Nchi: Indonesia
Lugha: Kiindonesia
Chanzo: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PALBOCICLIB
PFIZER INDONESIA - Indonesia
PALBOCICLIB
125 MG
KAPSUL
DUS, 1 BLISTER @ 7 KAPSUL
PFIZER MANUFACTURING DEUTSCHLAND GMBH - Federal Republic of Germany
2019-10-24
PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Palbociclib Trade Name: Ibrance CDS Effective Date: June 12, 2017 Supersedes: NA 1. NAME OF THE MEDICINAL PRODUCT 1.1. PRODUCT NAME IBRANCE ® 1.2. STRENGTH 75 mg, 100 mg, and 125 mg 1.3. PHARMACEUTICAL DOSAGE FORM Hard capsules _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1. QUALITATIVE DECLARATION Each capsule contains 75 mg or 100 mg or 125 mg of palbociclib freebase. N N N N N N M M E E O O N N H H N N N N H H N N O O M M E E Palbociclib is a yellow to orange powder with a pKa of 7.4 (the secondary piperazine nitrogen) and 3.9 (the pyridine nitrogen). 2.2. QUANTITATIVE DECLARATION Excipients: see Section 6.1 (List of excipients) for the full list of excipients. 3. PHARMACEUTICAL FORM Hard gelatin capsules 75 mg, 100 mg, and 125 mg DISETUJUI OLEH BPOM : 18/9/2019 EREG10024111800010 EREG10024111800011 EREG10024111800012 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS IBRANCE in combination with letrozole is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with proven diagnosis of adenocarcinoma of the breast with evidence of loco regionally recurrent or metastatic disease not amenable to resection or radiation. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose of IBRANCE is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment (Schedule 3/1) to comprise a complete cycle of 28 days. When coadministered with palbociclib, the recommended dose of letrozole is 2.5 mg taken orally once daily continuously throughout the 28-day cycle. Please refer to the full prescribing information of letrozole. Treatment of pre/perimenopausal women with the combination of palbociclib plus an aromatase inhibitor should always be combined with an LHRH agonist (see S Soma hati kamili