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
50 Binney 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 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.

Limitations of Use:

Important Safety Information

CONTRAINDICATIONS

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:

WARNINGS AND PRECAUTIONS

CERDELGA is predicted to cause increases in ECG intervals (PR, QTc, and QRS) at substantially elevated plasma concentrations and may increase risk of cardiac arrhythmias. Use of CERDELGA is contraindicated, to be avoided, or requires dosage adjustment in patients taking CYP2D6 or CYP3A inhibitors, depending CYP2D6 metabolizer status, type of inhibitor, or degree of hepatic impairment. Avoid use of CERDELGA in patients with pre-existing cardiac disease, long QT syndrome, or in combination with Class IA or Class III antiarrhythmic medications.

ADVERSE REACTIONS

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

DRUG INTERACTIONS

Coadministration of CERDELGA with CYP2D6 or CYP3A inhibitors may increase eliglustat concentrations, which may increase the risk of cardiac arrhythmias from prolongations of the PR, QTc, and/or QRS cardiac interval. Use of CERDELGA is contraindicated, to be avoided, or may require dosage adjustment depending on the concomitant drug and CYP2D6 metabolizer status. See section 7 of the full Prescribing Information for more details and other potentially significant drug interactions.

USE IN SPECIFIC POPULATIONS

Available data on the use of CERDELGA in pregnant women is not sufficient to assess drug- associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CERDELGA and any potential adverse effects on the breastfed child from CERDELGA or from the underlying maternal condition.

Use of CERDELGA in patients with renal impairment is based on the patient’s CYP2D6 metabolizer status. Avoid use of CERDELGA in EMs with end-stage renal disease (ESRD), and IMs and PMs with any degree of renal impairment.

Use of CERDELGA is contraindicated or may require dosage adjustment in patients with hepatic impairment based on CYP2D6 metabolizer status, concomitant use of CYP2D6 or CYP3A inhibitors, and degree of hepatic impairment.

To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Genzyme Medical Information at 1-800-745-4447, Option 2.

Please see accompanying full Prescribing Information.