Actemra (tocilizumab) Product Information (PI) - Roche Australia
Actemra (tocilizumab) Product Information (PI) - Roche Australia
Actemra (tocilizumab) Product Information (PI) - Roche Australia
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Systemic Juvenile Idiopathic Arthritis (sJIA)<br />
The recommended dose of ACTEMRA for patients with sJIA is:<br />
• 12 mg/kg for patients < 30 kilograms,<br />
• 8 mg/kg for patients ≥ 30 kilograms,<br />
given once every two weeks as an IV infusion. A change in dose should only be based on<br />
a consistent change in the patient’s body weight over time. ACTEMRA can be used alone<br />
or in combination with MTX.<br />
Dose Modification Recommendations for pJIA and sJIA:<br />
Dose reduction of ACTEMRA has not been studied in the pJIA or sJIA population. Dose<br />
interruptions of ACTEMRA for laboratory abnormalities are recommended in patients<br />
with pJIA or sJIA and are similar to what is outlined above for patients with RA (see<br />
PRECAUTIONS - Haematological Abnormalities). If appropriate, concomitant MTX<br />
and/or other medications should be dose modified or stopped and ACTEMRA dosing<br />
interrupted until the clinical situation has been evaluated. In pJIA or sJIA the decision to<br />
discontinue ACTEMRA for a laboratory abnormality should be based upon the medical<br />
assessment of the individual patient.<br />
Special Patient Groups<br />
Children: The safety and efficacy of ACTEMRA in children below 18 years of age with<br />
conditions other than pJIA or sJIA have not been established. Children under the age of<br />
two have not been studied.<br />
Elderly: No dose adjustment is required in elderly patients aged 65 years and older.<br />
Renal impairment: No dose adjustment is required in patients with mild renal<br />
impairment (see PHARMACOLOGY – Pharmacokinetics in Special Populations).<br />
ACTEMRA has not been studied in patients with moderate to severe renal impairment.<br />
Hepatic impairment: The safety and efficacy of ACTEMRA has not been studied in<br />
patients with hepatic impairment (see PRECAUTIONS – Active Hepatic Disease and<br />
Hepatic Impairment) and therefore no dose recommendations can be made.<br />
Preparing the Infusion<br />
Parenteral medications should be inspected visually for particulate matter or<br />
discolouration prior to administration.<br />
Only solutions which are clear to opalescent, colourless to pale yellow and free of visible<br />
particles must be infused.<br />
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