Cerdelga® Eligibility Testing

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~90% of adult patients with Gaucher disease type 1 tested for CYP2D6 status are eligible for Cerdelga¹

A blood test can determine eligibility for Cerdelga treatment

CYP2D6 is an enzyme that plays an important role in metabolizing certain drugs, including Cerdelga. To determine patient eligibility for Cerdelga, first conduct a blood test to identify the patient’s CYP2D6 metabolizer status.^2,3

Cerdelga is indicated for 3 out of the 4 main types of metabolizers:

Poor metabolizers (PMs)

Intermediate metabolizers (IMs)

Extensive metabolizers (EMs)

Ultra rapid metabolizers (URMs)

Patients with Gaucher disease type 1 should be selected for Cerdelga use based on their CYP2D6 metabolizer status. It is recommended that patient genotypes be established using an FDA-cleared test for determining CYP2D6 genotype.²

Use of Cerdelga may be contraindicated or require dosage adjustment in certain patients based on their CYP2D6 metabolizer status, concomitant use of CYP2D6 or CYP3A inhibitors, and degree of renal or hepatic impairment.² Please see full Prescribing Information for additional details.

Determining eligibility for Cerdelga treatment

Patient blood draw is performed

Lab results are processed

Results will likely include the patient’s CYP2D6 genotype, which can be used to determine their metabolizer status

Results usually sent directly to the referring healthcare provider

GD1 is rare, but more common than you think⁴

Gaucher disease follows an autosomal recessive inheritance pattern⁵

See the Pattern →

GD1 is more prevalent in some populations⁵

Patients of Ashkenazi Jewish heritage showing signs and symptoms should be tested⁶

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Indication

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:

Patients who are CYP2D6 ultra-rapid metabolizers (URMs) may not achieve adequate concentrations of CERDELGA to achieve a therapeutic effect.
A specific dosage cannot be recommended for those patients whose CYP2D6 genotype cannot be determined (indeterminate metabolizers).

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:

Extensive Metabolizers (EMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, EMs with moderate or severe hepatic impairment, or EMs with mild hepatic impairment and taking a strong or moderate CYP2D6 inhibitor.
Intermediate Metabolizers (IMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, IMs taking a strong CYP3A inhibitor, or IMs with any degree of hepatic impairment.
Poor Metabolizers (PMs) taking a strong CYP3A inhibitor, or PMs with any degree of hepatic impairment.

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 on 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.

Please see accompanying full Prescribing Information.

Indication

Important Safety Information

References: 1. Cox TM et al. Lancet. 2015;385(9985):2355-2362. 2. Cerdelga (eliglustat). Prescribing Information. Sanofi. 3. Ogu CC et al. Proc (Bayl Univ Med Cent). 2000;13(4):421-423. 4. Pastores GM et al. Semin Hematol. 2004;41(4 Suppl 5):4-14. 5. Mistry PK et al. Clin Adv Hematol Onc. 2012;10(6 Suppl 8):1-16. 6. Mistry PK et al. Am J Hematol. 2011;86(1):110-115.

Cerdelga® (eliglustat) Eligibility Testing

~90% of adult patients with Gaucher disease type 1 tested for CYP2D6 status are eligible for Cerdelga1

A blood test can determine eligibility for Cerdelga treatment

Cerdelga is indicated for 3 out of the 4 main types of metabolizers:

Determining eligibility for Cerdelga treatment

GD1 is rare, but more common than you think4

GD1 is more prevalent in some populations5

Indication

Limitations of Use:

Important Safety Information

Contraindications

Warnings and Precautions

Adverse Reactions

Drug interactions

Use in specific populations

Indication

Important Safety Information

Cerdelga^® (eliglustat) Eligibility Testing

~90% of adult patients with Gaucher disease type 1 tested for CYP2D6 status are eligible for Cerdelga¹

GD1 is rare, but more common than you think⁴

GD1 is more prevalent in some populations⁵