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NAVELBINE

 
Package(a):
SOFT CAPSULE: 1 x 20 mg.
Dosage(a):
It is recommended to take with some food. Indicated as a single agent.
First three administrations: 60 mg/m² of body surface area, administered once weekly in a single administration. 
Subsequent administrations (beyond the third administration): It is recommended to increase the dose to 80 mg/m² once weekly except in those patients for whom the neutrophil count dropped once below 500/mm³ or more than once between 500 and 1,000/mm³ during the first three administrations at 60 mg/m². See prescribing information for full details.
Prescribing Restrictions:  None

Package(b):
SOFT CAPSULE: 1 x 30 mg.
Dosage(b):
It is recommended to take with some food. Indicated as a single agent.
First three administrations: 60 mg/m² of body surface area, administered once weekly in a single administration. 
Subsequent administrations (beyond the third administration): It is recommended to increase the dose to 80 mg/m² once weekly except in those patients for whom the neutrophil count dropped once below 500/mm³ or more than once between 500 and 1,000/mm³ during the first three administrations at 60 mg/m². See prescribing information for full details.
Prescribing Restrictions:  None

Package(c):
VIALS: 1 ml.
Dosage(c):
For I.V. administration. See prescribing information for full details.
Prescribing Restrictions:   

Package(d):
VIALS: 5 ml.
Dosage(d):
For I.V. administration. See prescribing information for full details.
Prescribing Restrictions:     


Indications:
Capsules: Non small cell lung cancer, advanced breast cancer. 
I.V: Non small cell lung cancer, advanced breast cancer. Hormone refractory prostate cancer, especially in combination with low dose oral corticoid therapy or estramustine.
Contra-Indications:
Known hypersensitivity to vinorelbine or other vinca alkaloids. Disease significantly affecting absorption. Pre-treatment granlocyte counts <1,000 cells/mm³. Previous significant surgical resection of stomach or small bowel. Neutrophil count <1,500/mm³ or severe infection current or recent (within 2 weeks). Severe hepatic insufficiency not related to the tumoral process. 
Pregnancy and lactation: Should not be used during pregnancy. Breast feeding should be discontinued prior to use. Patients requiring long-term oxygen therapy. See prescribing information for full details.
Special Precautions:
In combination with yellow fever vaccine. In combination with phenytoin used prophylactically. This drug is generally not advised in combination with live attenuated vaccine and itraconazole. Only to be administered under the supervision of a physician experienced in the use of chemotherapy. If the patient chews or sucks the capsule by error, proceed to mouth rinses with water or preferably a normal saline solution. Damaged capsules should not be swallowed. In the case of vomiting within a few hours after drug intake, never repeat administration of this dose. Dosing should be determined by hematological status. Close hematological monitoring should be undertaken during treatment. Patients with history of ischemic cardiac disease. Should not be given concomitantly with radiotherapy if the treatment field includes the liver. See prescribing information for full details.
Side Effects:
Neutropenia, anemia, thrombocytopenia. Nausea, vomiting, diarrhea, anorexia, stomatitis, esophagitis, neurosensory disorders, neuromotor disorders, neuroconstipation. Alopecia, fatigue. See prescribing information for full details.
Drug Interactions:
Other drugs with known bone marrow toxicity. Incidence of granulocytopenia associated with Navelbine in combination with cisplatin was higher than the ones associated with Navelbine single agent. Omenprazole and fluoxetine. Phenytoin, doxorubicin, daunorubicin, carboplatin, cisplatin, carmustine, vincristine, vinblastine, bleomycin, methotrexate. Yellow fever vaccine, life attenuated vaccines. Cyclosporin, itraconazole, mitomycin, mitomycin C.