This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Nigeria, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.
The drug KADCYLA contains one active pharmaceutical ingredient (API):
1
|
UNII
SE2KH7T06F - TRASTUZUMAB EMTANSINE
|
|
Trastuzumab emtansine is a HER2-targeted antibody-drug conjugate which contains the humanised anti-HER2 IgG1, trastuzumab, covalently linked to the microtubule inhibitor DM1 (a maytansine derivative) via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate). Conjugation of DM1 to trastuzumab confers selectivity of the cytotoxic agent for HER2-overexpressing tumour cells, thereby increasing intracellular delivery of DM1 directly to malignant cells. |
|
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| KADCYLA Powder for concentrate for solution for infusion | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| L01FD03 | Trastuzumab emtansine | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FD HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 10281D, 10282E, 11951B, 11956G |
| BR | Câmara de Regulação do Mercado de Medicamentos | 529214040025701, 529214040025801 |
| CA | Health Products and Food Branch | 02412365, 02473224 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 114-MBE-0917 |
| EE | Ravimiamet | 1633339, 1633340 |
| ES | Centro de información online de medicamentos de la AEMPS | 113885001, 113885001IP, 113885002, 113885002IP |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 121104, 466278 |
| FR | Base de données publique des médicaments | 62170212, 64565603 |
| GB | Medicines & Healthcare Products Regulatory Agency | 239649, 239652, 383735, 383737 |
| HK | Department of Health Drug Office | 63486, 63487 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 7398, 7399 |
| IT | Agenzia del Farmaco | 043092016, 043092028 |
| JP | 医薬品医療機器総合機構 | 4291426D1026, 4291426D2022 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1072123, 1072124 |
| NG | Registered Drug Product Database | A6-0506, A6-100105 |
| NL | Z-Index G-Standaard, PRK | 108723, 108731 |
| NZ | Medicines and Medical Devices Safety Authority | 15712, 15713 |
| PL | Rejestru Produktów Leczniczych | 100306629, 100306635 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W64383001, W64384001 |
| SG | Health Sciences Authority | 14496P, 14497P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699505792088, 8699505792095 |
| US | FDA, National Drug Code | 50242-087, 50242-088 |
| ZA | Health Products Regulatory Authority | 49/32.16/0197, 49/32.16/0198 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.