ELELYSO taliglucerase alfa rpc 200 units powder for injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Taliglucerase alfa, Quantity: 212 U

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Taliglucerase alfa

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: mannitol; citric acid; sodium citrate dihydrate; polysorbate 80

Administration route:

Intravenous

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ELELYSO is indicated for long-term enzyme replacement therapy for adult and paediatric patients with a confirmed diagnosis of Type 1 Gaucher disease associated with at least one of the following: splenomegaly, hepatomegaly, anaemia, thrombocytopenia.

Product summary:

Visual Identification: white to off-white powder, may form cake.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-05-21

Patient Information leaflet

ELELYSO
®
E
L
E
L
Y
S
O
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ELELYSO?
Elelyso contains the active ingredient taliglucerase alfa rpc and is
an Enzyme Replacement Therapy which is used to treat Type
1 Gaucher disease in adults and children (2 to 17 years of age) with
at least one of the following signs of the condition: a spleen
or liver that is larger than expected; a low number of red blood cells
(anaemia); a tendency to bleed easily caused by a low blood
platelet count (platelets stop blood loss by forming a plug inside a
blood vessel). For more information, see Section 1. Why am I
using Elelyso? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ELELYSO?
Do not use if you have ever had an allergic reaction to any medicine
containing taliglucerase alfa rpc, other Enzyme Replacement
Therapies such as Cerezyme® or Vpriv®, to carrots, or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have previously experienced a reaction
during an infusion or allergic reaction to other Enzyme
Replacement Therapy for Gaucher disease; if you are on a low salt
diet; if you have experienced difficulty breathing; if you take any
other medicines; or if you are pregnant or plan to become pregnant or
are breastfeeding.
For more information, see Section 2. What should I know before I use
Elelyso? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Elelyso and affect how it works. For
more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ELELYSO?
Elelyso should only be given under the supervision of a doctor (or
healthcare professional) who is knowledgeable in the treatment of
Gaucher disease. Your doctor will decide the dosage and the frequency
of the dose suitable for you.
More instructions can be found in Section 4. How do I use Elelyso? in
the full CMI.
5.
WH

Summary of Product characteristics

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Page 1 of 19
AUSTRALIAN
PRODUCT
INFORMATION
–
ELELYSO
®
(TALIGLUCERASE
ALFA
RECOMBINANT
PLANT
CARROT (RPC))
1.
NAME OF THE MEDICINE
Taliglucerase alfa recombinant plant carrot (rpc).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ELELYSO
®
(taliglucerase alfa rpc) 200 units powder for injection.
Each vial of ELELYSO contains 200 units* of taliglucerase alfa rpc**.
After reconstitution, the solution contains 40 units (approximately
1.2 mg) of taliglucerase alfa
rpc per mL (200 units/5 mL).
*An enzyme unit is defined as the amount of enzyme that catalyses the
hydrolysis of one
micromole of the synthetic substrate
para-nitrophenyl-β-D-glucopyranoside (pNP-Glc) per
minute at 37ºC.
**Taliglucerase alfa rpc is a recombinant form of human
glucocerebrosidase expressed in
genetically modified carrot plant cells in suspension that naturally
bears terminal mannose
structures for targeting macrophages.
For the full list of excipients, see Section 6.1 – List of
excipients.
3.
PHARMACEUTICAL FORM
ELELYSO powder for injection
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ELELYSO is indicated for long-term enzyme replacement therapy for
adult and paediatric
patients with a confirmed diagnosis of Type 1 Gaucher disease
associated with at least one of
the following: splenomegaly, hepatomegaly, anaemia, thrombocytopenia.
4.2 DOSE AND METHOD OF ADMINISTRATION
Treatment
with
ELELYSO
should
be
supervised
by
a
physician
experienced
in
the
management of patients with Gaucher disease. Home administration under
the supervision of
a
healthcare
professional
trained
in
recognising
and
medically
managing
serious
infusion-related reactions under the direction of a practising
physician may be considered only
for those patients who have been tolerating their infusions.
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Due to the heterogeneity and the multi-systemic nature of Gaucher
disease, dosage must be
individualised to each patient. Dose requirements may increase or
dec