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Vinorelbin is used together with cisplatin as first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). It is also used on its own, as a single agent, to treat patients with metastatic NSCLC.
Pharmacology
Vinorelbine is a vinca alkaloid that interferes with microtubule assembly. Its antitumor activity is thought to come mainly from stopping mitosis at metaphase, which it does by interacting with tubulin. Vinorelbine may also interfere with 1) amino acid, cyclic AMP and glutathione metabolism, 2) calmodulin-dependent Ca2+ transport ATPase activity, 3) cellular respiration, and 4) nucleic acid and lipid biosynthesis. In intact mouse embryo tectal plates, vinorelbine blocked mitotic microtubule formation at a concentration of 2 µM, and this held cells at metaphase. It caused depolymerization of axonal microtubules only at a concentration of 40 µM, which suggests that vinorelbine has a modest selectivity for mitotic microtubules.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
In combination with cisplatin 100 mg/m2, the recommended dose of Vinorelbine Tartrate is 25 mg/m2. It is given as an intravenous injection or infusion over 6 to 10 minutes on Days 1, 8, 15 and 22 of a 28-day cycle. The cisplatin 100 mg/m2 is given on Day 1 only of each 28-day cycle.
In combination with cisplatin 120 mg/m2, the recommended dose of Vinorelbine Tartrate is 30 mg/m2, given as an intravenous injection or infusion over 6 to 10 minutes once a week. The cisplatin 120 mg/m2 is given on Days 1 and 29, then every 6 weeks.
As a single agent, the recommended dose of Vinorelbine Tartrate is 30 mg/m2, given intravenously over 6 to 10 minutes once a week.
Pediatric use: the safety and effectiveness of Vinorelbine Tartrate in pediatric patients have not been established.
Side Effects
Most common side effects of vinorelbine tartrate, seen in 20% or more of patients, are leukopenia, neutropenia, anemia, increased aspartate aminotransferase, nausea, vomiting, constipation, asthenia, injection site reaction and peripheral neuropathy.
Cautions & Contraindications
Warnings & Precautions
Hepatic toxicity: check liver function before starting Vinorelbine Tartrate and again during treatment. Severe constipation and bowel obstruction occur, including necrosis and perforation. Start a preventive bowel regimen to reduce the risk of constipation, bowel obstruction and/or paralytic ileus. Extravasation can cause severe tissue injury, local tissue necrosis and/or thrombophlebitis, so stop Vinorelbine immediately and follow the recommended management procedures. Neurologic toxicity: severe sensory and motor neuropathies occur. Watch patients for new or worsening signs and symptoms of neuropathy, and discontinue the medicine for Grade 2 or greater neuropathy. Pulmonary toxicity and respiratory failure also occur. Interrupt Vinorelbine in any patient who develops unexplained dyspnea or shows any evidence of pulmonary toxicity, and stop it permanently for confirmed interstitial pneumonitis or ARDA. Embryo-fetal toxicity: Vinorelbine can cause fetal harm. Females of reproductive potential should be told about the possible risk to the fetus and advised to use effective contraception.
Contraindications
Vinorelbine Tartrate must not be used in people who are hypersensitive to vinorelbine or to other vinca alkaloids. It is also not for anyone with a severe infection, either current or within the last 2 weeks, or with neutropenia, thrombocytopenia or severe hepatic impairment. It must never be given intrathecally. Don't give it together with radiotherapy if the liver is in the treatment field. It is also contraindicated in pregnancy and during lactation.
Pregnancy & Breastfeeding
Vinorelbine Tartrate can harm an unborn baby if it is given to a pregnant woman. This is based on animal studies and on how the medicine works. There isn't enough human data to say what the risk is for major birth defects, miscarriage, or other bad outcomes for the mother or the baby. In animal studies, embryo and fetal toxicity were seen in mice and rabbits at vinorelbine doses of about 0.33 and 0.18 times the human therapeutic dose, respectively. Pregnant women should be told about the possible risk to the fetus.
No data exist on whether vinorelbine passes into human milk, or on what it does to a breastfed infant or to milk production. Because it could cause serious adverse reactions in a breastfed infant, women are advised not to breastfeed during treatment with Vinorelbine Tartrate and for 9 days after the final dose.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Keep the vials in their carton at 2° to 8°C and protect them from light. Do not freeze them. Unopened vials of Vinorelbin are stable at 25°C for up to 72 hours. Diluted solutions of NAVELBINE should be stored at 5° to 30°C.
Common questions about Vinorelbine Sandoz 10 mg/ml
What is Vinorelbine Sandoz 10 mg/ml Injection?
Vinorelbine Sandoz 10 mg/ml Injection is a medicine that contains Vinorelbine Tartrate. It is made by Nevian Lifescience PLC. It belongs to the Cytotoxic Chemotherapy group of medicines.
What is Vinorelbine Sandoz used for?
Vinorelbin is used together with cisplatin as first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). It is also used on its own, as a single agent, to treat patients with metastatic NSCLC.
What are the side effects of Vinorelbine Sandoz?
Most common side effects of vinorelbine tartrate, seen in 20% or more of patients, are leukopenia, neutropenia, anemia, increased aspartate aminotransferase, nausea, vomiting, constipation, asthenia, injection site reaction and peripheral neuropathy.
Can I take Vinorelbine Sandoz during pregnancy or while breastfeeding?
Vinorelbine Tartrate can harm an unborn baby if it is given to a pregnant woman. This is based on animal studies and on how the medicine works. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Vinorelbine Sandoz?
Keep the vials in their carton at 2° to 8°C and protect them from light. Do not freeze them.
Do I need a prescription for Vinorelbine Sandoz?
Vinorelbine Sandoz is a prescription (Rx) medicine. Take it as your doctor advises.