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 & fistulizing Crohn's disease; ulcerative colitis.
Dosage/Direction for Use
Adult RA In combination w/ methotrexate: 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. Ankylosing spondylitis/psoriatic arthritis 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. Psoriasis/ulcerative colitis 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. Maintenance: 5 mg/kg 8 wkly thereafter, may be adjusted up to 10 mg/kg. 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. Re-administration for Crohn's diseases & RA Re-administer w/in 16 wk following last infusion. Ped Crohn's disease 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. Exclude source of possible infection in fistulising Crohn's disease w/ acute suppurative fistulas. Avoid exposure to potential risk factors for infection. Patients w/ chronic infection or history of recurrent infections; history of latent or active TB; invasive fungal infections; HBV reactivation; initiation of an autoimmune process; preexisting or recent onset of demyelinating disorders; history of malignancy; mild heart failure (NYHA class I/II); haematologic reactions. Increased risk for malignancy due to heavy smoking. Patients w/ psoriasis & medical history of extensive immunosuppressant therapy or prolonged PUVA treatment. Surgical procedures including arthroplasty. Patients on controlled Na diet. Monitor switching between biological DMARDs. Periodic skin exam in patients w/ risk factors for skin cancer. Not recommended in combination w/ anakinra, abatacept, other biological therapeutics, live vaccines. Not to be given concurrently w/ therapeutic infectious agents eg, live attenuated bacteria. Concomitant use w/ TNF-blockers. May affect ability to drive & use machines. Hepatic dysfunction. Women of childbearing potential should use effective contraception. Pregnancy & lactation. Ped patients. Elderly ≥65 yr.
Adverse Reactions
Viral infection; headache; upper resp tract infection, 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
Increased plasma conc w/ methotrexate & other immunomodulators. Not recommended in combination w/ other biological therapeutics eg, anakinra & abatacept. Not to be given concurrently w/ live vaccines; therapeutic infectious agents.
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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