ELELYSO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TALIGLUCERASE ALFA

Available from:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC code:

A16AB11

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION

Composition:

TALIGLUCERASE ALFA 200 U/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

PFIZER GLOBAL MANUFACTURIN, PHARMACIA AND UPJOHN COMPANY LLC, USA

Therapeutic group:

TALIGLUCERASE ALFA

Therapeutic area:

TALIGLUCERASE ALFA

Therapeutic indications:

ELELYSO™ (taliglucerase alfa) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for adults and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease

Authorization date:

2017-08-31

Patient Information leaflet

Elelyso PIL CC 190522 ENG
2022-0075212
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor's prescription only
ELELYSO
®
POWDER FOR SOLUTION FOR INFUSION
Each vial with powder contains:
taliglucerase alfa 200 Units
Inactive ingredients and allergens: see section 2 under ‘Important
information about some of this
medicine’s ingredients’ and section 6 ‘Further information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
ELELYSO is a hydrolytic lysosomal glucocerebroside-specific enzyme
given by injection that is
indicated for long-term enzyme replacement therapy for adults and
pediatric patients above 2
years with a confirmed diagnosis of Type 1 Gaucher disease.
THERAPEUTIC GROUP: Recombinant active hydrolytic lysosomal enzyme,
β-glucocerebrosidase
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other
ingredients in this medicine (see section 6).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH ELELYSO, TELL YOUR DOCTOR IF:
•
You previously had a severe hypersensitivity reaction following
intravenous infusion with
ELELYSO.
•
You are pregnant or breastfeeding.
TESTS AND FOLLOW-UP
In patients who developed anti-drug antibodies or who had
hypersensitivity reactions after
treatment with ELELYSO or after treatment with other enzyme
replacement therapy, it may be
necessary to monitor the antibody levels.
DRUG INTERACTIONS
IF YOU ARE TAKING OR HAVE RECENTLY TAKEN, OTHER MEDICINES, INCLUDING
NONPRESCRIPTION
MEDICINES AND DIETARY SUPPLEMENTS, TELL YOUR DOCTOR OR PHARMACIST.

Summary of Product characteristics

Elelyso LPD CC 141223
1
2022-0083203
NAME OF THE MEDICINAL PRODUCT
Elelyso
®
QUALITATIVE AND QUANTITATIVE COMPOSITION
Taliglucerase alfa 200 U/vial
For the full list of excipients, see section "DESCRIPTION" below.
PHARMACEUTICAL FORM
Powder for solution for infusion
1
INDICATIONS AND USAGE
ELELYSO (taliglucerase alfa) for injection is a hydrolytic lysosomal
glucocerebroside-specific
enzyme indicated for long-term enzyme replacement therapy (ERT) for
adults and pediatric patients
above 2 years with a confirmed diagnosis of Type 1 Gaucher disease.
2
DOSAGE AND ADMINISTRATION
2.1
RECOMMENDED DOSAGE
Treatment-naïve patients: The recommended dosage for treatment-naïve
adult and pediatric patients
above 2 years of age and older is 60 units per kg of body weight
administered every other week as a 60 to
120 minute intravenous infusion.
Patients switching from imiglucerase: If it is acceptable to switch
from a stable imiglucerase dosage to
ELELYSO, initiate ELELYSO intravenous treatment (60- to 120-minute
infusion) with the same units/kg
imiglucerase dosage and subsequently administer ELELYSO every other
week.
Dosage adjustments can
be made based on achievement and maintenance of each patient’s
therapeutic goals
2.2
PREPARATION INSTRUCTIONS
ELELYSO should be reconstituted, diluted, and administered under the
supervision of a healthcare
professional.
Prepare ELELYSO according to the following steps using aseptic
technique:
a.
Determine the number of vials to be reconstituted based on the
patient’s weight in kg and the
recommended dose _[see Dosage and Administration_ _(2.1)]_. Round the
number of vials up to the next
whole number.
b.
Remove the required number of vials from the refrigerator. Do not
leave these vials at room
temperature longer than 24 hours prior to reconstitution. Do not heat
or microwave these vials.
Elelyso LPD CC 141223
2
2022-0083203
c.
Reconstitute each vial of ELELYSO with 5.1 mL of Sterile Water for
Injection to yield a
reconstituted product with a concentration of 40 units/mL and an
extracta