Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
carfilzomib
Amgen Europe B.V.
L01XX45
carfilzomib
Antineoplastic agents
Multiple Myeloma
Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Revision: 20
Authorised
2015-11-19
50 B. PACKAGE LEAFLET 51 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT KYPROLIS 10 MG POWDER FOR SOLUTION FOR INFUSION KYPROLIS 30 MG POWDER FOR SOLUTION FOR INFUSION KYPROLIS 60 MG POWDER FOR SOLUTION FOR INFUSION carfilzomib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Kyprolis is and what it is used for 2. What you need to know before you use Kyprolis 3. How to use Kyprolis 4. Possible side effects 5. How to store Kyprolis 6. Contents of the pack and other information 1. WHAT KYPROLIS IS AND WHAT IT IS USED FOR Kyprolis is a medicine that contains the active substance carfilzomib. Carfilzomib works by blocking the proteasome. The proteasome is a system within the cells that breaks down proteins when they are damaged or no longer needed. By preventing the breakdown of proteins in cancer cells, which are more likely to contain more abnormal proteins, Kyprolis causes the death of cancer cells. Kyprolis is used to treat adult patients with multiple myeloma who have had at least one previous treatment for this disease. Multiple myeloma is a cancer of plasma cells (a type of white blood cell). Kyprolis will be given to you together with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or only with dexamethasone. Daratumumab, lenalidomide and dexamethasone are other medicines used to treat multiple myeloma. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE KYPROLIS _ _ Your doctor will examine you and review your full medical history. You will be monitored closely during treatment. Before starting Kyprolis, and during treatment, you will undergo blood testing. This is to check that you have enough blood cells and your liver and kidneys are working Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Kyprolis 10 mg powder for solution for infusion Kyprolis 30 mg powder for solution for infusion Kyprolis 60 mg powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Kyprolis 10 mg powder for solution for infusion Each vial contains 10 mg of carfilzomib. _Excipient with known effect _ Each vial contains 37 mg sodium. Each vial contains 500 mg of cyclodextrin (betadex sulfobutyl ether sodium). Kyprolis 30 mg powder for solution for infusion Each vial contains 30 mg of carfilzomib. _Excipient with known effect _ Each vial contains 109 mg sodium. Each vial contains 1,500 mg of cyclodextrin (betadex sulfobutyl ether sodium). Kyprolis 60 mg powder for solution for infusion Each vial contains 60 mg of carfilzomib. _Excipient with known effect _ Each vial contains 216 mg sodium. Each vial contains 3,000 mg of cyclodextrin (betadex sulfobutyl ether sodium). After reconstitution, 1 mL of solution contains 2 mg of carfilzomib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. White to off-white lyophilised powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Kyprolis treatment should be supervised by a physician experienced in the use of anti-cancer therapy. 3 Posology The dose is calculated using the patient’s baseline body surface area (BSA). Patients with a BSA greater than 2.2 m 2 should receive a dose based upon a BSA of 2.2 m 2 . Dose adjustments do not need to be made for weight changes of less than or equal to 20%. Kyprolis in combination with lenalidomide and dexamethasone When combined with lenalidomide and dexamethasone, Kyprolis is administered intra Lestu allt skjalið