Reblozyl

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

Luspatercept

Tillgänglig från:

Bristol Myers Squibb Pharma EEIG

ATC-kod:

B03XA06

INN (International namn):

luspatercept

Terapeutisk grupp:

Other antianemic preparations

Terapiområde:

Anemia; Myelodysplastic Syndromes; beta-Thalassemia

Terapeutiska indikationer:

Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (see section 5.1).Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia (see section 5.1).

Produktsammanfattning:

Revision: 5

Bemyndigande status:

Authorised

Tillstånd datum:

2020-06-25

Bipacksedel

40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
REBLOZYL 25 MG POWDER FOR SOLUTION FOR INJECTION
REBLOZYL 75 MG POWDER FOR SOLUTION FOR INJECTION
luspatercept
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 ARE GIVEN 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. This includes any
possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Reblozyl is and what it is used for
2.
What you need to know before you are given Reblozyl
3.
How Reblozyl is given
4.
Possible side effects
5.
How to store Reblozyl
6.
Contents of the pack and other information
1.
WHAT REBLOZYL IS AND WHAT IT IS USED FOR
Reblozyl contains the active substance luspatercept. It is used for:
MYELODYSPLASTIC SYNDROMES
Myelodysplastic syndromes (MDS) are a collection of many different
blood and bone marrow
disorders.
•
Red blood cells become abnormal and do not develop properly.
•
Patients can get a number of signs and symptoms including a low red
blood cell count
(anaemia) and may need red blood cell transfusions.
Reblozyl is used in adults with anaemia caused by MDS, who need red
blood cell transfusions.
It is used in adults who have already had or are not able to have
erythropoietin therapies.
BETA-THALASSAEMIA
β-thalassaemia is a blood problem that is passed down through genes.
•
It affects the production of haemoglobin.
•
Patients can get a number of signs and symptoms including a low red
blood cell count
(anaemia) and may need red blood cell transfusions.
Reblozyl is used to treat anaemia in adults with β-thalassaemia who
may or may not need
regular red blood cell transfu

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Reblozyl 25 mg powder for solution for injection
Reblozyl 75 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
U
Reblozyl 25 mg powder for solution for injection
Each vial contains 25 mg of luspatercept. After reconstitution, each
mL of solution contains
50 mg luspatercept.
U
Reblozyl 75 mg powder for solution for injection
Each vial contains 75 mg of luspatercept. After reconstitution, each
mL of solution contains
50 mg luspatercept.
Luspatercept is produced in Chinese Hamster Ovary (CHO) cells by
recombinant DNA
technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection (powder for injection).
White to off-white lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reblozyl is indicated for the treatment of adult patients with
transfusion-dependent anaemia due
to very low, low and intermediate-risk myelodysplastic syndromes (MDS)
with ring
sideroblasts, who had an unsatisfactory response to or are ineligible
for erythropoietin-based
therapy (see section 5.1).
Reblozyl is indicated in adults for the treatment of anaemia
associated with
transfusion-dependent and non-transfusion-dependent beta-thalassaemia
(see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Reblozyl treatment should be initiated by a physician experienced in
treatment of
haematological diseases.
3
U
Posology
Prior to each Reblozyl administration, the haemoglobin (Hb) level of
patients should be
assessed. In case of a red blood cell (RBC) transfusion occurring
prior to dosing, the
pre-transfusion Hb level must be considered for dosing purposes.
The recommended starting dose of Reblozyl is 1.0 mg/kg admin