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

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• Single use vial containing 80 mg of ACTEMRA in 4 mL (20 mg/mL). Packs of 1 and 4* vials. • Single use vial containing 200 mg of ACTEMRA in 10 mL (20 mg/mL). Packs of 1 and 4* vials. • Single use vial containing 400 mg of ACTEMRA in 20 mL (20 mg/mL). Packs of 1 and 4* vials. Store vials at 2ºC – 8ºC. (Refrigerate. Do not freeze.) Keep the container in the outer carton in order to protect from light. ACTEMRA does not contain any antimicrobial agent; therefore care must be taken to ensure the sterility of the prepared solution. Product is for single use in one patient only. Discard any residue. The prepared infusion solution of ACTEMRA is physically and chemically stable in 0.9% w/v sodium chloride solution at 30ºC for 24 hours. To reduce microbiological hazard, the prepared infusion should be used immediately. If storage is necessary, hold at 2ºC – 8ºC for not more than 24 hours. Do not use after the expiry date (EXP) shown on the pack. Disposal of Medicines The release of medicines into the environment should be minimised. Medicines should not be disposed of via wastewater and disposal through household waste should be avoided. Unused or expired medicine should be returned to a pharmacy for disposal. POISON SCHEDULE Prescription Only Medicine (S4) SPONSOR Roche Products Pty Limited ABN 70 000 132 865 4-10 Inman Road Dee Why NSW 2099 AUSTRALIA Customer enquiries: 1800 233 950 Distributed in New Zealand by: Actemra ® PI 131004 36 of 37 CDS 8.0
Roche Products (New Zealand) Limited PO Box 12492 Penrose Auckland 1642 NEW ZEALAND Customer enquiries: 0800 656 464 DATE OF FIRST INCLUSION IN THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS (THE ARTG) 21 May 2009 DATE OF MOST RECENT AMENDMENT 4 October 2013 Actemra ® PI 131004 37 of 37 CDS 8.0
Page 1 and 2: ACTEMRA Tocilizumab (rch) CAS 37582
Page 3 and 4: Polyarticular Juvenile Idiopathic A
Page 5 and 6: CLINICAL TRIALS Rheumatoid Arthriti
Page 7 and 8: durable responses were seen for ove
Page 9 and 10: following 2 years of treatment (83%
Page 11 and 12: 1:1 to receive either ACTEMRA 8 mg/
Page 13 and 14: temperature recording ≥ 37.5°C i
Page 15 and 16: Systemic Juvenile Idiopathic Arthri
Page 17 and 18: Infusion Reactions). In the post-ma
Page 19 and 20: Assessment of lipid parameters shou
Page 21 and 22: Treatment with a murine analogue di
Page 23 and 24: of the studies was 6 months and in
Page 25 and 26: Infusion Reactions In the 6 month c
Page 27 and 28: Immunogenicity One patient in the 1
Page 29 and 30: eported in 0.3% patients receiving
Page 31 and 32: ACTEMRA in clinical trials experien
Page 33 and 34: 3 to 5 x ULN (confirmed by repeat t
Page 35: Rheumatoid Arthritis From a 100 mL

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

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