Revised SPC: Cerdelga (eliglustat) 84 mg capsules, hard

Due to significantly increased eliglustat plasma concentrations, use is contraindicated in CYP2D6 extensive metabolisers (EMs) with severe hepatic impairment and in CYP2D6 EMs with mild or moderate hepatic impairment taking a strong or moderate CYP2D6 inhibitor.

Limited/no data are available in CYP2D6 EMs with moderate hepatic impairment, and in CYP2D6 intermediate metabolisers or poor metabolisers with any degree of hepatic impairment. Use in these patients is not recommended.

 

Concomitant use with CYP2D6 or CYP3A4 inhibitors in CYP2D6 EMs with mild hepatic impairment can result in further elevation of eliglustat plasma concentrations, with the magnitude of the effect depending on the enzyme inhibited and the potency of the inhibitor. In CYP2D6 EMs with mild hepatic impairment taking a weak CYP2D6 inhibitor or strong, moderate or weak CYP3A inhibitor, a dose of 84mg eliglustat mg once daily should be considered.

 

Limited or no data are available in CYP2D6 EMs, intermediate metabolisers or poor metabolisers with ESRD and in CYP2D6 intermediate metabolisers or poor metabolisers with mild, moderate, or severe renal impairment; use in these patients is not recommended.