Cerdelga® demonstrated comparable efficacy to imiglucerase in maintenance of patients’ stability across visceral and haematologic parameters in patients previously stabilized on ERT.**1 The stability in visceral and haematologic parameters was maintained for up to 4 years.†1
Primary Composite Endpoint
Stability in 4 parameters; haemoglobin levels, platelet count, spleen and liver volume
*All patients transitioned to Cerdelga® treatment after 9 months.
**Excludes patients with a total splenectomy and all patients transitioned to Cerdelga® after 52 weeks.
†Excludes patients with a total splenectomy.
‡18 patients completed 8 years of treatment. 16 patients had an efficacy endpoint assessment at year 8.
Cerdelga® improved skeletal measures in treatment-naïve patients and patients previously stabilised on ERT1
Skeletal measures (bone marrow burden (BMB) and bone mineral density (BMD) scores) improved during Cerdelga® treatment in treatment-naïve patients. BMD remained stable under Cerdelga® treatment in patients previously stabilised on ERT.1
Cerdelga® improved BMD from osteopenia to normal range after 4 years3
- No adverse events have been reported as ‘very common’ (>10%)1
- The most commonly reported AE with Cerdelga® is dyspepsia, in approximately 6% of the clinical trial patients1
System organ class
|Common (≥1/100 to <1/10)|
|Nervous System disorders||Headache, dizziness, dysgeusia|
|Respiratory, thoracic and mediastinal disorders||Throat irritation|
|Gastrointestinal disorders||Dyspepsia, abdominal pain upper, diarrhoea, nausea, constipation, abdominal pain, gastroesophageal reflux disease, abdominal distension, gastritis, dysphagia, vomiting, dry mouth, flatulence|
|Skin and subcutaneous tissue disorders||Dry skin, urticaria|
|Musculoskeletal and connective tissue disorders||Arthralgia, pain in extremity, back pain|
|General disorders and administration site conditions||Fatigue|
Cerdelga® (eliglustat) drug-drug interaction checker
To access the drug-drug interaction checker click here
The patient’s experience
To access post–prescription patient materials that can be ordered or downloaded, click here
Cerdelga® mechanism of action
Please view the video of Cerdelga® mode of action, below:
Cerdelga® should only be used in patients who, based on genotyping, have a predicted CYP2D6 poor, intermediate or extensive metaboliser phenotype. Determination of the patient's CYP2D6 phenotype is required prior to initiating treatment with Cerdelga®.1
Genotyping to determine the patient's CYP2D6 phenotype is to be performed using an established genetic laboratory test that is able to detect a specific set of CYP2D6 allelles with adequate accuracy, sensitivity and specificity in order to ensure consistent identification of CYP2D6 metaboliser status.
Sanofi Genzyme offers a CYP2D6 testing service to UK clinicians treating patients with Gaucher disease through LabCorp Ltd. However, there are several suitable commercial tests available.
In the UK, for more information on gaining access to testing via LabCorp Ltd. or for accredited laboratories, you can contact Sanofi Genzyme on 0800 035 2525, or your local representative.
- Cerdelga®. Summary of Product Characteristics.
- Cox TM et al. Lancet. 2015 Jun 13;385(9985):2355–62.
- Lukina E et al. Blood Cells Mol Dis. 2014 Dec;53(4):274–6.
- Cox TM et al. Blood. 2017 Apr 27;129(17):2375–2383.
- Belmatoug N et al. Eur J Intern Med. 2016. pii: S0953–6205(16)30217–5.
- McEachern KA et al. Mol Genet Metab. 2007;91:259–267
- Shayman JA. Drugs Fut. 2010;35:613–620.