Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Cabozantinib (S)-malate
ZUELLIG PHARMA SDN BHD
Cabozantinib (S)-malate
30 Tablets
PATHEON INC.
CABOMETYX TM Film-coated Tablets Cabozantinib (20mg, 40mg, 60mg) 1 Consumer Medication Information Leaflet (RiMUP) What is in this leaflet 1. What CABOMETYX is used for 2. How CABOMETYX works 3. Before you use CABOMETYX 4. How to use CABOMETYX 5. While you are using it 6. Side effects 7. Storage and Disposal of CABOMETYX 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number What CABOMETYX is used for CABOMETYX is a cancer medicine that contains the active substance cabozantinib. It is used in adults to treat: - advanced stages of a type of kidney cancer called renal cell carcinoma - liver cancer when a specific anticancer medicine (sorafenib) is no longer stopping the disease from progressing. CABOMETYX is also used to treat locally advanced or metastatic differentiated thyroid cancer, a type of cancer in the thyroid gland, in adults when radioactive iodine and anticancer medicine treatments are no longer stopping the disease from progressing. CABOMETYX may be given in combination with nivolumab for advanced kidney cancer. It is important that you also read the package leaflet of nivolumab. If you have any questions about these medicines, please ask your doctor. How CABOMETYX works CABOMETYX blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them. These proteins can be present in high amounts in cancer cells, and by blocking their action this medicine can slow down the rate at which the tumour grows and help to cut off the blood supply that the cancer needs. Before you use CABOMETYX When you must not use it if you are allergic to cabozantinib or any of the other ingredients of this medicine (listed under Ingredients). Pregnancy and lactation Avoid becoming pregnant while being treated with CABOMETYX. If you or your partner could become pregnant, use adequate contraception during treatment and for at least 4 months after treatment has finishe Soma hati kamili
1 1. NAME OF THE MEDICINAL PRODUCT CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CABOMETYX 20 mg film-coated tablets Each film-coated tablet contains cabozantinib (S)-malate equivalent to 20 mg cabozantinib. _Excipients with known effect _ Each film-coated tablet contains 15.54 mg lactose. CABOMETYX 40 mg film-coated tablets Each film-coated tablet contains cabozantinib (S)-malate equivalent to 40 mg cabozantinib. _Excipients with known effect _ Each film-coated tablet contains 31.07 mg lactose. CABOMETYX 60 mg film-coated tablets Each film-coated tablet contains cabozantinib (S)-malate equivalent to 60 mg cabozantinib. _Excipients with known effect _ Each film-coated tablet contains 46.61 mg lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. CABOMETYX 20 mg film-coated tablets The tablets are yellow round with no score and debossed with “XL” on one side and “20” on the other side of the tablet. CABOMETYX 40 mg film-coated tablets The tablets are yellow triangle shaped with no score and debossed with “XL” on one side and “40” on the other side of the tablet. CABOMETYX 60 mg film-coated tablets The tablets are yellow oval shaped with no score and debossed with “XL” on one side and “60” on the other side of the tablet. 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Renal Cell Carcinoma (RCC) CABOMETYX is indicated as monotherapy for advanced renal cell carcinoma - as first line treatment of adult patients with intermediate or poor risk (see section 5.1) - in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy (see section 5.1). CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1). Hepatocellular Carcinoma (HCC) CABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults wh Soma hati kamili