Protocol for administration of Infliximab as a treatment in uveitis
Pre-treatment Investigations Prior to administration of the first infusion, the following investigations should be performed:
Medical history to exclude TB CRP, U+E, LFTs ESR, FBC dsDNA Urinary pregnancy test as appropriate CXR to exclude active TB
Mantoux testing is not helpful. False positive results may be obtained in those previously vaccinated and false negatives may also occur.
Administration and monitoring of Infliximab treatment
Dosage 5mg/kg of body weight as a single intravenous infusion. Dosage may be repeated at 2 and 6 weeks following first infusion, and then 6 weekly as required thereafter.
1 Reconstitution, dilution and administration 1. Calculate the dose required according to the patient’s body weight (5mg/kg): Weight = kg Total dose required = mg Volume of reconstituted solution required = ml (Doses should be rounded up or down to nearest 5mg) (Each reconstituted vial contains 100mg in 10ml ie 10mg/ml)
2. Reconstitution of powder Each vial should be reconstituted with 10ml for injections- using 21 gauge or smaller needle. Remove flip-top from each vial and wipe with 70% alcohol wipe. Insert needle through centre of rubber stopper and direct stream of water onto glass wall of vial. Swirl the vial to dissolve the powder- DO NOT SHAKE. If foaming of the solution occurs, allow to stand for 5 minutes. The solution should be colourless/light yellow and opalescent. As infliximab is a protein, the solution may contain a few fine translucent particles. Do not use the solution if it is discoloured or contains opaque or other foreign particles.
3. Dilution Dilute the solution to a total volume of 250ml with NaCl 0.9% w/v infusion solution ie withdrawn from the bag a volume equivalent to the total volume of reconstituted solution to be added. Add the reconstituted solution slowly to the infusion bag, gently mix and inspect the solution for particulate contamination. Any remaining solution should be discarded.
2 4. Administration Infuse over a period of not less than 2 hours (ie not more than 2ml/minute) using an infusion set with an inline filter pore size of 1.2 micrometer or less). The infusion rate should be calculated by counting the drip rate and not controlled by the use of an infusion pump. DO NOT USE PUMP AS TUBING IS NOT DEFORMABLE
5. The infusion must be started within 3 hours of reconstitution of the powder and must not be given concomitantly in the same intravenous line with other agents.
3 Monitoring of Treatment The patient should be given the Patient Information Leaflet and asked to report any adverse effects that may occur during or in the 2 hours after completion of the infusion. The patient should be made aware of the possibility of delayed adverse reactions and should be advised to report any symptoms which may give them cause for concern. The risk of development of hypersensitivity reactions may be greater with second and subsequent treatments.
Supervision of Infusions and Routine Observations The first infusion must be supervised by a doctor at the patient’s bedside for the first 15 minutes of treatment. Temperature, pulse and blood pressure should be checked prior to commencing each infusion and monitored every 15 minutes for the first hour of treatment. These observations should be continued every 30 minutes for the remaining duration of the infusion and for 2 hours after completion. A doctor must be available for immediate assistance should any infusion reaction develop. Emergency resuscitation equipment and appropriate drug treatment should be immediately available. The rate of infusion may be reduced or the infusion temporarily stopped should the patient experience any milder adverse reactions such as nausea and vomiting, headache and mild abdominal pain.
Post-treatment follow-up Patients should be followed up after each treatment. At each follow up visit, the patient’s U+E, FBC, CRP, ESR and LFTs should be rechecked.
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