Vinorelbine Axios
Generic Name
Vinorelbine 10 mg Injection
Manufacturer
Axios Pharmaceuticals (Hypothetical)
Country
Global
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| vinorelbine axios 10 mg injection | ৳ 9,500.00 | N/A |
Description
Overview of the medicine
Vinorelbine is a vinca alkaloid antineoplastic agent used in the treatment of various cancers, including non-small cell lung cancer and metastatic breast cancer. It works by interfering with microtubule assembly, which is essential for cell division.
Uses & Indications
Dosage
Adults
For NSCLC: 25-30 mg/m² intravenously once weekly or 30 mg/m² on days 1 and 8 every 3 weeks. For breast cancer: Similar dosing regimens or as per specific protocol. Adjust dose based on hematologic parameters and liver function.
Elderly
No specific dose reduction required based on age alone, but monitor closely for age-related decline in hepatic/renal function and increased susceptibility to myelosuppression and neurotoxicity.
Renal_impairment
No specific dosage adjustment guideline for mild to moderate renal impairment, but caution is advised. For severe renal impairment, consider dose reduction or increased monitoring.
Hepatic_impairment
Dose reduction recommended for moderate to severe hepatic impairment (e.g., 50% reduction for total bilirubin 2-3 times ULN, or 75% reduction for >3 times ULN).
How to Take
For intravenous use only. Administer as a slow intravenous infusion (over 6 to 10 minutes) or as a longer infusion after dilution with 0.9% sodium chloride or 5% glucose solution. Never administer intrathecally.
Mechanism of Action
Vinorelbine selectively binds to tubulin and inhibits the polymerization of tubulin into microtubules, leading to mitotic arrest at metaphase and subsequent apoptosis of cancer cells. It primarily affects mitotic microtubules at low concentrations and axonal microtubules at higher concentrations.
Pharmacokinetics
Onset
Rapid distribution into tissues after intravenous administration.
Excretion
Mainly excreted via bile/feces (approximately 70%), with a small percentage excreted renally (10-20%).
Half life
Biphasic elimination with a terminal half-life of approximately 27.7 to 43.6 hours.
Absorption
Administered intravenously, hence 100% systemic bioavailability.
Metabolism
Extensively metabolized in the liver, primarily by cytochrome P450 3A4 (CYP3A4) to its active metabolite, 4-O-deacetylvinorelbine.
Side Effects
Contraindications
- Hypersensitivity to vinorelbine or other vinca alkaloids
- Severe neutropenia (ANC < 1500 cells/mm³)
- Severe infection (current or recent) within 2 weeks
- Severe hepatic impairment (for some protocols)
- Pregnancy and breastfeeding
- Intrathecal administration (fatal)
Drug Interactions
Cisplatin
Increased risk of neutropenia.
Paclitaxel
Concurrent administration may increase neurotoxicity.
Other myelosuppressive agents
Increased risk of severe myelosuppression.
CYP3A4 inducers (e.g., rifampicin, phenytoin)
May decrease vinorelbine plasma concentrations and efficacy.
CYP3A4 inhibitors (e.g., ketoconazole, erythromycin)
May increase vinorelbine plasma concentrations and toxicity.
Storage
Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light. Keep in the original container until use.
Overdose
Symptoms of overdose include profound myelosuppression (especially neutropenia), severe infections, and peripheral neuropathy. Management is supportive, including granulocyte-colony stimulating factor (G-CSF) for neutropenia and symptomatic treatment for other toxicities. Closely monitor vital signs and laboratory parameters.
Pregnancy & Lactation
Pregnancy Category D: Vinorelbine can cause fetal harm. Avoid use during pregnancy. Advise women of reproductive potential to use effective contraception. Lactation: It is unknown whether vinorelbine is excreted in human milk. Due to potential serious adverse reactions in breastfed infants, breastfeeding is contraindicated.
Side Effects
Contraindications
- Hypersensitivity to vinorelbine or other vinca alkaloids
- Severe neutropenia (ANC < 1500 cells/mm³)
- Severe infection (current or recent) within 2 weeks
- Severe hepatic impairment (for some protocols)
- Pregnancy and breastfeeding
- Intrathecal administration (fatal)
Drug Interactions
Cisplatin
Increased risk of neutropenia.
Paclitaxel
Concurrent administration may increase neurotoxicity.
Other myelosuppressive agents
Increased risk of severe myelosuppression.
CYP3A4 inducers (e.g., rifampicin, phenytoin)
May decrease vinorelbine plasma concentrations and efficacy.
CYP3A4 inhibitors (e.g., ketoconazole, erythromycin)
May increase vinorelbine plasma concentrations and toxicity.
Storage
Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light. Keep in the original container until use.
Overdose
Symptoms of overdose include profound myelosuppression (especially neutropenia), severe infections, and peripheral neuropathy. Management is supportive, including granulocyte-colony stimulating factor (G-CSF) for neutropenia and symptomatic treatment for other toxicities. Closely monitor vital signs and laboratory parameters.
Pregnancy & Lactation
Pregnancy Category D: Vinorelbine can cause fetal harm. Avoid use during pregnancy. Advise women of reproductive potential to use effective contraception. Lactation: It is unknown whether vinorelbine is excreted in human milk. Due to potential serious adverse reactions in breastfed infants, breastfeeding is contraindicated.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years when stored unopened at recommended conditions. Refer to product label for specific shelf life.
Availability
Hospitals, specialized oncology centers, retail pharmacies with proper handling facilities
Approval Status
Approved by regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Original patent expired; generic versions available
WHO Essential Medicine
YesClinical Trials
Vinorelbine has undergone numerous clinical trials establishing its efficacy and safety in various cancer types. Ongoing trials continue to explore new indications, combination therapies, and optimal dosing regimens.
Lab Monitoring
- Complete Blood Count (CBC) with differential before each dose (ensure ANC ≥ 1500 cells/mm³)
- Liver Function Tests (LFTs) before each dose
- Renal Function Tests (RFTs) periodically
- Neurological examination for signs of peripheral neuropathy
Doctor Notes
- Crucial to confirm ANC > 1500 cells/mm³ prior to each administration; adjust dose or delay therapy if below.
- Never administer intrathecally; fatal outcome. Ensure proper intravenous access and prevent extravasation.
- Monitor for signs of neurotoxicity (e.g., paresthesia, loss of deep tendon reflexes, constipation) throughout treatment.
- Consider G-CSF support for patients at high risk of neutropenic fever.
Patient Guidelines
- Report any signs of infection (fever, chills) immediately.
- Inform your doctor about any numbness, tingling, or weakness in hands or feet.
- Drink plenty of fluids to prevent constipation and kidney issues.
- Avoid contact with people who are sick or have infections.
- Do not receive any vaccinations without consulting your doctor.
Missed Dose Advice
If a dose is missed, contact your healthcare provider immediately to reschedule. Do not double the dose.
Driving Precautions
Vinorelbine may cause fatigue, dizziness, or visual disturbances. Patients should be advised to exercise caution when driving or operating machinery if they experience these side effects.
Lifestyle Advice
- Maintain good oral hygiene to prevent mouth sores.
- Use soft toothbrushes and avoid harsh mouthwashes.
- Eat a balanced diet and stay hydrated.
- Get adequate rest and manage stress.
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