Non-small cell lung cancer, Metastatic breast cancer
#仿單變更2021

Vinorelbine tartrate, a semisynthetic vinca alkaloid, binds to tubulin and inhibits microtubule formation, therefore, arresting the cell at metaphase by disrupting the formation of the mitotic spindle; it is specific for the M and S phases.

Bioavailability: 26% to 45%; Protein binding: 80% to 91%; Distribution: Vd: 25-40 L/kg; binds extensively to human platelets and lymphocytes; Metabolism: Extensively hepatic, via CYP3A4, to two metabolites; Excretion: Feces (46%); urine (18%, 10% to 12% as unchanged drug); Elimination half-life: Triphasic: Terminal: 28-44 hours.

Pretreatment granulocyte counts <1000/mm3

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Based on the mechanism and on findings in animal reproduction studies, vinorelbine may cause fetal harm if administered to a pregnant female.

Excretion in breast milk unknown/not recommended. Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer does not recommend breastfeeding during treatment and for 9 days after the final vinorelbine dose.

Leukopenia, granulocytopenia (nadir: 7-10 days; recovery 14-21 days; dose-limiting), neutropenia, anemia, nausea, vomiting, diarrhea, anorexia, alopecia
Post marketing: pulmonary toxicity (including acute respiratory distress syndrome, interstitial pneumonitis, severe acute bronchospasm), SIADH (syndrome of inappropriate antidiuretic hormone secretion) <20210504>

First three administration: Dose of 60 mg/m2 of body surface area, administered once a week in a single administration. Then 80 mg/m2/w, except in patients whose neutrophil count has fallen on one occasion below 500/mm3, or more than once between 500 and 1000/mm3 during the first three administrations at a dose of 60 mg/m2. Navelbine (soft capsules) should be swallowed whole with water, without chewing or sucking on the capsule. It is recommended that the capsule be taken at the end of a meal. Never take another capsule after vomiting.

Should be stored in the original package at 2-8℃