País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Ribociclib succinate
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
Ribociclib succinate
21 Tablets; 42 Tablets; 63 Tablets
Novartis Pharmaceutical Manufacturing LLC
KRYXANA ® FILM-COATED TABLETS Ribociclib (200 mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Kryxana is used for 2. How Kryxana works 3. Before you use Kryxana 4. How to use Kryxana 5. While you are using Kryxana 6. Side effects 7. Storage and Disposal of Kryxana 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT KRYXANA IS USED FOR KRYXANA is a prescription medicine used to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative breast cancer that has gotten worse or has spread to other parts of the body (metastatic), in combination with: • an aromatase inhibitor as the first endocrine-based therapy in pre/perimenopausal or postmenopausal women or in men; or • fulvestrant as the first endocrine- based therapy or following disease progression on endocrine therapy in postmenopausal women or in men. It is not known if KRYXANA is safe and effective in children. HOW KRYXANA WORKS KRYXANA works by blocking the effects of enzymes called cyclin dependent kinases (CDK) which signal cancer cells to grow and divide to make new cells. By blocking these enzymes, KRYXANA can reduce cancer cell growth, the ability to make new cancer cells, and can kill cancer cells. BEFORE YOU USE KRYXANA - _When you must not use it _ • Avoid eating grapefruit and avoid grapefruit juice during treatment with KRYXANA since these may increase the amount of KRYXANA in your blood. _ _ _ _ • Do not breast-feed during your treatment with KRYXANA and for at least 3 weeks after the last dose of KRYXANA. _ _ • Do not take if you have hypersensitivity to the active substance or to peanut, soya or any of the excipients. _ _ _ _ - _Before you start use it _ BEFORE YOU TAKE KRYXANA, TELL YOUR HEALTHCARE PROVIDER IF YOU: • have any heart problems, including heart failure, irregular heartbeats, and QT prolongation • have ever had a heart attack • have a slow heartbeat (bradycardia) • h Llegiu el document complet
KRYXANA ® FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE KRYXANA is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: • an aromatase inhibitor as initial endocrine-based therapy in pre/perimenopausal or postmenopausal women or in men; or • fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men. 2 DOSAGE AND ADMINISTRATION 2.1 DOSING AND ADMINISTRATION The recommended dose of KRYXANA is 600 mg (three 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days. KRYXANA can be taken with or without food _[see Clinical Pharmacology (12.3)]_ . When given with KRYXANA, refer to the Full Prescribing Information for the recommended dose of the aromatase inhibitor being used. When given with KRYXANA, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Please refer to the Full Prescribing Information of fulvestrant. Pre/perimenopausal women, or men, treated with the combination KRYXANA plus an aromatase inhibitor should be treated with a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards. Men treated with the combination of KRYXANA plus fulvestrant should be treated with a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards. Patients should take their dose of KRYXANA at approximately the same time each day, preferably in the morning. If the patient vomits after taking the dose, or misses a dose, no additional dose should be taken that day. The next prescribed dose should be taken at the usual time. KRYXANA tablets should be swallowed whole (tablets should not be chewed, crushed or split prior to swallowing). No tablet should be ingested if it is Llegiu el document complet