국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Enzalutamide
Astellas Pharma Malaysia Sdn Bhd
Enzalutamide
56capsule Capsules; 112capsule Capsules; 112capsule Capsules
Catalent Pharma Solutions, LLC
XTANDI ® SOFT CAPSULES Enzalutamide (40mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Xtandi_ _®_ is used for 2. How _Xtandi_ ® works 3. Before you use _Xtandi_ _®_ 4. How to use _Xtandi_ _®_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Xtandi_ _®_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 1. WHAT _XTANDI_ _®_ IS USED FOR Xtandi ® contains the active substance enzalutamide. Xtandi ® is used to treat adult men with prostate cancer that: - No longer responds to a hormone therapy or surgical treatment to lower testosterone Or - Has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone. 2. HOW _XTANDI_ ® WORKS Xtandi ® is a medicine that works by blocking the activity of hormones called androgens (such as testosterone). By blocking androgens, enzalutamide stops prostate cancer cells from growing and dividing. 3. BEFORE YOU USE _XTANDI_ _®_ _When you must not use it _ If you are allergic to enzalutamide or any of the other ingredients of this medicine listed in section ‘_Ingredients’ _ If you are pregnant or may become pregnant (see ‘_Pregnancy, breast-_ _feeding and fertility’_) _ _ _Before you start use it _ Warnings and precautions_ _ Seizure Seizures were reported in 5 in every 1,000 people taking Xtandi ® , and fewer than 3 in every 1,000 people taking placebo (see ‘_Taking other _ _medicines_’ in this section and section ‘_Side effects_’). If you are taking a medicine that can cause seizures or that can increase the susceptibility for having seizures (see ‘_Taking other medicines_’). If you have a seizure during treatment: See your doctor as soon as possible. Your doctor may decide that you should stop taking Xtandi ® . Posterior Reversible Encephalopathy Syndrome (PRES) _ _ There have been rare reports of PRES, a rare, reversible condition involving the brain, in patients treated with Xtandi ® . I 전체 문서 읽기
1 1. NAME OF THE MEDICINAL PRODUCT Xtandi 40 mg Soft Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 40 mg of enzalutamide. Excipient with known effect: Each soft capsule contains 57.8 mg of sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule. White to off-white oblong soft capsules (approximately 20 mm x 9 mm) imprinted with “ENZ” in black ink on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS XTANDI is indicated for: • the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) (see section 5.1). • the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). • the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). • the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 160 mg enzalutamide (four 40 mg capsules) as a single oral daily dose. Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated. If a patient misses taking Xtandi at the usual time, the prescribed dose should be taken as close as possible to the usual time. If a patient misses a dose for a whole day, treatment should be resumed the following day with the usual daily dose. If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction, dosing should be withheld for one week or until symptoms improve to ≤ Grade 2, then resumed at the same or a reduced dose (120 mg or 80 mg) if warranted. 2 _ _ _Concomitant use with strong CYP2C8 inhibitors _ The concomitant use of strong CYP2C8 inhibitors should be avoided if possible 전체 문서 읽기