Vinorelbine

Vinorelbine is a prescription medicine used to treat locally advanced or metastatic non-small cell lung cancer (NSCLC).

• Vinorelbine is available under the following different brand names: Navelbine

Adult dosage

Injectable solution

• 10mg/1mL
• 50mg/5mL

Non-small Cell Lung Cancer

Adult dosage

Monotherapy

• 30 mg/m² IV infused over 6-10 minutes every Week 

Combination therapy

• 25 mg/m² IV every Week on Days 1, 8, 15, and 22 of a 28-day cycle with IV cisplatin 100 mg/m² on Day 1 OR
• 30 mg/m² IV every Week with cisplatin 120 mg/m² IV on Days 1 and 29, and then every 6 Weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Vinorelbine include:

• nausea, 
• vomiting, 
• constipation,
• weakness;
• numbness or tingling in the hands or feet,
• low blood cell counts,
• abnormal liver function tests, and
• pain, redness, bruising, or irritation around the IV needle.

Serious side effects of Vinorelbine include:

• severe constipation, 
• stomach pain, 
• bloody or black stools,
• numbness, 
• tingling, 
• muscle weakness,
• pain, redness, and peeling skin on hands or feet,
• new or worsening cough, 
• wheezing, 
• chest tightness, 
• trouble breathing,
• dark urine, jaundice (yellowing of the skin or eyes),
• pain, burning, irritation, or skin changes where the injection was given, and
• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands, and feet, feeling light-headed or short of breath.

Rare side effects of Vinorelbine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Vinorelbine has severe interactions with no other drugs.
• Vinorelbine has serious interactions with the following drugs:
  • abametapir
  • adenovirus types 4 and 7 live, oral
  • apalutamide
  • deferiprone
  • fexinidazole
  • idelalisib
  • influenza virus vaccine quadrivalent, adjuvanted
  • influenza virus vaccine trivalent, adjuvanted
  • ivosidenib
  • lonafarnib
  • nefazodone
  • palifermin
  • ropeginterferon alfa 2b
  • selinexor
  • tofacitinib
  • tucatinib
  • voxelotor
• Vinorelbine has moderate interactions with at least 65 other drugs.
• Vinorelbine has minor interactions with at least 55 other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Vinorelbine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Vinorelbine?”

Cautions

• Myelosuppression, manifested by neutropenia, anemia, and thrombocytopenia reported; neutropenia is the major dose-limiting toxicity; monitor complete blood counts before each dose
• Risk of extravasation and tissue injury
• Sensory and motor neuropathies reported
• Can cause fetal harm if administered to pregnant women based on findings from animal studies and mechanism of action
• Hepatic toxicity
  • Drug-induced liver injury manifested by elevated aspartate aminotransferase (AST) and bilirubin occurs in patients receiving the drug as a single agent and in combination with cytotoxic agents
  • Assess hepatic function before initiation of therapy and periodically during treatment
  • Reduce dose for patients who develop elevations in total bilirubin greater than or equal to 2 times the upper limit of normal
• Gastrointestinal effects
  • Severe and fatal paralytic ileus, constipation, intestinal obstruction, necrosis, and perforation reported
  • Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction, and/or paralytic ileus
  • Consider adequate dietary fiber intake, hydration, and routine use of stool softeners
• Pulmonary toxicity
  • Pulmonary toxicity, including severe acute bronchospasm, interstitial pneumonitis, acute respiratory distress syndrome (ARDS) occurs in patients receiving therapy
  • Interrupt therapy in patients who develop unexplained dyspnea or have any evidence of pulmonary toxicity
  • Permanently discontinue therapy for confirmed interstitial pneumonitis or ARDS
• Preparation in IV infusion bag only
  • On January 15, 2021, FDA alerted that vinca alkaloids should be prepared in IV infusion bags only
  • Intrathecal (IT) administration will result in severe neurological injury and/or death
  • The label update is to reduce the potential for unintended IT administration

Pregnancy and Lactation

• Based on animal findings, can cause fetal harm when administered to pregnant women
• Verify pregnancy status in females of reproductive potential before initiating
• Contraception
  • Females: Use effective contraception during treatment and for 6 months after the final dose
  • Males: May damage spermatozoa; advise males with female sexual partners of reproductive potential to use effective contraception during treatment and for 3 months after the final dose
• Infertility
  • Males: Based on animal findings, may impair fertility
• Lactation
  • Data are not available regarding the drug in human milk or effects on the breastfed infant or milk production
  • Because of potential harm; advise women not to breastfeed during treatment and for 9 days after the final dose