Brand Name
Cerdelga
Generic Name
Eliglustat
View Brand Information FDA approval date: September 03, 2014
Classification: Glucosylceramide Synthase Inhibitor
Form: Capsule
What is Cerdelga (Eliglustat)?
CERDELGA 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 [see Dosage and Administration.
Approved To Treat
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Brand Information
Cerdelga (eliglustat)
1INDICATIONS AND USAGE
CERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test
2DOSAGE FORMS AND STRENGTHS
Capsules: 84 mg of eliglustat is in a capsule with a pearl blue-green opaque cap and pearl white opaque body imprinted with "GZ02" in black.
3CONTRAINDICATIONS
CERDELGA is contraindicated in the following patients based on CYP2D6 metabolizer status due to the risk of cardiac arrhythmias from prolongation of the PR, QTc, and/or QRS cardiac intervals.
4OVERDOSAGE
The highest eliglustat plasma concentration experienced to date occurred in a single-dose, dose escalation study in healthy subjects, in a subject taking a dose equivalent to approximately 21 times the recommended dose for GD1 patients. At the time of the highest plasma concentration (59-fold higher than normal therapeutic conditions), the subject experienced dizziness marked by disequilibrium, hypotension, bradycardia, nausea, and vomiting.
In the event of acute overdose, the patient should be carefully observed and given symptomatic and supportive treatment.
Hemodialysis is unlikely to be beneficial given that eliglustat has a large volume of distribution
5DESCRIPTION
CERDELGA (eliglustat) capsules contain eliglustat tartrate, which is a small molecule inhibitor of glucosylceramide synthase that resembles the ceramide substrate for the enzyme, with the chemical name N-((1
Each capsule of CERDELGA for oral use contains 84 mg of eliglustat (equivalent to 100 mg of eliglustat tartrate). The inactive ingredients are candurin silver fine, FD&C blue 2, gelatin, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, and yellow iron oxide.
6HOW SUPPLIED/STORAGE AND HANDLING
CERDELGA is supplied as 84 mg eliglustat in a capsule with a pearl blue-green opaque cap and pearl white opaque body imprinted with "GZ02" in black.
CERDELGA 84 mg capsules are supplied as:
NDC 58468-0220-1 – Carton containing 4 packs of capsules (56 capsules total). Each pack is composed of 1 blister card of 14 capsules and a cardboard wallet.
NDC 58468-0220-2 – Carton containing 1 pack of capsules (14 capsules total). Each pack is comprised of 1 blister card of 14 capsules and a cardboard wallet.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
8PRINCIPAL DISPLAY PANEL - 4 Blister Pack Carton
NDC 58468-0220-1
Cerdelga
(eliglustat) capsules
(eliglustat) capsules
84 mg*
*Each capsule contains 84 mg of eliglustat which is
Dispense the enclosed Medication Guide to each patient
Four cartons of 14 capsules each
Rx Only
