Country: Israel
Language: English
Source: Ministry of Health
ELIGLUSTAT
SANOFI ISRAEL LTD
A16AX10
HARD CAPSULE
ELIGLUSTAT 84.4 MG
PER OS
Required
GENZYME IRELAND LTD
ELIGLUSTAT
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).
2021-11-30
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 Read the complete document
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 Read the complete document