国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Palbociclib
PFIZER (MALAYSIA) SDN. BHD.
Palbociclib
21capsule Capsules; 21capsule Capsules; 7 Capsules
Pfizer Manufacturing Deutschland GmbH.
Pfizer Confidential _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ IBRANCE ® CAPSULES Palbociclib (75 mg, 100 mg and 125 mg) PLD Title : Palbociclib (Ibrance) PLD Date : 02 July 2020 Country : Malaysia Reference Document : 125 mg, 100 mg and 75 mg Palbociclib capsules of Malaysia CLD dated 18 June 2020 Reason for change : PfLEET No: 2019-0047091 (S2): Alterations in dosing for severe hepatic impairment : PfLEET No: 2020-0060643 (S1): To update as per latest CLD : To update as per BOH query Pfizer Confidential _ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ IBRANCE ® CAPSULES Palbociclib (75 mg, 100 mg and 125 mg) 1 WHAT IS IN THIS LEAFLET 1. What Ibrance is used for 2. How Ibrance works 3. Before you use Ibrance 4. How to use Ibrance 5. While you are using it 6. Side effects 7. Storage and Disposal of Ibrance 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT IBRANCE IS USED FOR Ibrance is a prescription medicine used to treat hormone receptor (HR)- positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic) in combination with: • an aromatase inhibitor as the first hormonal based therapy in women who have gone through menopause, or • fulvestrant in women with disease progression following hormonal therapy HOW IBRANCE WORKS Ibrance belongs to the group of medicines called antineoplastics. Ibrance interferes with the growth of cancer cells, which are eventually destroyed. BEFORE YOU USE IBRANCE - _When you must not use it _ It is not known if Ibrance is safe and effective in children. _Pregnancy and lactation _ Do not take Ibrance if you are pregnant, trying to get pregnant or think you may be pregnant. Ibrance can harm your unborn baby. Females who are able to become pregnant and who take Ibrance should use effective birth control during treatment and for atleast 3 weeks after stopping Ibrance. The male partner of the female patient (who are able to 阅读完整的文件
Pfizer Confidential 1 IBRANCE CAPSULES PALBOCICLIB 75 MG, 100 MG AND 125 MG FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with: • an aromatase inhibitor as initial endocrine based therapy in postmenopausal women, or • fulvestrant in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist. 2 DOSAGE AND ADMINISTRATION 2.1 RECOMMENDED DOSE AND SCHEDULE The recommended dose of IBRANCE is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. IBRANCE should be taken with food [ _see Clinical Pharmacology (11.3)_ ]. Administer the recommended dose of an aromatase inhibitor when given with IBRANCE. Please refer to the full prescribing information for the aromatase inhibitor being used. When given with IBRANCE, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Please refer to the full prescribing information of fulvestrant. Patients should be encouraged to take their dose of IBRANCE at approximately the same time each day. If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. IBRANCE capsules should be swallowed whole (do not chew, crush or open them prior to swallowing). Capsules should not be ingested if they are broken, cracked, or otherwise not intact. Pre/perimenopausal women treated with the combination IBRANCE plus fulvestrant therapy should also be treated with luteinizing hormone releasing hormone (LHRH) agonists according to current clinical practice standards. 2.2 DOSE MODIFICATION The recommended dose modifications for adverse reactions are listed in Tables 1, 2 a 阅读完整的文件