Eliglustat

Generic name
Eliglustat
Brand name
ATC Code
A16AX10

Eliglustat

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The steady-state exposure in children treated with the recommended dose is comparable to the exposure in adults.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Enzyme replacement therapy in Gaucher’s disease, type 1
  • Oral
    • 6 years up to 18 years and 15 up to 25 kg
      •   CYP2D6 extensive and intermediate metabolizers CYP2D6 poor metabolizers
        Dosis 84 mg/day in 2 doses 21 mg/day in 1 dose
    • 6 years up to 18 years and 25 up to 50 kg
      •   CYP2D6 extensive and intermediate metabolizers CYP2D6 poor metabolizers
        Dosis 168 mg/day in 2 doses 42 mg/day in 1 dose
    • 6 years up to 18 years and ≥ 50 kg
      •   CYP2D6 extensive and intermediate metabolizers CYP2D6 poor metabolizers
        Dosis 168 mg/day in 2 doses 84 mg/day in 1 dose

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The most common side effects with monotherapy in children are dyspepsia (9.8%) and dry skin (3.6%). With combination therapy with eliglustat/imiglucerase, the most common side effects were headache, dyspepsia, gastritis, and fatigue.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

  • CYP2D6 normal metabolizers with severe hepatic impairment;
  • CYP2D6 normal metabolizers with mild or moderate hepatic impairment who are taking a moderate or strong CYP2D6 inhibitor.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Amino acids and derivatives
A16AA06
A16AA05
A16AA01
A16AA04
Enzymes
A16AB03
A16AB04
A16AB07
A16AB13
A16AB22
A16AB17
A16AB08
A16AB09
A16AB02
A16AB05
A16AB14
A16AB10
Various alimentary tract and metabolism products
A16AX09
A16AX
A16AX18
A16AX06
A16AX04
A16AX07
A16AX
A16AX08
A16AX07
A16AX05
AMINO ACIDS AND DERIVATIVES
A16AA06
A16AA05
A16AA01
A16AA04

Reference

  1. Sanofi B.V., SmPC Cerdelga (EU/1/14/974/001) Rev 20, 16-05-2025, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose