Remicade

Remicade

infliximab

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Concise Prescribing Info
Contents
Infliximab
Indications/Uses
Dosage/Direction for Use
RA Initially 3 mg/kg IV infusion over 2 hr followed w/ 3 mg/kg administered 2 & 6 wk after 1st infusion then every 8 wk thereafter. For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg &/or treating as often as every 4 wk. Should be given in combination w/ MTX. Adult or Ped Crohn's disease or adult fistulizing Crohn's disease Induction regimen: 5 mg/kg as single IV infusion over 2 hr at 0, 2 & 6 wk. Maintenance regimen: 5 mg/kg every 8 wk thereafter. For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg. Ped Crohn's disease 5 mg/kg as IV infusion followed by additional 5 mg/kg infusion doses at 2 & 6 wk after the 1st infusion then every 8 wk thereafter. In incomplete response, dose may be adjusted up to 10 mg/kg. Ankylosing spondylitis 5 mg/kg IV infusion over 2 hr followed by 5 mg/kg doses administered at 2 & 6 wk after 1st infusion then every 6 wk thereafter. Plaque, psoriasis, psoriatic arthritis 5 mg/kg IV infusion over 2 hr followed by additional 5 mg/kg infusion at 2 & 6 wk after the 1st infusion then every 8 wk thereafter. Adult or ped Ulcerative colitis 5 mg/kg IV infusion over 2 hr followed by additional 5 mg/kg infusion at 2 & 6 wk after the 1st infusion then every 8 wk thereafter. For adult patients who have an incomplete response or lose their response, consideration may be given to treatment 10 mg/kg. Re-administration for Crohn's disease & RA May be re-administered w/in 16 wk following last infusion if signs & symptoms recur.
Contraindications
Sensitivity to murine proteins. TB, sepsis, abscesses, opportunistic infections. Moderate to severe heart failure (NYHA class III/IV).
Special Precautions
Monitor patients for at least 1 hr post-infusion for acute infusion effects & delayed hypersensitivity reactions. Evaluate patients for infections prior to therapy. Clinically manifested infections &/or abscesses. Lupus-like syndrome (discontinue treatment). Elderly. Liver or renal impairment. Childn. Pregnancy & lactation.
Adverse Reactions
Viral infection, fever, serum sickness-like reactions, headache, vertigo/dizziness, flushing, URTI & lower resp tract infection, dyspnea, sinusitis, GI disturbances, abnormal hepatic function, rash, pruritus, urticaria, increased sweating, dry skin, fatigue, chest pain, infusion-related reactions.
Drug Interactions
Formation of antibodies to infliximab reduced w/ MTX & other immunomodulators. Combination w/ anakinra, abatacept, other biological therapeutics is not recommended.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AB02 - infliximab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Remicade infusion 100 mg
Packing/Price
1's
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