Infliximab
Anti-rheumatic, Systemic · Monoclonal antibody
Indications
In combination with methotrexate to improve physical function in patients with active rheumatoid arthritis unresponsive to DMARDs, including methotrexate. Treatment of ankylosing spondylitis in patients with severe axial symptoms, elevated serological markers of inflammation and who have responded inadequately to conventional therapy. Severe active Crohn's disease or fistulising Crohn's disease in patients unresponsive to corticosteroid and/or immunosuppressant therapy.
Dosage
Adults: Rheumatoid Arthritis: 3 mg/kg by IV inf over 2 hr, repeated 2 wk and 6 wk after first inf, then every 8 wk. Methotrexate must be given concurrently. Ankylosing Spondylitis: 5 mg/kg by IV inf over 2 hr, repeated 2 wk and 6 wk after first inf, then every 6-8 wk. Discontinue if no response by 6 wk. Crohn's disease: Severe active: 5 mg/kg by IV inf over 2 hr. Discontinue if no response within 2 wk. If patient responds, additional inf of 5 mg/kg 2 wk and 6 wk after first inf, then every 8 wk or 5 mg/kg if symptoms recur. Fistulising: Initially 5 mg/kg by IV inf over 2 hr repeated 2 wk and 6 wk after first inf. Repeat if necessary within 16 wk of last inf. Children: Severe active Crohn’s disease, severe active ulcerative colitis: IV infusion: 6-18 yr, initially 5 mg/kg, then 5 mg/kg 2 wk and 6 wk after initial dose, then 5 mg/kg every 8 wk; interval between maintenance doses adjusted…
Administration
Infuse over at least 2 hours using polyethylene- lined infusion set and in-line, sterile, nonpyrogenic, low protein binding filter with pores 1.2 microns or less. Do not reuse. Reconstitution: Reconstitute vials by using 21G (or smaller) needle to add 10 mL SWFI. Do not shake. Allow the solution to stand for 5 min. Total dose of reconstituted product should be further diluted to 250 mL of 0.9% NS; infusion of dose should be given within 3 hours of preparation. Compatibility: Do not infuse infliximab in same IV line with other drugs or through plasticized polyvinyl chloride infusion equipment or devices. Stability: Store the lyophilized product under refrigeration at 2°C-8°C (36°F-46°F). This product contains no preservatives.
Adverse Effects
Viral infection, fever, headache, vertigo, dizziness, flushing, upper or lower respiratory tract infection, dyspnoea, sinusitis, GI upset, skin reactions, fatigue, chest pain, abnormal liver function.
Risk Factor (Pregnancy/Lactation)
Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: Congestive heart failure. Opportunistic or severe infections such as sepsis, abscesses, tuberculosis, Hypersensitivity to murine proteins. Ensure adequate contraception. Precautions: Monitor for active and latent tuberculosis before and during treatment; re-evaluate therapy if latent tuberculosis is found, stop treatment it active tuberculosis is suspected or until treated. Monitor for acute inf reactions during or within 2 hours of dose; if necessary slow rate, interrupt inf or discontinue. Ensure emergency treatment is available. Monitor for delayed hypersensitivity if patient retreated after prolonged period; do not retreat if interval exceeds 16 weeks. Discontinue if lupus-like symptoms appear or anti-nuclear antibodies are detected. Elderly, hepatic or renal impairment.
Advice to Patient
This medication is administered by infusion. Contact prescriber if there is fever, chills, mouth sores, skin rash, itching, sore throat, severe nausea, abdominal pain, headache, unusual fatigue, chest pain, cough, constant dizziness, runny nose, difficulty in breathing, fatigue, muscle pain, weakness, back pain, vaginal itching, vaginal discharge, unhealed sores.
Pharmacokinetics
Half-life elimination: Terminal: 8-9.5 days.
Unlicensed Use
Children: Fistulating Crohn’s disease: IV infusion: 6-18 yr, initially 5 mg/kg, then 5 mg/kg 2 wk and 6 wk after initial dose, then if condition has responded.
Brands with this active ingredient
Compiled by Healify Pharmacy from published drug references. How we compile it →
Always consult a pharmacist or doctor.