Updated Contraindications, Dosing for Gaucher Disease Treatment Cerdelga

The prescribing information for Cerdelga (eliglustat; Sanofi Genzyme) has been updated with new contraindications, warnings and precautions, and dosing information.

Cerdelga, a glucosylceramide synthase inhibitor, is indicated for the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers, intermediate metabolizers, or poor metabolizers as detected by an FDA-cleared test. 

Due to the risk of cardiac arrhythmias from prolongation of the PR, QTc, and/or QRS cardiac intervals, Cerdelga is contraindicated in the following patients based on CYP2D6 metabolizer status:

Extensive metabolizers

• Taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor
• Moderate or severe hepatic impairment
• Mild hepatic impairment and taking a strong or moderate CYP2D6 inhibitor

Intermediate metabolizers 

• Taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor
• Taking a strong CYP3A inhibitor
• Any degree of hepatic impairment

Poor metabolizers

• Taking a strong CYP3A inhibitor
• Any degree of hepatic impairment

The Dosage and Administration section has been updated to include dosage adjustments based on both hepatic impairment status and concomitant use of CYP inhibitors.

In the Warnings and Precautions section, the labeling now states that Cerdelga has not been studied in patients with pre-existing cardiac conditions and therefore should be avoided in patients with congestive heart failure, recent acute myocardial infarction, bradycardia, heart block, ventricular arrhythmia, long QT syndrome, or in combination with Class IA or Class III antiarrhythmic drugs.

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