Besremi

Land: Europäische Union

Sprache: Englisch

Quelle: EMA (European Medicines Agency)

Wirkstoff:

ropeginterferon alfa-2b

Verfügbar ab:

AOP Orphan Pharmaceuticals GmbH

ATC-Code:

L03AB15

INN (Internationale Bezeichnung):

ropeginterferon alfa-2b

Therapiegruppe:

Immunostimulants,

Therapiebereich:

Polycythemia Vera

Anwendungsgebiete:

Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.

Produktbesonderheiten:

Revision: 4

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2019-02-15

Gebrauchsinformation

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
BESREMI 250 MICROGRAMS/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
ropeginterferon alfa-2b
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 pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Besremi is and what it is used for
2.
What you need to know before you use Besremi
3.
How to use Besremi
4.
Possible side effects
5.
How to store Besremi
6.
Contents of the pack and other information
1.
WHAT BESREMI IS AND WHAT IT IS USED FOR
Besremi contains the active substance ropeginterferon alfa-2b, which
belongs to the class of medicines
called interferons. Interferons are produced by your immune system to
block the growth of cancer
cells.
Besremi is used as monotherapy for the treatment of polycythaemia vera
in adults. Polycythaemia vera
is a type of cancer in which the bone marrow produces too many red
blood cells, white blood cells and
platelets (cells that help the blood to clot).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BESREMI
DO NOT USE BESREMI
-
if you are allergic to ropeginterferon alfa-2b or any of the other
ingredients of this medicine
(listed in section 6).
-
if you have thyroid disease that is not controlled with medicines.
-
if you have or had severe mental disorders (such as depression or
suicidal thoughts or if you
tried to kill yourself).
-
if you have recently had severe heart problems (such as heart attack
or stroke)
-
if you have or had an autoimmune disease (such as rheumatoid
arthritis, psoriasis or
inflammatory bowel disease).
-
if you had an organ transplantati

Fachinformation

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen
Each pre-filled pen of 0.5 mL solution contains 250 micrograms of
ropeginterferon alfa-2b as
measured on a protein basis, corresponding to 500 micrograms/mL.
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen
Each pre-filled pen of 0.5 mL solution contains 500 micrograms of
ropeginterferon alfa-2b as
measured on a protein basis, corresponding to 1.000 micrograms/mL.
The strength indicates the quantity of the interferon alpha-2b moiety
of ropeginterferon alfa-2b
without consideration of the pegylation.
Ropeginterferon alfa-2b is a covalent conjugate of the protein
interferon alpha-2b, produced in
_Escherichia coli_
cells by recombinant DNA technology, with a methoxypolyethylene glycol
(mPEG)
moiety.
The potency of this medicinal product should not be compared to that
of another pegylated or non-
pegylated protein of the same therapeutic class (see section 5.1).
Excipient with known effect
Each pre-filled pen contains 10 mg benzyl alcohol per mL.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled pen (injection).
Clear, colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Besremi is indicated as monotherapy in adults for the treatment of
polycythaemia vera without
symptomatic splenomegaly.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under supervision of a physician
experienced in the management of the
disease.
Posology
3
_Titration phase_
The dose is titrated individually with a recommended starting dose of
100 micrograms (or
50 micrograms in patients under another cytoreductive therapy). The
dose should be gradually
increased by 50 microgra