Remicade Dosage/Direction for Use

Remicade is for intravenous use in adults.
Remicade treatment is to be administered under the supervision of specialized physicians experienced in the diagnosis and treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or inflammatory bowel diseases.
The recommended infusion time is 2 hours. All patients administered Remicade are to be observed for at least 1 hour post infusion for side effects. Medications, an artificial airway and other appropriate materials must be available for the treatment of these effects. The infusion rate may be slowed in order to decrease the risk of infusion related reactions especially if infusion related reactions have occurred previously (see Precautions).
Rheumatoid arthritis: Initially 3 mg/kg intravenous infusion over a 2-hour period is to be followed with additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. After 22 weeks of therapy, the dose may be increased up to 10 mg/kg if necessary. Remicade should be given in combination with methotrexate.
Ankylosing spondylitis: 5 mg/kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6-8 weeks thereafter.
Psoriatic arthritis: 5 mg/kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Psoriasis: 5 mg/kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Moderate to severe Crohn's Disease: For optimal long-term symptom control, 5 mg/kg given as a single intravenous infusion over a 2-hour period as an induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter. For patients who have an incomplete response during maintenance treatment, consideration may be given to adjusting the dose up to 10 mg/kg.
Alternatively, an initial 5 mg/kg intravenous infusion administered over a 2-hour period may be followed by repeat infusions of 5 mg/kg when signs and symptoms of the disease recur; however, there is limited data on dosing intervals beyond 16 weeks.
Fistulizing Crohn's disease: 5 mg/kg intravenously over a 2-hour period and followed with additional 5 mg/kg doses administered at 2 and 6 weeks after the first infusion for treatment of fistula(s) in Crohn's disease. If a patient does not respond after these 3 doses, no additional treatment with infliximab should be given.
The strategies for continued treatment are: Additional infusions of 5 mg/kg every 8 weeks or; Re-administration if signs and symptoms of the disease recur followed by infusions of 5 mg/kg every 8 weeks (see 'Re-administration' as follows and Precautions).
In Crohn's disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/risk of the alternative strategies for continued treatment are lacking.
Ulcerative colitis: 5 mg/kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion dose at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. In some patients, consideration may be given to adjusting the dose up to 10 mg/kg to sustain clinical response and remission.
Re-administration for Crohn's diseases and rheumatoid arthritis: If the signs and symptoms of disease recur, Remicade can be re-administered within 16 weeks following the last infusion. Re-administration of an alternate formulation of infliximab with a drug free interval of 2 to 4 years following a previous infusion has been associated with a delayed hypersensitivity reaction in 10 patients with Crohn's disease (see Precautions and "Delayed hypersensitivity" under Adverse Reactions). After a drug free interval of 16 weeks to 2 years, the risk of delayed hypersensitivity following re-administration is not known. Therefore, after a drug free interval of 16 weeks, re-administration can not be recommended.
Re-administration for ulcerative colitis: Data supporting re-administration, other than every 8 weeks, are not available at this time (see Precautions and Adverse Reactions).
Re-administration for ankylosing spondylitis: Data supporting re-administration, other than every 6-8 weeks, are not available at this time (see Precautions and Adverse Reactions).
Re-administration for psoriatic arthritis: Data supporting readministration, other than every 8 weeks, are not available at this time (see Precautions and Adverse Reactions).
Re-administration for psoriasis: Experience from intermittent treatment with Remicade in psoriasis after a period of no treatment suggests reduced efficacy and a higher incidence of infusion reactions when compared to the approved dosing guidance (see Precautions and Adverse Reactions).
Paediatric Crohn's disease: 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg. Remicade should be administered with concomitant immunomodulators, including 6-mercaptopurine (6-MP), azathioprine (AZA) or methotrexate (MTX).
Ulcerative colitis (6 to 17 years): 5 mg/kg given as an intraveneous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Available data do not support further infliximab treatment in paediatric patients not responding within the first 8 weeks of treatment (see Pharmacology: Pharmacodynamics under Actions).
This safety and efficacy of Remicade have not been studied in children with ulcerative colitis below the age of 6 years. Currently available pharmacokinetic data are described in pharmacokinetics section but no recommendation on a posology can be made in children younger than 6 years.
Shortened infusions across adult indications: In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of Remicade (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour. If an infusion reaction occurs in association with a shortened infusion, a slower infusion rate may be considered for future infusions if treatment is to be continued. Shortened infusions at doses > 6 mg/kg have not been studied (see Adverse Reactions).