Actemra (tocilizumab) Product Information (PI) - Roche Australia

Rheumatoid Arthritis
From a 100 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal
to the volume of the ACTEMRA solution required for the patient’s dose, and discard.
Withdraw the required amount of ACTEMRA (0.4 mL per kg of the patient’s body
weight) under aseptic conditions and add to the infusion bag. To mix the solution, gently
invert the bag to avoid foaming.
pJIA and sJIA patients ≥ 30 kg
From a 100 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal
to the volume of the ACTEMRA solution required for the patient’s dose. Withdraw the
required amount of ACTEMRA (0.4 mL per kg of the patient’s body weight) under
aseptic conditions and dilute in a 100 mL infusion bag containing sterile, non-pyrogenic
0.9% sodium chloride solution. To mix the solution, gently invert the bag to avoid
foaming.
pJIA patients < 30 kg
From a 50 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal
to 0.5 mL/kg of the patient’s body weight and discard. This volume should be replaced in
the saline bag with an equal volume of ACTEMRA under aseptic conditions. To mix the
solution, gently invert the bag to avoid foaming.
sJIA patients < 30 kg
From a 50 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal
to 0.6 mL/kg of the patient’s body weight and discard. This volume should be replaced in
the saline bag with an equal volume of ACTEMRA under aseptic conditions. To mix the
solution, gently invert the bag to avoid foaming.
OVERDOSAGE
There are limited data available on overdosage with ACTEMRA. One case of accidental
overdose was reported in which a patient with multiple myeloma received a single dose
of 40 mg/kg. No adverse drug reactions were observed. No serious adverse drug reactions
were observed in healthy volunteers who received a single dose up to 28 mg/kg, although
dose-limiting neutropenia was observed.
Treatment of overdose should consist of general supportive measures.
Contact the Poisons Information Centre for advice on management of overdosage.
PRESENTATION AND STORAGE
ACTEMRA is available as:
*(not marketed)
Actemra ® PI 131004 35 of 37
CDS 8.0