Manufacturer
Corden Pharma GmbH(GERMANY)
Registraction Number
MAL23086001ACRZ
Contents:
• Active Ingredient: Tucatinib 50 mg (equivalent to 52.40 mg tucatinib hemiethanolate)
• Inactive Ingredients: Copovidone, crospovidone, sodium chloride, potassium chloride, sodium bicarbonate, colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose
Indications:
TUKYSA is indicated for the treatment of:
• Adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
Instructions:
1. Dosage: The recommended dosage is 300 mg orally twice daily with or without food.
2. Administration: Take TUKYSA exactly as prescribed by your healthcare provider.
3. Storage: Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F).
4. Precautions:
o Do not take TUKYSA if you are allergic to tucatinib or any of the other ingredients.
o Inform your doctor if you have liver problems or if you are pregnant or planning to become pregnant.
o Report any side effects to your healthcare provider immediately.