Remicade

Remicade

infliximab

Manufacturer:

Janssen

Distributor:

Zuellig Pharma

Marketer:

Johnson & Johnson
Concise Prescribing Info
Contents
Infliximab
Indications/Uses
RA; ankylosing spondylitis; psoriatic arthritis; psoriasis; Crohn's disease; paed Crohn's disease; fistulizing Crohn's disease; ulcerative colitis; paed ulcerative colitis.
Dosage/Direction for Use
Adult RA In combination w/ MTX: Initially 3 mg/kg IV infusion over 2 hr, followed by additional 3 mg/kg at 2 & 6 wk after 1st infusion, then 8 wkly thereafter. May be increased up to 10 mg/kg after 22 wk of therapy if necessary. Ankylosing spondylitis 5 mg/kg IV infusion over 2 hr, followed by additional 5 mg/kg at 2 & 6 wk after 1st infusion, then 6-8 wkly thereafter. Psoriatic arthritis/psoriasis 5 mg/kg IV infusion over 2 hr, followed by additional 5 mg/kg at 2 & 6 wk after 1st infusion, then 8 wkly thereafter. Moderate to severe Crohn's disease 5 mg/kg as single IV infusion over 2 hr as an induction regimen at 0, 2 & 6 wk for optimum long-term symptom control. Maintenance: 5 mg/kg 8 wkly thereafter, may be adjusted up to 10 mg/kg. Alternative: Initially 5 mg/kg IV infusion over 2 hr, followed up repeat infusions of 5 mg/kg when signs & symptoms recur (limited data on dosing intervals beyond 16 wk). Fistulizing Crohn's disease 5 mg/kg IV over 2 hr, followed by additional 5 mg/kg at 2 & 6 wk after the 1st infusion. If patient does not respond after these 3 doses, no additional treatment w/ infliximab should be given. Continued treatment: Additional infusions of 5 mg/kg every 8 wk or readministration if signs & symptoms of disease recur followed by infusions of 5 mg/kg every 8 wk. Re-administration for Crohn's diseases & RA If signs & symptoms of disease recur, re-administer w/in 16 wk following last infusion. Ped Crohn's disease In combination w/ MTX, 6-MP or AZA: 5 mg/kg IV infusion followed by additional 5 mg/kg at 2 & 6 wk after 1st infusion, then 8 wkly thereafter, may be adjusted up to 10 mg/kg. 6-17 yr Ulcerative colitis 5 mg/kg IV infusion followed by additional 5 mg/kg at 2 & 6 wk after 1st infusion, then 8 wkly thereafter.
Contraindications
Hypersensitivity to infliximab & other murine proteins. TB or other severe infections eg, sepsis, abscesses & opportunistic infections; moderate or severe heart failure (NYHA class III/IV).
Special Precautions
Infusion reactions & hypersensitivity, emergency equipment must be available, pretreatment w/ antihistamine, hydrocortisone &/or paracetamol to prevent mild & transient effects. Infections, monitor for infections including TB, caution in patients w/ chronic infection or history of recurrent infections, including concomitant immunosuppressive therapy, patients taking TNF-blockers. Hepatitis B reactivation, test for HBV infection before initiating treatment. Hepatobiliary events, monitor for symptoms or signs of liver dysfunction. Concurrent administration of TNFα inhibitor & anakinra/abatacept w/ other biological therapeutics, combination w/ anakinra, abatacept or other biological therapeutics is not recommended. Switching between biological DMARDs. Vaccinations, patients on infliximab may receive concurrent vaccinations, except for live vaccines. Live vaccines/therapeutic infectious agents, use not recommended. Infant exposure in utero, at least 6-mth waiting period following birth is recommended before administration of live vaccines to infant exposed in utero to infliximab. Therapeutic infectious agents, not to be given concurrently w/ infliximab. Autoimmune processes, monitor for symptoms suggestive of a lupus-like syndrome. Neurological events, discontinue infliximab if these disorders develop. Malignancies & lymphoproliferative disorders, caution treated w/ TNF-antagonist, heavy smoking, psoriasis, medical history of extensive immunosuppressant therapy or prolonged PUVA treatment. Heart failure. Haematologic reactions, discontinue infliximab if confirmed significant haematologic abnormalities occur. May affect ability to drive & use machines. Women of childbearing potential should use effective contraception. Pregnancy & lactation. Ped patients. Elderly ≥65 yr.
Adverse Reactions
Viral infection; headache; URTI, sinusitis; abdominal pain, nausea; infusion-relation reaction, pain. Bacterial infections; neutropenia, leucopenia, anaemia, lymphadenopathy; allergic resp symptom; depression, insomnia; vertigo, dizziness, hypoaesthesia, paraesthesia; conjunctivitis; tachycardia, palpitation; hypotension, HTN, ecchymosis, hot flush, flushing; lower resp tract infection, dyspnoea, epistaxis; GI haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation; abnormal hepatic function, increased transaminases; new onset or worsening psoriasis, urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia; arthralgia, myalgia, back pain; UTI; chest pain, fatigue, fever, inj site reaction, chills, oedema.
Drug Interactions
Not recommended in combination w/ other biological therapeutics eg, anakinra & abatacept. Not to be given concurrently w/ live vaccines; therapeutic infectious agents.
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 conc (vial) 100 mg
Packing/Price
1's
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