Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PALBOCICLIB
Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.
PALBOCICLIB
21 Capsules; 7 Capsules
DR. REDDY'S LABORATORIES LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ PALVORED CAPSULES Palbociclib (75 mg, 100 mg and 125 mg) 2 WHAT IS IN THIS LEAFLET 1. What Palvored is used for 2. How Palvored works 3. Before you use Palvored 4. How to use Palvored 5. While you are using it 6. Side effects 7. Storage and Disposal of Palvored 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT PALVORED IS USED FOR PALVORED 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 PALVORED WORKS Palvored belongs to the group of medicines called antineoplastics. Palvored interferes with the growth of cancer cells, which are eventually destroyed. BEFORE YOU USE PALVORED - _When you must not use it _ _ _ It is not known if Palvored is safe and effective in children. _Pregnancy and lactation _ Do not take Palvored if you are pregnant, trying to get pregnant or think you may be pregnant. Palvored can harm your unborn baby. Females who are able to become pregnant and who take Palvored should use effective birth control during treatment, and for atleast 2 weeks after stopping Palvored. Talk to your healthcare provider about birth control methods that may be right for you during this time. If you become pregnant or think you are pregnant, tell your healthcare provider right away. It is not known if Palvored passes into your breast milk. Do not take Palvored if you are breast-feeding or plan to breastfeed. - _Before you start to use it _ _ _ Tell your doctor if you: • have fever, chills, or any other signs or symptoms of infection. • have dizziness, shortness of breath, weakness or any increased tendency to bleed and/or to bruise. • have li Read the complete document
FONT SIZE: Minimum 7 Times New Roman PRESCRIBING INFORMATION PALVORED (PALBOCICLIB CAPSULES 75MG/100MG/125 MG) COMPOSITION Each Capsule contains: Palbociclib 75 mg, 100 mg, 125 mg Source of Capsules: Bovine CLINICAL INFORMATION THERAPEUTIC INDICATIONS PALVORED 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. POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose of PALVORED 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. PALVORED should be taken with food _ _ _ _ Administer the recommended dose of an aromatase inhibitor when given with PALVORED. Please refer to the full prescribing information for the aromatase inhibitor being used. When co-administered with PALVORED, 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 PALVORED 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. PALVORED capsules should be swallowed whole (do not chew, crush or open them prior to swallowing). Capsules should not be ingested if it is broken, cracked, or otherwise not intact. Pre/perimenopausal women treated with the combination PALVORED plus fulvestrant therapy should be treated with luteinizing hormone releasing hormone (LHRH) agonists according to current clinical practice standards. DOSE MODIFICATION The recommende Read the complete document