SPINRAZA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

NUSINERSEN

Available from:

MEDISON PHARMA LTD

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

NUSINERSEN 2.4 MG / 1 ML

Administration route:

INTRATHECAL

Prescription type:

Required

Manufactured by:

BIOGEN NETHERLANDS B.V

Therapeutic indications:

Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy except type 0 and type IV.

Authorization date:

2019-08-19

Summary of Product characteristics

1
PHYSICIAN PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
SPINRAZA
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
except type 0 and type
IV
.
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
Spinraza is for intrathecal use by lumbar puncture.
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 thera
py.
2
_Missed or delayed doses _
If a loading dose is delayed or missed Spinraza should be administered
as soon as possible, with at
least 14 days between doses, and continue dosing at the prescribed
frequency. If a maintenance dose is
delayed or missed, Spinraza should be administered