U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C45H54N4O8
Molecular Weight 778.934
Optical Activity UNSPECIFIED
Defined Stereocenters 8 / 8
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of VINORELBINE

SMILES

CCC1=C[C@@]2([H])C[C@](c3cc4c(cc3OC)N(C)[C@]5([H])[C@@]64CCN7CC=C[C@](CC)([C@@]67[H])[C@]([H])([C@@]5(C(=O)OC)O)OC(=O)C)(c8c(CN(C1)C2)c9ccccc9[nH]8)C(=O)OC

InChI

InChIKey=GBABOYUKABKIAF-IELIFDKJSA-N
InChI=1S/C45H54N4O8/c1-8-27-19-28-22-44(40(51)55-6,36-30(25-48(23-27)24-28)29-13-10-11-14-33(29)46-36)32-20-31-34(21-35(32)54-5)47(4)38-43(31)16-18-49-17-12-15-42(9-2,37(43)49)39(57-26(3)50)45(38,53)41(52)56-7/h10-15,19-21,28,37-39,46,53H,8-9,16-18,22-25H2,1-7H3/t28-,37-,38+,39+,42+,43+,44-,45-/m0/s1

HIDE SMILES / InChI

Description
Curator's Comment:: Description was created based on several sources, including http://www.fda.gov/ohrms/dockets/ac/04/briefing/4021B1_10_Vinorelbine%20label.pdf | https://www.medicines.org.uk/emc/medicine/1604 | http://adisinsight.springer.com/drugs/800004195

of anti-tumour activity. Vinorelbine is a mitotic spindle poison that impairs chromosomal segregation during mitosis. It blocks cells at G2/M. Microtubules (derived from polymers of tubulin) are the principal target of vinorelbine. Vinorelbine was developed by Pierre Fabre under licence from the CNRS in France. NAVELBINE (vinorelbine tartrate) as a single agent or in combination is indicated for the first line treatment of non small cell lung cancer and advanced breast cancer.

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
NAVELBINE

Approved Use

NAVELBINE (vinorelbine tartrate) is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced nonsmall cell lung cancer (NSCLC). In patients with Stage IV NSCLC, NAVELBINE is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, NAVELBINE is indicated in combination with cisplatin.

Launch Date

788140800000
Primary
NAVELBINE

Approved Use

Oral NAVELBINE (vinorelbine tartrate) as a single agent or in combination for the first line treatment of stage 3 or 4 non small cell lung cancer, and treatment of advanced breast cancer stage 3 and 4 relapsing after or refractory to an anthracycline containing regimen.

Launch Date

788140800000
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
761.8 ng/mL
25 mg/m² single, intravenous
dose: 25 mg/m²
route of administration: Intravenous
experiment type: SINGLE
co-administered:
VINORELBINE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
133.4 ng/mL
80 mg/m² single, oral
dose: 80 mg/m²
route of administration: Oral
experiment type: SINGLE
co-administered:
VINORELBINE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
1042 ng × h/mL
25 mg/m² single, intravenous
dose: 25 mg/m²
route of administration: Intravenous
experiment type: SINGLE
co-administered:
VINORELBINE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1299 ng × h/mL
80 mg/m² single, oral
dose: 80 mg/m²
route of administration: Oral
experiment type: SINGLE
co-administered:
VINORELBINE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
37.9 h
25 mg/m² single, intravenous
dose: 25 mg/m²
route of administration: Intravenous
experiment type: SINGLE
co-administered:
VINORELBINE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
29.4 h
80 mg/m² single, oral
dose: 80 mg/m²
route of administration: Oral
experiment type: SINGLE
co-administered:
VINORELBINE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
14.6%
VINORELBINE plasma
Homo sapiens
population: UNHEALTHY
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
DLT: Neutropenia, Neutropenia...
Other AEs: Leukopenia, Leukopenia...
Dose limiting toxicities:
Neutropenia (grade 1, 80%)
Neutropenia (grade 4, 29%)
Other AEs:
Leukopenia (grade 1, 81%)
Leukopenia (grade 4, 12%)
Thrombocytopenia (grade 1, 4%)
Anemia (grade 1, 77%)
Anemia (grade 3, 1%)
AST increased (grade 3-4, 3%)
Bilirubin increased (grade 3-4, 5%)
Nausea (grade 3-4, 1%)
Asthenia (grade 3-4, 5%)
Constipation (grade 3-4, 2%)
Injection site reaction (grade 3-4, 5%)
Injection site pain (grade 3-4, 1%)
Neuropathy peripheral (grade 3-4, 1%)
Vomiting (grade 3-4, 1%)
Diarrhea (grade 3-4, 1%)
Alopecia (grade 3-4, 1%)
Phlebitis (grade 3-4, 1%)
Dyspnea (grade 3-4, 2%)
Sources:
100 mg/m2 1 times / week multiple, oral
MTD
Dose: 100 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 100 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
DLT: Neutropenia...
Other AEs: Leukopenia, Vomiting...
Dose limiting toxicities:
Neutropenia (grade 3-4, 3 patients)
Other AEs:
Leukopenia (grade 3-4, 2 patients)
Vomiting (grade 3-4, 2 patients)
Diarrhoea (grade 1, 3 patients)
Stomatitis (grade 3-4, 1 patient)
Constipation (grade 3-4, 3 patients)
Alopecia (grade 1-2, 2 patients)
Sources:
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
DLT: Neutropenia, Neutropenia...
Other AEs: Leukopenia, Vomiting...
Dose limiting toxicities:
Neutropenia (grade 3-4, 10 patients)
Neutropenia (all grades, 11 patient)
Other AEs:
Leukopenia (grade 3-4, 7 patients)
Vomiting (grade 3-4, 2 patients)
Constipation (grade 3-4, 1 patient)
Alopecia (grade 3-4, 1 patient)
Anaemia (all grades, 9 patients)
Leukopenia (all grades, 12 patients)
Thrombocytopenia (all grades, 1 patient)
Nausea (all grades, 13 patients)
Vomiting (all grades, 11 patient)
Diarrhoea (all grades, 9 patients)
Stomatitis (all grades, 2 patients)
Constipation (all grades, 8 patients)
Alopecia (all grades, 9 patients)
Sources:
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
DLT: Neutropenia...
Other AEs: Anemia, Leukopenia...
Dose limiting toxicities:
Neutropenia (grade 3-4, 82%)
Other AEs:
Anemia (grade 3-4, 24%)
Leukopenia (grade 3-4, 58%)
Thrombocytopenia (grade 3-4, 5%)
Febrile neutropenia (grade 3-4, 11%)
Blood creatinine increased (grade 3-4, 4%)
Malaise and fatigue (grade 3-4, 12%)
Vomiting (grade 3-4, 13%)
Nausea (grade 3-4, 14%)
Constipation (grade 3-4, 3%)
Weight decreased (grade 3-4, 1%)
Fever (grade 3-4, 2%)
Hearing impaired (grade 3-4, 4%)
Injection site reaction (grade 3-4, <1%)
Diarrhea (grade 3-4, <3%)
Paraesthesia (grade 3-4, <1%)
Numbness (grade 3-4, 2%)
Arthralgia (grade 3-4, <1%)
Embolism and thrombosis (grade 3-4, 3%)
Weakness (grade 3-4, <3%)
Infection (grade 3-4, <6%)
Respiratory tract infection (grade 3-4, <5%)
Sources:
AEs

AEs

AESignificanceDosePopulation
Thrombocytopenia grade 1, 4%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Anemia grade 1, 77%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Neutropenia grade 1, 80%
DLT
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Leukopenia grade 1, 81%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Anemia grade 3, 1%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Alopecia grade 3-4, 1%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Diarrhea grade 3-4, 1%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Injection site pain grade 3-4, 1%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Nausea grade 3-4, 1%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Neuropathy peripheral grade 3-4, 1%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Phlebitis grade 3-4, 1%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Vomiting grade 3-4, 1%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Constipation grade 3-4, 2%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Dyspnea grade 3-4, 2%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
AST increased grade 3-4, 3%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Asthenia grade 3-4, 5%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Bilirubin increased grade 3-4, 5%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Injection site reaction grade 3-4, 5%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Leukopenia grade 4, 12%
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Neutropenia grade 4, 29%
DLT
30 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 30 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 30 mg/m2, 1 times / week
Sources:
unhealthy, 61 years (range: 32-79 years)
Health Status: unhealthy
Age Group: 61 years (range: 32-79 years)
Sex: M+F
Sources:
Diarrhoea grade 1, 3 patients
100 mg/m2 1 times / week multiple, oral
MTD
Dose: 100 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 100 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Alopecia grade 1-2, 2 patients
100 mg/m2 1 times / week multiple, oral
MTD
Dose: 100 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 100 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Stomatitis grade 3-4, 1 patient
100 mg/m2 1 times / week multiple, oral
MTD
Dose: 100 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 100 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Leukopenia grade 3-4, 2 patients
100 mg/m2 1 times / week multiple, oral
MTD
Dose: 100 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 100 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Vomiting grade 3-4, 2 patients
100 mg/m2 1 times / week multiple, oral
MTD
Dose: 100 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 100 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Constipation grade 3-4, 3 patients
100 mg/m2 1 times / week multiple, oral
MTD
Dose: 100 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 100 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Neutropenia grade 3-4, 3 patients
DLT
100 mg/m2 1 times / week multiple, oral
MTD
Dose: 100 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 100 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Thrombocytopenia all grades, 1 patient
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Vomiting all grades, 11 patient
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Neutropenia all grades, 11 patient
DLT
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Leukopenia all grades, 12 patients
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Nausea all grades, 13 patients
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Stomatitis all grades, 2 patients
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Constipation all grades, 8 patients
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Alopecia all grades, 9 patients
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Anaemia all grades, 9 patients
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Diarrhoea all grades, 9 patients
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Alopecia grade 3-4, 1 patient
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Constipation grade 3-4, 1 patient
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Neutropenia grade 3-4, 10 patients
DLT
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Vomiting grade 3-4, 2 patients
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Leukopenia grade 3-4, 7 patients
80 mg/m2 1 times / week multiple, oral
RP2D
Dose: 80 mg/m2, 1 times / week
Route: oral
Route: multiple
Dose: 80 mg/m2, 1 times / week
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: F
Sources:
Weight decreased grade 3-4, 1%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Febrile neutropenia grade 3-4, 11%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Malaise and fatigue grade 3-4, 12%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Vomiting grade 3-4, 13%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Nausea grade 3-4, 14%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Fever grade 3-4, 2%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Numbness grade 3-4, 2%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Anemia grade 3-4, 24%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Constipation grade 3-4, 3%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Embolism and thrombosis grade 3-4, 3%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Blood creatinine increased grade 3-4, 4%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Hearing impaired grade 3-4, 4%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Thrombocytopenia grade 3-4, 5%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Leukopenia grade 3-4, 58%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Neutropenia grade 3-4, 82%
DLT
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Arthralgia grade 3-4, <1%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Injection site reaction grade 3-4, <1%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Paraesthesia grade 3-4, <1%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Diarrhea grade 3-4, <3%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Weakness grade 3-4, <3%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Respiratory tract infection grade 3-4, <5%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
Infection grade 3-4, <6%
25 mg/m2 1 times / week multiple, intravenous
Recommended
Dose: 25 mg/m2, 1 times / week
Route: intravenous
Route: multiple
Dose: 25 mg/m2, 1 times / week
Sources:
unhealthy
OverviewDrug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
likely
likely
likely
no [IC50 >10 uM]
no [IC50 >10 uM]
no [IC50 >10 uM]
no
yes [IC50 10.6 uM]
unlikely (co-administration study)
Comment: Coadministration of Vinorelbine significantly did not affect the exposure of Cyclophosphamide.
Page: (PMDA) 7
yes [Ki 22 uM]
yes
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
unlikely
unlikely
unlikely
unlikely
unlikely
unlikely
unlikely
unlikely
unlikely
unlikely
unlikely
yes [Km 2.63 uM]
yes [Km 3.64 uM]
yes
yes
yes
yes
Tox targets
PubMed

PubMed

TitleDatePubMed
Vinorelbine, epirubicin, and methotrexate (VEM) as primary treatment in locally advanced breast cancer.
2001
Ongoing trials with trastuzumab in metastatic breast cancer.
2001
Spontaneous erections in a patient with erectile dysfunction after palliative chemotherapy for non-small cell lung cancer.
2001
Phase I-II vinorelbine (Navelbine) by continuous infusion in patients with metastatic breast cancer: cumulative toxicities limit dose escalation.
2001
A systematic overview of chemotherapy effects in non-small cell lung cancer.
2001
A systematic overview of chemotherapy effects in breast cancer.
2001
Activity and safety of vinorelbine combined with doxorubicin or fluorouracil as first-line therapy in advanced breast cancer: a stratified phase II study.
2001
Nonanthracycline containing docetaxel-based combinations in metastatic breast cancer.
2001
Chemotherapy of metastatic breast cancer: what to expect in 2001 and beyond.
2001
[Subcutaneous inflammatory edema induced by MINE chemotherapy].
2001 Apr
Treatment of patients with metastatic germ cell tumors relapsing after high-dose chemotherapy.
2001 Apr
Phase III trial of cisplatin/gemcitabine with or without vinorelbine or paclitaxel in advanced non-small cell lung cancer.
2001 Apr
Preoperative chemotherapy for lung cancer does not increase surgical morbidity.
2001 Apr
Sensitive determination of vinorelbine and its metabolites in human serum using liquid chromatography-electrospray mass spectrometry.
2001 Apr 5
Acute respiratory failure caused by vinorelbine tartrate in a patient with non-small cell lung cancer.
2001 Aug
New cytotoxic agents and schedules for advanced breast cancer.
2001 Aug
Marked antitumor activity of a new potent acronycine derivative in orthotopic models of human solid tumors.
2001 Aug
The current status of docetaxel for advanced non-small cell lung cancer.
2001 Feb
Phase I dose-finding and pharmacokinetic study of docetaxel and vinorelbine as first-line chemotherapy for metastatic breast cancer.
2001 Jul
Recent advances in the chemotherapy of non-small cell lung cancer.
2001 Jul
Rationale for non-platinum chemotherapy in advanced NSCLC.
2001 Jul
Markedly diminished drug resistance-inducing properties of vinflunine (20',20'-difluoro-3',4'-dihydrovinorelbine) relative to vinorelbine, identified in murine and human tumour cells in vivo and in vitro.
2001 Jul
High-dose ifosfamide and vinorelbine as salvage therapy for relapsed or refractory Hodgkin's disease.
2001 Jul
A cost--utility analysis comparing second-line chemotherapy schemes in patients with metastatic breast cancer.
2001 Jul
Gemcitabine plus vinorelbine for the treatment of advanced non-small cell lung cancer.
2001 Jul
Mechanism of mitotic block and inhibition of cell proliferation by the semisynthetic Vinca alkaloids vinorelbine and its newer derivative vinflunine.
2001 Jul
Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non--small-cell lung cancer: a Southwest Oncology Group trial.
2001 Jul 1
Evaluating new treatments for advanced cancer.
2001 Jul 6
Linear immunoglobulin A bullous dermatosis induced by gemcitabine.
2001 Jul-Aug
Sequential docetaxel and vinorelbine for patients with advanced breast cancer previously treated with anthracyclines: a phase II study.
2001 Jul-Aug
In vitro activity of vinorelbine on human leukemia cells.
2001 Jun
Review of two phase III randomized trials of single-agent docetaxel in previously treated advanced non--small cell lung cancer.
2001 Jun
Non-platinum based combination chemotherapy: phase I and II trials of docetaxel plus gemcitabine, vinorelbine, or irinotecan.
2001 Jun
Phase III randomized trial of docetaxel in combination with cisplatin or carboplatin or vinorelbine plus cisplatin in advanced non--small cell lung cancer: interim analysis.
2001 Jun
Paclitaxel and docetaxel enhance the metabolism of doxorubicin to toxic species in human myocardium.
2001 Jun
Results of a phase III prospective, randomised trial, comparing mitoxantrone and vinorelbine (MV) in combination with standard FAC/FEC in front-line therapy of metastatic breast cancer.
2001 Jun
Importance of surgery as salvage treatment after high dose chemotherapy failure in germ cell tumors.
2001 Jun
Oral fluoropyrimidines among the new drugs for patients with metastatic breast cancer.
2001 Jun 1
[Cisplatin and vinorelbine therapy of previously treated advanced breast cancer (preliminary studies)].
2001 Mar
Prevention of vinorelbine phlebitis with cimetidine. A two-step design study.
2001 Mar
Treatment of elderly patients with non-small-cell lung cancer.
2001 Mar
Gemcitabine for the treatment of non-small-cell lung cancer.
2001 Mar
Correspondence re: Cicchetti S, Jemec B, Gault DT: two case reports of vinorelbine extravasation: management and review of the literature. Tumori, 86: 289-292, 2000.
2001 Mar-Apr
[Non-small cell lung cancer with liver metastasis responsive to gemcitabine--a case report].
2001 May
[Non-small-cell lung cancer (NSCLC) in an elderly patient--a case of squamous cell carcinoma successfully treated with chemotherapy using vinorelbine].
2001 May
Gemcitabine and vinorelbine as second-line therapy in non-small-cell lung cancer after prior treatment with taxane+platinum-based regimens.
2001 May
Carboplatin and vinorelbine in untreated locally advanced and metastatic non-small cell lung cancer.
2001 May
Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer.
2001 May 15
Multi-institutional phase I/II trial of oral bexarotene in combination with cisplatin and vinorelbine in previously untreated patients with advanced non-small-cell lung cancer.
2001 May 15
Vinflunine, a second generation novel Vinca Alkaloid with a distinctive pharmacological profile, now in clinical development and prospects for future mitotic blockers.
2001 Sep
Patents

Sample Use Guides

NAVELBINE (vinorelbine tartrate) for intravenous injections is indicated for the treatment of non-small cell lung cancer. Single-Agent NAVELBINE (vinorelbine tartrate): The usual initial dose of single-agent NAVELBINE is 30 mg/m2 administered weekly.
Route of Administration: Other
IC(50) values for inhibition of HeLa cell proliferation for vinorelbine was 1.25 nM, similar to the concentrations that induced mitotic block at the metaphase/anaphase transition (3.8 nM).
Name Type Language
VINORELBINE
HSDB   INN   MI   ORANGE BOOK   VANDF   WHO-DD  
INN  
Official Name English
NAVELBIN
Common Name English
VINORELBINE [ORANGE BOOK]
Common Name English
VINORELBINE [INN]
Common Name English
VINORELBINE TARTRATE IMPURITY J [EP]
Common Name English
ASPIDOSPERMIDINE-3-CARBOXYLIC ACID, 4-(ACETYLOXY)-6,7-DIDEHYDRO-15-((2R,6R,8S)-4-ETHYL-1,3,6,7,8,9-HEXAHYDRO-8-(METHOXYCARBONYL)-2,6-METHANO-2H-AZECINO(4,3-B)INDOL-8-YL)-3-HYDROXY-16-METHOXY-1-METHYL-, METHYL ESTER, (2.BETA.,3.BETA.,4.BETA.,5.ALPHA.,12R,
Systematic Name English
4-DEOXY-3,4-DIDEHYDROVINCALEUKOBLASTINE
Systematic Name English
C'-NORVINCALEUKOBLASTINE, 3',4'-DIDEHYDRO-4'-DEOXY-
Systematic Name English
NSC-760087
Code English
VINORELBINE [HSDB]
Common Name English
VINORELBINE [WHO-DD]
Common Name English
VINORELBINE [MI]
Common Name English
VINORELBINE [VANDF]
Common Name English
Classification Tree Code System Code
NDF-RT N0000007780
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
NCI_THESAURUS C67422
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
NCI_THESAURUS C932
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
NDF-RT N0000007780
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
NDF-RT N0000175612
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
FDA ORPHAN DRUG 540716
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
WHO-ATC L01CA04
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
FDA ORPHAN DRUG 588417
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
LIVERTOX 1031
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
WHO-VATC QL01CA04
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
Code System Code Type Description
CAS
71486-22-1
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY
EPA CompTox
71486-22-1
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY
MERCK INDEX
M11457
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY Merck Index
ChEMBL
CHEMBL553025
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY
FDA UNII
Q6C979R91Y
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY
RXCUI
39541
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY RxNorm
DRUG BANK
DB00361
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY
EVMPD
SUB00069MIG
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY
PUBCHEM
5311497
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY
DRUG CENTRAL
2827
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY
IUPHAR
7105
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY
INN
6054
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY
NCI_THESAURUS
C1275
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY
WIKIPEDIA
VINORELBINE
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY
MESH
C030852
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY
LACTMED
Vinorelbine
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY
HSDB
7665
Created by admin on Fri Jun 25 21:52:21 UTC 2021 , Edited by admin on Fri Jun 25 21:52:21 UTC 2021
PRIMARY