U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
This repository is under review for potential modification in compliance with Administration directives.

Details

Stereochemistry ABSOLUTE
Molecular Formula C19H14F2N6O
Molecular Weight 380.3509
Optical Activity UNSPECIFIED
Defined Stereocenters 2 / 2
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of TALAZOPARIB

SMILES

CN1N=CN=C1[C@@H]2[C@H](NC3=CC(F)=CC4=C3C2=NNC4=O)C5=CC=C(F)C=C5

InChI

InChIKey=HWGQMRYQVZSGDQ-HZPDHXFCSA-N
InChI=1S/C19H14F2N6O/c1-27-18(22-8-23-27)15-16(9-2-4-10(20)5-3-9)24-13-7-11(21)6-12-14(13)17(15)25-26-19(12)28/h2-8,15-16,24H,1H3,(H,26,28)/t15-,16-/m1/s1

HIDE SMILES / InChI
Molecular Formula C19H14F2N6O
Molecular Weight 380.3509
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 2 / 2
E/Z Centers 0
Optical Activity UNSPECIFIED

Description
Curator's Comment: Description was created based on several sources, including https://www.ncbi.nlm.nih.gov/pubmed/26652717 | https://www.ncbi.nlm.nih.gov/pubmed/23881923 | https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm623540.htm

BMN-673 (8R,9S) is the (8R,9S) enantiomer of BMN-673, known as talazoparib. BMN 673 is a novel inhibitor of nuclear enzyme poly (ADP-ribose) polymerase (PARP) with potential antineoplastic activity.

CNS Activity

CNS Non-penetrant
1040
Curator's Comment: This lack of intracranial efficacy is associated with limited brain distribution due to active efflux mediated by Mdr1 at the blood-brain barrier (animal study). No human data available.

Originator

Approval Year

2018
425
Targets

Targets

Primary TargetPharmacologyConditionPotency
Inhibitor
8504
 1.2 nM [Ki]
Inhibitor
8504
 0.87 nM [Ki]
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Approved
8583
TALZENNA

Approved Use

TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.

Launch Date

2018
Primary
Phase III
665
Unknown

Approved Use

Unknown
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
9.97 ng/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/31489639/
1 mg single, oral
dose: 1 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
TALAZOPARIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: FASTED
19.8 ng/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/31489639/
1 mg 1 times / day steady-state, oral
dose: 1 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
TALAZOPARIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
16.4 ng/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
1 mg 1 times / day steady-state, oral
dose: 1 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
TALAZOPARIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
193 ng × h/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/31489639/
1 mg single, oral
dose: 1 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
TALAZOPARIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: FASTED
196 ng × h/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/31489639/
1 mg 1 times / day steady-state, oral
dose: 1 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
TALAZOPARIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
208 ng × h/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
1 mg 1 times / day steady-state, oral
dose: 1 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
TALAZOPARIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
90 h
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
1 mg 1 times / day steady-state, oral
dose: 1 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
TALAZOPARIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
26%
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
1 mg 1 times / day steady-state, oral
dose: 1 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
TALAZOPARIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://clincancerres.aacrjournals.org/content/clincanres/25/9/2717.full.pdf
unhealthy, 31 - 75 years
Health Status: unhealthy
Age Group: 31 - 75 years
Sex: F
Sources:
https://clincancerres.aacrjournals.org/content/clincanres/25/9/2717.full.pdf
Disc. AE: Anemia, Function liver abnormal...
Other AEs: Myelosuppression...
AEs leading to
discontinuation/dose reduction:
Anemia (1 patient)
Function liver abnormal (2 patients)
Other AEs:
Myelosuppression (23 patients)
Sources:
https://clincancerres.aacrjournals.org/content/clincanres/25/9/2717.full.pdf
1.1 mg 1 times / day multiple, oral
MTD
Dose: 1.1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1.1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Disc. AE: Thrombocytopenia, Thrombocytopenia...
AEs leading to
discontinuation/dose reduction:
Thrombocytopenia (grade 3, 16.67%)
Thrombocytopenia (grade 4, 16.67%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Other AEs: Decreased hemoglobin, Leukocyte count decreased...
Other AEs:
Decreased hemoglobin (grade 1-4, 90%)
Leukocyte count decreased (grade 1-4, 84%)
Neutropenia (grade 1-4, 68%)
Lymphocyte count low (grade 1-4, 76%)
Platelets decreased (grade 1-4, 55%)
Glucose increased (grade 1-4, 54%)
Aspartate aminotransferase increase (grade 1-4, 37%)
Alkaline phosphatase increased (grade 1-4, 36%)
Alanine aminotransferase increase (grade 1-4, 33%)
Calcium decreased (grade 1-4, 28%)
Decreased hemoglobin (grade 3, 39%)
Leukocyte count decreased (grade 3, 14%)
Neutropenia (grade 3, 17%)
Lymphocyte count low (grade 3, 17%)
Platelets decreased (grade 3, 11%)
Glucose increased (grade 3, 2%)
Aspartate aminotransferase increase (grade 3, 2%)
Alkaline phosphatase increased (grade 3, 2%)
Alanine aminotransferase increase (grade 3, 1%)
Calcium decreased (grade 3, 1%)
Leukocyte count decreased (grade 4, 0%)
Neutropenia (grade 4, 3%)
Lymphocyte count low (grade 4, 1%)
Platelets decreased (grade 4, 4%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Disc. AE: Anemia, Accidental overdose...
AEs leading to
discontinuation/dose reduction:
Anemia (2%)
Accidental overdose (1%)
Cerebral hemorrhage (1%)
Dyspnea (1%)
Glioblastoma multiforme (1%)
Headache (1%)
Metastases to meninges (1%)
Neutropenia (1%)
Chronic obstructive airways disease (1%)
Thrombocytopenia (1%)
Transient ischemic attack (1%)
Vomiting (1%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Other AEs: Anemia, Neutropenia...
Other AEs:
Anemia (32%)
Neutropenia (15%)
Thrombocytopenia (6%)
Anemia (>5)
Neutropenia (>5)
Thrombocytopenia (>5)
Platelet count decreased (>5)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Other AEs: Anemia, Neutropenia...
Other AEs:
Anemia (grade 1-4, 53%)
Neutropenia (grade 1-4, 35%)
Thrombocytopenia (grade 1-4, 27%)
Decreased appetite (grade 1-4, 21%)
Headache (grade 1-4, 33%)
Nausea (grade 1-4, 49%)
Vomiting (grade 1-4, 25%)
Diarrhea (grade 1-4, 22%)
Alopecia (grade 1-4, 25%)
Fatigue (grade 1-4, 62%)
Anemia (grade 3, 38%)
Neutropenia (grade 3, 18%)
Thrombocytopenia (grade 3, 11%)
Decreased appetite (grade 3, <1%)
Headache (grade 3, 2%)
Nausea (grade 3, <1%)
Vomiting (grade 3, 2%)
Diarrhea (grade 3, 1%)
Fatigue (grade 3, 3%)
Anemia (grade 4, 1%)
Neutropenia (grade 4, 3%)
Thrombocytopenia (grade 4, 4%)
Abdominal pain (19%)
Dizziness (17%)
Leukopenia (17%)
Dysgeusia (10%)
Dyspepsia (10%)
Stomatitis (8%)
Lymphopenia (7%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
AEs

AEs

AESignificanceDosePopulation
Anemia 1 patient
Disc. AE
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://clincancerres.aacrjournals.org/content/clincanres/25/9/2717.full.pdf
unhealthy, 31 - 75 years
Health Status: unhealthy
Age Group: 31 - 75 years
Sex: F
Sources:
https://clincancerres.aacrjournals.org/content/clincanres/25/9/2717.full.pdf
Function liver abnormal 2 patients
Disc. AE
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://clincancerres.aacrjournals.org/content/clincanres/25/9/2717.full.pdf
unhealthy, 31 - 75 years
Health Status: unhealthy
Age Group: 31 - 75 years
Sex: F
Sources:
https://clincancerres.aacrjournals.org/content/clincanres/25/9/2717.full.pdf
Myelosuppression 23 patients
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://clincancerres.aacrjournals.org/content/clincanres/25/9/2717.full.pdf
unhealthy, 31 - 75 years
Health Status: unhealthy
Age Group: 31 - 75 years
Sex: F
Sources:
https://clincancerres.aacrjournals.org/content/clincanres/25/9/2717.full.pdf
Thrombocytopenia grade 3, 16.67%
Disc. AE
1.1 mg 1 times / day multiple, oral
MTD
Dose: 1.1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1.1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Thrombocytopenia grade 4, 16.67%
Disc. AE
1.1 mg 1 times / day multiple, oral
MTD
Dose: 1.1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1.1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Calcium decreased grade 1-4, 28%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Alanine aminotransferase increase grade 1-4, 33%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Alkaline phosphatase increased grade 1-4, 36%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Aspartate aminotransferase increase grade 1-4, 37%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Glucose increased grade 1-4, 54%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Platelets decreased grade 1-4, 55%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Neutropenia grade 1-4, 68%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Lymphocyte count low grade 1-4, 76%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Leukocyte count decreased grade 1-4, 84%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Decreased hemoglobin grade 1-4, 90%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Alanine aminotransferase increase grade 3, 1%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Calcium decreased grade 3, 1%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Platelets decreased grade 3, 11%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Leukocyte count decreased grade 3, 14%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Lymphocyte count low grade 3, 17%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Neutropenia grade 3, 17%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Alkaline phosphatase increased grade 3, 2%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Aspartate aminotransferase increase grade 3, 2%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Glucose increased grade 3, 2%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Decreased hemoglobin grade 3, 39%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Leukocyte count decreased grade 4, 0%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Lymphocyte count low grade 4, 1%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Neutropenia grade 4, 3%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Platelets decreased grade 4, 4%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Accidental overdose 1%
Disc. AE
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Cerebral hemorrhage 1%
Disc. AE
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Chronic obstructive airways disease 1%
Disc. AE
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Dyspnea 1%
Disc. AE
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Glioblastoma multiforme 1%
Disc. AE
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Headache 1%
Disc. AE
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Metastases to meninges 1%
Disc. AE
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Neutropenia 1%
Disc. AE
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Thrombocytopenia 1%
Disc. AE
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Transient ischemic attack 1%
Disc. AE
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Vomiting 1%
Disc. AE
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Anemia 2%
Disc. AE
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Neutropenia 15%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Anemia 32%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Thrombocytopenia 6%
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Anemia >5
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Neutropenia >5
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Platelet count decreased >5
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Thrombocytopenia >5
1 mg 1 times / day multiple, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: multiple
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000MultidisciplineR.pdf
Dysgeusia 10%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Dyspepsia 10%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Dizziness 17%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Leukopenia 17%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Abdominal pain 19%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Lymphopenia 7%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Stomatitis 8%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Decreased appetite grade 1-4, 21%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Diarrhea grade 1-4, 22%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Alopecia grade 1-4, 25%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Vomiting grade 1-4, 25%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Thrombocytopenia grade 1-4, 27%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Headache grade 1-4, 33%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Neutropenia grade 1-4, 35%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Nausea grade 1-4, 49%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Anemia grade 1-4, 53%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Fatigue grade 1-4, 62%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Diarrhea grade 3, 1%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Thrombocytopenia grade 3, 11%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Neutropenia grade 3, 18%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Headache grade 3, 2%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Vomiting grade 3, 2%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Fatigue grade 3, 3%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Anemia grade 3, 38%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Decreased appetite grade 3, <1%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Nausea grade 3, <1%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Anemia grade 4, 1%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Neutropenia grade 4, 3%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Thrombocytopenia grade 4, 4%
1 mg 1 times / day steady, oral
Recommended
Dose: 1 mg, 1 times / day
Route: oral
Route: steady
Dose: 1 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
unhealthy, unknown
Health Status: unhealthy
Age Group: unknown
Sex: F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
inducer
1087
inhibitor
2438
inhibitor
2507
inhibitor
2217

OverviewOther

Other InhibitorOther SubstrateOther Inducer
CYP1A2
2153

CYP2B6
926

CYP2C8
1057

CYP2C19
2057

CYP3A4/5
296

UGT1A1
246

UGT1A4
98

UGT1A6
136

UGT1A9
148

UGT2B7
197

UGT2B15
84

BSEP
550
P-gp
2052

BCRP
697

OAT1
395

OAT3
391

OCT1
393

OCT2
434

OATP1B1
503

OATP1B3
435

MATE1
182

MATE2
98

BSEP
63

hepatic enzymes
2
CYP1A2
832

CYP2B6
669
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
BSEP
554
 no
CYP1A2
2333
 no
CYP1A2
2333
 no
CYP2B6
1160
 no
CYP2B6
1160
 no
CYP2C19
2141
 no
CYP2C8
1117
 no
CYP2C9
2497
 no
CYP2D6
2546
 no
CYP3A4
2633
 no
CYP3A4/5
357
 no
UGT1A1
303
 no
UGT1A4
100
 no
UGT1A6
171
 no
UGT1A9
155
 no
UGT2B15
84
 no
UGT2B7
210
 no
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
hepatic enzymes
2
 minor
BSEP
63
 no
MATE1
182
 no
MATE2
98
 no
OAT1
395
 no
OAT3
391
 no
OATP1B1
503
 no
OATP1B3
435
 no
OCT1
393
 no
OCT2
434
 no
BCRP
697
 yes
P-gp
2052
 yes
yes (co-administration study)
Comment: itraconazole increases talazoparib AUC >50%; rifampicin did not inrease talazoparib AUC; both increased talazoparib plasma concentrations by 40% and 37%, respectively
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
hERG
2263
Sourcing

Sourcing

Vendor/AggregatorIDURL
AbMole Bioscience
1732
http://www.abmole.com/product.asp?id=1732
AbMole Bioscience
M1732
http://www.abmole.com/products/bmn673.html
Achemtek
0102-014244
http://www.achemtek.com/1207456-01-6
Acorn PharmaTech
ACN-053048
http://www.acornpharmatech.com/
AK Scientific, Inc. (AKSCI)
X5821
http://www.aksci.com/item_detail.php?cat=X5821
Ambinter
Amb24093138
http://www.ambinter.com/reference/24093138
ApexBio Technology
A3246
http://www.apexbt.com/bmn-673-8r-9s.html
Aurora Fine Chemicals LLC
K16.649.136
http://online.aurorafinechemicals.com/info?ID=K16.649.136
Aurum Pharmatech LLC
S-7826
http://www.Aurumpharmatech.com/Product/ProductDetails/S_7826
Axon MedChem
2502
https://www.axonmedchem.com/product/2502
BioCrick
BCC2205
http://www.biocrick.com/BMN-673-BCC2205.html
Boerchem
BC600324
http://www.boerchem.com/?product_43159.html
Chem Scene
CS-0937
http://www.chemscene.com/1207456-01-6.html
Chemspace
CSSB00015188901
https://chem-space.com/CSSB00015188901
Chemspace
CSSB00025726212
https://chem-space.com/CSSB00025726212
DC Chemicals
DC2008
http://www.dcchemicals.com/product_show-Talazoparib_BMN_673_.html
eNovation Chemicals
D596724
https://www.enovationchem.com/ProductDetails.asp?ProductID=D596724
eNovation Chemicals
Y0974305
https://www.enovationchem.com/ProductDetails.asp?ProductID=Y0974305
Excenen
EX-A1356
http://www.excenen.com/searchresultlist.php?id=1207456-01-6
iChemical
EBD2207497
http://www.ichemical.com/products/1207456-01-6.html?utm_source=PubChem&utm_medium=website&utm_campaign=product%20catalogs
Lab Network
LN01262559
https://labnetwork.com/frontend-app/p/#!/moleculedetails/LN01262559
Matrix Scientific
131612
https://www.matrixscientific.com/131612.html
MedChem Express
HY-16106
https://www.medchemexpress.com/BMN-673.html
MolPort
MolPort-042-652-822
https://www.molport.com/shop/molecule-link/MolPort-042-652-822
MuseChem
I000776
https://www.musechem.com/product/I000776.html
Selleck Chemicals
S7048
http://www.selleckchem.com/products/bmn-673.html
Sinfoo Biotech
S061615
http://www.sinfoobiotech.com/product/1065028
Smolecule
S002091
http://www.smolecule.com/products/s002091
Smolecule
S548582
http://www.smolecule.com/products/s548582
Synblock Inc
SB16478
http://www.synblock.com/product/1207456-01-6.html
THE BioTek
bt-253535
https://www.thebiotek.com/product/inhibitors/bt-253535
THE BioTek
bt-287988
https://www.thebiotek.com/product/inhibitors/bt-287988
PubMed

PubMed

TitleDatePubMed
Patents

Patents

WO/2015/164586A1
2
WO/2016/018089A1
2

Sample Use Guides

In Vivo Use Guide
Signs of activity of talazoparib were observed at 100 µg/day doses, and the maximum tolerated dose was 1.0 mg/day
Route of Administration: Oral
In Vitro Use Guide
Talazoparib (BMN 673) induces DNA damage at picomolar concentrations
Substance Class Chemical
Created
by admin
on Mon Mar 31 22:01:11 GMT 2025
Edited
by admin
on Mon Mar 31 22:01:11 GMT 2025
Record UNII
9QHX048FRV
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
talazoparib [INN]
Preferred Name English
TALAZOPARIB
INN   USAN  
USAN   INN  
Official Name English
BMN 673
Code English
3H-PYRIDO(4,3,2-DE)PHTHALAZIN-3-ONE, 5-FLUORO-8-(4-FLUOROPHENYL)-2,7,8,9-TETRAHYDRO-9-(1-METHYL-1H-1,2,4-TRIAZOL-5-YL)-, (8S,9R)-
Systematic Name English
TALAZOPARIB [USAN]
Common Name English
PF-06944076
Code English
BMN-673
Code English
(8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one
Systematic Name English
Talazoparib [WHO-DD]
Common Name English
TALAZOPARIB [MI]
Common Name English
LT-673
Code English
Classification Tree Code System Code
NCI_THESAURUS C62554
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
WHO-ATC L01XX60
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
NDF-RT N0000191623
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
Code System Code Type Description
USAN
BC-63
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
DAILYMED
9QHX048FRV
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
RXCUI
2099704
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
CAS
1207456-01-6
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
FDA UNII
9QHX048FRV
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
EVMPD
SUB180394
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
LACTMED
Talazoparib
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
WIKIPEDIA
Talazoparib
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
PUBCHEM
135565082
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
MERCK INDEX
m12100
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
INN
9868
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
EPA CompTox
DTXSID001025928
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
DRUG BANK
DB11760
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
NCI_THESAURUS
C95733
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
ChEMBL
CHEMBL3137320
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
SMS_ID
100000166294
Created by admin on Mon Mar 31 22:01:11 GMT 2025 , Edited by admin on Mon Mar 31 22:01:11 GMT 2025
PRIMARY
Related Record Type Details
PLASMA PROTEIN FRACTION (HUMAN)
BINDER->LIGAND
In vitro, protein binding of talazoparib is 74% and is independent of talazoparib concentration.
BINDING
Structure of TALAZOPARIB TOSYLATE
SALT/SOLVATE -> PARENT
ATP-BINDING CASSETTE SUB-FAMILY G MEMBER 2
TRANSPORTER -> SUBSTRATE
Co-administration with BCRP inhibitors may increase talazoparib exposure.
MULTIDRUG RESISTANCE PROTEIN 1
TRANSPORTER -> SUBSTRATE
Co-administration of talazoparib with certain P-gp inhibitors including amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil in the clinical studies (PRP-001, PRP-002, ABRAZO and EMBRACA) increased talazoparib exposure by 44.7%, in conjunction with an increased rate of Talzenna dose reductions (41%).
Structure of TALAZOPARIB
EXCRETED UNCHANGED
FECAL
Structure of TALAZOPARIB
EXCRETED UNCHANGED
POLY (ADP-RIBOSE) POLYMERASE 2
TARGET -> INHIBITOR
IC50
Related Record Type Details
Structure of TALAZOPARIB
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Tmax PHARMACOKINETIC
Biological Half-life PHARMACOKINETIC
Volume of Distribution PHARMACOKINETIC
NIH
NCATS
PRIVACY ACT
ACCESSIBILITY
DISCLAIMER
HHS VULNERABILITY DISCLOSURE
For language access assistance, contact the NCATS Public Information Officer
National Center for Advancing Translational Sciences (NCATS),
6701 Democracy Boulevard, Bethesda MD 20892-4874 • 301-594-8966