国: イスラエル
言語: 英語
ソース: Ministry of Health
ENZALUTAMIDE
ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL
L02BB04
CAPSULES SOFT
ENZALUTAMIDE 40 MG
PER OS
Required
ASTELLAS PHARMA EUROPE B.V., THE NETHERLANDS
ENZALUTAMIDE
xtandi is indicated for:• the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC).• 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.• the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
2015-11-16
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only XTANDI 40 MG. _SOFT CAPSULES. _ COMPOSITION: Each Xtandi 40 mg soft capsule contains: enzalutamide 40 mg. INACTIVE INGREDIENTS AND ALLERGENS - see section 6 "Further information". READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, consult the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment . Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. The medicine is intended for adult men only. The medicine is not intended for use by women. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended to treat 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. THERAPEUTIC GROUP: androgen receptor antagonist. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: - if you are sensitive (allergic) to the active ingredient or to any of the other ingredients included in the medicine (see section 6). - If you are pregnant or may become pregnant (see ‘Pregnancy, breast-feeding and fertility’). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE - Seizures: Seizures were reported in 5 in every 1,000 patients taking Xtandi, and in fewer than 1 in 1,000 pa- tients receiving placebo (see ‘Other medicines and Xtandi’ below and section 4 ‘Possible side ef- fects’). If you are taking medicines that may cause seizures or that can increase the chance of having seizures (the list of medicines is provided below, see section "IF YOU CURRENTLY TAKE, OR HAVE TAKEN LATELY, OTHER DRUGS INCLUDING NON-PRESCRIPTION MEDICINES AND NUTRITIONAL SUPPLEMENTS "). IF YOU HAVE SEIZURES DURING TREATMENT 完全なドキュメントを読む
1 1. NAME OF THE MEDICINAL PRODUCT Xtandi 40 mg soft capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Xtandi 40 mg soft capsules 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 (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 Treatment with enzalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer. _ _ Posology The recommended dose is 160 mg enzalutamide (four 40 mg soft 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 完全なドキュメントを読む