CERDELGA eliglustat (as tartrate) 84 mg capsule blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
eliglustat tartrate, Quantity: 100 mg (Equivalent: eliglustat, Qty 84.4 mg)
Available from:
Sanofi-Aventis Australia Pty Ltd
INN (International Name):
eliglustat tartrate
Pharmaceutical form:
Capsule, hard
Composition:
Excipient Ingredients: lactose monohydrate; hypromellose; microcrystalline cellulose; glycerol dibehenate; iron oxide yellow; Gelatin; indigo carmine aluminium lake; titanium dioxide; mica; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid
Administration route:
Oral
Units in package:
56 capsules
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1).
Product summary:
Visual Identification: Pearl blue-green opaque cap and pearl white opaque body capsules with GZ02 printed in black on the capsule.; Container Type: Blister Pack; Container Material: PCTFE (Aclar)/AI; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2015-02-17
Patient Information leaflet
CERDELGA
®
_eliglustat_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cerdelga. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Cerdelga
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CERDELGA IS USED
FOR
Cerdelga contains the active
substance eliglustat. It belongs to a
group of medicines that decrease the
production of a substance called
glucosylceramide in the body.
Cerdelga is used for the long term
treatment of adult patients with
Gaucher disease type 1.
Gaucher disease type 1 is a rare,
inherited condition in which a
substance called glucosylceramide
builds up in the cells of your spleen,
liver and bones.
The build-up can prevent these
organs from working properly.
Cerdelga decreases the production of
glucosylceramide, preventing its
build-up. In turn this helps your
affected organs to work better.
Some people’s bodies break down
this medicine faster than others. As a
result the amount of this medicine in
the blood can differ between patients
which could affect how you will
respond. Cerdelga is meant to be
used in patients whose body breaks
down this medicine at normal speed
(known as intermediate metaboliser
and extensive metaboliser) or slow
speed (known as poor metaboliser).
Your doctor will determine if
Cerdelga is suitable for you before
you start taking it, using a simple
laboratory test.
Gaucher disease type 1 is a lifelong
condition and you must continue to
take Cerdelga as prescribed by your
doctor to gain the maximum benefit
from your medicine.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
There is not enough information to
Read the complete document
Summary of Product characteristics
PRODUCT INFORMATION
Cerdelga - eliglustat
AUSTRALIAN PRODUCT INFORMATION – CERDELGA
(ELIGLUSTAT)
1
NAME OF THE MEDICINE
Cerdelga (eliglustat)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Cerdelga capsule contains 84 mg eliglustat (equivalent to 100 mg
eliglustat tartrate).
For the full list of excipients, see Section 6.1- List of excipients.
Eliglustat is a synthetic small molecule and is a white to off-white
powder. Eliglustat tartrate
is highly soluble in water. It has a pKa of 8.79 and log P of 2.84.
3
PHARMACEUTICAL FORM
Cerdelga is formulated as a hard capsule for oral administration.
Cerdelga is available as pearl blue-green opaque cap and pearl white
opaque body capsules
with “GZ02” printed in black on the capsule. The size of the
capsule is ‘size 2’ (dimensions
18.0 x 6.4 mm).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cerdelga is indicated for the long-term treatment of adult patients
with Gaucher disease type
1 (GD1).
4.2
DOSE AND METHOD OF ADMINISTRATION
Therapy with Cerdelga should be initiated and supervised by a
physician knowledgeable in
the management of Gaucher disease.
Before initiation of treatment with eliglustat, patients should be
genotyped for CYP2D6 to
determine the CYP2D6 metaboliser status.
Eliglustat can be taken with or without food. Avoid consumption of
grapefruit or grapefruit
juice with eliglustat because grapefruit is a strong CYP3A inhibitor.
The capsules should be swallowed whole, preferably with water, and
should not be crushed,
dissolved, or opened.
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PRODUCT INFORMATION
Cerdelga - eliglustat
If a dose is missed, the prescribed dose should be taken at the next
scheduled time; the next
dose should not be doubled.
_CYP2D6 INTERMEDIATE METABOLISERS (IMS) AND EXTENSIVE METABOLISERS
(EMS): _
The recommended dose of Cerdelga in CYP2D6 IMs and EMs is 84 mg twice
daily taken
orally.
_IMPORTANT DOSING INFORMATION _
Co-administration of eliglustat with other CYP2D6 or CYP3A inhibitors
affects its systemic
exposure (see section 4.5
Read the complete document
