Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LAPATINIB DITOSYLATE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
LAPATINIB DITOSYLATE
70 Tablets
S.C. Sandoz S.R.L.
_CUSTOMER MEDICATION INFORMATION LEAFLET (RIMUP) _ TYKERB ® FILM-COATED TABLET Lapatinib ditosylate (250mg) 1 WHAT IS IN THIS LEAFLET 1. What Tykerb is used for 2. How Tykerb works 3. Before you use Tykerb 4. How to use Tykerb 5. While you are using Tykerb 6. Side Effects 7. Storage and Disposal of Tykerb 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial number WHAT TYKERB IS USED FOR Tykerb is a prescription medicine used: • with the medicine capecitabine to treat people with breast cancer that is advanced or that has spread to other parts of the body (metastatic), and. o that is HER2-positive (tumors that produce large amounts of a protein called human epidermal growth factor receptor-2), AND o who have already had certain other breast cancer treatments Before taking Tykerb with capecitabine, your breast cancer should have gotten worse (progressed) with the medicine trastuzumab. • with the medicine letrozole to treat women who: o have gone through the change of life (postmenopausal), and o who have metastatic breast cancer that is hormone receptor- positive, HER2-positive, and hormonal therapy is a treatment option for them. HOW TYKERB WORKS Tykerb belongs to a group of medicines known as protein kinase inhibitors. It is used to treat certain types of breast cancer. Breast cancer is caused by cells that divide abnormally in the breast. These cells may reach other tissues of the body at a later stage in a process called metastasis. It may slow the growth of cancer cells or may kill them. BEFORE YOU USE TYKERB _-When you must not use it _ Do not take Tykerb if you are allergic to Lapatinib or any of the ingredients in Tykerb. A complete list of ingredients in Tykerb can be found at the end of this Customer Medication Information Leaflet. _- Before you start to use it _ Before you take Tykerb, tell your doctor if you: • have heart problems. • have liver problems. You may need a lower dose of Tykerb. • have any other medical conditions. For females, te Les hele dokumentet
Novartis Page 2 Malaysia Package Leaflet 18 Aug 2021 Tykerb FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE TYKERB is indicated in combination with: • capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. Limitations of Use: Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. • letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. 2 DOSAGE AND ADMINISTRATION 2.1 RECOMMENDED DOSING HER2-Positive Metastatic Breast Cancer: The recommended dose of TYKERB is 1,250 mg given orally once daily on Days 1-21 continuously in combination with capecitabine 2,000 mg/m 2 /day (administered orally in 2 doses approximately 12 hours apart) on Days 1-14 in a repeating 21-day cycle. TYKERB should be taken at least one hour before or one hour after a meal. The dose of TYKERB should be once daily (5 tablets administered all at once); dividing the daily dose is not recommended _[see Clinical Pharmacology (12.3)]_ . Capecitabine should be taken with food or within 30 minutes after food. If a day’s dose is missed, the patient should not double the dose the next day. Treatment should be continued until disease progression or unacceptable toxicity occurs. Hormone Receptor-Positive, HER2-Positive Metastatic Breast Cancer: The recommended dose of TYKERB is 1,500 mg given orally once daily continuously in combination with letrozole. When coadministered with TYKERB, the recommended dose of letrozole is 2.5 mg once daily. TYKERB should be taken at least one hour before or one hour after a meal. The dose of TYK Les hele dokumentet