Nazione: Singapore
Lingua: inglese
Fonte: HSA (Health Sciences Authority)
Palbociclib
PFIZER PRIVATE LIMITED
L01XE33
TABLET, FILM COATED
Palbociclib 75 mg
ORAL
Prescription Only
Pfizer Manufacturing Deutschland GmbH
ACTIVE
2021-09-15
IBRANCE ® TAB TABLE OF CONTENT _Please click on either of the following links to access the required information: _ PRESCRIBING INFORMATION PATIENT INFORMATION LEAFLET Page 1 of 26 1. NAME OF THE MEDICINAL PRODUCT IBRANCE ® 75 mg, 100 mg, and 125 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg or 100 mg or 125 mg of palbociclib freebase. Excipients: see Section 6.1 (List of excipients) for the full list of excipients. Palbociclib is a yellow to orange powder with a pKa of 7.4 (the secondary piperazine nitrogen) and 3.9 (the pyridine nitrogen). The 75 mg tablet is presented as a round, light purple, film-coated tablet with “Pfizer” debossed on one tablet face and “PBC 75” debossed on the opposite tablet face. The 100 mg tablet is presented as an oval, green, film-coated tablet with “Pfizer” debossed on one tablet face and “PBC 100” debossed on the opposite tablet face. The 125 mg tablet is presented as an oval, light purple, film-coated tablet with “Pfizer” debossed on one tablet face and “PBC 125” debossed on the opposite tablet face. 3. PHARMACEUTICAL FORM Film-coated tablets 75 mg, 100 mg, and 125 mg Page 2 of 26 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Ibrance is indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: - an aromatase inhibitor as initial endocrine-based therapy; or - fulvestrant in patients with disease progression following endocrine therapy. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose of Ibrance is a 125 mg tablet 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 co-administered with palbociclib, the aromatase inhibitor should be administered according to the dose reported in the approved prescribing information. When co-administered with palbociclib, the Leggi il documento completo
1. NAME OF THE MEDICINAL PRODUCT IBRANCE 75 mg, 100 mg, and 125 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg or 100 mg or 125 mg of palbociclib freebase. Excipients: see Section 6.1 (List of excipients) for the full list of excipients. Palbociclib is a yellow to orange powder with a pKa of 7.4 (the secondary piperazine nitrogen) and 3.9 (the pyridine nitrogen). The 75 mg tablet is presented as a round, light purple, film-coated tablet with “Pfizer” debossed on one tablet face and “PBC 75” debossed on the opposite tablet face. The 100 mg tablet is presented as an oval, green, film-coated tablet with “Pfizer” debossed on one tablet face and “PBC 100” debossed on the opposite tablet face. The 125 mg tablet is presented as an oval, light purple, film-coated tablet with “Pfizer” debossed on one tablet face and “PBC 125” debossed on the opposite tablet face. 3. PHARMACEUTICAL FORM Film-coated tablets 75 mg, 100 mg, and 125 mg 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Ibrance is indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: - an aromatase inhibitor as initial endocrine-based therapy; or - fulvestrant in patients with disease progression following endocrine therapy. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose of Ibrance is a 125 mg tablet 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 co-administered with palbociclib, the aromatase inhibitor should be administered according to the dose reported in the approved prescribing information. When co-administered with palbociclib, the recommended dose of fulvestrant is 500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter. Please refer to the full prescribing information of fulvestrant. Ibrance table Leggi il documento completo