Cerdelga

ELIGLUSTAT

Manufacturer: Genzyme Corporation

Score: 141.0

Quick Summary

Cerdelga (eliglustat) is a medication used for the long-term treatment of adult patients with Gaucher disease type 1 (GD1). It works by inhibiting the enzyme glucosylceramide synthase, which helps reduce the accumulation of glucosylceramide in the body. The recommended dosage is based on the patient's CYP2D6 metabolizer status, with extensive metabolizers (EMs) and intermediate metabolizers (IMs) taking 84 mg twice daily and poor metabolizers (PMs) taking 84 mg once daily. Important safety information includes the risk of cardiac arrhythmias, and contraindications include the use of strong or moderate CYP2D6 inhibitors with strong or moderate CYP3A inhibitors in EMs and IMs, as well as any degree of hepatic impairment in IMs and PMs. Adverse reactions include fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain.

Key Clinical Findings and Indications

Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1)
It is a glucosylceramide synthase inhibitor that reduces the accumulation of glucosylceramide in the body
The recommended dosage is based on the patient's CYP2D6 metabolizer status

Important Safety Information

Warning

Risk of cardiac arrhythmias from prolongation of the PR, QTc, and/or QRS cardiac intervals

Contraindications

Use of strong or moderate CYP2D6 inhibitors with strong or moderate CYP3A inhibitors in EMs and IMs
Any degree of hepatic impairment in IMs and PMs
Moderate or severe hepatic impairment in EMs
Mild hepatic impairment and taking a strong or moderate CYP2D6 inhibitor in EMs

Adverse Reactions

Fatigue
Headache
Nausea
Diarrhea
Back pain
Pain in extremities
Upper abdominal pain

Dosing Recommendations

General Guidance

Reduce dosage frequency to once daily in EMs and IMs with or without hepatic impairment taking CYP2D6 or CYP3A inhibitors

Gaucher disease type 1

Adult Dose

84 mg twice daily for EMs and IMs, 84 mg once daily for PMs

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Available data on Cerdelga use in pregnant women are limited
Use during pregnancy may exacerbate existing Gaucher disease type 1 symptoms or result in new disease manifestations

Nursing Mothers

No data available on the use of Cerdelga in nursing mothers

Pediatric Use

Safety and effectiveness in pediatric patients have not been established

Geriatric Use

Clinical experience has not identified differences in responses between the elderly and younger patients

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