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 C45H54N4O8
Molecular Weight 778.9323
Optical Activity UNSPECIFIED
Defined Stereocenters 8 / 8
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of VINORELBINE

SMILES

CCC1=C[C@@H]2CN(C1)CC3=C(NC4=C3C=CC=C4)[C@@](C2)(C(=O)OC)C5=CC6=C(C=C5OC)N(C)[C@@H]7[C@]68CCN9CC=C[C@](CC)([C@@H]89)[C@@H](OC(C)=O)[C@]7(O)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

Vinorelbine (trade name Navelbine) is a semi-synthetic vinca-alkaloid with a broad spectrum 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

1994
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

1994
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
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
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
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
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
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
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
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
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
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
Activity and safety of vinorelbine combined with doxorubicin or fluorouracil as first-line therapy in advanced breast cancer: a stratified phase II study.
2001
Chemoradiation in locally advanced non-small cell lung cancer.
2001
A reexamination of PSC 833 (Valspodar) as a cytotoxic agent and in combination with anticancer agents.
2001
Induction chemotherapy followed by concomitant chemoradiotherapy for non-small cell lung cancer.
2001
Carboplatin/paclitaxel or carboplatin/vinorelbine followed by accelerated hyperfractionated conformal radiation therapy: a preliminary report of a phase I dose escalation trial from the Carolina Conformal Therapy Consortium.
2001
Preoperative chemotherapy for lung cancer does not increase surgical morbidity.
2001 Apr
Cisplatin and vinorelbine as second-line chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) resistant to taxol plus gemcitabine.
2001 Feb-Mar
Anti-vascular effects of vinflunine in the MAC 15A transplantable adenocarcinoma model.
2001 Jan
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
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
Typhlitis (neutropenic enterocolitis) after a single dose of vinorelbine.
2001 Mar
Gemcitabine for the treatment of non-small-cell lung cancer.
2001 Mar
Triplet combination chemotherapy and targeted therapy regimens.
2001 Mar
Gemcitabine and nonplatinum combinations in non-small-cell lung cancer.
2001 Mar
Carboplatin and vinorelbine in untreated locally advanced and metastatic non-small cell lung cancer.
2001 May
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. Oral NAVELBINE is indicated for the treatment of non-small cell lung cancer and advanced breast cancer. As a single agent, the recommended regimen is: First three administrations 60mg/m² of body surface area, administered once weekly. Subsequent administrations Beyond the third administration, it is recommended to increase the dose of Navelbine to 80mg/m² once weekly except in those patients for whom the neutrophil count dropped once below 500/mm3 or more than once between 500 and 1000/mm3 during the first three administrations at 60mg/m².
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
VINORELBINE [HSDB]
Preferred Name English
VINORELBINE TARTRATE IMPURITY J [EP IMPURITY]
Common Name English
NAVELBIN
Common Name English
Vinorelbine [WHO-DD]
Common Name English
VINORELBINE [ORANGE BOOK]
Common Name English
vinorelbine [INN]
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 [MI]
Common Name English
VINORELBINE [VANDF]
Common Name English
Classification Tree Code System Code
NDF-RT N0000007780
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
NCI_THESAURUS C67422
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
NCI_THESAURUS C932
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
NDF-RT N0000007780
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
NDF-RT N0000175612
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
FDA ORPHAN DRUG 540716
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
WHO-ATC L01CA04
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
FDA ORPHAN DRUG 588417
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
LIVERTOX 1031
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
WHO-VATC QL01CA04
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
Code System Code Type Description
CAS
71486-22-1
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
EPA CompTox
DTXSID8040640
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
SMS_ID
100000079114
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
MERCK INDEX
m11457
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY Merck Index
ChEMBL
CHEMBL553025
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
FDA UNII
Q6C979R91Y
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
RXCUI
39541
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY RxNorm
DRUG BANK
DB00361
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
EVMPD
SUB00069MIG
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
PUBCHEM
5311497
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
DRUG CENTRAL
2827
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
IUPHAR
7105
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
DAILYMED
Q6C979R91Y
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
INN
6054
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
NCI_THESAURUS
C1275
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
WIKIPEDIA
VINORELBINE
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
CHEBI
480999
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
MESH
C030852
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
LACTMED
Vinorelbine
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
HSDB
7665
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY
NSC
760087
Created by admin on Mon Mar 31 18:14:25 GMT 2025 , Edited by admin on Mon Mar 31 18:14:25 GMT 2025
PRIMARY