Important Safety Information: CERDELGA can affect how other medicines work and other medicines can affect how CERDELGA works. Especially tell your doctor if you take St. John's Wort (Hypercium perforatum) or medicines for fungal infections, tuberculosis, seizures, heart rhythm and rate problems, high blood pressure, or depression. Tell your doctor about all of your medical conditions, including history of heart attacks or heart rhythm problems. View more

Cerdelga® (eliglustat) capsules for oral use

A First-line Oral Treatment for Certain People with Gaucher Disease Type 1

CERDELGA is a glucosylceramide synthase inhibitor indicated for the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.

Limitations of Use: CYP2D6 ultra-rapid metabolizers may not achieve adequate concentrations of CERDELGA to achieve a therapeutic effect. A specific dose cannot be recommended for CYP2D6 indeterminate metabolizers.

Contact Us

Sanofi Genzyme
500 Kendall Street
Cambridge, MA 02142

Tel: 617-768-9000
Fax: 617-252-7600
Toll Free: 1-800-745-4447


Determining Your Patient's CYP2D6 Metabolizer Status

CYP enzymes play an important role in metabolizing certain drugs. Cerdelga, the only first-line oral treatment for Gaucher disease type 1 (GD1), is metabolized by the CYP2D6 protein.

CYP2D6 genotyping is a simple blood test to help you determine which patients are eligible for treatment with Cerdelga.

Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6:

  • Extensive metabolizers (EM), or
  • Intermediate metabolizers (IM), or
  • Poor metabolizers (PM)

Limitations of Use: Ultra-rapid CYP2D6 metabolizers may not achieve adequate concentrations of Cerdelga to achieve a therapeutic effect. A specific dosage cannot be recommended for the indeterminate CYP2D6 metabolizers.

For more information on the test, contact Sanofi Genzyme Medical Information at 800-745-4447 or 617-768-9000 (option 2).


Indications & Usage

CERDELGA (eliglustat) capsules is a glucosylceramide synthase inhibitor indicated for the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.

Limitations of Use:

Important Safety Information

CERDELGA is contraindicated in the following patients due to the risk of significantly increased eliglustat plasma concentrations, which may result in prolongation of the PR, QTc, and/or QRS cardiac intervals that could result in cardiac arrhythmias: EMs or IMs taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor and IMs or PMs taking a strong CYP3A inhibitor.

Drugs that inhibit CYP2D6 and CYP3A may significantly increase the exposure to eliglustat; CERDELGA dose adjustment may be needed, depending on metabolizer status. See section 7 of the full Prescribing Information for more details and other potentially significant drug interactions.

Because CERDELGA is predicted to cause increases in ECG intervals at substantially elevated plasma concentrations, use is not recommended in patients with pre-existing cardiac disease, long QT syndrome, or in combination with Class IA and Class III antiarrhythmic medications.

The most common adverse reactions (≥10%) for CERDELGA are: fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain.

Only administer CERDELGA during pregnancy if the potential benefit justifies the potential risk; based on animal data, CERDELGA may cause fetal harm. Discontinue drug or nursing based on importance of drug to mother. CERDELGA is not recommended in patients with moderate to severe renal impairment, end-stage renal disease or in patients with hepatic impairment or cirrhosis.

To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Genzyme Corporation at (1-800-745-4447) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information, including the patient Medication Guide, for additional important safety information.