Home Drug Guide Eliglustat Tartrate

Drug Guide

Generic Name

Eliglustat Tartrate

Brand Names Cerdelga

Classification

Therapeutic: Treatment of Gaucher disease type 1

Pharmacological: Substrate reduction therapy

FDA Approved Indications

Treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive, intermediate, or poor metabolizers

Mechanism of Action

Eliglustat inhibits glucosylceramide synthase, an enzyme responsible for the synthesis of glycosphingolipids, reducing the accumulation of substrate in Gaucher disease cells.

Dosage and Administration

Adult: Recommended dose is 84 mg twice daily, adjusted based on CYP2D6 metabolizer status.

Pediatric: Not established.

Geriatric: No specific dosage adjustments; monitor for comorbidities.

Renal Impairment: Use with caution; no specific dosage adjustment recommended.

Hepatic Impairment: Contraindicated in moderate or severe hepatic impairment.

Pharmacokinetics

Absorption: Rapidly absorbed with peak plasma levels in approximately 2 hours.

Distribution: Extensively bound to plasma proteins (~97%).

Metabolism: Metabolized mainly by CYP2D6 and CYP3A4 enzymes.

Excretion: Primarily via feces (about 63%) and urine (about 20%).

Half Life: Approximately 4-6 hours in extensive metabolizers.

Contraindications

Severe hepatic impairment.
Use with strong CYP2D6 or CYP3A4 inhibitors or inducers.

Precautions

Use with caution in patients with cardiac disease; monitor for arrhythmias, as QT prolongation has been observed.

Adverse Reactions - Common

Headache (Common)
Tiredness/Fatigue (Common)
Diarrhea (Common)

Adverse Reactions - Serious

QT prolongation (Uncommon)
Hepatotoxicity (Uncommon)
Cardiac arrhythmias (Uncommon)

Drug-Drug Interactions

CYP2D6 or CYP3A4 inhibitors or inducers (e.g., ketoconazole, rifampin).

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for adverse reactions, including cardiac arrhythmias, hepatotoxicity.

Diagnoses:

Risk of altered cardiac rhythm
Potential liver injury

Implementation: Monitor ECG, liver function tests, and assess patient adherence.

Evaluation: Evaluate effectiveness through clinical assessment and laboratory tests.

Patient/Family Teaching

Take medication exactly as prescribed.
Report any dizziness, palpitations, or symptoms of liver problems.
Inform about potential drug interactions.
Avoid grapefruit and other CYP3A4 inhibitors unless advised.

Special Considerations

Black Box Warnings:

None at present.

Genetic Factors: CYP2D6 metabolizer status affects dosing.

Lab Test Interference: None known.

Overdose Management

Signs/Symptoms: Dizziness, nausea, vomiting, arrhythmias.

Treatment: Supportive care; consider activated charcoal if ingestion is recent; monitor cardiac status.

Storage and Handling

Storage: Store at room temperature (20-25°C).

Stability: Stable up to the expiration date on the packaging.