BRINEURA cerliponase alfa (rch) 150 mg/5 mL solution for injection vial with flushing solution vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cerliponase alfa, Quantity: 30 mg/mL

Available from:

BioMarin Pharmaceutical Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: dibasic sodium phosphate heptahydrate; sodium chloride; potassium chloride; magnesium chloride hexahydrate; calcium chloride dihydrate; water for injections; monobasic sodium phosphate monohydrate

Administration route:

Intracerebroventricular

Units in package:

2 vials of cerliponase alfa solution and 1 vial of flushing solution

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.

Product summary:

Visual Identification: Clear, colourless liquid, essentially particle free; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at minus 20 plus or minus 5 degrees Celsius (deep freeze)

Authorization status:

Registered

Authorization date:

2018-08-28

Patient Information leaflet

BRINEURA
®
1
This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You
can help by reporting any side affects you may get. You can report
side effects to your doctor, or directly at
www.tga.gov.au/reporting-problems
BRINEURA
cerliponase alfa (rch)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about Brineura.
It does not contain all the available
information. It does not take the
place of talking to the doctor or
pharmacist.
All medicines have benefits and
risks. The doctor has weighed the
risks of treating your child with
Brineura against the expected
benefits .
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, TALK TO THE DOCTOR, NURSE
OR THE HOSPITAL PHARMACIST.
KEEP THIS LEAFLET WHILE YOUR CHILD IS
BEING TREATED WITH BRINEURA.
You may need to read it again.
What Brineura is used
for
Brineura contains the active
substance cerliponase alfa, which
belongs to a group of medicines
known as enzyme replacement
therapies. It is used to treat patients
with neuronal ceroid lipofuscinosis
type 2 (CLN2) disease, also known
as tripeptidyl peptidase 1 (TPP1)
deficiency.
CLN2 disease is an inherited
condition that causes progressive
irreversible decline in ability to speak
and move, loss of balance,
convulsions (seizures), blindness and
ultimately, death in children.
Brineura has been shown to reduce
the rate of decline in ability to speak
and move.
People with CLN2 disease do not
have any enzyme called TPP1 or they
have too little of it and this causes a
build-up of substances called
lysosomal storage materials. In
people with CLN2 disease, these
materials build-up in certain parts of
the body, mainly the brain.
Brineura has not been given to
patients with advanced disease at the
start of treatment or in children
younger than 2 years of age. The
doctor will discuss whether Brineura
treatment is right for your child.
Brineura is a new medicine. It has
been used in a limited number of
children and its long term effects

Summary of Product characteristics

V2
Supersedes: V1.0
Page 1 of 20
This medicinal product is subject to additional monitoring in
Australia. This will
allow quick identification of new safety information. Healthcare
professionals are
asked to report any suspected adverse events at
https://www.tga.gov.au/reporting-
problems.
AUSTRALIAN PRODUCT INFORMATION – CERLIPONASE ALFA
(BRINEURA
TM
)
30 MG/ML SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
cerliponase alfa
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Brineura contains 150 mg of cerliponase alfa* in 5 mL of
solution.
Each mL of solution for injection contains 30 mg of cerliponase alfa.
*Cerliponase alfa is produced in mammalian Chinese Hamster Ovary
cells.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear to slightly opalescent and colourless to pale yellow solution,
that may occasionally
contain thin translucent fibres or opaque particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Brineura is indicated for the treatment of neuronal ceroid
lipofuscinosis type 2 (CLN2)
disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.
4.2
DOSE AND METHOD OF ADMINISTRATION
Brineura must only be administered by a trained healthcare
professional knowledgeable in
intracerebroventricular administration in a healthcare setting.
DOSE
The recommended dose is 300 mg cerliponase alfa administered once
every other week by
intracerebroventricular infusion.
V2
Supersedes: V1.0
Page 2 of 20
In patients less than 2 years of age, lower doses are recommended, see
_Paediatric population_
section.
Pre-treatment of patients with antihistamines with or without
antipyretics is recommended 30
to 60 minutes prior to the start of infusion.
Continuation of long-term treatment should be subject to regular
clinical evaluation whether
the benefits are considered to outweigh the potential risks to
individual patients.
_ _
_DOSE ADJUSTMENTS _
Consideration of dose adjustments may be necessary for patients who
may not tolerate the
inf