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Eliglustat oral

Updated 2 Feb 2023 | Gaucher's disease


Oral formulations containing eliglustat.

Drugs List

  • CERDELGA 84mg capsules
  • eliglustat 84mg capsules
  • Therapeutic Indications


    Type 1 Gaucher disease in CYP2D6 intermediate and extensive metabolisers
    Type 1 Gaucher disease in CYP2D6 poor metabolisers



    CYP2D6 Intermediate Metabolisers and Extensive Metabolisers
    84mg twice daily.

    CYP2D6 Poor Metabolisers
    84mg once daily.

    In the case of a missed dose, take the dose at the next scheduled time.

    Patients with Renal Impairment

    CYP2D6 extensive metaboliser

    Mild, moderate or severe renal impairment: No dosage adjustment is necessary.
    End stage renal disease: Eliglustat is not recommended.

    CYP2D6 intermediate metabolisers or poor metabolisers

    Mild, moderate or severe renal impairment or end stage renal disease: Eliglustat is not recommended.

    Patients with Hepatic Impairment

    CYP2D6 extensive metabolisers

    Mild hepatic impairment (Child-Pugh class A): No dosage adjustment necessary.
    Moderate hepatic impairment (Child-Pugh class B): Eliglustat not recommended.
    Severe hepatic impairment (Child-Pugh class C): Eliglustat contraindicated.

    Mild or moderate hepatic impairment taking a strong or moderate CYP2D6 inhibitor: Eliglustat is contraindicated.
    Mild hepatic impairment taking a weak CYP2D6 inhibitor or a strong moderate or weak CYP3A inhibitor: 84mg once daily.

    CYP2D6 intermediate metabolisers and poor metabolisers

    Any degree of hepatic impairment: Eliglustat is not recommended.


    Children under 18 years
    Atrioventricular block
    Congestive cardiac failure
    CYP2D6 ultra-rapid metaboliser genotype
    End stage renal disease
    Long QT syndrome
    Recent myocardial infarction
    Severe hepatic impairment
    Torsade de pointes
    Ventricular arrhythmias

    Precautions and Warnings

    Family history of long QT syndrome
    Electrolyte imbalance
    Glucose-galactose malabsorption syndrome
    History of torsade de pointes
    Lactose intolerance
    Mild hepatic impairment
    Renal impairment

    Correct electrolyte disorders before treatment
    Determine CYP2D6 metaboliser status before initiation of treatment
    Treatment to be initiated and supervised by a specialist
    Contains lactose
    Contains propylene glycol: may cause irritation
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor disease progression when switching from enzyme replacement therapy
    Monitor serum electrolytes
    Advise patient not to take St John's wort concurrently
    Advise patient grapefruit products may increase plasma level

    In patients who have sub-optimal response (less than 20% reduction in spleen volume after 9 months) to treatment with eliglustat, consider the reintroduction of enzyme replacement therapy or an alternative treatment.

    Pregnancy and Lactation


    Use eliglustat with caution during pregnancy.

    The manufacturer advises that eliglustat should be avoided during pregnancy.

    Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. No clinical studies on exposed pregnancies are available.


    Use eliglustat with caution during breastfeeding.

    The manufacturer advises that mothers do not breastfeed during treatment with eliglustat.

    It is not known whether eliglustat is excreted in human breast milk. Animal studies have shown excretion of eliglustat in milk.

    Side Effects

    Abdominal distension
    Abdominal pain
    Gastroesophageal reflux disease


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: August 2019

    Reference Sources

    Summary of Product Characteristics: Cerdelga 84 mg capsules, hard. Sanofi Genzyme. Revised April 2019.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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