Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Seagen B.V., Evert van de Beekstraat 1-104, 1118CL Schiphol, The Netherlands
TUKYSA 50 mg film-coated tablets.
TUKYSA 150 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. TUKYSA 50 mg film-coated tablets: Round, yellow, film-coated tablet, debossed with “TUC” on one side and “50” on the other side. The 50 mg tablet has a diameter of approximately 8 mm. TUKYSA 150 mg film-coated tablets: Oval-shaped, yellow, film-coated tablet, debossed with “TUC” on one side and “150” on the other side. The 150 mg tablet is approximately 17 mm in length and 7 mm in width. |
TUKYSA 50 mg film-coated tablets: Each film-coated tablet contains 50 mg of tucatinib.
TUKYSA 150 mg film-coated tablets: Each film-coated tablet contains 150 mg of tucatinib.
Excipients with known effect: Each 150 mg film-coated tablet contains 27.64 mg of sodium and 30.29 mg of potassium.
A 300 mg dose of TUKYSA contains 55.3 mg of sodium and 60.6 mg of potassium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
| List of Excipients |
|---|
|
Tablet core: Copovidone (E1208) Film-coating: Poly(vinyl alcohol) (E1203) |
oPA/ALU/PVC blister sealed with aluminium foil.
TUKYSA 50 mg film-coated tablets: Each carton contains 88 film-coated tablets (11 blisters with 8 tablets each).
TUKYSA 150 mg film-coated tablets: Each carton contains 84 film-coated tablets (21 blisters with 4 tablets each).
Not all pack sizes may be marketed.
Seagen B.V., Evert van de Beekstraat 1-104, 1118CL Schiphol, The Netherlands
TUKYSA 50 mg film-coated tablets: EU/1/20/1526/001
TUKYSA 150 mg film-coated tablets: EU/1/20/1526/002
11 February 2021
| Drug | Countries | |
|---|---|---|
| TUKYSA | Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Lithuania, Poland, Romania, United States |
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