Eliglustat oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing eliglustat.
Drugs List
Therapeutic Indications
Uses
Type 1 Gaucher disease in CYP2D6 intermediate and extensive metabolisers
Type 1 Gaucher disease in CYP2D6 poor metabolisers
Dosage
Adults
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.
Contraindications
Children under 18 years
Atrioventricular block
Bradycardia
Congestive cardiac failure
CYP2D6 ultra-rapid metaboliser genotype
End stage renal disease
Galactosaemia
Long QT syndrome
Recent myocardial infarction
Severe hepatic impairment
Torsade de pointes
Ventricular arrhythmias
Precautions and Warnings
Family history of long QT syndrome
Breastfeeding
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Lactose intolerance
Mild hepatic impairment
Pregnancy
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
Pregnancy
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.
Lactation
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
Arthralgia
Constipation
Diarrhoea
Dizziness
Dyspepsia
Fatigue
Gastritis
Gastroesophageal reflux disease
Headache
Nausea
Palpitations
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
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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