Navelbine 10mg/ml Inj, 1ml
WARNING: This drug may lower the ability of the bone marrow to make blood cells that the body needs. This may raise the chance of bleeding or infection. Some infections need to be treated in the hospital and can sometimes be deadly. If you have questions, talk with the doctor.Your doctor will need to watch your blood cell counts and follow you closely to change the dose to match your body's needs. Talk with your doctor. @ COMMON USES: It is used to treat lung cancer.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antineoplastic Agent
Pharmacologic Class
Vinca Alkaloid; Microtubule Inhibitor
Pregnancy Category
Category D
FDA Approved
Dec 1994
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vinorelbine is a chemotherapy drug used to treat certain types of cancer. It works by stopping cancer cells from growing and dividing, which helps to slow or stop the spread of the cancer.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. Administer the medication as directed, which typically involves intravenous infusion over a specified period. Unless your doctor advises you to limit fluid intake, drink plenty of non-caffeinated liquids to stay hydrated.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep the medication at home. If you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep the medication at home. If you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
Lifestyle & Tips
- Report any signs of infection (fever, chills, sore throat) immediately.
- Avoid contact with people who are sick or have infections.
- Practice good hand hygiene.
- Avoid activities that could cause cuts or bruises.
- Use a soft toothbrush and be gentle when flossing.
- Stay well-hydrated and maintain a high-fiber diet to prevent constipation. Take laxatives as prescribed.
- Avoid grapefruit and grapefruit juice during treatment.
- Do not receive any live vaccines without consulting your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
25 mg/m² administered intravenously over 6 to 10 minutes once weekly
Dose Range:
20 - 30 mg
Condition-Specific Dosing:
Non-Small Cell Lung Cancer (NSCLC):
25 mg/m² IV weekly. In combination with cisplatin, 25.0 mg/m² IV on day 1 and day 8 of each 21-day cycle.
Breast Cancer (off-label):
25 mg/m² IV weekly or 30 mg/m² IV every 3 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but use with caution due to limited data.
Dialysis:
Not available; Vinorelbine is highly protein bound and extensively metabolized, making dialysis unlikely to be effective.
Hepatic Impairment:
Mild:
If total bilirubin is 2-3 mg/dL, reduce dose by 50%.
Moderate:
If total bilirubin is 2-3 mg/dL, reduce dose by 50%.
Severe:
If total bilirubin is >3 mg/dL, reduce dose by 75%. If AST/ALT >2x ULN, consider dose reduction or delay.
Confidence:
Medium
Pharmacology
Mechanism of Action
Vinorelbine is a vinca alkaloid that exerts its antineoplastic effect by interfering with microtubule assembly. It binds to tubulin, the protein subunit of microtubules, and inhibits the polymerization of tubulin into microtubules. This leads to the disruption of the mitotic spindle, causing metaphase arrest and subsequent cell death (apoptosis). Vinorelbine primarily affects cells in the M-phase of the cell cycle but can also affect cells in the S-phase.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV administration)
Tmax:
Not applicable (IV)
FoodEffect:
Not applicable (IV)
Distribution:
Vd:
25.4-40.1 L/kg (large volume of distribution, indicating extensive tissue binding)
ProteinBinding:
Approximately 80% (primarily to plasma proteins and platelets)
CnssPenetration:
Limited (poor penetration into the central nervous system)
Elimination:
HalfLife:
27.7-43.6 hours (terminal half-life)
Clearance:
0.97-1.26 L/hr/kg
ExcretionRoute:
Primarily biliary/fecal (approximately 46% of dose excreted in feces, 18% in urine)
Unchanged:
Approximately 10-12% (in urine)
Pharmacodynamics
OnsetOfAction:
Rapid (IV administration, cellular effects begin immediately)
PeakEffect:
Not directly applicable for cytotoxic effect; cellular effects are sustained.
DurationOfAction:
Effects persist as long as drug concentrations are sufficient to inhibit microtubule dynamics, leading to prolonged cell cycle arrest and apoptosis.
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
Severe myelosuppression, including neutropenia, febrile neutropenia, and anemia, is the dose-limiting toxicity of vinorelbine. Perform complete blood counts on Day 1 and Day 8 of each cycle of vinorelbine. Do not administer vinorelbine to patients with an absolute neutrophil count (ANC) less than 1500 cells/mm³.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellowing of the skin or eyes.
Abnormal burning, numbness, or tingling sensations.
Muscle weakness.
Chest pain.
Lung Problems
Some people have experienced severe lung problems while taking this medication, which can be life-threatening. If you notice any of the following symptoms, contact your doctor immediately: shortness of breath, difficulty breathing, new or worsening cough, or fever.
Constipation and Bowel Problems
This medication can cause severe constipation, which may lead to life-threatening complications such as bowel blockage, tears, or tissue death. If you experience any of the following symptoms, contact your doctor right away: constipation, rectal pain, or bleeding from the rectum.
Tissue Damage
If the medication leaks from the vein, it can cause tissue damage. Inform your nurse immediately if you notice any redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
Other Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only mild ones. However, if you notice any of the following side effects or if they persist or bother you, contact your doctor:
Constipation, diarrhea, stomach upset, vomiting, or decreased appetite.
Fatigue or weakness.
Hair loss.
Weight loss.
Muscle or joint pain.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellowing of the skin or eyes.
Abnormal burning, numbness, or tingling sensations.
Muscle weakness.
Chest pain.
Lung Problems
Some people have experienced severe lung problems while taking this medication, which can be life-threatening. If you notice any of the following symptoms, contact your doctor immediately: shortness of breath, difficulty breathing, new or worsening cough, or fever.
Constipation and Bowel Problems
This medication can cause severe constipation, which may lead to life-threatening complications such as bowel blockage, tears, or tissue death. If you experience any of the following symptoms, contact your doctor right away: constipation, rectal pain, or bleeding from the rectum.
Tissue Damage
If the medication leaks from the vein, it can cause tissue damage. Inform your nurse immediately if you notice any redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
Other Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only mild ones. However, if you notice any of the following side effects or if they persist or bother you, contact your doctor:
Constipation, diarrhea, stomach upset, vomiting, or decreased appetite.
Fatigue or weakness.
Hair loss.
Weight loss.
Muscle or joint pain.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Fever of 100.4°F (38°C) or higher, or chills
- Unusual bleeding or bruising
- Numbness, tingling, or weakness in your hands or feet
- Severe constipation or abdominal pain
- Shortness of breath or difficulty breathing
- Pain, redness, or swelling at the injection site
- Severe fatigue or dizziness
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms you experienced.
A low white blood cell count, as this may affect your ability to take this medication.
If you are breastfeeding, as you should not breastfeed while taking this medication and for 9 days after your last dose.
Additionally, this medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your health problems, including any medical conditions or concerns
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. This will help you avoid any potential interactions or complications.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms you experienced.
A low white blood cell count, as this may affect your ability to take this medication.
If you are breastfeeding, as you should not breastfeed while taking this medication and for 9 days after your last dose.
Additionally, this medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your health problems, including any medical conditions or concerns
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. This will help you avoid any potential interactions or complications.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests and other laboratory assessments will be necessary, as directed by your doctor, to monitor your condition.
As this medication may increase your risk of developing infections, it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.
You may also experience an increased risk of bleeding, so it is vital to be cautious and avoid injuries. To minimize this risk, use a soft-bristled toothbrush and an electric razor for shaving.
If you experience gastrointestinal side effects such as stomach upset, vomiting, diarrhea, or decreased appetite, consult your doctor, as they may be able to suggest ways to alleviate these symptoms.
To manage constipation, your doctor may recommend increasing your fluid intake, engaging in regular exercise, or incorporating more fiber into your diet. Additionally, your doctor may suggest using a stool softener or laxative to help regulate your bowel movements.
This medication may affect fertility in men, so it is essential to discuss this potential side effect with your doctor.
Women of childbearing potential should be aware that this medication may harm an unborn baby. A pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant. If you or your partner may become pregnant, it is crucial to use effective birth control methods during treatment and for a specified period after the last dose, as advised by your doctor. If you or your partner becomes pregnant, notify your doctor immediately.
As this medication may increase your risk of developing infections, it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.
You may also experience an increased risk of bleeding, so it is vital to be cautious and avoid injuries. To minimize this risk, use a soft-bristled toothbrush and an electric razor for shaving.
If you experience gastrointestinal side effects such as stomach upset, vomiting, diarrhea, or decreased appetite, consult your doctor, as they may be able to suggest ways to alleviate these symptoms.
To manage constipation, your doctor may recommend increasing your fluid intake, engaging in regular exercise, or incorporating more fiber into your diet. Additionally, your doctor may suggest using a stool softener or laxative to help regulate your bowel movements.
This medication may affect fertility in men, so it is essential to discuss this potential side effect with your doctor.
Women of childbearing potential should be aware that this medication may harm an unborn baby. A pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant. If you or your partner may become pregnant, it is crucial to use effective birth control methods during treatment and for a specified period after the last dose, as advised by your doctor. If you or your partner becomes pregnant, notify your doctor immediately.
Overdose Information
Overdose Symptoms:
- Severe myelosuppression (e.g., profound neutropenia, thrombocytopenia)
- Severe peripheral neuropathy
- Paralytic ileus
- Severe hepatic dysfunction
What to Do:
There is no known antidote for vinorelbine overdose. Management is supportive, including close monitoring of hematologic parameters, administration of growth factors (e.g., G-CSF) for neutropenia, management of neurological symptoms, and aggressive bowel regimen for ileus. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice): May significantly increase vinorelbine plasma concentrations, leading to increased toxicity (e.g., myelosuppression).
- Live vaccines: Risk of severe or fatal infection in immunocompromised patients.
Moderate Interactions
- Strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, St. John's Wort): May decrease vinorelbine plasma concentrations, potentially reducing efficacy.
- Other myelosuppressive agents (e.g., other chemotherapies, radiation therapy): Increased risk of severe myelosuppression.
- Paclitaxel: Concurrent administration may increase risk of neurotoxicity and myelosuppression (administer vinorelbine first if given sequentially).
- Cisplatin: May increase vinorelbine exposure when given in combination.
Minor Interactions
- Warfarin: Potential for altered INR, monitor closely.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To assess baseline bone marrow function and identify pre-existing cytopenias, as myelosuppression is a dose-limiting toxicity.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs) including bilirubin, AST, ALT
Rationale: Vinorelbine is extensively metabolized by the liver; hepatic impairment necessitates dose adjustment.
Timing: Prior to initiation of therapy.
Renal Function Tests (serum creatinine, BUN)
Rationale: To assess baseline kidney function, though renal excretion is minor, caution is advised in severe impairment.
Timing: Prior to initiation of therapy.
Neurological Examination
Rationale: To assess baseline neurological status, as peripheral neuropathy is a common side effect.
Timing: Prior to initiation of therapy.
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: Weekly (prior to each dose)
Target: Absolute Neutrophil Count (ANC) ≥ 1500 cells/mm³; Platelets ≥ 100,000 cells/mm³
Action Threshold: If ANC < 1500 cells/mm³ or platelets < 100,000 cells/mm³, delay dose until recovery. Consider dose reduction for subsequent doses if prolonged or severe myelosuppression occurs.
Liver Function Tests (LFTs)
Frequency: Periodically, or as clinically indicated (e.g., every 3-4 weeks or with dose adjustments)
Target: Within acceptable limits for dosing
Action Threshold: If bilirubin >2 mg/dL or AST/ALT >2x ULN, consider dose reduction or delay.
Neurological Assessment
Frequency: Prior to each dose and as clinically indicated
Target: No new or worsening signs of peripheral neuropathy
Action Threshold: If moderate to severe peripheral neuropathy develops, consider dose reduction or discontinuation.
Bowel Habits
Frequency: Daily patient inquiry
Target: Regular bowel movements
Action Threshold: If constipation develops, initiate prophylactic laxatives; if severe, consider dose delay or reduction.
Symptom Monitoring
- Fever (especially with chills or other signs of infection)
- Unusual bleeding or bruising
- Numbness, tingling, or weakness in hands or feet (peripheral neuropathy)
- Severe constipation or abdominal pain
- Shortness of breath or cough
- Pain or redness at injection site (extravasation)
- Fatigue, dizziness
Special Patient Groups
Pregnancy
Vinorelbine can cause fetal harm when administered to a pregnant woman. It is classified as Pregnancy Category D. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.
Trimester-Specific Risks:
First Trimester:
High risk of major birth defects and miscarriage due to rapid cell division and organogenesis.
Second Trimester:
Risk of fetal growth restriction, myelosuppression, and other developmental abnormalities.
Third Trimester:
Risk of fetal myelosuppression and other adverse effects.
Lactation
It is not known whether vinorelbine is excreted in human milk. Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with vinorelbine and for 3 months after the last dose.
Infant Risk:
High risk of serious adverse effects, including myelosuppression and developmental toxicity.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Limited data suggest that vinorelbine is not effective in pediatric solid tumors and may cause significant toxicity.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, elderly patients may be more susceptible to myelosuppression and neurotoxicity. Careful monitoring of hematologic parameters and neurological status is recommended.
Clinical Information
Clinical Pearls
- Vinorelbine is a vesicant; ensure proper IV access and monitor for extravasation. If extravasation occurs, stop infusion immediately, aspirate residual drug, and consider local hyaluronidase injection.
- Myelosuppression, particularly neutropenia, is the dose-limiting toxicity. Weekly CBC monitoring is crucial.
- Constipation is a common and potentially severe side effect; prophylactic laxatives (e.g., stool softeners, stimulant laxatives) should be initiated at the start of therapy.
- Peripheral neuropathy is cumulative and can be dose-limiting. Monitor for symptoms like numbness, tingling, and weakness.
- Administer vinorelbine over 6-10 minutes into the side port of a free-flowing IV line, followed by a flush, to minimize vein irritation and extravasation risk.
- Do not administer intrathecally; intrathecal administration of vinca alkaloids is fatal.
Alternative Therapies
- Other vinca alkaloids (e.g., Vincristine, Vinblastine)
- Taxanes (e.g., Paclitaxel, Docetaxel) for NSCLC or breast cancer
- Pemetrexed (for NSCLC)
- Gemcitabine (for NSCLC)
- Platinum-based chemotherapy (e.g., Cisplatin, Carboplatin)
- Targeted therapies or immunotherapies depending on specific cancer type and molecular profile.
Cost & Coverage
Average Cost:
Highly variable, typically several hundred to over a thousand USD per vial depending on dose and supplier. per 10mg/ml vial
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (often covered under medical benefit for oncology indications)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure your safety and the safety of others, never share your medication with anyone, and do not take medication prescribed to someone else.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best disposal method, as some communities have drug take-back programs in place.
Additionally, some medications may come with a separate patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time it was ingested, to ensure prompt and effective treatment.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best disposal method, as some communities have drug take-back programs in place.
Additionally, some medications may come with a separate patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time it was ingested, to ensure prompt and effective treatment.