Country: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ixazomib citrate
Takeda UK Ltd
L01XX50
Ixazomib citrate
4mg
Capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 5035382000022
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NINLARO 2.3 MG HARD CAPSULES NINLARO 3 MG HARD CAPSULES NINLARO 4 MG HARD CAPSULES ixazomib This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 produce Aqra d-dokument sħiħ
OBJECT 1 NINLARO 2.3 MG HARD CAPSULES Summary of Product Characteristics Updated 09-Oct-2017 | Takeda UK Ltd This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 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 hard gelatin 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 hard gelatin capsule, marked “Takeda” on the cap and “3 mg” on the body with black ink. NINLARO 4 mg hard capsules Light orange, size 3 hard gelatin 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. Posology The recommended starting dose of NINLARO 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 i Aqra d-dokument sħiħ