Vinorelbine, sold under the brand name Navelbine among others, is a chemotherapy medication used to treat a number of types of cancer. This includes breast cancer and non-small cell lung cancer. It is given by injection into a vein or by mouth. Common side effects include neutropenia, constipation, peripheral neuropathy, fatigue, nausea and anemia; clinically the drug is classified as a semi synthetic vinca alkaloid with antimitotic activity, preferentially disrupting microtubule polymerization during M phase, showing activity as a single agent and in combination regimens, and undergoing extensive hepatic metabolism with primary biliary and fecal elimination.
Parent: Vinorelbine
Parent: Vinorelbine
Parent: Vinorelbine
Parent: Vinorelbine
Parent: Vinorelbine
Parent: Vinorelbine
Parent: Vinorelbine
Parent: Vinorelbine
Parent: Vinorelbine
Parent: Vinorelbine Tartrate
The principal related substances monitored in vinorelbine active pharmaceutical ingredient and finished formulations are deacetylvinorelbine (desacetyl derivative), anhydrovinorelbine species, N oxidized metabolites and trace process-related alkaloid analogs; manufacturers and pharmacopeial monographs typically set quantitative limits rather than allowing uncontrolled levels, for example specified impurities such as desacetylvinorelbine often controlled to the low tenths of a percent range, individual unspecified impurities commonly limited to 0.1 to 0.5 percent w by w, and total related substances generally controlled to below about 1.0 to 2.0 percent w by w depending on the regulatory specification and the impurity qualification status, with tighter limits applied to genotoxic or otherwise safety relevant impurities.
Vinorelbine is a semi synthetic vinca alkaloid antimitotic agent; it is classified as an antineoplastic microtubule inhibitor used as single agent chemotherapy or in combination regimens for solid tumors such as non small cell lung cancer and metastatic breast cancer.
Vinorelbine binds to tubulin and inhibits microtubule polymerization, disrupting mitotic spindle formation, causing cell cycle arrest in M phase and triggering apoptotic pathways in dividing tumor cells; it is cell cycle specific and primarily affects rapidly proliferating cells.
Effectiveness depends on tumor type, stage and regimen; vinorelbine has demonstrated objective response rates as a single agent in metastatic breast cancer and non small cell lung cancer and improves disease control when combined with other agents; clinical benefit is regimen dependent and measurable outcomes include response rate, progression free survival and sometimes overall survival in selected settings.
Vinorelbine is extensively metabolized in the liver and excreted largely via bile, so hepatic impairment can increase exposure; clinically significant hepatotoxicity is uncommon but transaminase elevations occur and dose reductions or avoidance are recommended for moderate to severe hepatic dysfunction, with liver function monitoring advised during treatment.
