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Last Updated: May 13, 2024

Claims for Patent: 10,888,544


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Summary for Patent: 10,888,544
Title:Methods for treating Gaucher disease
Abstract: Methods for treating Gaucher disease in patients with renal or hepatic impairment.
Inventor(s): Li; Jing (Bridgewater, NJ), Peterschmitt; M. Judith (Watertown, MA), Kanamaluru; Vanaja (Bridgewater, NJ), Chen; Jun (Bridgewater, NJ), Gaemers; Sebastiaan J. M. (Naarden, NL), Rudin; Dan (Cambridge, MA)
Assignee: GENZYME CORPORATION (Cambridge, MA)
Application Number:16/219,064
Patent Claims: 1. 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 strong or moderate CYP3A inhibitor.

2. The method according to claim 1, wherein the adjusted effective amount is a once daily dose of 84 mg of eliglustat or a pharmaceutically acceptable salt thereof, measured in base form.

3. The method according to claim 2, wherein the eliglustat or pharmaceutically acceptable salt thereof is eliglustat hemitartrate.

4. A method of treating Gaucher disease comprising administering to a patient in need thereof an effective amount of eliglustat, or a pharmaceutically acceptable salt thereof, wherein said patient is an extensive CYP2D6 metabolizer with moderate or severe renal impairment.

5. The method according to claim 4, wherein the effective amount is a twice daily dose of 84 mg of eliglustat or a pharmaceutically acceptable salt thereof, measured in base form.

6. The method according to claim 5, wherein the eliglustat or pharmaceutically acceptable salt thereof is eliglustat hemitartrate.

7. 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 strong or moderate CYP3A inhibitor, wherein said patient is a CYP2D6 extensive metabolizer and wherein said patient has mild hepatic impairment.

8. The method according to claim 7, wherein the adjusted effect amount of eliglustat, or pharmaceutically acceptable salt thereof, is a dose of 84 mg of eliglustat, measured in base form, once daily.

9. The method according to claim 8, wherein the eliglustat or pharmaceutically acceptable salt thereof is eliglustat hemitartrate.

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