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

Approved

THERAPEUTIC

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

F. Hoffmann-La Roche Ltd (Bulk Production, Primary Packager) (SWITZERLAND)BSP Pharmaceutical S.p.A. (ITALY)🇸🇬 Health Sciences Authority

Approval Date: Jan 24, 2014
Approval ID: 5f59ab83159be25f
Company: F. Hoffmann-La Roche Ltd (Bulk Production, Primary Packager) (SWITZERLAND)BSP Pharmaceutical S.p.A. (ITALY)
Type: Therapeutic

Approval Details

Approval Id: 5f59ab83159be25f
Drug Name: KADCYLA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL
Product Name: KADCYLA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL
Approval Number: SIN14497P
Approval Date: 2014-01-24
Registrant: ROCHE SINGAPORE PTE. LTD.
Licence Holder: ROCHE SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, POWDER, FOR SOLUTION
Dosage: 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. <img src="/TGIF/Kadcyla-Table1_050422.png" alt="Kadcyla Dosage Table 1" /> <img src="/TGIF/Kadcyla-Table2a_050422.png" alt="Kadcyla Dosage Table 2" /> <img src="/TGIF/Kadcyla-Table2b_050422.png" alt="Kadcyla Dosage Table 2" /> 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).
Route Of Administration: INTRAVENOUS
Indication Info: 2.1 Therapeutic Indication(s) Breast Cancer Metastatic Breast Cancer (MBC) Kadcyla, as a single agent, is indicated for the treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with trastuzumab and a taxane, separately or in combination. Patients should have either: <ul class="dash"> <li>Received prior therapy for advanced or metastatic disease, or</li> <li>Developed disease recurrence during or within six months of completing adjuvant therapy.</li> </ul> Early Breast Cancer (EBC) Kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease, after neoadjuvant trastuzumab and taxane-based treatment.
Contraindications: 2.3 Contraindications Kadcyla is contraindicated in patients with a known hypersensitivity to Kadcyla or any of the excipients.
Atc Code: L01XC14
Atc Item Name: xl 01 xc 14
Pharma Manufacturer Name: ROCHE SINGAPORE PTE. LTD.

Active Ingredients

Trastuzumab emtansine

100 mg/vial

Trastuzumab emtansine

100 mg/vial

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jan 24, 2014

Approval ID

5f59ab83159be25f

Type

Therapeutic

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