TUKYSA Film-coated tablet Ref.[49738] Active ingredients: Tucatinib

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Seagen B.V., Evert van de Beekstraat 1-104, 1118CL Schiphol, The Netherlands

Product name and form

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.

Qualitative and quantitative composition

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)
Crospovidone (E1202)
Sodium chloride
Potassium chloride (E508)
Sodium hydrogen carbonate (E500)
Silica, colloidal anhydrous (E551)
Magnesium stearate
Microcrystalline cellulose

Film-coating:

Poly(vinyl alcohol) (E1203)
Titanium dioxide (E171)
Macrogol 4000 (E1521)
Talc (E553b)
Yellow iron oxide (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Seagen B.V., Evert van de Beekstraat 1-104, 1118CL Schiphol, The Netherlands

Marketing authorization dates and numbers

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

Drugs

Drug Countries
TUKYSA Canada, Estonia, Finland, France, Ireland, Israel, Lithuania, Poland, Romania, United States

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