Ország: Izrael
Nyelv: angol
Forrás: 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.• the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy
2020-10-31
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only XTANDI 40MG XTANDI 80MG FILM COATED TABLETS COMPOSITION: Each Xtandi 40 mg film coated tablet contains: enzalutamide 40 mg. Each Xtandi 80 mg film coated tablet contains: enzalutamide 80 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 your 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: hormone antagonists and related agents, anti-androgens. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: - you are sensitive (allergic) to the active ingredient or to any of the other ingredients included in the medicine (see section 6 ‘Further information’). - you are pregnant or may become pregnant (see ‘Pregnancy, breastfeeding and fertility’). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE Seizures: Seizures were reported in 5 in every 1,000 people taking Xtandi, and in fewer than 3 in every 1,000 people receiving placebo (see ‘Drug interactions’ below and section 4 ‘Side effects’). If you are taking medicines that may cause seizures or that can increase the susceptibility for having seizures (see ‘Drug interactions’ below). If you have a seizure during treatment: 2 See your doctor as Olvassa el a teljes dokumentumot
1 1. NAME OF THE MEDICINAL PRODUCT Xtandi 40 mg Xtandi 80 mg Film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Xtandi 40 mg, film-coated tablets Each film-coated tablet contains 40 mg of enzalutamide. Xtandi 80 mg, film-coated tablets Each film-coated tablet contains 80 mg of enzalutamide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Xtandi 40 mg Yellow round – film-coated tablets, debossed with E 40. Xtandi 80 mg Yellow oval – film-coated tablets, debossed with E 80. 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 film-coated tablets or two 80 mg film-coated tablets) 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. 2 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, do Olvassa el a teljes dokumentumot