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Vinorel10 mg/ml
Beacon Pharmaceuticals PLC
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Vinorelbine Tartrate: Brands, Price & Uses in Bangladesh
FDA-Approved Indications Non-Small Cell Lung Cancer (NSCLC), first-line: Vinorelbine Tartrate is indicated, in combination with cisplatin, for the first-line treatment of patients with unresectable and more.
About Vinorelbine Tartrate
Indications of Vinorelbine Tartrate
FDA-Approved Indications
- Non-Small Cell Lung Cancer (NSCLC), first-line: Vinorelbine Tartrate is indicated, in combination with cisplatin, for the first-line treatment of patients with unresectable, advanced non-small cell lung cancer.
- Non-Small Cell Lung Cancer (NSCLC), single agent: Vinorelbine Tartrate is indicated as a single agent for the first-line treatment of patients with advanced non-small cell lung cancer for whom cisplatin-based therapy is not appropriate.
Other Guideline-Supported / Off-Label Use
- Metastatic Breast Cancer: Vinorelbine Tartrate is used, as a single agent or in combination with other antineoplastic agents, for the treatment of metastatic breast cancer that has progressed after anthracycline- and/or taxane-containing therapy. This use is supported by oncology treatment guidelines and is well established in clinical practice internationally, although it is off-label in some jurisdictions where Vinorelbine Tartrate is approved for NSCLC only.
Vinorelbine Tartrate is a cytotoxic chemotherapy agent that must only be prescribed, dispensed, and administered under the direct supervision of a physician experienced in the use of cancer chemotherapeutic agents. It is not an outpatient self-administered medication.
Dosage & Administration of Vinorelbine Tartrate
Dosage by Indication (Adult)
| Indication | Recommended Dose | Schedule |
|---|---|---|
| NSCLC, single agent | 25-30 mg/m² IV over 6-10 minutes | Once weekly |
| NSCLC, with cisplatin | 25-30 mg/m² IV over 6-10 minutes | Once weekly, on a cisplatin-containing regimen defined by the treating oncologist |
| Metastatic breast cancer (guideline-supported/off-label) | 25-30 mg/m² IV over 6-10 minutes | Once weekly, as a single agent or per combination protocol |
Dose Modification for Hematologic Toxicity
A complete blood count with differential must be obtained on the day of each scheduled dose of Vinorelbine Tartrate. Dosing is adjusted according to the absolute granulocyte count (AGC) as follows:
| AGC on day of treatment | Dose of Vinorelbine Tartrate |
|---|---|
| ≥1,500 cells/mm³ | 100% of dose |
| 1,000-1,499 cells/mm³ | 50% of dose |
| <1,000 cells/mm³ | Withhold; repeat count in one week. Discontinue Vinorelbine Tartrate if the count remains below 1,000 cells/mm³ for three consecutive weekly assessments, or if febrile neutropenia occurs. |
Hepatic Impairment
Dose reduction of Vinorelbine Tartrate is recommended based on serum total bilirubin: reduce to 50% of dose for bilirubin 2.1-3 mg/dL, and to 25% of dose for bilirubin greater than 3 mg/dL. See Precautions and Warnings.
Renal Impairment
Formal dose-adjustment guidance for renal impairment has not been established for Vinorelbine Tartrate; use with caution and clinical monitoring in patients with significant renal impairment.
Administration
Vinorelbine Tartrate is for INTRAVENOUS USE ONLY and must NEVER be administered by the intrathecal route, as this is fatal. It is given as a slow intravenous injection over 6 to 10 minutes into the tubing of a free-flowing IV line, followed by flushing with at least 75-125 mL of appropriate IV fluid, or diluted and given as a short intravenous infusion. Vinorelbine Tartrate is a vesicant; extravasation can cause severe local tissue damage or necrosis, so it must be administered only by personnel experienced in the handling and administration of vesicant chemotherapy, with careful confirmation of line patency.
Side Effects of Vinorelbine Tartrate
Very Common / Common Side Effects
- Myelosuppression: granulocytopenia (dose-limiting), anemia, thrombocytopenia
- Nausea, vomiting, constipation, diarrhea, stomatitis
- Peripheral neuropathy (paresthesia, decreased or absent deep tendon reflexes)
- Fatigue, asthenia, malaise
- Mild, reversible alopecia
- Injection-site reactions: pain, erythema, phlebitis at the injection site
- Elevated liver transaminases
- Jaw pain
Serious Side Effects
Serious myelosuppression with risk of infection/sepsis, fatal outcomes with intrathecal administration, vesicant tissue injury from extravasation, and acute pulmonary reactions (particularly with mitomycin) are discussed in Precautions and Warnings. Rare severe complications include paralytic ileus, syndrome of inappropriate antidiuretic hormone secretion (SIADH), and severe hepatic dysfunction.
Contraindications of Vinorelbine Tartrate
- Known hypersensitivity to Vinorelbine Tartrate or to other vinca alkaloids.
- Severe, pre-existing (baseline) granulocytopenia not due to the malignancy itself (baseline absolute granulocyte count below 1,000 cells/mm³) - treatment with Vinorelbine Tartrate should not be initiated until recovery.
- Intrathecal administration is absolutely contraindicated: Vinorelbine Tartrate is for intravenous use only, and intrathecal injection is fatal.
Frequently Asked Questions about Vinorelbine Tartrate
What is Vinorelbine Tartrate used for?
Vinorelbine Tartrate is a chemotherapy medicine used mainly for the first-line treatment of advanced non-small cell lung cancer, either combined with cisplatin or alone. It is also used for metastatic breast cancer that has progressed after other chemotherapy, based on oncology treatment guidelines.
How is Vinorelbine Tartrate given?
Vinorelbine Tartrate is given only by intravenous injection or infusion by trained oncology staff, usually once weekly. It is never taken by mouth and must never be injected into the spinal fluid (intrathecally), as this route is fatal.
What are the most serious risks of Vinorelbine Tartrate?
Vinorelbine Tartrate carries boxed warnings for severe bone marrow suppression, which increases the risk of serious infection and requires regular blood count monitoring with dose adjustment or delay, and for fatal outcomes if it is ever given by the intrathecal (spinal) route instead of intravenously. Vinorelbine Tartrate is also a vesicant, meaning it can cause serious tissue damage if it leaks out of the vein during administration, so it must be given only by experienced oncology personnel.
Can Vinorelbine Tartrate be used during pregnancy or breastfeeding?
Vinorelbine Tartrate can harm an unborn baby and should be used during pregnancy only if the potential benefit clearly outweighs the risk, as judged by your physician; effective contraception is recommended during and after treatment. Breastfeeding is not recommended while receiving Vinorelbine Tartrate, as it is not known whether it passes into breast milk. Always discuss pregnancy or breastfeeding plans with your oncologist before starting Vinorelbine Tartrate.
What side effects should I watch for with Vinorelbine Tartrate?
Common side effects of Vinorelbine Tartrate include low blood counts (increasing infection, bleeding, or fatigue risk), nausea, constipation, tingling or numbness in the hands or feet, and temporary hair thinning. Report fever, signs of infection, new shortness of breath, or pain/swelling at the injection site to your care team promptly.
What happens if too much Vinorelbine Tartrate is given?
An overdose of Vinorelbine Tartrate can severely worsen its known side effects, especially bone marrow suppression and risk of serious infection. If overdose is suspected, seek immediate medical attention or contact emergency services or a poison control center right away; treatment involves close monitoring and supportive care in a medical facility.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.