Kyprolis

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

carfilzomib

Tilgængelig fra:

Amgen Europe B.V.

ATC-kode:

L01XX45

INN (International Name):

carfilzomib

Terapeutisk gruppe:

Antineoplastic agents

Terapeutisk område:

Multiple Myeloma

Terapeutiske indikationer:

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.

Produkt oversigt:

Revision: 20

Autorisation status:

Authorised

Autorisation dato:

2015-11-19

Indlægsseddel

49
B. PACKAGE LEAFLET
50
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

Produktets egenskaber

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