Riik: Malaisia
keel: inglise
Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
pomalidomide
Celgene Sdn. Bhd.
pomalidomide
21capsule Capsules
Celgene International Sarl
POMALYST ® CAPSULES Pomalidomide (1mg, 2mg, 3mg, 4mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What POMALYST ® is used for 2. How POMALYST ® works 3. Before you use POMALYST ® 4. How to use POMALYST ® 5. While you are using it 6. Side effects 7. Storage and Disposal of POMALYST ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT POMALYST ® IS USED FOR POMALYST ® is used to treat adults with a type of cancer called ‘multiple myeloma’. Multiple myeloma is a type of cancer which affects a certain type of white blood cell (called the ‘plasma cell’). These cells grow out of control and accumulate in the bone marrow. This results in damage to the bones and kidneys. Multiple myeloma generally cannot be cured. However, treatment can reduce the signs and symptoms of the disease or make them disappear for a period of time. When this happens, it is called ‘response’. POMALYST ® contains the active substance ‘pomalidomide’. This medicine is related to thalidomide and belongs to a group of medicines which affect the immune system (the body’s natural defences). POMALYST ® is either used with: • two other medicines - called ‘bortezomib’ (a type of chemotherapy medicine) and ‘dexamethasone’ (an anti-inflammatory medicine) in people who have had at least one other treatment - including lenalidomide. Or • one other medicine - called ‘dexamethasone’ in people whose myeloma has become worse, despite having at least two other treatments - including lenalidomide and bortezomib. HOW POMALYST ® _ _WORKS POMALYST ® works in several different ways: • by stopping the myeloma cells developing. • by stimulating the immune system to attack the cancer cells. • by stopping the formation of blood vessels supplying the cancer cells. The benefit of using POMALYST ® with bortezomib and dexamethasone When POMALYST ® is used with bortezomib and dexamethasone, in people who have had at least one other treatment, it Lugege kogu dokumenti
1 1. NAME OF THE MEDICINAL PRODUCT Pomalyst ® 1 mg hard capsules Pomalyst ® 2 mg hard capsules Pomalyst ® 3 mg hard capsules Pomalyst ® 4 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 1 mg of pomalidomide. Each hard capsule contains 2 mg of pomalidomide. Each hard capsule contains 3 mg of pomalidomide. Each hard capsule contains 4 mg of pomalidomide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Pomalyst ® 1 mg hard capsule: Dark blue opaque cap and yellow opaque body, imprinted “POML” in white ink and “1 mg” in black ink, size 3, hard gelatin capsule. Hard capsule. Pomalyst ® 2 mg hard capsule: Dark blue opaque cap and orange opaque body, imprinted “POML 2 mg” in white ink, size 1, hard gelatin capsule. Hard capsule. Pomalyst ® 3 mg hard capsule: Dark blue opaque cap and green opaque body, imprinted “POML 3 mg” in white ink, size 1, hard gelatin capsule. Hard capsule. Pomalyst ® 4 mg hard capsule: Dark blue opaque cap and blue opaque body, imprinted “POML 4 mg” in white ink, size 1, hard gelatin capsule. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pomalyst ® in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalyst ® in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma. 2 Dosing is continued or modified based upon clinical and laboratory findings (see section 4.4). Posology • _Pomalidomide in combination with bortezomib a Lugege kogu dokumenti