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Details

Stereochemistry ABSOLUTE
Molecular Formula C28H22ClF3N6O3
Molecular Weight 582.961
Optical Activity UNSPECIFIED
Defined Stereocenters 2 / 2
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of IVOSIDENIB

SMILES

FC1=CN=CC(=C1)N([C@H](C(=O)NC2CC(F)(F)C2)C3=CC=CC=C3Cl)C(=O)[C@@H]4CCC(=O)N4C5=NC=CC(=C5)C#N

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
Cancer-associated IDH1 mutations produce 2-hydroxyglutarate.
2009 Dec 10
IDH1 inhibitor shows promising early results.
2015 Jan
Oncometabolic mutation IDH1 R132H confers a metformin-hypersensitive phenotype.
2015 May 20
Evidence for Clinical Differentiation and Differentiation Syndrome in Patients With Acute Myeloid Leukemia and IDH1 Mutations Treated With the Targeted Mutant IDH1 Inhibitor, AG-120.
2016 Aug
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
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 [WHO-DD]
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 562216
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
FDA ORPHAN DRUG 739720
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
FDA ORPHAN DRUG 938423
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
FDA ORPHAN DRUG 637718
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
EU-Orphan Drug EU/3/16/1802
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
NCI_THESAURUS C137826
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
FDA ORPHAN DRUG 481515
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
Code System Code Type Description
CAS
1448347-49-6
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
PRIMARY
DRUG BANK
DB14568
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
PRIMARY
WIKIPEDIA
Ivosidenib
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
PRIMARY
DAILYMED
Q2PCN8MAM6
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
PRIMARY
PUBCHEM
71657455
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
PRIMARY
FDA UNII
Q2PCN8MAM6
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
PRIMARY
CHEBI
145430
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
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INN
10225
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
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RXCUI
2049873
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
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MERCK INDEX
m12089
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
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SMS_ID
100000175066
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
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LACTMED
Ivosidenib
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
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NCI_THESAURUS
C114383
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
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USAN
EF-21
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
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DRUG CENTRAL
5292
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
PRIMARY
EPA CompTox
DTXSID801027928
Created by admin on Sat Dec 16 10:49:08 UTC 2023 , Edited by admin on Sat Dec 16 10:49:08 UTC 2023
PRIMARY