade (Infliximab):-Tuberculosis (TB)-Viral, fungal, and bacterial infections that can prove fatal-Liver injury-Blood problems-Nervous system problems-Allergic reactions-Heart failure-Increased risk for certain types of cancer: lymphoma, hepatosplenic T-cell lymphoma ( a rare and usually fatal cancer of the white blood cells), certain types of skin cancer

Contradictions• Hypersensitivity to infliximab, any

component of the formulation • Doses >5 mg/kg in patients with

moderate or severe heart failure• Severe infections -Sepsis -Tuberculosis -opportunistic infections

Controversial News6/7 people died in USASome serious side effectsIn some case it did not show any type

of effect in bodyBut Remicade is not responsible for

thisIt has no toxicity It can happen for dosage problem