Country: Israel
Language: English
Source: Ministry of Health
CABOZANTINIB AS (S) MALATE
MEDISON PHARMA LTD
L01XE26
FILM COATED TABLETS
CABOZANTINIB AS (S) MALATE 40 MG
PER OS
Required
IPSEN PHARMA, FRANCE
CABOZANTINIB
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, per IMDC criteria.- in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.Hepatocellular Carcinoma (HCC)Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC), in adults with Child-Pugh Class A hepatic impairment who have previously been treated with sorafenib.Differentiated thyroid carcinoma (DTC)Cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.
2023-10-31
CABO-PIL-0123-V1 Page 1 of 10 Cabometyx-PIL-ENG-D64-F PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor's prescription only CABOMETYX ® 20 MG CABOMETYX ® 40 MG CABOMETYX ® 60 MG FILM-COATED TABLETS NAME AND QUANTITY OF ACTIVE INGREDIENTS Cabometyx 20 mg Each tablet contains 20 mg cabozantinib (as (_S_)-malate) Cabometyx 40 mg Each tablet contains 40 mg cabozantinib (as (_S_)-malate) Cabometyx 60 mg Each tablet contains 60 mg cabozantinib (as (_S_)-malate) Inactive ingredients and allergens in this medicine - See section 6 "ADDITIONAL INFORMATION". See also "IMPORTANT INFORMATION ABOUT SOME OF THE MEDICINE'S INGREDIENTS" in section 2. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult the doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? KIDNEY CANCER (RENAL CELL CARCINOMA) Cabometyx is indicated as monotherapy for an advanced kidney cancer called advanced renal cell carcinoma: - as first-line treatment of adult patients who are at moderate or high risk according to the IMDC classification. - in adult patients who have been previously treated with VEGF (vascular endothelial growth factor) inhibitors. Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. LIVER CANCER (HEPATOCELLULAR CARCINOMA) Cabometyx is used as monotherapy to treat a type of liver cancer called carcinoma in adults with impaired liver function (Child-Pugh Class A) who have been previously treated with sorafenib. CABO-PIL-0123-V1 Page 2 of 10 Cabometyx-PIL-ENG-D64-F THYROID CANCER (DTC) Cabometyx is used as monotherapy for the treatment of adult patients with locally advanced or metastatic differen Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cabometyx ® 20 mg Cabometyx ® 40 mg Cabometyx ® 60 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cabometyx 20 mg 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 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 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 tablets Cabometyx 20 mg 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 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 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. 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, per IMDC criteria. - in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. 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 with Child-Pugh Class A hepatic impairment who have previously been treated with sorafenib. Differentiated thyroid carcinoma (DTC) CABOMETYX is indicated a Read the complete document