Cerdelga
(Eliglustat)Dosage & Administration
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
The recommended dosage of CERDELGA in adults is based on the patient's CYP2D6 metabolizer status.
| CYP2D6 Metabolizer Status | CERDELGA Dosage |
|---|---|
| EMs | 84 mg twice daily |
| IMs | |
| PMs | 84 mg once daily |
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Cerdelga Prescribing Information
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
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
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
- Select patients using an FDA-cleared test for determining CYP2D6 genotype.
The recommended dosage of CERDELGA in adults is based on the patient's CYP2D6 metabolizer status.
| CYP2D6 Metabolizer Status | CERDELGA Dosage |
|---|---|
| EMs | 84 mg twice daily |
| IMs | |
| PMs | 84 mg once daily |
- 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 Recommended Adult DosageThe 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 ,4 CONTRAINDICATIONSCERDELGA 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.
- Moderate or severe hepatic impairment.
- Mild hepatic impairment taking a strong or moderate CYP2D6 inhibitor.
IMs- Taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor.
- Taking a strong CYP3A inhibitor.
- Any degree of hepatic impairment.
PMs- Taking a strong CYP3A inhibitor
- Any degree of hepatic impairment
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)]
- Any degree of hepatic impairment[see Use in Specific Populations (8.7)]
PMs- Taking a strong CYP3A inhibitor[see Drug Interactions (7.1)]
- Any degree of hepatic impairment[see Use in Specific Populations (8.7)]
,7.1 Effect of Other Drugs on CERDELGACoadministration 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 5for 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 InhibitorStrong Reduce frequency of CERDELGA 84 mg to once daily Continue CERDELGA 84 mg once dailyNo effect of CYP2D6 inhibitor due to little or no CYP2D6 activity in CYP2D6 PMs. Moderate Weak Continue CERDELGA 84 mg twice daily CYP3A InhibitorStrong Reduce frequency of CERDELGA 84 mg to once daily Contraindicated Moderate Avoid coadministration Weak Continue CERDELGA 84 mg twice daily Avoid coadministration CYP2D6 Inhibitor Concomitantly with a strong CYP3A InhibitorStrong Contraindicated Moderate CYP2D6 Inhibitor Concomitantly with a moderate CYP3A InhibitorStrong Contraindicated Avoid coadministration Moderate CYP3A InducerStrong Avoid coadministration ,8.6 Renal ImpairmentUse CERDELGA in patients with renal impairment based on the patient's CYP2D6 metabolizer status
[see Clinical Pharmacology (12.3)].EMs- Avoid CERDELGA in patients with end-stage renal disease (ESRD) (estimated creatinine clearance (eCLcr) less than 15 mL/min not on dialysis or requiring dialysis).
- No dosage adjustment is recommended in patients with mild, moderate, or severe renal impairment (eCLcr at least 15 mL/min).
IMs and PMs- Avoid CERDELGA in patients with any degree of renal impairment.
)8.7 Hepatic ImpairmentUse CERDELGA in patients with hepatic impairment based on CYP2D6 metabolizer status and concomitant use of CYP2D6 or CYP3A inhibitors
[see Clinical Pharmacology (12.3)].EMs- CERDELGA is contraindicated in patients with[see Contraindications (4)]:
- severe (Child-Pugh Class C) hepatic impairment
- moderate (Child-Pugh Class B) hepatic impairment
- mild (Child-Pugh Class A) hepatic impairment taking a strong or moderate CYP2D6 inhibitor
- Reduce dosage frequency of CERDELGA 84 mg to once daily[see Dosage and Administration (2.3)]in patients with mild hepatic impairment taking:
- a weak CYP2D6 inhibitor
- a strong, moderate, or weak CYP3A inhibitor
- No dosage adjustment is recommended in patients with mild hepatic impairment, unless otherwise specified above.
IMs and PMs- CERDELGA is contraindicated in patients with any degree of hepatic impairment[see Contraindications (4)].
- Swallow capsules whole, preferably with water, and do not crush, dissolve, or open the capsules.
- CERDELGA can be taken with or without food.
- Avoid the consumption of grapefruit or grapefruit juice (strong CYP3A inhibitors) with CERDELGA[see Drug Interactions (7.1)].
- If a dose of CERDELGA is missed, take the prescribed dose at the next scheduled time; do not double the next dose.
- For patients currently treated with imiglucerase, velaglucerase alfa, or taliglucerase alfa, CERDELGA may be administered 24 hours after the last dose of the previous enzyme replacement therapy (ERT).
- Swallow capsules whole, do not crush, dissolve or open capsules. ()
2.4 Important Administration Instructions- Swallow capsules whole, preferably with water, and do not crush, dissolve, or open the capsules.
- CERDELGA can be taken with or without food.
- Avoid the consumption of grapefruit or grapefruit juice (strong CYP3A inhibitors) with CERDELGA[see Drug Interactions (7.1)].
- If a dose of CERDELGA is missed, take the prescribed dose at the next scheduled time; do not double the next dose.
- For patients currently treated with imiglucerase, velaglucerase alfa, or taliglucerase alfa, CERDELGA may be administered 24 hours after the last dose of the previous enzyme replacement therapy (ERT).
- Avoid eating grapefruit or drinking grapefruit juice. ()
2.4 Important Administration Instructions- Swallow capsules whole, preferably with water, and do not crush, dissolve, or open the capsules.
- CERDELGA can be taken with or without food.
- Avoid the consumption of grapefruit or grapefruit juice (strong CYP3A inhibitors) with CERDELGA[see Drug Interactions (7.1)].
- If a dose of CERDELGA is missed, take the prescribed dose at the next scheduled time; do not double the next dose.
- For patients currently treated with imiglucerase, velaglucerase alfa, or taliglucerase alfa, CERDELGA may be administered 24 hours after the last dose of the previous enzyme replacement therapy (ERT).
Capsules: 84 mg of eliglustat is in a capsule with a pearl blue-green opaque cap and pearl white opaque body imprinted with "GZ02" in black.
Available data on CERDELGA use in pregnant women includes 20 pregnancies that occurred during the clinical development program and a small number of post-marketing case reports. These data are not sufficient to assess drug-associated risks major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies in pregnant rats administered oral eliglustat during organogenesis, a spectrum of various developmental abnormalities were observed at doses 6 times the recommended human dose. No adverse developmental outcomes were observed with oral administration of eliglustat to pregnant rabbits at dose levels 10 times the recommended human dose
Animal data
Reproduction studies have been performed in pregnant rats at oral doses up to 120 mg/kg/day (about 6 times the recommended human dose based on body surface area) and in pregnant rabbits at oral doses up to 100 mg/kg/day (about 10 times the recommended human dose based on body surface area) following administration of eliglustat during the period of organogenesis (gestation days 6 to 17 in the rat and 6 to 18 in the rabbit).
In rats, at 120 mg/kg/day (about 6 times the recommended human dose based on body surface area), eliglustat increased the number of late resorptions, dead fetuses and post implantation loss, reduced fetal body weight, and caused fetal cerebral variations (dilated cerebral ventricles), fetal skeletal variations (poor bone ossification) and fetal skeletal malformations (abnormal number of ribs or lumbar vertebra). Eliglustat-related effects on fetal rats were observed in association with signs of maternal toxicity.
Eliglustat did not cause fetal harm in rabbits at oral doses up to 100 mg/kg/day (about 10 times the recommended human dose based on body surface area). Mild maternal toxicity was observed at the 100 mg/kg/day dose.
In a pre and postnatal development study in rats (dosed daily from gestation day 6 to postpartum day 21), eliglustat did not show any significant adverse effects on pre and postnatal development at doses up to 100 mg/kg/day (about 5 times the recommended human dose based on body surface area).
The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
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.
CERDELGA is predicted to cause increases in ECG intervals (PR, QTc, and QRS) at substantially elevated eliglustat plasma concentrations and may increase the 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[see Dosage and Administration (2.3), Contraindications (4), Drug Interactions (7.1)].
Use of CERDELGA in patients with pre-existing cardiac conditions has not been studied during clinical trials. Avoid use of CERDELGA in patients with:
- pre-existing cardiac disease (congestive heart failure, recent acute myocardial infarction, bradycardia, heart block, ventricular arrhythmia)
- long QT syndrome
- in combination with Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications[see Clinical Pharmacology (12.2)]