TUKYSA

This brand name is authorized in United States. It is also authorized in Austria, Canada, Croatia, Estonia, Finland, France, Ireland, Israel, Lithuania, Poland, Romania, Spain.

Active ingredients

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

1
UNII 234248D0HH - TUCATINIB
 

Tucatinib is a tyrosine kinase inhibitor of HER2. It is used in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer.

 
Read more about Tucatinib

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 TUKYSA Film-coated tablet MPI, US: SPL/PLR FDA, National Drug Code (US)
 TUKYSA Film-coated tablet MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

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

ATC Group Classification
L01EH03 L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EH Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors
Discover more medicines within L01EH03

Authorization and marketing

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

Country Identification scheme Identifier(s)
CA Health Products and Food Branch 02499827, 02499835
EE Ravimiamet 1842544, 1842555, 1862647
ES Centro de información online de medicamentos de la AEMPS 1201526001, 1201526002
FI Lääkealan turvallisuus- ja kehittämiskeskus 037635, 408097
FR Base de données publique des médicaments 61156829, 69401038
IL מִשְׂרַד הַבְּרִיאוּת 9038, 9039
LT Valstybinė vaistų kontrolės tarnyba 1092085, 1092086
PL Rejestru Produktów Leczniczych 100448401, 100448418
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W69027001, W69028001
US FDA, National Drug Code 51144-001, 51144-002

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