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

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ALT and AST levels should be monitored in RA every 4 to 8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter. For recommended modifications based on transaminases see DOSAGE AND ADMINISTRATION. For ALT or AST elevations > 3 to 5 x ULN, confirmed by repeat testing, ACTEMRA treatment should be interrupted. Once the patient’s hepatic transaminases are below 3 x ULN, treatment with ACTEMRA may recommence at 4 or 8 mg/kg. In pJIA and sJIA ALT and AST should be monitored at the time of the second infusion and thereafter every 4 to 8 weeks for pJIA and every 2 to 4 weeks for sJIA (see DOSAGE AND ADMINISTRATION). Haematological Abnormalities Decreases in neutrophil and platelet counts have occurred following treatment with ACTEMRA 8 mg/kg in combination with MTX (see section ADVERSE EFFECTS – Laboratory Abnormalities). There may be an increased risk of neutropenia in patients who have previously been treated with a TNF antagonist. In patients not previously treated with ACTEMRA, initiation is not recommended in patients with an absolute neutrophil count (ANC) below 2 x 10 9 /L. Caution should be exercised when considering initiation of ACTEMRA treatment in patients with a low platelet count (i.e. platelet count < 100 x 10 9 /L). In patients with an ANC < 0.5 x 10 9 /L or a platelet count < 50 x 10 9 /L treatment is not recommended (See PRECAUTIONS – Effects of Laboratory Tests). Severe neutropenia may be associated with an increased risk of serious infections, although there has been no clear association between decreases in neutrophils and the occurrence of serious infections in clinical trials with ACTEMRA to date. Neutrophils and platelets should be monitored in RA 4 to 8 weeks after start of therapy and thereafter according to standard clinical practice. For recommended dose modifications based on ANC and platelet counts, see DOSAGE AND ADMINISTRATION. In pJIA and sJIA neutrophils and platelets should be monitored at the time of the second infusion and thereafter every 4 to 8 weeks for pJIA and every 2 to 4 weeks for sJIA (see DOSAGE AND ADMINISTRATION). Lipid Parameters Elevations in lipid parameters including total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides were observed in patients treated with ACTEMRA (see ADVERSE EFFECTS – Elevations in lipid parameters). In the majority of patients, there was no increase in atherogenic indices, and elevations in total cholesterol responded to treatment with lipid lowering agents. Actemra ® PI 131004 18 of 37 CDS 8.0
Assessment of lipid parameters should be performed in RA, pJIA and sJIA 4 to 8 weeks following initiation of ACTEMRA therapy. RA and sJIA patients should then be managed according to local clinical guidelines for management of hyperlipidaemia. For pJIA patients assessment of lipid parameters should be performed at 3 monthly intervals during ACTEMRA treatment until it is clear the risk of development of significant changes in lipid parameters has diminished. Demyelinating Disorders Physicians should be vigilant for symptoms potentially indicative of new-onset central demyelinating disorders. The potential for central demyelination with ACTEMRA is currently unknown. Multiple sclerosis and chronic inflammatory demyelinating polyneuropathy were reported rarely in RA clinical studies. Malignancy The risk of malignancy is increased in patients with RA. Immunomodulatory medicinal products may increase the risk of malignancy. Infusion Reactions Infusion reactions have been observed during and within 24 hours of treatment with ACTEMRA (see ADVERSE EFFECTS – Infusion Reactions). Cardiovascular Risk RA patients have an increased risk for cardiovascular disorders and should have risk factors (e.g. hypertension, hyperlipidaemia) managed as part of usual standard of care (see PRECAUTIONS – Lipid Parameters). Elevations in LDL and HDL lipids have been observed, with no clinical consequences identified. No data are available concerning cardiovascular outcomes with long-term use of ACTEMRA. Combination with TNF Antagonists and/or other Biological Therapies There is no experience with the use of ACTEMRA with TNF antagonists or other biological treatments for RA. ACTEMRA is not recommended for use with other biological agents including TNF antagonists, anakinra, rituximab and abatacept. Sodium This medicinal product contains 1.17 mmol (26.55 mg) of sodium per maximum dose of 1200 mg. This should be taken into consideration by patients on a controlled sodium diet. Doses below 1025 mg of ACTEMRA contain less than 1 mmol of sodium (23 mg) and can essentially be considered ‘sodium free’. Actemra ® PI 131004 19 of 37 CDS 8.0
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Page 5 and 6: CLINICAL TRIALS Rheumatoid Arthriti
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