Spinraza
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
12-10-2023
Fachinformation
(SPC)
12-10-2023
Öffentlichen Beurteilungsberichts
(PAR)
11-01-2018
Wirkstoff:
nusinersen sodium
Verfügbar ab:
Biogen Netherlands B.V.
ATC-Code:
M09
INN (Internationale Bezeichnung):
nusinersen
Therapiegruppe:
Other nervous system drugs
Therapiebereich:
Muscular Atrophy, Spinal
Anwendungsgebiete:
Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.
Produktbesonderheiten:
Revision: 14
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2017-05-30
Gebrauchsinformation
26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
SPINRAZA 12 MG SOLUTION FOR INJECTION
nusinersen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD RECEIVES
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 or your child gets 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 Spinraza is and what it is used for
2.
What you need to know before you or your child are given Spinraza
3.
How Spinraza is given
4.
Possible side effects
5.
How to store Spinraza
6.
Contents of the pack and other information
1.
WHAT SPINRAZA IS AND WHAT IT IS USED FOR
Spinraza contains the active substance
_nusinersen_
which belongs to a group of medicines known as
_antisense oligonucleotides_
. Spinraza is used to treat a genetic disease called
_spinal muscular atrophy_
(SMA).
SPINAL MUSCULAR ATROPHY
is caused by a shortage of a protein called
_survival motor neuron_
(SMN) in
the body. This results in the loss of nerve cells in the spine,
leading to weakness of the muscles in the
shoulders, hips, thighs and upper back. It may also weaken the muscles
used for breathing and
swallowing.
Spinraza works by helping the body to produce more of the SMN protein
that people with SMA are
lacking. This reduces the loss of nerve cells and so may improve
muscle strength.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD ARE GIVEN SPINRAZA
_ _
SPINRAZA MUST NOT BE GIVEN
•
If you or your child are
ALLERGIC TO NUSINERSEN
or any of the other ingredients of this medicine
(listed in section 6).
If you are not sure, talk to your doctor or nurse before you or your
child are given Spinraza.
WARNINGS AND PRECAUTIONS
There is a risk of side effects occuring after Spinraza is given by a
lumbar puncture procedure (see
section 3). This can include headaches, vomiting and back pain. The
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Spinraza 12 mg solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml vial contains nusinersen sodium equivalent to 12 mg
nusinersen.
Each ml contains 2.4 mg of nusinersen.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless solution with pH of approximately 7.2.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Spinraza should only be initiated by a physician with
experience in the management of
spinal muscular atrophy (SMA).
The decision to treat should be based on an individualised expert
evaluation of the expected benefits of
treatment for that individual, balanced against the potential risk of
treatment with Spinraza. Patients
with profound hypotonia and respiratory failure at birth, where
Spinraza has not been studied, may not
experience a clinically meaningful benefit due to severe survival
motor neuron (SMN) protein
deficiency.
Posology
The recommended dosage is 12 mg (5 ml) per administration.
Spinraza treatment should be initiated as early as possible after
diagnosis with 4 loading doses on
Days 0, 14, 28 and 63. A maintenance dose should be administered once
every 4 months thereafter.
_ _
_Duration of treatment _
Information on long term efficacy of this medicinal product is not
available. The need for continuation
of therapy should be reviewed regularly and considered on an
individual basis depending on the
patient’s clinical presentation and response to the therapy.
_Missed or delayed doses _
If a loading or a maintenance dose is delayed or missed, Spinraza
should be administered according to
the schedule in Table 1 below.
3
TABLE 1: RECOMMENDATIONS FOR DELAYED OR MISSED DOSE
DELAYED OR MISSED DOSE
TIMING OF DOSING ADMINISTRATION
LOADING DOSE
•
Administer the delayed or missed loading dose as soon as pos
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