ELELYSO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 200 UNITS VIAL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Taliglucerase Alfa

Available from:

PFIZER PRIVATE LIMITED

ATC code:

A16AB11

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composition:

Taliglucerase Alfa 200Units/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Pharmacia and Upjohn Company LLC

Authorization status:

ACTIVE

Authorization date:

2023-05-03

Summary of Product characteristics

ELELYSO
®
TALIGLUCERASE ALFA
1.
NAME OF THE MEDICINAL PRODUCT
Elelyso
®
powder for concentrate for solution for infusion 200 units/vial.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 200 units* of taliglucerase alfa**.
After reconstitution, the solution contains 40 units of taliglucerase
alfa per mL
(200 units/5 mL).
*An enzyme unit is defined as the amount of enzyme that catalyzes the
hydrolysis of one
micromole of the synthetic substrate
para-nitrophenyl-β-D-glucopyranoside (pNP-Glc) per
minute at 37°C.
**Taliglucerase alfa 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.
Excipients with known effect
One vial contains 0.3 mmol sodium.
For a full list of excipients, see section
6.1. LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
Taliglucerase alfa is a white to off-white lyophilized powder that may
form a cake.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Taliglucerase alfa for infusion is a hydrolytic lysosomal
glucocerebroside-specific enzyme
indicated for long-term enzyme replacement therapy for adult and
pediatric patients with a
confirmed diagnosis of Type 1 Gaucher disease associated with at least
one of the following:
splenomegaly, hepatomegaly, anemia, thrombocytopenia.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with taliglucerase alfa should be supervised by a physician
experienced in the
management of patients with Gaucher disease. Home administration under
the supervision of
a healthcare professional may be considered only for those patients
who have been tolerating
their infusions (see section
4.8. UNDESIRABLE EFFECTS
).
Posology
Due to the heterogeneity and the multi-systemic nature of Gaucher
disease, dosage
adjustments should be made on an individual basis. Dose requirements
may increase or
decrease, based on achievement of therapeutic goals, as assessed by
regular comprehensive
evaluati