Details
Stereochemistry | ABSOLUTE |
Molecular Formula | 2C23H36N2O4.C4H6O6 |
Molecular Weight | 959.1727 |
Optical Activity | UNSPECIFIED |
Defined Stereocenters | 6 / 6 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
O[C@H]([C@@H](O)C(O)=O)C(O)=O.CCCCCCCC(=O)N[C@H](CN1CCCC1)[C@H](O)C2=CC=C3OCCOC3=C2.CCCCCCCC(=O)N[C@H](CN4CCCC4)[C@H](O)C5=CC=C6OCCOC6=C5
InChI
InChIKey=KUBARPMUNHKBIQ-VTHUDJRQSA-N
InChI=1S/2C23H36N2O4.C4H6O6/c2*1-2-3-4-5-6-9-22(26)24-19(17-25-12-7-8-13-25)23(27)18-10-11-20-21(16-18)29-15-14-28-20;5-1(3(7)8)2(6)4(9)10/h2*10-11,16,19,23,27H,2-9,12-15,17H2,1H3,(H,24,26);1-2,5-6H,(H,7,8)(H,9,10)/t2*19-,23-;1-,2-/m111/s1
Molecular Formula | C23H36N2O4 |
Molecular Weight | 404.5429 |
Charge | 0 |
Count |
|
Stereochemistry | ABSOLUTE |
Additional Stereochemistry | No |
Defined Stereocenters | 2 / 2 |
E/Z Centers | 0 |
Optical Activity | UNSPECIFIED |
Molecular Formula | C4H6O6 |
Molecular Weight | 150.0868 |
Charge | 0 |
Count |
|
Stereochemistry | ABSOLUTE |
Additional Stereochemistry | No |
Defined Stereocenters | 2 / 2 |
E/Z Centers | 0 |
Optical Activity | UNSPECIFIED |
DescriptionCurator's Comment: description was created based on several sources, including http://www.ncbi.nlm.nih.gov/pubmed/?term=PMC3715929
Curator's Comment: description was created based on several sources, including http://www.ncbi.nlm.nih.gov/pubmed/?term=PMC3715929
Eliglustat, marketed by Genzyme as CERDELGA, is a glucosylceramide synthase inhibitor indicated for the long-term treatment of type 1 Gaucher disease who are CYP2D6 extensive metabolizers, intermediate metabolizers, or poor metabolizers (PMs) as detected by an FDA-cleared test.
CNS Activity
Sources: http://www.ncbi.nlm.nih.gov/pubmed/?term=PMC3715929
Curator's Comment: Eliglustat, does not cross the blood brain barrier due to recognition by the multidrug transporter pgp-1. Thus, there is no significant distribution of the drug into the brain.
Originator
Sources: http://www.ncbi.nlm.nih.gov/pubmed/?term=PMC3715929
Curator's Comment: In pre-clinical studies, the molecule was developed at the Michigan University. James A. Shayman is an inventor on patents covering the composition of matter, synthesis, and uses of eliglustat tartrate and related compounds. These patents are held by the University of Michigan were licensed to Genzyme/Sanofi Corporation.
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: Q16739 Gene ID: 7357.0 Gene Symbol: UGCG Target Organism: Homo sapiens (Human) Sources: http://www.ncbi.nlm.nih.gov/pubmed/?term=25239269 |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Secondary | CERDELGA Approved UseIndicated for the long-term treatment of adult patients with Gaucher disease type 1 Launch Date2014 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
158 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
200 mg 2 times / day steady-state, oral dose: 200 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE food status: FASTED |
|
265 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
350 mg 2 times / day steady-state, oral dose: 350 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
303 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
350 mg 2 times / day steady-state, oral dose: 350 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE food status: FASTED |
|
4.83 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
50 mg 2 times / day steady-state, oral dose: 50 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
130 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
200 mg 2 times / day steady-state, oral dose: 200 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
10.5 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
50 mg 2 times / day steady-state, oral dose: 50 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE food status: FASTED |
|
1852 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
30 mg/kg single, oral dose: 30 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
13.3 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
2 mg/kg single, oral dose: 2 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
10.4 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
1 mg/kg single, oral dose: 1 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
267 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
10 mg/kg single, oral dose: 10 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
2.7 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
0.3 mg/kg single, oral dose: 0.3 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
88.3 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
300 mg single, oral dose: 300 mg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
91.1 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
5 mg/kg single, oral dose: 5 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
79.1 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
300 mg single, oral dose: 300 mg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: HIGH-FAT |
|
12.1 ng/mL |
84 mg 2 times / day multiple, oral dose: 84 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
ELIGLUSTAT TARTRATE plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
1000 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
200 mg 2 times / day steady-state, oral dose: 200 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE food status: FASTED |
|
1042 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
350 mg 2 times / day steady-state, oral dose: 350 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
1776 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
350 mg 2 times / day steady-state, oral dose: 350 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE food status: FASTED |
|
21.7 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
50 mg 2 times / day steady-state, oral dose: 50 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
556 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
200 mg 2 times / day steady-state, oral dose: 200 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
62.1 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
50 mg 2 times / day steady-state, oral dose: 50 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE food status: FASTED |
|
10528 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
30 mg/kg single, oral dose: 30 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
112 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
2 mg/kg single, oral dose: 2 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
151 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
1 mg/kg single, oral dose: 1 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
1562 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
10 mg/kg single, oral dose: 10 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
28.1 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
0.3 mg/kg single, oral dose: 0.3 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
623 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
300 mg single, oral dose: 300 mg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
692 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
5 mg/kg single, oral dose: 5 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
696 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
300 mg single, oral dose: 300 mg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: HIGH-FAT |
|
76.3 ng × h/mL |
84 mg 2 times / day multiple, oral dose: 84 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
ELIGLUSTAT TARTRATE plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
5.77 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
200 mg 2 times / day steady-state, oral dose: 200 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE food status: FASTED |
|
5.64 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
350 mg 2 times / day steady-state, oral dose: 350 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
5.44 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
350 mg 2 times / day steady-state, oral dose: 350 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE food status: FASTED |
|
4.32 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
50 mg 2 times / day steady-state, oral dose: 50 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
6.19 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
200 mg 2 times / day steady-state, oral dose: 200 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
7.28 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
50 mg 2 times / day steady-state, oral dose: 50 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE food status: FASTED |
|
6.8 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
30 mg/kg single, oral dose: 30 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
6.4 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
2 mg/kg single, oral dose: 2 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
6.5 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
1 mg/kg single, oral dose: 1 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
6.1 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
10 mg/kg single, oral dose: 10 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
4.8 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
0.3 mg/kg single, oral dose: 0.3 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
6.2 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/20864621 |
5 mg/kg single, oral dose: 5 mg/kg route of administration: Oral experiment type: SINGLE co-administered: |
ELIGLUSTAT TARTRATE blood | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
6.5 h |
84 mg 2 times / day multiple, oral dose: 84 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
ELIGLUSTAT TARTRATE plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
Funbound
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
17% |
84 mg 2 times / day multiple, oral dose: 84 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
ELIGLUSTAT TARTRATE plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
Doses
Dose | Population | Adverse events |
---|---|---|
30 mg/kg 1 times / day single, oral Highest studied dose Dose: 30 mg/kg, 1 times / day Route: oral Route: single Dose: 30 mg/kg, 1 times / day Sources: |
healthy, mean age 26 years n = 74 Health Status: healthy Age Group: mean age 26 years Sex: M Population Size: 74 Sources: |
DLT: Bradycardia, Dizziness... Other AEs: Dizziness, Nausea... Dose limiting toxicities: Bradycardia (grade 2, 1.3%) Other AEs:Dizziness (grade 3, 1.3%) Dysequilibrium (grade 2, 1.3%) Hypotension (grade 2, 1.3%) Vomiting (grade 2, 1.3%) Dizziness (grade 2, 1.3%) Sources: Nausea (grade 2, 1.3%) |
20 mg/kg 1 times / day single, oral MTD Dose: 20 mg/kg, 1 times / day Route: oral Route: single Dose: 20 mg/kg, 1 times / day Sources: |
healthy, mean age 26 years n = 74 Health Status: healthy Age Group: mean age 26 years Sex: M Population Size: 74 Sources: |
Other AEs: Nausea... |
200 mg 2 times / day multiple, oral MTD Dose: 200 mg, 2 times / day Route: oral Route: multiple Dose: 200 mg, 2 times / day Sources: |
healthy, mean age 28 years n = 24 Health Status: healthy Age Group: mean age 28 years Sex: M+F Population Size: 24 Sources: |
Other AEs: Nausea... |
350 mg 2 times / day multiple, oral Studied dose Dose: 350 mg, 2 times / day Route: oral Route: multiple Dose: 350 mg, 2 times / day Sources: |
healthy, mean age 28 years n = 24 Health Status: healthy Age Group: mean age 28 years Sex: M+F Population Size: 24 Sources: |
Other AEs: Vomiting, Nausea... Other AEs: Vomiting (16.7%) Sources: Nausea (grade 1-2, 29.2%) |
100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
Other AEs: Atrioventricular block second degree, Atrioventricular block... Other AEs: Atrioventricular block second degree (1%) Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135Atrioventricular block (<1%) Atrioventricular block first degree (<1%) Sinoatrial block (<1%) Supraventricular tachycardia (1%) Arrhythmia supraventricular (<1%) Atrial tachycardia (<1%) Ventricular tachycardia (1%) Ventricular extrasystoles (<1%) Tachycardia (<1%) |
100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Other AEs: Nasopharyngitis, Upper respiratory tract infection... Other AEs: Nasopharyngitis (13%) Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140Upper respiratory tract infection (11%) Influenza (6%) Sinusitis (6%) Infection urinary tract (6%) Bronchitis (3%) Gastroenteritis (3%) Viral infection (3%) Gastroenteritis viral (2%) Ear infection (2%) Oral herpes (2%) Pharyngitis (2%) Pneumonia (2%) Diarrhoea (10%) Abdominal pain upper (8%) Nausea (8%) Dyspepsia (7%) Abdominal pain (6%) Constipation (6%) Gastrooesophageal reflux disease (5%) Vomiting (4%) Abdominal distension (3%) Dysphagia (2%) Flatulence (2%) Toothache (2%) Gastritis (2%) Dry mouth (2%) Headache (17%) Dizziness (10%) Paraesthesia (2%) Neuropathy peripheral (2%) Syncope (2%) Dysgeusia (2%) Somnolence (2%) Arthralgia (14%) Back pain (9%) Pain in extremity (8%) Bone pain (5%) Myalgia (3%) Musculoskeletal pain (3%) Fatigue (7%) Asthenia (4%) Oedema peripheral (4%) Chest pain (3%) Pyrexia (3%) Influenza like illness (2%) Cough (6%) Epistaxis (4%) Oropharyngeal pain (4%) Nasal congestion (2%) Throat irritation (2%) Blood creatine phosphokinase increased (5%) Weight decreased (2%) ALT increased (2%) Rash (2%) Pruritus (2%) Dermatitis contact (2%) Dry skin (2%) Laceration (2%) Contusion (2%) Palpitations (5%) Dysmenorrhoea (2%) Metrorrhagia (2%) Splenomegaly (2%) Anxiety (2%) Hypertension (2%) Flushing (2%) Haematuria (2%) Hepatomegaly (2%) Hypersensitivity (2%) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Dizziness | grade 2, 1.3% | 30 mg/kg 1 times / day single, oral Highest studied dose Dose: 30 mg/kg, 1 times / day Route: oral Route: single Dose: 30 mg/kg, 1 times / day Sources: |
healthy, mean age 26 years n = 74 Health Status: healthy Age Group: mean age 26 years Sex: M Population Size: 74 Sources: |
Nausea | grade 2, 1.3% | 30 mg/kg 1 times / day single, oral Highest studied dose Dose: 30 mg/kg, 1 times / day Route: oral Route: single Dose: 30 mg/kg, 1 times / day Sources: |
healthy, mean age 26 years n = 74 Health Status: healthy Age Group: mean age 26 years Sex: M Population Size: 74 Sources: |
Bradycardia | grade 2, 1.3% DLT |
30 mg/kg 1 times / day single, oral Highest studied dose Dose: 30 mg/kg, 1 times / day Route: oral Route: single Dose: 30 mg/kg, 1 times / day Sources: |
healthy, mean age 26 years n = 74 Health Status: healthy Age Group: mean age 26 years Sex: M Population Size: 74 Sources: |
Dysequilibrium | grade 2, 1.3% DLT |
30 mg/kg 1 times / day single, oral Highest studied dose Dose: 30 mg/kg, 1 times / day Route: oral Route: single Dose: 30 mg/kg, 1 times / day Sources: |
healthy, mean age 26 years n = 74 Health Status: healthy Age Group: mean age 26 years Sex: M Population Size: 74 Sources: |
Hypotension | grade 2, 1.3% DLT |
30 mg/kg 1 times / day single, oral Highest studied dose Dose: 30 mg/kg, 1 times / day Route: oral Route: single Dose: 30 mg/kg, 1 times / day Sources: |
healthy, mean age 26 years n = 74 Health Status: healthy Age Group: mean age 26 years Sex: M Population Size: 74 Sources: |
Vomiting | grade 2, 1.3% DLT |
30 mg/kg 1 times / day single, oral Highest studied dose Dose: 30 mg/kg, 1 times / day Route: oral Route: single Dose: 30 mg/kg, 1 times / day Sources: |
healthy, mean age 26 years n = 74 Health Status: healthy Age Group: mean age 26 years Sex: M Population Size: 74 Sources: |
Dizziness | grade 3, 1.3% DLT |
30 mg/kg 1 times / day single, oral Highest studied dose Dose: 30 mg/kg, 1 times / day Route: oral Route: single Dose: 30 mg/kg, 1 times / day Sources: |
healthy, mean age 26 years n = 74 Health Status: healthy Age Group: mean age 26 years Sex: M Population Size: 74 Sources: |
Nausea | 20 mg/kg 1 times / day single, oral MTD Dose: 20 mg/kg, 1 times / day Route: oral Route: single Dose: 20 mg/kg, 1 times / day Sources: |
healthy, mean age 26 years n = 74 Health Status: healthy Age Group: mean age 26 years Sex: M Population Size: 74 Sources: |
|
Nausea | grade 1-2, 12.5% | 200 mg 2 times / day multiple, oral MTD Dose: 200 mg, 2 times / day Route: oral Route: multiple Dose: 200 mg, 2 times / day Sources: |
healthy, mean age 28 years n = 24 Health Status: healthy Age Group: mean age 28 years Sex: M+F Population Size: 24 Sources: |
Vomiting | 16.7% | 350 mg 2 times / day multiple, oral Studied dose Dose: 350 mg, 2 times / day Route: oral Route: multiple Dose: 350 mg, 2 times / day Sources: |
healthy, mean age 28 years n = 24 Health Status: healthy Age Group: mean age 28 years Sex: M+F Population Size: 24 Sources: |
Nausea | grade 1-2, 29.2% | 350 mg 2 times / day multiple, oral Studied dose Dose: 350 mg, 2 times / day Route: oral Route: multiple Dose: 350 mg, 2 times / day Sources: |
healthy, mean age 28 years n = 24 Health Status: healthy Age Group: mean age 28 years Sex: M+F Population Size: 24 Sources: |
Atrioventricular block second degree | 1% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
Supraventricular tachycardia | 1% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
Ventricular tachycardia | 1% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
Arrhythmia supraventricular | <1% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
Atrial tachycardia | <1% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
Atrioventricular block first degree | <1% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
Atrioventricular block | <1% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
Sinoatrial block | <1% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
Tachycardia | <1% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
Ventricular extrasystoles | <1% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.135 |
Diarrhoea | 10% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Dizziness | 10% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Upper respiratory tract infection | 11% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Nasopharyngitis | 13% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Arthralgia | 14% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Headache | 17% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
ALT increased | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Anxiety | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Contusion | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Dermatitis contact | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Dry mouth | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Dry skin | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Dysgeusia | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Dysmenorrhoea | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Dysphagia | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Ear infection | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Flatulence | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Flushing | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Gastritis | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Gastroenteritis viral | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Haematuria | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Hepatomegaly | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Hypersensitivity | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Hypertension | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Influenza like illness | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Laceration | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Metrorrhagia | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Nasal congestion | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Neuropathy peripheral | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Oral herpes | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Paraesthesia | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Pharyngitis | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Pneumonia | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Pruritus | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Rash | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Somnolence | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Splenomegaly | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Syncope | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Throat irritation | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Toothache | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Weight decreased | 2% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Abdominal distension | 3% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Bronchitis | 3% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Chest pain | 3% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Gastroenteritis | 3% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Musculoskeletal pain | 3% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Myalgia | 3% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Pyrexia | 3% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Viral infection | 3% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Asthenia | 4% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Epistaxis | 4% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Oedema peripheral | 4% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Oropharyngeal pain | 4% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Vomiting | 4% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Blood creatine phosphokinase increased | 5% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Bone pain | 5% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Gastrooesophageal reflux disease | 5% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Palpitations | 5% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Abdominal pain | 6% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Constipation | 6% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Cough | 6% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Infection urinary tract | 6% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Influenza | 6% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Sinusitis | 6% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Dyspepsia | 7% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Fatigue | 7% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Abdominal pain upper | 8% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Nausea | 8% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Pain in extremity | 8% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Back pain | 9% | 100 mg 2 times / day multiple, oral (mean) Studied dose Dose: 100 mg, 2 times / day Route: oral Route: multiple Dose: 100 mg, 2 times / day Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
unhealthy, mean age 37.1 years n = 393 Health Status: unhealthy Condition: Gaucher disease type 1 Age Group: mean age 37.1 years Sex: M+F Population Size: 393 Sources: Page: nda/2014/205494Orig1s000MedR.pdf - p.140 |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
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OverviewOther
Other Inhibitor | Other Substrate | Other Inducer |
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Drug as perpetrator
Drug as victim
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
Page: 11.0 |
major | yes (co-administration study) Comment: Following multiple doses of CERDELGA 127 mg twice daily (1.5 times the recommended dosage), metoprolol (a CYP2D6 substrate) mean Cmax and AUC increased by 1.7-fold and 2.3- fold in CYP2D6 EMs, respectively, and by 1.2-fold and 1.6-fold in IMs, respectively Page: 11.0 |
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Page: 11.0 |
minor | yes (co-administration study) Comment: As enzyme substrate: In healthy subjects, co-administration with a strong CYP2D6 and a weak CYP3A inhibitor paroxetine and a strong CYP3A inhibitor ketoconazole increased steady state eliglustat AUC Page: 11.0 |
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Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205494Orig1s000ClinPharmR.pdf#page=37 Page: 37.0 |
no | |||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205494Orig1s000ClinPharmR.pdf#page=37 Page: 37.0 |
no | |||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205494Orig1s000ClinPharmR.pdf#page=37 Page: 37.0 |
no | |||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205494Orig1s000ClinPharmR.pdf#page=112 Page: 112.0 |
yes |
Tox targets
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205494Orig1s000ClinPharmR.pdf#page=167 Page: 167.0 |
Sample Use Guides
CYP2D6 extensive metabolizers (Ems) or intermediate metabolizers (IMs): 84 mg orally twice daily (2.2); CYP2D6 poor metabolizers (PMs): 84 mg orally once daily (2.2); Swallow capsules whole, do not crush, dissolve or open capsules (2.3); Avoid eating grapefruit or drinking grapefruit juice
Route of Administration:
Oral
Studies of eliglustat potency and efficacy in cell systems showed the reduction in GL-1 in a human microsome assay and in human K562 erythropoietic cells with an IC50 of around 20 nM. In murine and canine cells, potency was a lower with IC50 values of around 60 nM and 80 nM respectively.
Substance Class |
Chemical
Created
by
admin
on
Edited
Fri Dec 15 18:19:59 GMT 2023
by
admin
on
Fri Dec 15 18:19:59 GMT 2023
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Record UNII |
N0493335P3
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Record Status |
Validated (UNII)
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Record Version |
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Classification Tree | Code System | Code | ||
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FDA ORPHAN DRUG |
816821
Created by
admin on Fri Dec 15 18:19:59 GMT 2023 , Edited by admin on Fri Dec 15 18:19:59 GMT 2023
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EMA ASSESSMENT REPORTS |
CERDELGA (AUTHORIZED: GAUCHER DISEASE)
Created by
admin on Fri Dec 15 18:19:59 GMT 2023 , Edited by admin on Fri Dec 15 18:19:59 GMT 2023
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EU-Orphan Drug |
EU/3/07/514
Created by
admin on Fri Dec 15 18:19:59 GMT 2023 , Edited by admin on Fri Dec 15 18:19:59 GMT 2023
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NCI_THESAURUS |
C471
Created by
admin on Fri Dec 15 18:19:59 GMT 2023 , Edited by admin on Fri Dec 15 18:19:59 GMT 2023
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Code System | Code | Type | Description | ||
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CHEMBL2110588
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SUB180210
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928659-70-5
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PRIMARY | |||
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DTXSID50239166
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DBSALT001106
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52918379
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83353
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PRIMARY | |||
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C522917
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UU-09
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100000166190
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PRIMARY | |||
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CERDELGA
Created by
admin on Fri Dec 15 18:19:59 GMT 2023 , Edited by admin on Fri Dec 15 18:19:59 GMT 2023
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PRIMARY | APPROVED MARCH 2015 | ||
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C96283
Created by
admin on Fri Dec 15 18:19:59 GMT 2023 , Edited by admin on Fri Dec 15 18:19:59 GMT 2023
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PRIMARY | |||
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N0493335P3
Created by
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PRIMARY | |||
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m4869
Created by
admin on Fri Dec 15 18:19:59 GMT 2023 , Edited by admin on Fri Dec 15 18:19:59 GMT 2023
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PRIMARY | Merck Index | ||
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1547219
Created by
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PRIMARY | RxNorm |
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PARENT -> SALT/SOLVATE | |||
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PARENT -> SALT/SOLVATE |
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ACTIVE MOIETY |