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Details

Stereochemistry ABSOLUTE
Molecular Formula C18H21NO4
Molecular Weight 315.3643
Optical Activity UNSPECIFIED
Defined Stereocenters 3 / 3
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of OMACETAXINE

SMILES

COC1=C[C@@]23CCCN3CCc4cc5c(cc4[C@]2([H])[C@]1([H])O)OCO5

InChI

InChIKey=YMNCVRSYJBNGLD-KURKYZTESA-N
InChI=1S/C18H21NO4/c1-21-15-9-18-4-2-5-19(18)6-3-11-7-13-14(23-10-22-13)8-12(11)16(18)17(15)20/h7-9,16-17,20H,2-6,10H2,1H3/t16-,17-,18+/m1/s1

HIDE SMILES / InChI

Description
Curator's Comment:: description was created based on several sources, including http://www.ncbi.nlm.nih.gov/pubmed/?term=23790799

Omacetaxine mepesuccinate (trade name Synribo) formerly named as homoharringtonine or HHT, is a pharmaceutical drug substance that is indicated for treatment of chronic myeloid leukemia (CML). It is a natural ester of the alkaloid cephalotaxine from Cephalotaxus harringtonia, now manufactured by hemi-synthesis. It was approved by the US FDA in October 2012 for the treatment of adult patients with CML with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs). The mechanism of action of omacetaxine mepesuccinate has not been fully elucidated but includes inhibition of protein synthesis and is independent of direct Bcr-Abl binding. Omacetaxine mepesuccinate binds to the A-site cleft in the peptidyl-transferase center of the large ribosomal subunit from a strain of archaeabacteria. In vitro, omacetaxine mepesuccinate reduced protein levels of the Bcr Abl oncoprotein and Mcl-1, an anti-apoptotic Bcl-2 family member. Omacetaxine mepesuccinate showed activity in mouse models of wild-type and T315I mutated Bcr-Abl CML.

CNS Activity

Curator's Comment:: Homoharringtonine (omacetaxine mepesuccinate) can penetrate into brain tumors. Generally tritiated homoharringtonine ([3H]HHT, 150 microCi, 430 micrograms) was administered intravenously to seven patients at varying times before surgical resection of malignant brain tumor. Plasma, urine, cerebrospinal fluid (CSF), and tumor specimens were obtained during surgery, and the concentrations of HHT, its major metabolite, and [3H]HHT equivalent were determined chromatographically and radiochemically. A major metabolite of HHT was detectable in the tumor specimens of all the patients.

Originator

Curator's Comment:: Homoharringtonine (omacetaxine mepesuccinate ) and related compound esters of cephalotaxine were described first in 1970. Omacetaxine mepesuccinate has been marketed by IVAX International GmbH (Teva) under the trade name SYNRIBO approved by FDA in 2012.

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
Target ID: P39023
Gene ID: 6122.0
Gene Symbol: RPL3
Target Organism: Homo sapiens (Human)
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
SYNRIBO

Approved Use

Indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI). This indication is based upon response rate.There are no trials verifying an improvement in disease-related symptoms or increased survival with SYNRIBO

Launch Date

1.35120958E12
Primary
SYNRIBO

Approved Use

Indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI). This indication is based upon response rate.There are no trials verifying an improvement in disease-related symptoms or increased survival with SYNRIBO

Launch Date

1.35120958E12
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
25.1 ng/mL
1.25 mg/m² single, subcutaneous
dose: 1.25 mg/m²
route of administration: Subcutaneous
experiment type: SINGLE
co-administered:
[NO STEREO] OMACETAXINE MEPESUCCINATE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
136.2 ng × h/mL
1.25 mg/m² single, subcutaneous
dose: 1.25 mg/m²
route of administration: Subcutaneous
experiment type: SINGLE
co-administered:
[NO STEREO] OMACETAXINE MEPESUCCINATE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
6.96 h
1.25 mg/m² single, subcutaneous
dose: 1.25 mg/m²
route of administration: Subcutaneous
experiment type: SINGLE
co-administered:
[NO STEREO] OMACETAXINE MEPESUCCINATE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
5 mg/m2 1 times / day multiple, subcutaneous
MTD
Dose: 5 mg/m2, 1 times / day
Route: subcutaneous
Route: multiple
Dose: 5 mg/m2, 1 times / day
Sources:
unhealthy, 57 years (range: 20–79 years)
n = 12
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia
Age Group: 57 years (range: 20–79 years)
Sex: M+F
Population Size: 12
Sources:
DLT: Haematemesis, Pulmonary aspergillosis...
Other AEs: Anasarca...
Dose limiting toxicities:
Haematemesis (grade 3, 1 patient)
Pulmonary aspergillosis (grade 4, 1 patient)
Skin rash (grade 3, 1 patient)
Scalp pain (grade 3, 1 patient)
Other AEs:
Anasarca (grade 3, 1 patient)
Sources:
3 mg/m2 1 times / day multiple, subcutaneous
Dose: 3 mg/m2, 1 times / day
Route: subcutaneous
Route: multiple
Dose: 3 mg/m2, 1 times / day
Sources:
unhealthy, 57 years (range: 20–79 years)
n = 12
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia
Age Group: 57 years (range: 20–79 years)
Sex: M+F
Population Size: 12
Sources:
DLT: Hyperglycaemia, Diabetic hyperosmolar coma...
Dose limiting toxicities:
Hyperglycaemia (grade 3, 1 patient)
Diabetic hyperosmolar coma
Sources:
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Disc. AE: Thrombocytopenia, Alanine aminotransferase increased...
Other AEs: Thrombocytopenia, Thrombocytopenia...
AEs leading to
discontinuation/dose reduction:
Thrombocytopenia (2%)
Alanine aminotransferase increased (2%)
Other AEs:
Thrombocytopenia (all grades, 74%)
Thrombocytopenia (grade 3-4, 67%)
Anemia (all grades, 61%)
Anemia (grade 3-4, 36%)
Neutropenia (all grades, 50%)
Neutropenia (grade 3-4, 45%)
Lymphopenia (all grades, 17%)
Lymphopenia (grade 3-4, 16%)
Bone marrow failure (all grades, 10%)
Bone marrow failure (grade 3-4, 10%)
Febrile neutropenia (all grades, 10%)
Febrile neutropenia (grade 3-4, 10%)
Diarrhea (all grades, 42%)
Diarrhea (grade 3-4, 1%)
Nausea (all grades, 32%)
Nausea (grade 3-4, 1%)
Constipation (grade 1-2, 15%)
Abdominal pain upper (grade 1-2, 14%)
Vomiting (grade 1-2, 12%)
Fatigue (all grades, 26%)
Fatigue (grade 3-4, 5%)
Pyrexia (all grades, 24%)
Pyrexia (grade 3-4, 1%)
Asthenia (all grades, 23%)
Asthenia (grade 3-4, 1%)
Edema peripheral (grade 1-2, 13%)
Infusion site reactions (grade 1-2, 34%)
Arthralgia (all grades, 19%)
Arthralgia (grade 3-4, 1%)
Pain in extremity (all grades, 13%)
Pain in extremity (grade 3-4, 1%)
Back pain (all grades, 11%)
Back pain (grade 3-4, 2%)
Headache (all grades, 19%)
Headache (grade 3-4, 1%)
Insomnia (grade 1-2, 10%)
Cough (all grades, 16%)
Cough (grade 3-4, 1%)
Epistaxis (all grades, 15%)
Epistaxis (grade 3-4, 1%)
Alopecia (grade 1-2, 15%)
Rash (grade 1-2, 10%)
Sources:
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources: Page: p. 57
unhealthy, 59 years
n = 158
Health Status: unhealthy
Condition: chronic phase, Accelerated Phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 158
Sources: Page: p. 57
Disc. AE: Bone marrow failure, Sepsis...
AEs leading to
discontinuation/dose reduction:
Bone marrow failure (1%)
Sepsis (1%)
Multiorgan failure (1%)
Gout (1%)
Renal failure (1%)
Sources: Page: p. 57
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Other AEs: Anemia, Anemia...
Other AEs:
Anemia (all grades, 51%)
Anemia (grade 3-4, 36%)
Febrile neutropenia (all grades, 20%)
Febrile neutropenia (grade 3-4, 16%)
Neutropenia (all grades, 20%)
Neutropenia (grade 3-4, 18%)
Thrombocytopenia (all grades, 56%)
Thrombocytopenia (grade 3-4, 49%)
Diarrhea (all grades, 35%)
Diarrhea (grade 3-4, 7%)
Nausea (all grades, 27%)
Nausea (grade 3-4, 4%)
Vomiting (all grades, 15%)
Vomiting (grade 3-4, 2%)
Abdominal pain (grade 1-2, 13%)
Fatigue (all grades, 31%)
Fatigue (grade 3-4, 9%)
Pyrexia (all grades, 29%)
Pyrexia (grade 3-4, 2%)
Asthenia (all grades, 24%)
Asthenia (grade 3-4, 2%)
Chills (grade 1-2, 13%)
Infusion site reactions (grade 1-2, 22%)
Anorexia (all grades, 13%)
Anorexia (grade 3-4, 2%)
Pain in extremity (all grades, 11%)
Pain in extremity (grade 3-4, 2%)
Headache (grade 1-2, 13%)
Cough (grade 1-2, 15%)
Dyspnea (all grades, 11%)
Dyspnea (grade 3-4, 2%)
Epistaxis (all grades, 11%)
Epistaxis (grade 3-4, 2%)
Bacterial infection (all grades, 56%)
Bacterial infection (grade 3-4, 20%)
Infection viral (all grades, 56%)
Infection viral (grade 3-4, 20%)
Fungal infection (all grades, 56%)
Fungal infection (grade 3-4, 20%)
Infection NOS (all grades, 56%)
Infection NOS (grade 3-4, 20%)
Sources:
1.25 mg/m2 2 times / day steady, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: steady
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Disc. AE: Pancytopenia...
AEs leading to
discontinuation/dose reduction:
Pancytopenia (2%)
Sources:
1.25 mg/m2 2 times / day steady, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: steady
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase CML
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Disc. AE: Alanine aminotransferase increased...
AEs leading to
discontinuation/dose reduction:
Alanine aminotransferase increased (2%)
Sources:
1.25 mg/m2 2 times / day steady, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: steady
Dose: 1.25 mg/m2, 2 times / day
Sources: Page: p. 57
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase CML
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources: Page: p. 57
Disc. AE: Tachyarrhythmia, Diplopia...
AEs leading to
discontinuation/dose reduction:
Tachyarrhythmia (1%)
Diplopia (1%)
Sources: Page: p. 57
8 mg/m2 1 times / day multiple, intravenous
Highest studied dose
Dose: 8 mg/m2, 1 times / day
Route: intravenous
Route: multiple
Dose: 8 mg/m2, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Condition: refractory malignancies
Sources:
DLT: Hypotension...
Dose limiting toxicities:
Hypotension
Sources:
2.5 mg/m2 2 times / day multiple, subcutaneous
Overdose
Dose: 2.5 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 2.5 mg/m2, 2 times / day
Sources:
unhealthy
n = 1
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia
Population Size: 1
Sources:
Disc. AE: Gastrointestinal disorders, Gingival hemorrhage...
AEs leading to
discontinuation/dose reduction:
Gastrointestinal disorders (1 patient)
Gingival hemorrhage (1 patient)
Alopecia (1 patient)
Thrombocytopenia (grade 4, 1 patient)
Neutropenia (grade 4, 1 patient)
Sources:
2.5 mg/m2 2 times / day multiple, subcutaneous
Overdose
Dose: 2.5 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 2.5 mg/m2, 2 times / day
Sources: Page: p. 67
unhealthy
n = 1
Health Status: unhealthy
Condition: CML
Population Size: 1
Sources: Page: p. 67
Disc. AE: Gingival hemorrhage, Gastrointestinal disorders...
AEs leading to
discontinuation/dose reduction:
Gingival hemorrhage (1 patient)
Gastrointestinal disorders (1 patient)
Alopecia (1 patient)
Thrombocytopenia (grade 4, 1 patient)
Neutropenia (grade 4, 1 patient)
Sources: Page: p. 67
AEs

AEs

AESignificanceDosePopulation
Anasarca grade 3, 1 patient
5 mg/m2 1 times / day multiple, subcutaneous
MTD
Dose: 5 mg/m2, 1 times / day
Route: subcutaneous
Route: multiple
Dose: 5 mg/m2, 1 times / day
Sources:
unhealthy, 57 years (range: 20–79 years)
n = 12
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia
Age Group: 57 years (range: 20–79 years)
Sex: M+F
Population Size: 12
Sources:
Haematemesis grade 3, 1 patient
DLT
5 mg/m2 1 times / day multiple, subcutaneous
MTD
Dose: 5 mg/m2, 1 times / day
Route: subcutaneous
Route: multiple
Dose: 5 mg/m2, 1 times / day
Sources:
unhealthy, 57 years (range: 20–79 years)
n = 12
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia
Age Group: 57 years (range: 20–79 years)
Sex: M+F
Population Size: 12
Sources:
Scalp pain grade 3, 1 patient
DLT
5 mg/m2 1 times / day multiple, subcutaneous
MTD
Dose: 5 mg/m2, 1 times / day
Route: subcutaneous
Route: multiple
Dose: 5 mg/m2, 1 times / day
Sources:
unhealthy, 57 years (range: 20–79 years)
n = 12
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia
Age Group: 57 years (range: 20–79 years)
Sex: M+F
Population Size: 12
Sources:
Skin rash grade 3, 1 patient
DLT
5 mg/m2 1 times / day multiple, subcutaneous
MTD
Dose: 5 mg/m2, 1 times / day
Route: subcutaneous
Route: multiple
Dose: 5 mg/m2, 1 times / day
Sources:
unhealthy, 57 years (range: 20–79 years)
n = 12
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia
Age Group: 57 years (range: 20–79 years)
Sex: M+F
Population Size: 12
Sources:
Pulmonary aspergillosis grade 4, 1 patient
DLT
5 mg/m2 1 times / day multiple, subcutaneous
MTD
Dose: 5 mg/m2, 1 times / day
Route: subcutaneous
Route: multiple
Dose: 5 mg/m2, 1 times / day
Sources:
unhealthy, 57 years (range: 20–79 years)
n = 12
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia
Age Group: 57 years (range: 20–79 years)
Sex: M+F
Population Size: 12
Sources:
Diabetic hyperosmolar coma DLT
3 mg/m2 1 times / day multiple, subcutaneous
Dose: 3 mg/m2, 1 times / day
Route: subcutaneous
Route: multiple
Dose: 3 mg/m2, 1 times / day
Sources:
unhealthy, 57 years (range: 20–79 years)
n = 12
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia
Age Group: 57 years (range: 20–79 years)
Sex: M+F
Population Size: 12
Sources:
Hyperglycaemia grade 3, 1 patient
DLT
3 mg/m2 1 times / day multiple, subcutaneous
Dose: 3 mg/m2, 1 times / day
Route: subcutaneous
Route: multiple
Dose: 3 mg/m2, 1 times / day
Sources:
unhealthy, 57 years (range: 20–79 years)
n = 12
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia
Age Group: 57 years (range: 20–79 years)
Sex: M+F
Population Size: 12
Sources:
Alanine aminotransferase increased 2%
Disc. AE
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Thrombocytopenia 2%
Disc. AE
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Bone marrow failure all grades, 10%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Febrile neutropenia all grades, 10%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Back pain all grades, 11%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Pain in extremity all grades, 13%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Epistaxis all grades, 15%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Cough all grades, 16%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Lymphopenia all grades, 17%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Arthralgia all grades, 19%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Headache all grades, 19%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Asthenia all grades, 23%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Pyrexia all grades, 24%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Fatigue all grades, 26%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Nausea all grades, 32%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Diarrhea all grades, 42%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Neutropenia all grades, 50%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Anemia all grades, 61%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Thrombocytopenia all grades, 74%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Insomnia grade 1-2, 10%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Rash grade 1-2, 10%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Vomiting grade 1-2, 12%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Edema peripheral grade 1-2, 13%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Abdominal pain upper grade 1-2, 14%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Alopecia grade 1-2, 15%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Constipation grade 1-2, 15%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Infusion site reactions grade 1-2, 34%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Arthralgia grade 3-4, 1%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Asthenia grade 3-4, 1%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Cough grade 3-4, 1%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Diarrhea grade 3-4, 1%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Epistaxis grade 3-4, 1%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Headache grade 3-4, 1%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Nausea grade 3-4, 1%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Pain in extremity grade 3-4, 1%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Pyrexia grade 3-4, 1%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Bone marrow failure grade 3-4, 10%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Febrile neutropenia grade 3-4, 10%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Lymphopenia grade 3-4, 16%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Back pain grade 3-4, 2%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Anemia grade 3-4, 36%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Neutropenia grade 3-4, 45%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Fatigue grade 3-4, 5%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Thrombocytopenia grade 3-4, 67%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Bone marrow failure 1%
Disc. AE
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources: Page: p. 57
unhealthy, 59 years
n = 158
Health Status: unhealthy
Condition: chronic phase, Accelerated Phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 158
Sources: Page: p. 57
Gout 1%
Disc. AE
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources: Page: p. 57
unhealthy, 59 years
n = 158
Health Status: unhealthy
Condition: chronic phase, Accelerated Phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 158
Sources: Page: p. 57
Multiorgan failure 1%
Disc. AE
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources: Page: p. 57
unhealthy, 59 years
n = 158
Health Status: unhealthy
Condition: chronic phase, Accelerated Phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 158
Sources: Page: p. 57
Renal failure 1%
Disc. AE
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources: Page: p. 57
unhealthy, 59 years
n = 158
Health Status: unhealthy
Condition: chronic phase, Accelerated Phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 158
Sources: Page: p. 57
Sepsis 1%
Disc. AE
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources: Page: p. 57
unhealthy, 59 years
n = 158
Health Status: unhealthy
Condition: chronic phase, Accelerated Phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 158
Sources: Page: p. 57
Dyspnea all grades, 11%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Epistaxis all grades, 11%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Pain in extremity all grades, 11%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Anorexia all grades, 13%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Vomiting all grades, 15%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Febrile neutropenia all grades, 20%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Neutropenia all grades, 20%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Asthenia all grades, 24%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Nausea all grades, 27%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Pyrexia all grades, 29%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Fatigue all grades, 31%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Diarrhea all grades, 35%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Anemia all grades, 51%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Bacterial infection all grades, 56%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Fungal infection all grades, 56%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Infection NOS all grades, 56%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Infection viral all grades, 56%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Thrombocytopenia all grades, 56%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Abdominal pain grade 1-2, 13%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Chills grade 1-2, 13%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Headache grade 1-2, 13%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Cough grade 1-2, 15%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Infusion site reactions grade 1-2, 22%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Febrile neutropenia grade 3-4, 16%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Neutropenia grade 3-4, 18%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Anorexia grade 3-4, 2%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Asthenia grade 3-4, 2%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Dyspnea grade 3-4, 2%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Epistaxis grade 3-4, 2%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Pain in extremity grade 3-4, 2%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Pyrexia grade 3-4, 2%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Vomiting grade 3-4, 2%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Bacterial infection grade 3-4, 20%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Fungal infection grade 3-4, 20%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Infection NOS grade 3-4, 20%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Infection viral grade 3-4, 20%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Anemia grade 3-4, 36%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Nausea grade 3-4, 4%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Thrombocytopenia grade 3-4, 49%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Diarrhea grade 3-4, 7%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Fatigue grade 3-4, 9%
1.25 mg/m2 2 times / day multiple, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 55
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia – Accelerated Phase
Age Group: 59 years
Population Size: 55
Sources:
Pancytopenia 2%
Disc. AE
1.25 mg/m2 2 times / day steady, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: steady
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase chronic myeloid leukemia
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Alanine aminotransferase increased 2%
Disc. AE
1.25 mg/m2 2 times / day steady, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: steady
Dose: 1.25 mg/m2, 2 times / day
Sources:
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase CML
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources:
Diplopia 1%
Disc. AE
1.25 mg/m2 2 times / day steady, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: steady
Dose: 1.25 mg/m2, 2 times / day
Sources: Page: p. 57
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase CML
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources: Page: p. 57
Tachyarrhythmia 1%
Disc. AE
1.25 mg/m2 2 times / day steady, subcutaneous
Recommended
Dose: 1.25 mg/m2, 2 times / day
Route: subcutaneous
Route: steady
Dose: 1.25 mg/m2, 2 times / day
Sources: Page: p. 57
unhealthy, 59 years
n = 108
Health Status: unhealthy
Condition: chronic phase CML
Age Group: 59 years
Sex: M+F
Population Size: 108
Sources: Page: p. 57
Hypotension DLT
8 mg/m2 1 times / day multiple, intravenous
Highest studied dose
Dose: 8 mg/m2, 1 times / day
Route: intravenous
Route: multiple
Dose: 8 mg/m2, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Condition: refractory malignancies
Sources:
Alopecia 1 patient
Disc. AE
2.5 mg/m2 2 times / day multiple, subcutaneous
Overdose
Dose: 2.5 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 2.5 mg/m2, 2 times / day
Sources:
unhealthy
n = 1
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia
Population Size: 1
Sources:
Gastrointestinal disorders 1 patient
Disc. AE
2.5 mg/m2 2 times / day multiple, subcutaneous
Overdose
Dose: 2.5 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 2.5 mg/m2, 2 times / day
Sources:
unhealthy
n = 1
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia
Population Size: 1
Sources:
Gingival hemorrhage 1 patient
Disc. AE
2.5 mg/m2 2 times / day multiple, subcutaneous
Overdose
Dose: 2.5 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 2.5 mg/m2, 2 times / day
Sources:
unhealthy
n = 1
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia
Population Size: 1
Sources:
Neutropenia grade 4, 1 patient
Disc. AE
2.5 mg/m2 2 times / day multiple, subcutaneous
Overdose
Dose: 2.5 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 2.5 mg/m2, 2 times / day
Sources:
unhealthy
n = 1
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia
Population Size: 1
Sources:
Thrombocytopenia grade 4, 1 patient
Disc. AE
2.5 mg/m2 2 times / day multiple, subcutaneous
Overdose
Dose: 2.5 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 2.5 mg/m2, 2 times / day
Sources:
unhealthy
n = 1
Health Status: unhealthy
Condition: Chronic Myeloid Leukemia
Population Size: 1
Sources:
Alopecia 1 patient
Disc. AE
2.5 mg/m2 2 times / day multiple, subcutaneous
Overdose
Dose: 2.5 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 2.5 mg/m2, 2 times / day
Sources: Page: p. 67
unhealthy
n = 1
Health Status: unhealthy
Condition: CML
Population Size: 1
Sources: Page: p. 67
Gastrointestinal disorders 1 patient
Disc. AE
2.5 mg/m2 2 times / day multiple, subcutaneous
Overdose
Dose: 2.5 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 2.5 mg/m2, 2 times / day
Sources: Page: p. 67
unhealthy
n = 1
Health Status: unhealthy
Condition: CML
Population Size: 1
Sources: Page: p. 67
Gingival hemorrhage 1 patient
Disc. AE
2.5 mg/m2 2 times / day multiple, subcutaneous
Overdose
Dose: 2.5 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 2.5 mg/m2, 2 times / day
Sources: Page: p. 67
unhealthy
n = 1
Health Status: unhealthy
Condition: CML
Population Size: 1
Sources: Page: p. 67
Neutropenia grade 4, 1 patient
Disc. AE
2.5 mg/m2 2 times / day multiple, subcutaneous
Overdose
Dose: 2.5 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 2.5 mg/m2, 2 times / day
Sources: Page: p. 67
unhealthy
n = 1
Health Status: unhealthy
Condition: CML
Population Size: 1
Sources: Page: p. 67
Thrombocytopenia grade 4, 1 patient
Disc. AE
2.5 mg/m2 2 times / day multiple, subcutaneous
Overdose
Dose: 2.5 mg/m2, 2 times / day
Route: subcutaneous
Route: multiple
Dose: 2.5 mg/m2, 2 times / day
Sources: Page: p. 67
unhealthy
n = 1
Health Status: unhealthy
Condition: CML
Population Size: 1
Sources: Page: p. 67
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG



OverviewOther

Other InhibitorOther SubstrateOther Inducer






Drug as perpetrator​Drug as victimTox targets

Tox targets

Sourcing

Sourcing

Vendor/AggregatorIDURL
PubMed

PubMed

TitleDatePubMed
Concise total synthesis of (±)-cephalotaxine via a transannulation strategy: development of a facile reductive oxy-Nazarov cyclization.
2011 Jul 1
Patents

Sample Use Guides

In Vivo Use Guide
Unknown
Route of Administration: Unknown
In Vitro Use Guide
Unknown
Name Type Language
OMACETAXINE
VANDF   WHO-DD  
Common Name English
CEPHALOTAXINE [WHO-DD]
Common Name English
OMACETAXINE [VANDF]
Common Name English
NSC-128487
Code English
(-)-CEPHALOTAXINE
Common Name English
OMACETAXINE [WHO-DD]
Common Name English
NSC-245454
Code English
CEPHALOTAXINE
MI   WHO-DD  
Common Name English
CEPHALOTAXINE [MI]
Common Name English
(1S-(1.ALPHA.,3AS*,14B.BETA.))-1,5,6,8,9,14B-HEXAHYDRO-2-METHOXY-4H-CYCLOPENTA(A)(1,3)DIOXOLO(4,5-H)PYRROLO(2,1-B)(3)BENZAZEPIN-1-OL
Common Name English
Classification Tree Code System Code
LIVERTOX 708
Created by admin on Fri Jun 25 20:50:05 UTC 2021 , Edited by admin on Fri Jun 25 20:50:05 UTC 2021
Code System Code Type Description
RXCUI
1546446
Created by admin on Fri Jun 25 20:50:05 UTC 2021 , Edited by admin on Fri Jun 25 20:50:05 UTC 2021
PRIMARY RxNorm
CAS
24316-19-6
Created by admin on Fri Jun 25 20:50:05 UTC 2021 , Edited by admin on Fri Jun 25 20:50:05 UTC 2021
PRIMARY
MERCK INDEX
M3250
Created by admin on Fri Jun 25 20:50:05 UTC 2021 , Edited by admin on Fri Jun 25 20:50:05 UTC 2021
PRIMARY Merck Index
MESH
C001597
Created by admin on Fri Jun 25 20:50:05 UTC 2021 , Edited by admin on Fri Jun 25 20:50:05 UTC 2021
PRIMARY
EVMPD
SUB183934
Created by admin on Fri Jun 25 20:50:05 UTC 2021 , Edited by admin on Fri Jun 25 20:50:05 UTC 2021
PRIMARY
PUBCHEM
65305
Created by admin on Fri Jun 25 20:50:05 UTC 2021 , Edited by admin on Fri Jun 25 20:50:05 UTC 2021
PRIMARY
FDA UNII
84MI6OYN4Z
Created by admin on Fri Jun 25 20:50:05 UTC 2021 , Edited by admin on Fri Jun 25 20:50:05 UTC 2021
PRIMARY
NCI_THESAURUS
C179199
Created by admin on Fri Jun 25 20:50:05 UTC 2021 , Edited by admin on Fri Jun 25 20:50:05 UTC 2021
PRIMARY
EPA CompTox
24316-19-6
Created by admin on Fri Jun 25 20:50:05 UTC 2021 , Edited by admin on Fri Jun 25 20:50:05 UTC 2021
PRIMARY