Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
lenvatinib mesilate
EISAI (MALAYSIA) SDN BHD (18039-D)
lenvatinib mesilate
20capsule Capsules
Eisai Co., Ltd.
LENVIMA ® HARD CAPSULES Lenvatinib (4mg, 10mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What LENVIMA is used for 2. How LENVIMA works 3. Before you use LENVIMA 4. How to use LENVIMA 5. While you are using it 6. Side effects 7. Storage and Disposal of LENVIMA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT LENVIMA IS USED FOR LENVIMA is a medicine that contains the active substance lenvatinib. It is used to treat: progressive or advanced thyroid cancer in adults when radioactive iodine treatment has not helped to stop the disease. patients with advanced kidney cancer (advanced renal cell carcinoma) as first treatment when used in combination with pembrolizumab. patients with advanced kidney cancer (advanced renal cell carcinoma) where other treatments (so-called “VEGF-targeted therapy”) have not helped stop the disease. It is used in combination with everolimus. liver cancer ( _hepatocellular _ _carcinoma_ ) in adults who have not previously been treated with another anticancer medicine that travels through the bloodstream. People get LENVIMA when their liver cancer has spread or cannot be taken out by surgery. Advanced cancer of the lining of the uterus (endometrial carcinoma) in patients whose cancer has spread after being previously treated with another anticancer medicine that travels through the bloodstream and cannot be taken out by surgery or radiation treatment(a type of uterine cancer) that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), that has progressed after treatment with anticancer medicine that contained platinum and that cannot be treated with surgery or radiation, when used along together with another anticancer medicine called pembrolizumab. HOW LENVIMA WORKS LENVIMA blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the development of new blood vessels that supply oxygen and nutrients to cells and help them Izlasiet visu dokumentu
1 LENVIMA ® 4 mg, 10 mg1. PRODUCT NAME LENVIMA 4 mg hard capsules LENVIMA 10 mg hard capsules 2. PRODUCT DESCRIPTION AND COMPOSITION LENVIMA 4 mg: Each hard capsule contains 4 mg of lenvatinib (as mesilate). A yellowish-red body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body. LENVIMA 10 mg: Each hard capsule contains 10 mg of lenvatinib (as mesilate). A yellow body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body. Excipients: Calcium carbonate, Mannitol, Microcrystalline cellulose, Hydroxypropylcellulose, Low- substituted hydroxypropylcellulose, Talc, Hypromellose, Titanium dioxide (E171), Yellow iron oxide (E172), Red iron oxide (E172), Shellac, Black iron oxide (E172), Potassium hydroxide, Propylene glycol. 3. INDICATION LENVIMA is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). LENVIMA in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). LENVIMA is indicated in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy. LENVIMA is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy (see section 11.1) LENVIMA, in combination with pembrolizumab, is indicated for the treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with platinum-containing therapy in any setting and are not candidates for curative surgery or radiation. 4. DOSAGE AND ADMINISTRATION LENVIMA treatment Izlasiet visu dokumentu