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Details

Stereochemistry ABSOLUTE
Molecular Formula C28H22ClF3N6O3
Molecular Weight 582.9619
Optical Activity UNSPECIFIED
Defined Stereocenters 2 / 2
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of IVOSIDENIB

SMILES

c1ccc(c(c1)[C@@]([H])(C(=NC2CC(C2)(F)F)O)N(c3cc(cnc3)F)C(=O)[C@]4([H])CCC(=O)N4c5cc(ccn5)C#N)Cl

InChI

InChIKey=WIJZXSAJMHAVGX-DHLKQENFSA-N
InChI=1S/C28H22ClF3N6O3/c29-21-4-2-1-3-20(21)25(26(40)36-18-11-28(31,32)12-18)37(19-10-17(30)14-34-15-19)27(41)22-5-6-24(39)38(22)23-9-16(13-33)7-8-35-23/h1-4,7-10,14-15,18,22,25H,5-6,11-12H2,(H,36,40)/t22-,25-/m0/s1

HIDE SMILES / InChI

Description
Curator's Comment:: Description was created using several sources including: https://www.ncbi.nlm.nih.gov/pubmed/25980580 | http://www.bloodjournal.org/content/124/21/3734

Ivosidenib (AG-120) is an inhibitor of isocitrate dehydrogenase 1 (IDH1) This experimental drug inhibits mutant IDH1, leading to increased differentiation and decreased proliferation in IDH1 positive tumors and thus is thought to be promising for the treatment of IDH1-mutated tumors. In vivo treatment with AG-120 of TF-1 cells, primary human AML patient samples expressing mutant IDH1 and primary human blast cells cultured ex vivo showed that AG-120 is effective at lowering 2-HG levels and restoring cellular differentiation. It showed promising results in a phase I trial in patients with relapsed or refractory acute myeloid leukemia and is being evaluated in Phase III in previously-treated subjects with nonresectable or metastatic cholangiocarcinoma with an IDH1 mutation.

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
TIBSOVO

Approved Use

TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.

Launch Date

1.53195839E12
Primary
Unknown

Approved Use

Unknown
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
3657 ng/mL
500 mg single, oral
dose: 500 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
IVOSIDENIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
112490 ng × h/mL
500 mg single, oral
dose: 500 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
IVOSIDENIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
64.3 h
500 mg single, oral
dose: 500 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
IVOSIDENIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
6%
IVOSIDENIB plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
1200 mg single, oral
Highest studied dose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources: Page: 52
unhealthy, adult
n = 4
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 4
Sources: Page: 52
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 6.1
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 6.1
Disc. AE: Guillain Barre syndrome, Rash...
Other AEs: QT prolonged, Differentiation syndrome...
AEs leading to
discontinuation/dose reduction:
Guillain Barre syndrome (1%)
Rash (1%)
Stomatitis (1%)
Creatinine increased (1%)
Other AEs:
QT prolonged (7%)
Differentiation syndrome (3%)
Leukocytosis (3%)
Dyspnea (3%)
QT prolonged (1%)
Diarrhea (1%)
Nausea (1%)
Decreased hemoglobin (1%)
Transaminases increased (1%)
Sources: Page: 6.1
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Other AEs: Leukocytosis, Differentiation syndrome...
Other AEs:
Leukocytosis (all grades, 38%)
Differentiation syndrome (all grades, 19%)
Diarrhea (all grades, 34%)
Nausea (all grades, 31%)
Mucositis (all grades, 28%)
Constipation (all grades, 20%)
Vomiting (all grades, 18%)
Abdominal pain (all grades, 16%)
Fatigue (all grades, 39%)
Edema (all grades, 32%)
Pyrexia (all grades, 23%)
Chest pain (all grades, 16%)
Electrocardiogram QT prolonged (all grades, 26%)
Decreased appetite (all grades, 18%)
Tumor lysis syndrome (all grades, 8%)
Arthralgia (all grades, 36%)
Myalgia (all grades, 18%)
Headache (all grades, 16%)
Neuropathy (all grades, 12%)
Cough (all grades, 22%)
Dyspnea (all grades, 33%)
Pleural effusion (all grades, 13%)
Rash (all grades, 26%)
Hypotension (all grades, 12%)
Leukocytosis (grade 3-4, 8%)
Differentiation syndrome (grade 3-4, 13%)
Diarrhea (grade 3-4, 2%)
Nausea (grade 3-4, 1%)
Mucositis (grade 3-4, 3%)
Constipation (grade 3-4, 1%)
Vomiting (grade 3-4, 1%)
Abdominal pain (grade 3-4, 1%)
Fatigue (grade 3-4, 3%)
Edema (grade 3-4, 1%)
Pyrexia (grade 3-4, 1%)
Chest pain (grade 3-4, 3%)
Electrocardiogram QT prolonged (grade 3-4, 10%)
Decreased appetite (grade 3-4, 2%)
Tumor lysis syndrome (grade 3-4, 6%)
Arthralgia (grade 3-4, 4%)
Myalgia (grade 3-4, 1%)
Neuropathy (grade 3-4, 1%)
Cough (grade 3-4, <1%)
Dyspnea (grade 3-4, 9%)
Pleural effusion (grade 3-4, 3%)
Rash (grade 3-4, 2%)
Hypotension (grade 3-4, 4%)
Hemoglobin decreased (all grades, 60%)
Sources: Page: Table 2
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Other AEs: Sodium decreased, Magnesium decreased...
Other AEs:
Sodium decreased (all grades, 39%)
Magnesium decreased (all grades, 38%)
Uric acid increased (all grades, 32%)
Potassium decreased (all grades, 31%)
Alkaline phosphatase increased (all grades, 27%)
Aspartate aminotransferase increased (all grades, 27%)
Phosphate decreased (all grades, 25%)
Creatinine increased (all grades, 23%)
Alanine aminotransferase increased (all grades, 15%)
Bilirubin increased (all grades, 16%)
Hemoglobin decreased (grade 3-4, 46%)
Sodium decreased (grade 3-4, 4%)
Uric acid increased (grade 3-4, 6%)
Potassium decreased (grade 3-4, 6%)
Alkaline phosphatase increased (grade 3-4, 1%)
Aspartate aminotransferase increased (grade 3-4, 1%)
Phosphate decreased (grade 3-4, 8%)
Creatinine increased (grade 3-4, 1%)
Alanine aminotransferase increased (grade 3-4, 1%)
Bilirubin increased (grade 3-4, 1%)
Sources: Page: Table 3
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 122
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 122
Disc. AE: Sepsis, Fungal infection...
AEs leading to
discontinuation/dose reduction:
Sepsis (grade 4, 2%)
Fungal infection (2%)
Pneumonia (2%)
Renal insufficiency (1%)
Sources: Page: 122
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Other AEs: Infections and infestations, Blood and lymphatic system disorders...
Other AEs:
Infections and infestations (43%)
Blood and lymphatic system disorders (40%)
Respiratory, thoracic and mediastinal disorders (15%)
Cardiac disorders (11%)
Gastrointestinal disorders (11%)
Metabolism and nutrition disorders (8%)
Nervous system disorders (8%)
Musculoskeletal and connective tissue disorders (4%)
Injury, poisoning and procedural complications (4%)
Renal and urinary disorders (4%)
Vascular disorders (3%)
Neoplasm (2%)
Skin and subcutaneous tissue disorders (2%)
Immune system disorders (1%)
Psychiatric disorders (1%)
Ear and labyrinth disorders (1%)
Hepatobiliary disorders (1%)
Sources: Page: Table 3
AEs

AEs

AESignificanceDosePopulation
Decreased hemoglobin 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 6.1
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 6.1
Diarrhea 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 6.1
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 6.1
Nausea 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 6.1
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 6.1
QT prolonged 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 6.1
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 6.1
Transaminases increased 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 6.1
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 6.1
Creatinine increased 1%
Disc. AE
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 6.1
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 6.1
Guillain Barre syndrome 1%
Disc. AE
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 6.1
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 6.1
Rash 1%
Disc. AE
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 6.1
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 6.1
Stomatitis 1%
Disc. AE
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 6.1
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 6.1
Differentiation syndrome 3%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 6.1
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 6.1
Dyspnea 3%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 6.1
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 6.1
Leukocytosis 3%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 6.1
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 6.1
QT prolonged 7%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 6.1
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 6.1
Hypotension all grades, 12%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Neuropathy all grades, 12%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Pleural effusion all grades, 13%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Abdominal pain all grades, 16%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Chest pain all grades, 16%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Headache all grades, 16%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Decreased appetite all grades, 18%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Myalgia all grades, 18%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Vomiting all grades, 18%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Differentiation syndrome all grades, 19%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Constipation all grades, 20%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Cough all grades, 22%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Pyrexia all grades, 23%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Electrocardiogram QT prolonged all grades, 26%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Rash all grades, 26%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Mucositis all grades, 28%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Nausea all grades, 31%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Edema all grades, 32%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Dyspnea all grades, 33%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Diarrhea all grades, 34%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Arthralgia all grades, 36%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Leukocytosis all grades, 38%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Fatigue all grades, 39%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Hemoglobin decreased all grades, 60%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Tumor lysis syndrome all grades, 8%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Abdominal pain grade 3-4, 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Constipation grade 3-4, 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Edema grade 3-4, 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Myalgia grade 3-4, 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Nausea grade 3-4, 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Neuropathy grade 3-4, 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Pyrexia grade 3-4, 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Vomiting grade 3-4, 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Electrocardiogram QT prolonged grade 3-4, 10%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Differentiation syndrome grade 3-4, 13%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Decreased appetite grade 3-4, 2%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Diarrhea grade 3-4, 2%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Rash grade 3-4, 2%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Chest pain grade 3-4, 3%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Fatigue grade 3-4, 3%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Mucositis grade 3-4, 3%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Pleural effusion grade 3-4, 3%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Arthralgia grade 3-4, 4%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Hypotension grade 3-4, 4%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Tumor lysis syndrome grade 3-4, 6%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Leukocytosis grade 3-4, 8%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Dyspnea grade 3-4, 9%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Cough grade 3-4, <1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 2
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 2
Alanine aminotransferase increased all grades, 15%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Bilirubin increased all grades, 16%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Creatinine increased all grades, 23%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Phosphate decreased all grades, 25%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Alkaline phosphatase increased all grades, 27%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Aspartate aminotransferase increased all grades, 27%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Potassium decreased all grades, 31%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Uric acid increased all grades, 32%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Magnesium decreased all grades, 38%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Sodium decreased all grades, 39%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Alanine aminotransferase increased grade 3-4, 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Alkaline phosphatase increased grade 3-4, 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Aspartate aminotransferase increased grade 3-4, 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Bilirubin increased grade 3-4, 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Creatinine increased grade 3-4, 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Sodium decreased grade 3-4, 4%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Hemoglobin decreased grade 3-4, 46%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Potassium decreased grade 3-4, 6%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Uric acid increased grade 3-4, 6%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Phosphate decreased grade 3-4, 8%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Renal insufficiency 1%
Disc. AE
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 122
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 122
Fungal infection 2%
Disc. AE
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 122
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 122
Pneumonia 2%
Disc. AE
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 122
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 122
Sepsis grade 4, 2%
Disc. AE
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: 122
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: 122
Ear and labyrinth disorders 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Hepatobiliary disorders 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Immune system disorders 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Psychiatric disorders 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Cardiac disorders 11%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Gastrointestinal disorders 11%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Respiratory, thoracic and mediastinal disorders 15%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Neoplasm 2%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Skin and subcutaneous tissue disorders 2%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Vascular disorders 3%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Injury, poisoning and procedural complications 4%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Musculoskeletal and connective tissue disorders 4%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Renal and urinary disorders 4%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Blood and lymphatic system disorders 40%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Infections and infestations 43%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Metabolism and nutrition disorders 8%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Nervous system disorders 8%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources: Page: Table 3
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: acute myeloid leukemia
Age Group: adult
Sex: unknown
Population Size: 179
Sources: Page: Table 3
Overview

Overview

Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
inconclusive
no [Ki 22.8 uM]
no [Ki 9.56 uM]
no
no
no
no
no
no
no
yes [Ki 0.322 uM]
yes [Ki 19.6 uM]
yes
yes
yes
yes
yes
yes
yes
Drug as victimTox targets
PubMed

PubMed

TitleDatePubMed
IDH1 inhibitor shows promising early results.
2015 Jan
Oncometabolic mutation IDH1 R132H confers a metformin-hypersensitive phenotype.
2015 May 20
The Evolving Landscape in the Development of Isocitrate Dehydrogenase Mutant Inhibitors.
2016
Patents

Sample Use Guides

Patients in the study were given either 100 mg of AG-120 twice daily, or 300 mg, 500 mg, or 800 mg once daily, over continuous 28-day cycles.
Route of Administration: Oral
TF-1 cells or primary human AML patient samples expressing mutant IDH1 were treated with 0.5, 1.0, and 5.0 uM of AG-120 which decreased intracellular 2-HG levels, inhibited growth factor independent proliferation and restored erythropoietin (EPO)-induced differentiation in TF-1 IDH1-R132H cells.
Name Type Language
IVOSIDENIB
INN   USAN   WHO-DD  
INN   USAN  
Official Name English
TIBSOVO
Brand Name English
IVOSIDENIB [WHO-DD]
Common Name English
GLYCINAMIDE, 1-(4-CYANO-2-PYRIDINYL)-5-OXO-L-PROLYL-2-(2-CHLOROPHENYL)-N-(3,3-DIFLUOROCYCLOBUTYL)-N2-(5-FLUORO-3-PYRIDINYL)-, (2S)-
Systematic Name English
IVOSIDENIB [USAN]
Common Name English
AG-120
Code English
IVOSIDENIB [INN]
Common Name English
IVOSIDENIB [MI]
Common Name English
IVOSIDENIB [ORANGE BOOK]
Common Name English
(2S)-N-((1S)-1-(2-CHLOROPHENYL)-2-((3,3-DIFLUOROCYCLOBUTYL)AMINO)-2-OXOETHYL)-1-(4-CYANOPYRIDIN-2-YL)-N-(5-FLUOROPYRIDIN-3-YL)-5-OXOPYRROLIDINE-2-CARBOXAMIDE
Systematic Name English
Classification Tree Code System Code
FDA ORPHAN DRUG 739720
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
FDA ORPHAN DRUG 562216
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
FDA ORPHAN DRUG 481515
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
FDA ORPHAN DRUG 637718
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
EU-Orphan Drug EU/3/16/1802
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
NCI_THESAURUS C137826
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
Code System Code Type Description
CAS
1448347-49-6
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
PRIMARY
DRUG BANK
DB14568
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
PRIMARY
PUBCHEM
71657455
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
PRIMARY
FDA UNII
Q2PCN8MAM6
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
PRIMARY
INN
10225
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
PRIMARY
RXCUI
2049873
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
PRIMARY
MERCK INDEX
M12089
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
PRIMARY
LACTMED
Ivosidenib
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
PRIMARY
NCI_THESAURUS
C114383
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
PRIMARY
DRUG CENTRAL
5292
Created by admin on Sat Jun 26 00:53:14 UTC 2021 , Edited by admin on Sat Jun 26 00:53:14 UTC 2021
PRIMARY