Drug Index

Eliglustat

 
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Mechanism :

Eliglustat inhibits the enzyme needed to produce glycosphingolipids and decreases the rate of glycosphingolipid glucosylceramide formation.


Indication :

• Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs)


Contraindications :

Use in extensive metabolizers (EMs) with moderate or severe hepatic impairment; use in intermediate metabolizers (IMs) or poor metabolizers (PMs) with any degree of hepatic impairment; concomitant use of a moderate or strong CYP2D6 inhibitor with a moderate or strong CYP3A inhibitor in EMs or IMs; concomitant use of a strong CYP3A inhibitor in PMs or IMs; concomitant use of a moderate or strong CYP2D6 inhibitor in EMs with mild hepatic impairment.

Hypersensitivity to eliglustat or any component of the formulation; hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the Lapp lactase deficiency.


Dosing :

Safety and efficacy not established in pediatric patients

Adults:

Dose based on patient’s CYP2D6 metabolizer status

CYP2D6 EM or IM: 84 mg PO BD

CYP2D6 PM: 84 mg PO OD


Adverse Effect :

Headache, fatigue, diarrhea, nausea, arthralgia, back pain, limb pain, palpitations migraine, dizziness, skin rash, flatulence, upper abdominal pain, dyspepsia, gastroesophageal reflux disease, constipation, weakness, oropharyngeal pain.


Interaction :

CYP2D6 Inhibitors: May increase the serum concentration of Eliglustat.
CYP3A4 Inducers: May decrease the serum concentration of Eliglustat.
CYP3A4 Inhibitors: May increase the serum concentration of Eliglustat.
Dabigatran Etexilate: P-glycoprotein/ABCB1 Inhibitors may increase serum concentrations of the active metabolite(s) of Dabigatran Etexilate.
QTc-Prolonging Agents: May enhance the QTc-prolonging effect of QTc-Prolonging Agents.



Hepatic Dose :

Use eliglustat in patients with hepatic impairment based on CYP2D6 metabolizer status and
concomitant use of CYP2D6 or CYP3A inhibitors. Use with caution in children.
In Extensive metabolizers in adults:
Mild hepatic impairment and not taking a CYP2D6 or CYP3A inhibitor: No dosage adjustment necessary.
Mild hepatic impairment and taking a weak CYP2D6 inhibitor or a strong, moderate, or weak CYP3A inhibitor: Reduce the dose to 84 mg once daily.
Mild hepatic impairment and taking a strong to moderate CYP2D6 inhibitor: Use is contraindicated.
Moderate or severe hepatic impairment: Use is contraindicated.
In Intermediate and Poor metabolizers in adults:
Use is contraindicated in patients with any degree of hepatic impairment.
08/05/2020 08:56:06 Eliglustat
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