Navelbine 20 mg, 30 mg Capsules

/ Perrigo

In adult patients: Navelbine soft capsule is indicated 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. See prescribing information for full details.
Dose Modification: For any administration planned to be given at 80mg/m², if the neutrophil count is below 500/mm³, or more than once between 500 and 1000/mm3, the administration should bedelayed until recovery and the dose reduced from 80 to 60mg/m² per week during the 3 following administrations. See prescribing information for full details.
Administration: Navelbine must be given strictly by the oral route.
Navelbine should be swallowed with water without chewing or sucking the capsule. It is recommended to take the capsule with some food.
Administration in the elderly: Clinical experience has not detected any significant differences among elderly patients with regard to the response rate, although greater sensitivity in some of these patients cannot be excluded. Age does not modify the pharmacokinetics of vinorelbine.
Administration in children: Safety and effectiveness in children have not been established and administration is therefore not recommended.
Administration in patients with liver insufficiency: Navelbine can be administered at the standard dose of 60 mg/m²/week in patients with mild
liver impairment (bilirubin < 1.5 x ULN, and ALAT and/or ASAT from 1.5 to 2.5 x ULN). In patients with moderate liver impairment (bilirubin from 1.5 to 3 x ULN, whatever the levels of ALAT and ASAT), Navelbine should be administered at a dose of 50 mg/m²/week. The administration of Navelbine in patients with severe hepatic impairment is contra-indicated.
Administration in patients with renal insufficiency: Given the minor renal excretion, there is no pharmacokinetic justification for reducing the dose of Navelbine in patients with serious renal insufficiency.
Specific instructions must be observed for administration of Navelbine.
See prescribing information for full details.

Non small cell lung cancer and advanced breast cancer.

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.

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.

Neutropenia, anemia, thrombocytopenia. Nausea, vomiting, diarrhea, anorexia, stomatitis, esophagitis, neurosensory disorders, neuromotor disorders, neuroconstipation. Alopecia, fatigue.
See prescribing information for full details.

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.