CERDELGA

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

ELIGLUSTAT

MAH:

SANOFI ISRAEL LTD

ATC_code:

A16AX10

pharmaceutical_form:

HARD CAPSULE

composition:

ELIGLUSTAT 84.4 MG

administration_route:

PER OS

prescription_type:

Required

manufactured_by:

GENZYME IRELAND LTD

therapeutic_area:

ELIGLUSTAT

therapeutic_indication:

Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).

authorization_date:

2021-11-30

PIL

GUIDE FOR PRESCRIBER
MAT-IL-2100417
3
Guide for Prescriber
CERDELGA is indicated for the long-term treatment of adult patients
with Gaucher disease
type 1, who are CYP2D6 poor metabolisers (PMs), intermediate
metabolisers (IMs) or
extensive metabolisers (EMs).
This guide has been developed as part of the CERDELGA educational
programme and is
intended for physicians who initiate and supervise CERDELGA treatment.
It is intended to
improve the use of CERDELGA by positively influencing appropriate
actions.
It contains:
1.
Checklist of actions to be completed before and after treatment
initiation
2.
Information on CYP2D6 genotyping assessment
3.
Information on reporting suspected adverse reactions
In addition, a _Patient Alert Card _has been developed that you should
give to patients
initiating CERDELGA treatment. If needed, cards are available upon
request from Sanofi
Medical Information 09-8633700. This card is a liaison tool to inform
any healthcare
professionals who are treating patients receiving CERDELGA about
drug-drug
interactions that should be considered before prescription or delivery
of any additional
medicinal products, including herbal products. The patient (or care
givers when
appropriate) should be told to carry and show this card at all times
to any healthcare
professional who may be prescribing or delivering additional medicinal
products.
Moreover, it contains information to remind the patient about the risk
of self-medication
and consumption of grapefruit products.
For more information on CERDELGA, please refer to Summary of Product
Characteristics
or contact Sanofi at: 09-8633700
5
4
Prescriber Check List
1.
Before treatment initiation, it should be verified if the patient is
appropriate for
CERDELGA treatment
Three steps must be achieved to confirm patient’s eligibility for
CERDELGA treatment
initiation:
C
1
2.
Patient Education
You have informed the patient about the drug-drug interactions that
could occur with
CERDELGA and the importance of informing all healthcare professionals
about the
pati

SPC

1
CERDCAP-V8
NAME OF THE MEDICINAL PRODUCT
Cerdelga
Patient Safety Information Card
The marketing of Cerdelga is subject to a risk management plan (RMP)
including a 'Patient safety
information card'. The 'Patient safety information card', emphasizes
important safety information that
the patient should be aware of before and during treatment. Please
explain the patient the need to
review the card before starting treatment.
Prescriber Guide
This product is marked with prescriber guide providing important
safety information. Please ensure
you are familiar with this material as it contains important safety
information.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 84.4 mg of eliglustat (as tartrate).
Excipient(s) with known effect:
Each capsule contains 106 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Capsule with pearl blue-green opaque cap and pearl white opaque body
with “GZ02” printed in black
on the body of 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),
who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers
(IMs) or extensive metabolisers
(EMs).
4.2
Posology and method of administration
_ _
Therapy with Cerdelga should be initiated and supervised by a
physician knowledgeable in the
management of Gaucher disease.
Posology
The recommended dose is 84 mg eliglustat twice daily in CYP2D6
intermediate metabolisers (IMs)
and extensive metabolisers (EMs). The recommended dose is 84 mg
eliglustat once daily in CYP2D6
poor metabolisers (PMs).
_Missed dose _
2
If a dose is missed, the prescribed dose should be taken at the next
scheduled time; the next dose
should not be doubled.
_Special populations _
_CYP2D6 ultra-rapid metabolisers (URMs) and indeterminate metabolisers
_
Eliglustat should not be used in patients who are CYP2D6 ultr