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Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of rheumatoid arthritis (RA).

Posology

The recommended posology is 8mg/kg body weight, given once every four weeks.

Doses above 1.2g have not been evaluated in clinical studies.

Dose adjustments due to laboratory abnormalities.

Liver enzyme abnormalities

Laboratory Value	Action
> 1 to 3 x Upper Limit of Normal (ULN)	Dose modify concomitant MTX if appropriate For persistent increases in this range, reduce ACTEMRA dose to 4 mg/kg or interrupt ACTEMRA until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised Restart with 4 mg/kg or 8 mg/kg, as clinically appropriate
> 3 to 5 x ULN	Interrupt ACTEMRA dosing until < 3 x ULN When values reach < 3 x ULN, resume ACTEMRA at 4 mg/kg or 8 mg/kg dose For persistent increases > 3 x ULN, discontinue ACTEMRA
> 5 x ULN	Discontinue ACTEMRA

Low absolute neutrophil count (ANC)

Laboratory Value (cells x 109/ l)	Action
ANC > 1	Maintain dose
ANC 0.5 to 1	Interrupt ACTEMRA dosing When ANC increases > 1 x 109/ l resume ACTEMRA at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
ANC < 0.5	Discontinue ACTEMRA

Low platelet count

Laboratory Value (cells x 103/ μl)	Action
50 to 100	Interrupt ACTEMRA dosing When platelet count > 100 x 103/ μl resume ACTEMRA at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
< 50	Discontinue ACTEMRA

Special Populations

Paediatric patients: ACTEMRA is not recommended for use in children below 18 years of age due to insufficient data on safety and efficacy.

Elderly patients: No dose adjustment is required in patients aged 65 years and older.

Renal impairment: No dose adjustment is required in patients with mild renal impairment. ACTEMRA has not been studied in patients with moderate to severe renal impairment. Renal function should be monitored closely in these patients.

Hepatic impairment: ACTEMRA has not been studied in patients with hepatic impairment. Therefore, no dose recommendations can be made.

Method of Administration

After dilution, ACTEMRA should be administered as an intravenous infusion over one hour.

ACTEMRA should be diluted to a final volume of 100ml with sterile, non-pyrogenic sodium chloride 9mg/ml (0.9%) solution for injection using aseptic technique.

Instructions for Dilution prior to Administration

Parenteral medicinal products should be inspected visually for particulate matter or discolouration prior to administration. Only solutions which are clear to opalescent, colourless to pale yellow and free of visible particles should be diluted.

Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/ml (0.9%) solution for injection from a 100 ml infusion bag, equal to the volume of ACTEMRA concentrate required for the patient's dose, under aseptic conditions. The required amount of ACTEMRA concentrate (0.4 ml/kg) should be withdrawn from the vial and placed in the 100 ml infusion bag. This should be a final volume of 100 ml. To mix the solution, gently invert the infusion bag to avoid foaming.

ACTEMRA is for single-use only.

Any unused product or waste material should be disposed of in accordance with local requirements.

Reference:
1. Data on file, F. Hoffmann-La Roche. Summary of Clinical Efficacy
2. Actemra Product Information (HK). Current at August 2010