KADCYLA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL

INJECTION, POWDER, FOR SOLUTION

**2.2 Dosage and Administration** **IN ORDER TO PREVENT MEDICATION ERRORS IT IS IMPORTANT TO CHECK THE VIAL LABELS TO ENSURE THAT THE DRUG BEING PREPARED AND ADMINISTERED IS KADCYLA (TRASTUZUMAB EMTANSINE) AND NOT TRASTUZUMAB (HERCEPTIN).** Kadcyla therapy should only be administered under the supervision of a healthcare professional experienced in the treatment of cancer patients. Patients treated with Kadcyla should have HER2 positive tumour status, defined as a score of 3+ by immunohistochemistry (IHC) or a ratio of ≥ 2.0 by in situ hybridization (ISH) or by fluorescence in situ hybridization (FISH) assessed by a validated test. Substitution by any other biological medicinal product requires the consent of the prescribing physician. The safety and efficacy of alternating or switching between Kadcyla and products that are biosimilar but not deemed interchangeable to Kadcyla has not been established. Therefore, the benefit/risk of alternating or switching needs to be carefully considered. Kadcyla must be reconstituted and diluted by a healthcare professional and administrated as an intravenous infusion _(see section 4.2 Special Instructions for Use, Handling and Disposal_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. Do not administer as an intravenous push or bolus. _**Schedule**_ The recommended dose of Kadcyla is 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle). Administer the initial dose as a 90-minute intravenous infusion. Patients should be observed during the infusion and for at least 90 minutes following the initial dose for fever, chills, or other infusion-related reactions. The infusion site should be closely monitored for possible subcutaneous infiltration during drug administration _(see section 2.4.1 General, Warnings and Precautions, Extravasation_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. If prior infusions were well tolerated, subsequent doses of Kadcyla may be administered as 30-minute infusions and patients should be observed during the infusions and for at least 30 minutes after infusion. The infusion rate of Kadcyla should be slowed or interrupted if the patient develops infusion-related symptoms _(see section 2.4.1 General, Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. Discontinue Kadcyla for life-threatening infusion reactions. _**Duration of treatment**_ Patients with EBC should receive treatment for a total of 14 cycles unless there is disease recurrence or unmanageable toxicity. Patients with MBC should receive treatment until disease progression or unmanageable toxicity. _**Delayed or missed dose**_ If a planned dose of Kadcyla is missed, it should be administered as soon as possible; do not wait until the next planned cycle. The schedule of administration should be adjusted to maintain a 3-week interval between doses. The infusion may be administered at the rate the patient tolerated the most recent infusion. _**Dose modifications**_ Management of symptomatic adverse events may require temporary interruption, dose reduction, or treatment discontinuation of Kadcyla as per guidelines provided in Tables 1 and 2. Kadcyla dose should not be re-escalated after a dose reduction is made.    **2.2.1 Special Dosage Instructions** **_Geriatric use_** 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 section 2.5.5 Geriatric Use_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. _**Pediatric use**_ The safety and efficacy of Kadcyla in children and adolescents (< 18 years) 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 section 3.2.5 Pharmacokinetics in Special Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. The potential need for dose adjustment in patients with severe renal impairment cannot be determined due to insufficient data. _**Hepatic impairment**_ No adjustment to the starting dose is required for patients with mild or moderate hepatic impairment _(see section 3.2.5 Pharmacokinetics in Special Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. Kadcyla has not been studied in patients with severe hepatic impairment. Treatment of patients with hepatic impairment should be undertaken with caution due to known hepatotoxicity observed with Kadcyla _(see section 2.4 Warnings and Precautions, General, Hepatotoxicity_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_.