Eliglustat

Adults 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). Paediatric population (from 6 to <18 years of age) weighing ≥15 kg Cerdelga is indicated for paediatric patients with GD1 who are 6 years and older with a minimum body weight of 15 kg, who are stable on enzyme replacement therapy (ERT), and who are CYP2D6 PMs, IMs or EMs.

Adults 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). Paediatric population (from 6 to < 18 years of age) weighing ≥ 15 kg Cerdelga is indicated for paediatric patients with GD1 who are 6 years and older with a minimum body weight of 15 kg, who are stable on enzyme replacement therapy (ERT), and who are CYP2D6 PMs, IMs or EMs.

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CERDELGA (eliglustat) is indicated for: • the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 poor metabolizers (PMs), intermediate metabolizers (IMs) or extensive metabolizers (EMs), as determined by CYP2D6 genotype testing.

1 Pediatrics Pediatrics (< 18 years of age): Safety and effectiveness in pediatric patients have not been established; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (≥ 65 years of age): A limited number of patients aged 65 years and over were enrolled in clinical trials.

As greater rates of hepatic, renal, and cardiac function impairment are observed in elderly patients, this patient population may be more sensitive to the effects of CERDELGA (see 7 WARNINGS AND PRECAUTIONS and 4 DOSAGE AND ADMINISTRATION).