Manufacturer
Corden Pharma GmbH(GERMANY)
Registraction Number
MAL23086002ACRZ
Contents:
• Active Ingredient: Tucatinib (equivalent to Tucatinib Hemi Ethanolate) 150 mg.
• Inactive Ingredients: Copovidone, crospovidone, sodium chloride, potassium chloride, sodium bicarbonate, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol, talc, and yellow iron oxide non-irradiated.
Indications:
TUKYSA is indicated for the treatment of:
• Locally advanced unresectable or metastatic HER2-positive breast cancer in combination with trastuzumab and capecitabine, including patients with brain metastases who have received one or more prior anti-HER2-based regimens in the metastatic setting.
• RAS wild-type, HER2-positive breast cancer in combination with trastuzumab.
Instruction:
• Dosage: The recommended dose is 300 mg (two 150 mg tablets) taken twice daily continuously in combination with trastuzumab and capecitabine.
• Administration: Tablets should be swallowed whole with or without food.
• Timing: Take the tablets approximately 12 hours apart, at the same time each day.
• Missed Dose: If a dose is missed, take the next dose at the regularly scheduled time.
• Monitoring: Treatment should be initiated and supervised by a physician experienced in the administration of anti-cancer medicinal products.