Methods for treating gaucher disease

A method of treating Gaucher disease comprising administering to a patient in need thereof an adjusted effective amount of eliglustat, or a pharmaceutically acceptable salt thereof, wherein said patient is an extensive CYP2D6 metabolizer with mild hepatic impairment and wherein said patient is concurrently taking a drug that is a weak CYP2D6 inhibitor.

A method of treating Gaucher disease comprising administering to a patient in need thereof an adjusted effective amount of eliglustat, or a pharmaceutically acceptable salt thereof, wherein said patient is an extensive CYP2D6 metabolizer with mild hepatic impairment and wherein said patient is concurrently taking a drug that is a weak CYP3A inhibitor.

-12. (canceled)

A method of providing eliglustat, or a pharmaceutically acceptable salt thereof, wherein the eliglustat, or pharmaceutically acceptable salt thereof, is provided along with information indicating that it is useful for treating patients with Gaucher disease, and in cases wherein said patient is an extensive CYP2D6 metabolizer with mild hepatic impairment, no dose adjustment is required.

A package comprising eliglustat, or a pharmaceutically acceptable salt thereof, and a label, said label comprising a printed statement which informs a prospective user that eliglustat, or pharmaceutically acceptable salt thereof, is i) indicated for the treatment of Gaucher disease type 1 and ii) is contraindicated in CYP2D6 intermediate metabolizers (IMs) or poor metabolizers (PMs) with any degree of hepatic impairment and in CYP2D6 extensive metabolizers (EMs) with moderate or severe hepatic impairment.

A method for treating Gaucher disease, comprising administering an adjusted effective amount of eliglustat, or a pharmaceutically acceptable salt thereof, to a patient in need thereof in combination with a weak CYP2D6 inhibitor, wherein said patient is a CYP2D6 extensive metabolizer and wherein said patient has mild hepatic impairment.

A method for treating Gaucher disease, comprising administering an adjusted effective dose of eliglustat, or a pharmaceutically acceptable salt thereof, to a patient in need thereof in combination with a weak CYP3A inhibitor, wherein said patient is a CYP2D6 extensive metabolizer and wherein said patient has mild hepatic impairment.