Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
ixazomib citrate
Takeda Pharma A/S
L01XG03
ixazomib
Antineoplastic agents
Multiple Myeloma
Ninlaro in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Revision: 17
Authorised
2016-11-21
46 B. PACKAGE LEAFLET 47 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NINLARO 2.3 MG HARD CAPSULES NINLARO 3 MG HARD CAPSULES NINLARO 4 MG HARD CAPSULES ixazomib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What NINLARO is and what it is used for 2. What you need to know before you take NINLARO 3. How to take NINLARO 4. Possible side effects 5. How to store NINLARO 6. Contents of the pack and other information 1. WHAT NINLARO IS AND WHAT IT IS USED FOR WHAT NINLARO IS NINLARO is a cancer medicine that contains ixazomib, a ‘proteasome inhibitor’. NINLARO is used to treat a cancer of the bone marrow called multiple myeloma. Its active substance ixazomib works by blocking the action of proteasomes. These are structures inside the cell that digest proteins and are important for cell survival. Because myeloma cells produce a lot of proteins, blocking the action of proteasomes can kill the cancerous cells. WHAT NINLARO IS USED FOR NINLARO is used to treat adults with multiple myeloma. NINLARO will be given to you together with lenalidomide and dexamethasone, which are other medicines used to treat multiple myeloma. WHAT MULTIPLE MYELOMA IS Multiple myeloma is a cancer of the blood which affects a type of cell, called the plasma cell. A plasma cell is a blood cell that normally produces proteins to fight infections. People with multiple myeloma have cancerous plasma cells, also called myeloma cells, which can damage the bones. Protein produced by myeloma cells can damage the kidneys. Tr Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT NINLARO 2.3 mg hard capsules NINLARO 3 mg hard capsules NINLARO 4 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NINLARO 2.3 mg hard capsules Each capsule contains 2.3 mg of ixazomib (as 3.3 mg of ixazomib citrate) NINLARO 3 mg hard capsules Each capsule contains 3 mg of ixazomib (as 4.3 mg of ixazomib citrate) NINLARO 4 mg hard capsules Each capsule contains 4 mg of ixazomib (as 5.7 mg of ixazomib citrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. NINLARO 2.3 mg hard capsules Light pink, size 4 gelatin hard capsule, marked “Takeda” on the cap and “2.3 mg” on the body with black ink. NINLARO 3 mg hard capsules Light grey, size 4 gelatin hard capsule, marked “Takeda” on the cap and “3 mg” on the body with black ink. NINLARO 4 mg hard capsules Light orange, size 3 gelatin hard capsule, marked “Takeda” on the cap and “4 mg” on the body with black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NINLARO in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be initiated and monitored under the supervision of a physician experienced in the management of multiple myeloma. 3 Posology The recommended starting dose of ixazomib is 4 mg administered orally once a week on Days 1, 8, and 15 of a 28-day treatment cycle. The recommended starting dose of lenalidomide is 25 mg administered daily on Days 1 to 21 of a 28-day treatment cycle. The recommended starting dose of dexamethasone is 40 mg administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle. For additional information regarding lenalidomide and dexamethasone, refer to the Summary of Product Characteristics (SmPC) for these medicinal products. Prior to initiating a new cycle of therapy: • Absolute neutrophil count should be Lestu allt skjalið