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 R ,2 R )-1-(2,3-dihydrobenzo[b][1,4]dioxin-6-yl)-1-hydroxy-3-(pyrrolidin-1-yl)propan-2-yl)octanamide (2 R ,3 R )-2,3-dihydroxysuccinate. Its molecular weight is 479.59, and the empirical formula is C 23 H 36 N 2 O 4 +½(C 4 H 6 O 6 ) with the following chemical structure: 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. Chemical Structure

What kind of drug is eliglustat?

The FDA classifies eliglustat as a glucosylceramide synthase inhibitor. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take eliglustat with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run eliglustat against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is eliglustat sold under?

We track 2 eliglustat-containing products in the U.S.: Cerdelga and Eliglustat Tartrate. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does eliglustat come in?

Across the brands we track, eliglustat is currently marketed as capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic eliglustat?

Yes. Our catalog lists 1 generic eliglustat product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

Eliglustat: uses, dosing, side effects & brands

Eliglustat is a glucosylceramide synthase inhibitor sold in the U.S. under 2 brand and generic names, for gaucher disease. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesHow we research

Key facts

Drug class: Glucosylceramide Synthase Inhibitor
Treats: Gaucher Disease
Available as: Capsule
Sold as: 2 products — Cerdelga and Eliglustat Tartrate
Prescription?: Prescription only
Generic available?: Yes

How eliglustat is dosed

From the FDA label for Cerdelga (application NDA205494). Other eliglustat products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Patient Selection ( 2.1 ) : Select patients using an FDA-cleared test for determining CYP2D6 genotype. Recommended Dosage Based on CYP2D6 Metabolizer Status ( 2.2 ) : EMs and IMs: 84 mg orally twice daily. PMs: 84 mg orally once daily. See the Full Prescribing Information for dosing recommendations in patients receiving CYP2D6 and/or CYP3A inhibitors, or with renal or hepatic impairment. ( 2.2 , 4 , 7.1 , 8.6 , 8.7 ) Administration ( 2.4 ) : Swallow capsules whole, do not crush, dissolve or open capsules. ( 2.4 ) Avoid eating grapefruit or drinking grapefruit juice. ( 2.4 ) 2.1 Patient Selection Select patients with Gaucher disease type 1 based on their CYP2D6 metabolizer status. It is recommended patient genotypes be established using an FDA-cleared test for determining CYP2D6 genotype [see Indications and Usage (1) ] . 2.2 Recommended Adult Dosage The recommended dosage of CERDELGA in adults is based on the patient's CYP2D6 metabolizer status. Table 1: Recommended Dosage Regimen by CYP2D6 Metabolizer Status CYP2D6 Metabolizer Status CERDELGA Dosage EMs 84 mg twice daily IMs PMs 84 mg once daily 2.3 Dosage Adjustment in EMs and IMs With or Without Hepatic Impairment and Concomitant Use of CYP2D6 or CYP3A Inhibitors Reduce dosage frequency of CERDELGA 84 mg to once daily in CYP2D6 EMs and IMs with or without hepatic impairment taking CYP2D6 or CYP3A inhibitors, as shown in…

Eliglustat side effects

Most common adverse reactions (≥10%) are: fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions to CERDELGA (occurring in ≥10% of the 126 GD1 patients treated with CERDELGA across Trials 1 and 2) were fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain. The adverse reaction profile of CERDELGA is based on two controlled studies, Trials 1 and 2 [see Clinical Studies (14.1 , 14.2) ] . Table 3 presents the profile from the 9-month double-blind, randomized, placebo-controlled trial of 40 treatment-naive patients (Trial 1). Patients were between the ages of 16 and 63 on the date of the first dose of study drug, and included 20 males and 20 females. Table 3: Adverse Reactions Occurring in ≥10% of Treatment-Naive GD1 Patients and More Frequently than Placebo (Trial 1) CERDELGA (N=20) Placebo (N=20) Adverse Reaction Patients n (%) Patients…

Every eliglustat product we track (2)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Eliglustat products
#	Drug	Rating	Type	Form	Generic?	Typical price
1	Cerdelga	72/100	Prescription	Capsule	—	—	View →
2	Eliglustat Tartrate	Not yet rated	Prescription	Capsule	—	—	View →

Frequently asked questions

What is eliglustat?: 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 R ,2 R )-1-(2,3-dihydrobenzo[b][1,4]dioxin-6-yl)-1-hydroxy-3-(pyrrolidin-1-yl)propan-2-yl)octanamide (2 R ,3 R )-2,3-dihydroxysuccinate. Its molecular weight is 479.59, and the empirical formula is C 23 H 36 N 2 O 4 +½(C 4 H 6 O 6 ) with the following chemical structure: 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. Chemical Structure
What kind of drug is eliglustat?: The FDA classifies eliglustat as a glucosylceramide synthase inhibitor. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take eliglustat with other medicines?: It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run eliglustat against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is eliglustat sold under?: We track 2 eliglustat-containing products in the U.S.: Cerdelga and Eliglustat Tartrate. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does eliglustat come in?: Across the brands we track, eliglustat is currently marketed as capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Who shouldn’t take eliglustat

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. EMs Taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor. ( 4 , 5.1 , 7.1 , 12.3 ) Moderate or severe hepatic impairment. ( 4 , 5.1 , 8.7 , 12.3 ) Mild hepatic impairment taking a strong or moderate CYP2D6 inhibitor. ( 4 , 5.1 , 8.7 , 12.3 ) IMs Taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor. ( 4 , 5.1 , 7.1 , 12.3 ) Taking a strong CYP3A inhibitor. ( 4 , 5.1 , 7.1 , 12.3 ) Any degree of hepatic impairment. ( 4 , 5.1 , 8.7 , 12.3 ) PMs Taking a strong CYP3A inhibitor ( 4 , 5.1 , 7.1 , 12.3 ) Any degree of hepatic impairment ( 4 , 5.1 , 8.7 , 12.3 ) EMs Taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor [see Drug Interactions (7.1) ] Moderate or severe hepatic impairment [see Use in Specific Populations (8.7) ] Mild hepatic impairment and taking a strong or moderate CYP2D6 inhibitor [see Use in Specific Populations (8.7) ] IMs Taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor [see Drug Interactions (7.1) ] Taking a strong CYP3A inhibitor [see Drug Interactions (7.1) ]…

Eliglustat drug interactions

See Full Prescribing Information for a list of clinically significant drug interactions. ( 7.1 , 7.2 ) 7.1 Effect of Other Drugs on CERDELGA Coadministration of CERDELGA with: CYP2D6 or CYP3A inhibitors may increase eliglustat concentrations which may increase the risk of cardiac arrhythmias from prolongation of the PR, QTc, and/or QRS cardiac interval [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ] . strong CYP3A inducers decrease eliglustat concentrations which may reduce CERDELGA efficacy [see Clinical Pharmacology (12.3) ] . See Table 5 for prevention and management of interactions with drugs affecting CERDELGA. Use of CERDELGA is contraindicated, to be avoided, or may require dosage adjustment depending on the concomitant drug and CYP2D6 metabolizer status [see Dosage and Administration (2.2 , 2.3) , Contraindications (4) , Drug Interactions (7.1) ] . Table 5: Prevention and Management Strategies of Drug Interactions Affecting CERDELGA Based on CYP2D6 Metabolizer Status and Concomitant Interacting Drug Concomitant Drug(s) CYP2D6 Metabolizer Status EMs IMs PMs CYP2D6 Inhibitor Strong Reduce frequency of CERDELGA 84 mg to once daily Continue CERDELGA 84 mg once daily No effect of CYP2D6 inhibitor due to little or no CYP2D6 activity in CYP2D6 PMs. Moderate Weak Continue CERDELGA 84 mg twice daily CYP3A Inhibitor Strong Reduce frequency of CERDELGA 84 mg…