KADCYLA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug KADCYLA contains one active pharmaceutical ingredient (API):

1 Trastuzumab emtansine 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. Read about Trastuzumab emtansine

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
KADCYLA Powder for concentrate for solution for infusion	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	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
Discover more medicines within L01FD03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 10281D, 10282E, 11951B, 11956G
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 529214040025701, 529214040025801
Country: CA	Health Products and Food Branch	Identifier(s): 02412365, 02473224
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 114-MBE-0917
Country: EE	Ravimiamet	Identifier(s): 1633339, 1633340
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 113885001, 113885001IP, 113885002, 113885002IP
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 121104, 466278
Country: FR	Base de données publique des médicaments	Identifier(s): 62170212, 64565603
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 239649, 239652, 383735, 383737
Country: HK	Department of Health Drug Office	Identifier(s): 63486, 63487
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7398, 7399
Country: IT	Agenzia del Farmaco	Identifier(s): 043092016, 043092028
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291426D1026, 4291426D2022
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1072123, 1072124
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 108723, 108731
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 15712, 15713
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100306629, 100306635
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64383001, W64384001
Country: SG	Health Sciences Authority	Identifier(s): 14496P, 14497P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699505792088, 8699505792095
Country: US	FDA, National Drug Code	Identifier(s): 50242-087, 50242-088
Country: ZA	Health Products Regulatory Authority	Identifier(s): 49/32.16/0197, 49/32.16/0198