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Treatment with ACTEMRA/RoACTEMRA (tocilizumab) should be initiated by healthcare professionals experienced in the diagnosis and treatment of rheumatoid arthritis. Patients treated with ACTEMRA/RoACTEMRA should be given the Patient alert card.

Posology

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

For individuals whose body weight is more than 100 kg, doses exceeding 800 mg per infusion are not recommended.

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

Dose adjustments due to laboratory abnormalities

Recommended ACTEMRA/RoACTEMRA dose adjustments for liver enzyme abnormalities

Serum ALT/AST level	Action
>1–3 x Upper Limit of Normal (ULN)	Dose modify concomitant MTX if appropriate For persistent increases in this range, reduce ACTEMRA /RoACTEMRA dose to 4 mg/kg or interrupt ACTEMRA /RoACTEMRA until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised Restart with 4 mg/kg or 8 mg/kg, as clinically appropriate
>3–5 x ULN (confirmed by repeat testing).	Interrupt ACTEMRA/RoACTEMRA dosing until <3 x ULN and follow recommendations above for >1–3 x ULN For persistent increases >3 x ULN, discontinue ACTEMRA/RoACTEMRA
>5 x ULN	Discontinue ACTEMRA/RoACTEMRA

 

Recommended ACTEMRA/RoACTEMRA dose adjustments for low absolute neutrophil count

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

 

Recommended ACTEMRA/RoACTEMRA dose adjustments for low platelet counts

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

 

Special populations

Clinical studies have demonstrated that age, gender and ethnic origin have no clinical effect on the pharmacokinetics of ACTEMRA/RoACTEMRA

• Pharmacokinetic analyses of ACTEMRA/RoACTEMRA were performed in 1,793 adult patients treated with a 1-hour infusion of 8 mg/kg of ACTEMRA/RoACTEMRA every 4 weeks for a period of 24 weeks.
• Results showed that age, gender and ethnic origin did not affect the pharmacokinetics of ACTEMRA/RoACTEMRA and that there is no need to adjust the dose of ACTEMRA/RoACTEMRA for elderly patients.

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

• However, a Phase III randomised controlled trial is currently ongoing (ClinicalTrials.gov Identifier: NCT00642460).

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/RoACTEMRA has not been studied in patients with moderate to severe renal impairment. Renal function should be monitored closely in these patients.

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

Method of administration

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

ACTEMRA/RoACTEMRA should be diluted to a final volume of 100 ml with sterile, non-pyrogenic sodium chloride 9 mg/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/RoACTEMRA concentrate required for the patient's dose, under aseptic conditions. The required amount of ACTEMRA/RoACTEMRA 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/RoACTEMRA is for single use only.

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

Reference:
RoACTEMRA® (tocilizumab) Summary of Product Characteristics. Roche Registration Limited. August 2011.