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 News

6/7 people died in USA

Some serious side effects

In some case it did not show any type of effect

in body

But Remicade is not responsible for this

It has no toxicity

It can happen for dosage problem