Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 14 August 2018
4 CONTRAINDICATIONS CERDELGA is contraindicated in the following patients due to the risk of
See Table 3 and Table 4 for examples of drugs in each of the categories described [see Drug Interactions (7.1)]: EMs or IMs taking a strong or
IMs or PMs taking a strong CYP3A inhibitor.
CYP2D6 EMs and IMs taking a strong or
Table 1 presents the profile from the 9-month double-blind, randomized, placebo-controlled trial of 40 treatment-na?ve 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.
Patients were between the ages of 18 and 69 on the date of the first dose of CERDELGA, and included 87 females and 72 males.
5 % of GD1 Patients Switching from Enzyme Replacement Therapy to
CERDELGA and More Frequently than
Imiglucerase (Trial 2)Trial 2 was not designed to support comparative claims for CERDELGA for
CERDELGA (N=106) Imiglucerase (N=53)
2 DOSAGE AND ADMINISTRATION Select patients using an FDA-cleared test for determining CYP2D6 genotype (2.1) CYP2D6 EMs or IMs: 84 mg orally twice daily (2.2) CYP2D6 PMs: 84 mg orally once daily (2.2) Swallow capsules whole, do not crush, dissolve or open capsules (2.3)
The predicted exposures with 84 mg once daily in patients who are CYP2D6 PMs are expected to be similar to exposures observed with 84 mg twice daily in CYP2D6 IMs [see
Clinical Pharmacology (12.3)].
Some inhibitors of CYP2D6 and CYP3A are contraindicated with CERDELGA depending on the patient 's metabolizer status [see Contraindications (4)].
Reduce the dosage of CERDELGA to 84 mg once daily for: CYP2D6 EMs and IMs taking strong or
CERDELGA can be taken with or without food.
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).
8 USE IN SPECIFIC POPULATIONS Pregnancy: Only administer if the potential
Based on animal data, may cause fetal
However, animal reproduction studies have been conducted for eliglustat.
In these animal studies, a spectrum of
CERDELGA should be used during pregnancy only if the potential
Disease-associated maternal and embryo-fetal risk Women with Gaucher disease type 1 have an
Gaucher disease type 1 manifestations may lead to
Animal Data Reproduction studies have been performed in pregnant
Eliglustat did not cause fetal
In a pre and postnatal development study in
8.3 Nursing Mothers It is not known whether CERDELGA is present in human milk.
Because many drugs are present in human milk, and because of the
8.4 Pediatric Use
8.5 Geriatric Use Clinical studies of CERDELGA did not include
Clinical experience has not identified differences in responses between the elderly and younger patients.
CERDELGA has not been studied in
|Agency product number||DR40J4WA67|
|Date Last Revised||26-08-2014|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||Store at 68 °F - 77 °F (20 °C - 25 °C) with excursions permitted between 59 °F and 86 °F (15 °C to 30 °C) [see USP Controlled Room Temperature].|
|Marketing authorisation holder||Genzyme Corporation|