Država: Indonezija
Jezik: indonezijski
Izvor: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ENZALUTAMIDE
MEPROFARM - Indonesia
ENZALUTAMIDE
40 MG
KAPSUL LUNAK
DUS, 28 SACHET @ 1 BLISTER @ 4 KAPSUL LUNAK
ASTELLAS PHARMA MANUFACTURING, Inc - USA
2019-12-27
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 Excipients 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 in combination with androgen deprivation therapy is indicated for the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not clinically indicated. Xtandi is indicated for the second line treatment of adult men with metastatic castration- resistant prostate cancer 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 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 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. _Concomitant use with strong CYP2C8 inhibitors _ The concomitant use of strong CYP2C8 inhibitors should be avoided if possible. If patients must be co-administered a strong CYP2C8 inhibitor, the dose of enzalutamide should be reduced to 80 mg once daily. If co-administration of the strong Pročitajte cijeli dokument