IXIFI
INFLIXIMAB · by PFIZER
Composition
IV Inf 100 mg: Infliximab 100 mg in vial
Indications & Dosage
Severe active Crohns disease, Fistulating Crohns disease: BY IV INF: Adult: Initially 5 mg/kg, then 5 mg/kg after 2 weeks, then 5 mg/kg after 4 weeks, maintenance 5 mg/kg every 8 weeks according to response. Severe active ulcerative colitis: BY IV INF: Adult: Initially 5 mg/kg, then 5 mg/kg after 2 weeks, followed by 5 mg/kg after 4 weeks, then 5 mg/kg every 8 weeks, discontinue if no response. Rheumatoid arthritis (in combination with methotrexate): BY IV INF: Adult: Initially 3 mg/kg, then 3 mg/kg after 2 weeks, followed by 3 mg/kg after 4 weeks, then 3 mg/kg every 8 weeks, if response is inadequate after 12 weeks of initial treatment; increased in steps of 1.5 mg/kg every 8 weeks, up to 7.5 mg/kg every 8 weeks, discontinue if no response by 12 weeks of initial INF. Ankylosing spondylitis: BY IV INF: Adult: 5 mg/kg, then 5 mg/kg after 2 weeks, followed by 5 mg/kg after 4 weeks, then 5 mg/kg every 6-8 weeks, discontinue if no response by 6 weeks of initial INF. Psoriatic arthritis (in combination with methotrexate), Plaque psoriasis: BY IV INF: Adult: 5 mg/kg, then 5 mg/kg after 2 weeks, followed by 5 mg/kg after 4 weeks, followed by 5 mg/kg every 8 weeks.
Administration
Infuse over at least 2 hours. Reconstitute vials with 10 ml SWI; swirl vial gently to dissolve powder, and do not shake Allow solution to stand for 5 minutes. Dilute total volume of reconstituted infliximab solution dose to 250 ml with sterile 0.9% NaCl. Do not dilute reconstituted infliximab solution with any other diluent; final diluted concentration should range between 0.4 - 4 mg/ml Discard if particulate matter is present or discoloration observed. Start infusion within 3 hours of preparation (product contains no preservatives)
Compatibility
Stable in SWFI, 0.9% NaCl
Stability
Refrigerate at 2-8 C (36-46 F) or at temperatures up to 30 C (86 F) for a single period of up to 6 months, upon removal from refrigerator, vials cannot be returned to refrigerated storage. Refrigerate diluted solutions at 4-C for up to 14 days.
Contraindications
Moderate or severe heart failure, severe infections
Precautions
Development of malignancy, demyelinating disorders (risk of exacerbation), dermatomyositis, hepatitis B virus, history of colon carcinoma, history of dysplasia, history of malignancy, history of prolonged immunosuppressant or PUVA treatment in patients with psoriasis, mild heart failure (discontinue), predisposition to infection (discontinue if new serious infection develops), risk of delayed hypersensitivity reactions if drug-free interval exceeds 16 weeks (readministration after interval exceeding 16 weeks not recommended). Use adequate contraception during and for at least 6 months after last dose.
Interactions
Anthracyclines, cyclophosphamide, Live vaccines (avoid), BCG, belimumab, natalizumab, pimecrolimus, topical tacrolimus, fingolimod, leflunomide, tofacitinib, roflumilast, trastuzumab, nivolumab
Pregnancy
Use only if essential
Lactation
Caution advised
Side Effects
Alopecia, headache, development of antinuclear antibodies, upper respiratory tract infection, abdominal pain, nausea, anaphylacticlike reactions, development of antibodies to double-stranded DNA, other respiratory infection, diarrhea, elevated alanine transaminase (ALT), bronchitis, dyspepsia, rash, fatigue, back pain, rhinitis, urinary tract infection, arthralgia, fever, hypertension, pruritus, dyspnea, candidiasis, lupuslike symptoms, lymphocytosis, neoplasms, nerve disorders, pancreatitis, peripheral ischaemia, pulmonary oedema, seborrhea, seizure, syncope, thrombocytopenia, thrombophlebitis. Rare: Myocardial ischemia or infarction, transient visual loss, heart failure, agranulocytosis, serious infections and malignancies, circulatory collapse, cyanosis, demyelinating disorders, granuloma, haemolytic anaemia, hepatitis B reactivation, meningitis, pancytopenia, pericardial effusion, sarcoidosis, severe cutaneous adverse reactions (SCARs), transverse myelitis, vasculitis, vasospasm