Cerdelga
CYP2D6 poor metaboliser status, Gaucher Disease, CYP2D6 extensive metabolizer status + 1 more
Treatment
5 FDA approvals
0 Active Studies for Cerdelga
Treatment for
CYP2D6 poor metaboliser status
What is Cerdelga
Eliglustat
The Generic name of this drug
Treatment Summary
Eliglustat, also known as CERDELGA, is a medication used to treat type 1 Gaucher disease. Before using this drug, it is important to get an FDA-approved genotype test to determine if the patient is an extensive, intermediate, or poor metabolizer. If a person is an ultra-rapid or indeterminate metabolizer, Eliglustat is not recommended. Eliglustat was approved by the FDA in 2014.
Cerdelga
is the brand name
Cerdelga Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Cerdelga
Eliglustat
2014
1
Approved as Treatment by the FDA
Eliglustat, also called Cerdelga, is approved by the FDA for 5 uses such as Gaucher Disease, Type 1 and Gaucher Disease .
Gaucher Disease, Type 1
Helps manage Gaucher Disease, Type 1
Gaucher Disease
Helps manage Gaucher Disease, Type 1
Cytochrome P-450 CYP2D6 Inducers
Helps manage CYP2D6 intermediate metabolizer status
CYP2D6 poor metaboliser status
Helps manage CYP2D6 poor metaboliser status
CYP2D6 extensive metabolizer status
Helps manage CYP2D6 extensive metabolizer status
Effectiveness
How Cerdelga Affects Patients
Eliglustat works by slowing down an enzyme (glucosylceramide synthase) that is linked to certain diseases. It doesn't appear to affect other enzymes, such as alpha-glucosidase I and II, or lysosomal and non-lysosomal glucosylceramidases. When taken at 8 times the recommended dose, it did not have a significant effect on heart rhythm. However, high levels of the drug in the blood may increase the risk of cardiac arrhythmias. Those with existing heart conditions, long QT syndrome or taking certain antiarrhythmic drugs
How Cerdelga works in the body
Eliglustat is used to treat type 1 Gaucher disease, a rare genetic disorder. People with this condition do not have enough of an enzyme called acid β-glucosidase, which helps convert a molecule called glucosylceramide into glucose and ceramide. Without this enzyme, glucosylceramide builds up in the body, causing problems like anemia, low platelet count and enlarged liver or spleen. Eliglustat works by blocking the enzyme glucosylceramide synthase, which helps reduce the amount of glucosylceramide in the body. This helps balance out the lack of
When to interrupt dosage
The prescribed dosage of Cerdelga is contingent upon the determined ailment, including CYP2D6 poor metaboliser status, CYP2D6 extensive metabolizer status and Cytochrome P-450 CYP2D6 Inducers. The dosage is subject to change depending on the method of delivery (e.g. Oral or Capsule) mentioned in the accompanying table.
Condition
Dosage
Administration
CYP2D6 poor metaboliser status
, 84.0 mg
, Oral, Capsule - Oral, Capsule
Gaucher Disease
, 84.0 mg
, Oral, Capsule - Oral, Capsule
CYP2D6 extensive metabolizer status
, 84.0 mg
, Oral, Capsule - Oral, Capsule
Cytochrome P-450 CYP2D6 Inducers
, 84.0 mg
, Oral, Capsule - Oral, Capsule
Warnings
Cerdelga has twenty contraindications and should not be administered when there are any of the conditions detailed in the following table.
Cerdelga Contraindications
Condition
Risk Level
Notes
CYP2D6 extensive metabolizer status
Do Not Combine
Cytochrome P-450 CYP2D6 Inducers
Do Not Combine
CYP2D6 extensive metabolizer status
Do Not Combine
CYP2D6 extensive metabolizer status
Do Not Combine
CYP2D6 extensive metabolizer status
Do Not Combine
Cytochrome P-450 CYP2D6 Inducers
Do Not Combine
CYP2D6 extensive metabolizer status
Do Not Combine
CYP2D6 poor metaboliser status
Do Not Combine
Cytochrome P-450 CYP2D6 Inducers
Do Not Combine
Cytochrome P-450 CYP2D6 Inducers
Do Not Combine
Galactosemias
Do Not Combine
Cytochrome P-450 CYP2D6 Inducers
Do Not Combine
Liver Disease
Do Not Combine
Glucose-Galactose Malabsorption
Do Not Combine
CYP2D6 extensive metabolizer status
Do Not Combine
Lactose Intolerance
Do Not Combine
Moderate Hepatic Impairment
Do Not Combine
Severe Hypersensitivity Reactions
Do Not Combine
Eliglustat may interact with Pulse Frequency
CYP2D6 poor metaboliser status
Do Not Combine
CYP2D6 extensive metabolizer status
Do Not Combine
There are 20 known major drug interactions with Cerdelga.
Common Cerdelga Drug Interactions
Drug Name
Risk Level
Description
Abemaciclib
Major
The serum concentration of Abemaciclib can be increased when it is combined with Eliglustat.
Ajmaline
Major
The risk or severity of Cardiac Arrhythmia can be increased when Eliglustat is combined with Ajmaline.
Axitinib
Major
The serum concentration of Axitinib can be increased when it is combined with Eliglustat.
Azimilide
Major
The risk or severity of Cardiac Arrhythmia can be increased when Eliglustat is combined with Azimilide.
Bendamustine
Major
The serum concentration of Bendamustine can be increased when it is combined with Eliglustat.
Cerdelga Toxicity & Overdose Risk
Too much eliglustat may cause dizziness, low blood pressure, slow heart rate, nausea, and vomiting. There is no known antidote for eliglustat overdose, so patients should be carefully monitored and given supportive care. Hemodialysis is not an effective method for removing eliglustat from the body. In animal studies, adverse effects in the stomach, blood, reproductive organs, and lymphoid organs were observed at high doses. Eliglustat was found to not cause cancer or mutations in rats or mice.
Cerdelga Novel Uses: Which Conditions Have a Clinical Trial Featuring Cerdelga?
Currently, there are no active clinical trials examining the possibility of using Cerdelga to address CYP2D6 poor metaboliser status, Cytochrome P-450 CYP2D6 Inducers and Type 1 Gaucher Disease.
Condition
Clinical Trials
Trial Phases
Gaucher Disease
0 Actively Recruiting
Cytochrome P-450 CYP2D6 Inducers
0 Actively Recruiting
CYP2D6 poor metaboliser status
0 Actively Recruiting
CYP2D6 extensive metabolizer status
0 Actively Recruiting
Cerdelga Reviews: What are patients saying about Cerdelga?
2.7
Patient Review
11/1/2015
Cerdelga for Gaucher's Disease
Patient Q&A Section about cerdelga
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.