Discontinue Do not administer Do not administer Continue treatment KADCYLA KADCYLA. KADCYLA. with KADCYLA. Repeat LVEF Repeat LVEF Repeat LVEF assessment within 3 assessment within 3 assessment within 3 weeks. If LVEF weeks. If the LVEF <40% is confirmed, has not recovered to discontinue within 10% points KADCYLA. from baseline, discontinue KADCYLA. LVEF = Left Ventricular Ejection Fraction Special populations There are insufficient data to establish the safety and efficacy of KADCYLA in Elderly: patients 75 years of age or older. No dose adjustment of KADCYLA is required in patients aged 65 years (see Precautions; Use in the Elderly). ≥ The safety and efficacy of KADCYLA in paediatric patients have not been Children: established. No adjustment to the starting dose of KADCYLA is needed in patients Renal impairment: with mild or moderate renal impairment (see Pharmacology; Pharmacokinetics in Special The potential need for dose adjustment in patients with severe renal impairment Populations). cannot be determined due to insufficient data. The safety and efficacy of KADCYLA have not been studied in patients Hepatic impairment: with hepatic impairment. Instructions for use Appropriate aseptic technique should be used. Appropriate procedures for the preparation of chemotherapeutic drugs should be used. The reconstituted product does not contain preservative and is for single use in one patient only. Discard any residue. Using a sterile syringe, slowly inject 5 mL of Sterile Water for Injection (SWFI) into the 100 mg vial, or 8 mL of SWFI into the 160 mg vial. the vial gently until completely dissolved. SHAKE! Reconstituted solution should be inspected visually for particulate matter and discolouration prior to administration. The reconstituted solution should be free of visible particulates, clear to slightly opalescent. The colour of the reconstituted solution should be colourless to pale brown. Do not use if the reconstituted solution contains visible particulates, is cloudy or discoloured. Instructions for dilution Determine the volume of solution required based on a dose of 3.6 mg trastuzumab emtansine / kg body weight:
Discontinue KADCYLA Do not administer KADCYLA. Repeat LVEF assessment within 3 weeks. If LVEF <40% is confirmed, discontinue KADCYLA. Do not administer KADCYLA. Repeat LVEF assessment within 3 weeks. If the LVEF has not recovered to within 10% points from baseline, discontinue KADCYLA. Continue treatment with KADCYLA. Repeat LVEF assessment within 3 LVEF = Left Ventricular Ejection Fraction Special populations Elderly: There are insufficient data to establish the safety and efficacy of KADCYLA in patients 75 years of age or older. No dose adjustment of KADCYLA is required in patients aged ≥ 65 years (see Precautions; Use in the Elderly). Children: The safety and efficacy of KADCYLA in paediatric patients have not been established. Renal impairment: No adjustment to the starting dose of KADCYLA is needed in patients with mild or moderate renal impairment (see Pharmacology; Pharmacokinetics in Special Populations). The potential need for dose adjustment in patients with severe renal impairment cannot be determined due to insufficient data. Hepatic impairment: The safety and efficacy of KADCYLA have not been studied in patients with hepatic impairment. Instructions for use Appropriate aseptic technique should be used. Appropriate procedures for the preparation of chemotherapeutic drugs should be used. The reconstituted product does not contain preservative and is for single use in one patient only. Discard any residue. Using a sterile syringe, slowly inject 5 mL of Sterile Water for Injection (SWFI) into the 100 mg vial, or 8 mL of SWFI into the 160 mg vial. the vial gently until completely dissolved. SHAKE! Reconstituted solution should be inspected visually for particulate matter and discolouration prior to administration. The reconstituted solution should be free of visible particulates, clear to slightly opalescent. The colour of the reconstituted solution should be colourless to pale brown. Do not use if the reconstituted solution contains visible particulates, is cloudy or discoloured. Instructions for dilution Determine the volume of solution required based on a dose of 3.6 mg trastuzumab emtansine / kg body weight:
auspar-trastuzumab-emtansine-140317-pi.docx