Celltrion Healthcare


Zuellig Pharma
Concise Prescribing Info
In combination w/ MTX, reduction of signs & symptoms of active RA when response to DMARDs have been inadequate or in adults w/ severe, active & progressive RA not previously treated w/ MTX or other DMARDs. Moderately to severely active Crohn's disease in adults who have not responded w/ corticosteroid &/or immunosuppressants, or intolerant to or contraindicated to such therapy; fistulising, active Crohn's disease in adults not responding to conventional treatment (including antibiotics, drainage & immunosuppressive therapy). Severe, active Crohn's disease in childn & adolescents 6-17 yr not responding to conventional therapy including corticosteroid, immunomodulator & primary nutrition therapy or intolerant to or contraindicated to such therapies. Moderately (adults only) to severely active ulcerative colitis in adults, childn & adolescents 6-17 yr that had inadequate response to conventional therapy including corticosteroids & 6-mercaptopurine or azathioprine, or intolerant or contraindicated for such therapies. Severe, active ankylosing spondylitis in adults responding inadequately to conventional therapy. Active & progressive psoriatic arthritis in adults that respond to previous DMARD therapy is inadequate, in combination w/ MTX or alone for patients w/ MTX intolerance or is contraindicated. Improve physical function in patients w/ psoriatic arthritis, & reduce rate of progression of peripheral joint damage as measured by X-ray in patients w/ polyarticular symmetrical subtypes of the disease. Moderate to severe plaque psoriasis in adults that failed to respond to or contraindicated or intolerant to other systemic therapy including cyclosporine, MTX or psoralen UVA.
Dosage/Direction for Use
Administer IV infusion over a 2-hr period. Adult ≥18 yr RA 3 mg/kg followed by additional 3 mg/kg infusion doses at 2 & 6 wk after 1st infusion, then every 8 wk thereafter, in combination w/ MTX. If there is inadequate response after 12 wk, may increase dose by approx 1.5 mg/kg. Max: 7.5 mg/kg every 8 wk. Moderately to severely active Crohn's disease 5 mg/kg followed by an additional 5 mg/kg infusion 2 wk after the 1st infusion. Maintenance: Additional 5 mg/kg at 6 wk after initial dose, followed by infusions every 8 wk or re-administration of 5 mg/kg if signs & symptoms recur. Fistulising, active Crohn's disease 5 mg/kg followed by an additional 5 mg/kg infusions at 2 & 6 wk after the 1st infusion. Maintenance: Additional infusions of 5 mg/kg every 8 wk or a re-administration of 5 mg/kg if signs & symptoms recur followed by infusions of 5 mg/kg every 8 wk. Ankylosing spondylitis 5 mg/kg followed by additional 5 mg/kg infusion doses at 2 & 6-wk after 1st infusion, then every 6-8 wk therafter. Psoriasis & psoriatic arthritis 5 mg/kg followed by additional 5 mg/kg infusion doses at 2 & 6 wk after the 1st infusion, then every 8 wk thereafter. Adult ≥18 yr & childn 6-17 yr Crohn's disease, ulcerative colitis 5 mg/kg followed by an additional 5 mg/kg infusion doses at 2 & 6 wk after the 1st infusion, then every 8 wk thereafter.
Hypersensitivity to infliximab or to other murine proteins. TB or other severe infections eg, sepsis, abscesses & opportunistic infections. Moderate or severe heart failure (NYHA class III/IV).
Special Precautions
Closely monitor patients for signs & symptoms of delayed hypersensitivity after prolonged use; infections including TB before, during & after treatment & patients who develop new infection while undergoing treatment. Discontinue use if serious infection or sepsis, HBV reactivation, jaundice &/or ALT elevations ≥5x ULN, symptoms suggestive of lupus-like syndrome, significant haematologic abnormalities develops, & positive for antibodies against double-stranded DNA. Patients w/ chronic infection or history of recurrent infections including concomitant immunosuppressive therapy, increased risk for malignancy due to heavy smoking, history of malignancy, psoriasis, history of extensive immunosuppressant therapy or prolonged PUVA treatment, mild heart failure (NYHA class I/II), undergone surgical procedures including arthroplasty. Evaluate patients w/ signs & symptoms of liver dysfunction for evidence of liver injury; patients for active & latent TB before starting therapy. Perform appropriate screening test ie, tuberculin skin test & chest X-ray in all patients. Do not initiate therapy if diagnosed w/ active TB, fistulising Crohn's disease w/ acute suppurative fistulas. Ensure to start anti-TB therapy before initiation of treatment in patients w/ TB, history of latent or active TB therapy in whom adequate course of treatment cannot be confirmed. Invasive fungal infections. Perform test for HBV infection before initiation of therapy. Not recommended in concomitant use w/ anakinra, abatacept, other biological therapeutics, live vaccines or therapeutic infectious agents. Switching between biological DMARDs. Pre-existing or recent onset of demyelinating disorders. Risk of hepatosplenic T-cell lymphoma development. Periodic skin exam for patients w/ risk factors for skin cancer. Screen at regular intervals for dysplasia before therapy & throughout disease course in patients w/ ulcerative colitis or prior history of dysplasia. May have minor influence on the ability to drive & use machines. Women of childbearing potential must use adequate contraception during & for at least 6 mth after the last dose. Elderly ≥65 yr. Ped patients. Pregnancy. Not to breastfeed for at least 6 mth after treatment).
Adverse Reactions
Viral infection (eg, flu, herpes virus infection); headache; URTI, sinusitis; abdominal pain, nausea; infusion-related reaction, pain. Bacterial infections (eg, sepsis, cellulitis, abscess); 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 (eg, bronchitis, pneumonia), dyspnoea, epistaxis; GI haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation; abnormal hepatic function, increased transaminases; new onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), 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
Plasma conc may be increased w/ MTX & other immunomodulators. Concomitant use w/ other biological therapeutics eg, anakinra & abatacept; 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.
Remsima powd for conc for soln for infusion 100 mg
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