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Vinolee 10/50 Injection

Generic Name- Vinorelbine tartrate

Drug Class- Antineoplastic agent

Description- Vinorelbine is a semi-synthetic vinca-alkaloid which exhibits broad spectrum anti-tumor activity. It has been approved for treatment of non small cell lung cancer (NSCLC) and also has demonstrated activity against breast and ovarian cancer. It acts by inhibiting the polymerization of tubulin dimers into microtubules, which in turn disrupts mitotic spindle formation. Series of these events prevents cell division and promotes apoptosis of cancer cells.

Product Description

Vinolee 10/50 (Vinorelbine tartarate for injection) is a single use liquid injection, for intravenous infusion. Intravenous formulation of vinorelbine improves patient compliance and beneficial for patients with difficulty in swallowing or to avoid absorption variability.

Indications and Usage

Vinorelbine is indicated for:

  • First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with cisplatin
  • First-line treatment of patients with metastatic NSCLC, as a single agent

Dosage and Administration

Dosage and Administration

  • Dosage Regimen for NSCLC4
Vinorelbine Monotherapy
Vinorelbine 30 mg/m2 as a single intravenous injection weekly
Vinorelbine plus Cisplatin Regimen
Vinorelbine 25 mg/m2 per week
Cisplatin 100 mg/m2 every 4 weeks

Dosage Forms and Strengths

  • Supplied as a single use vial for intravenous infusion
  • Available as 10mg and 50mg for injection

Clinical Efficacy

  • Shows efficacy and a manageable tolerability profile against advanced NSCLC1
  • Produces objective response rate of about 15- 30%, when used as a single agent in inoperable/advanced NSCLC1
  • Increases response rate to 30- 50% and prolongs survival by further 9 weeks when used in combination with cisplatin1

Adverse Reactions

  • The most common adverse reactions that occurs after administration of vinorelbine are nausea, vomiting, constipation, anemia, neutropenia, liver enzyme elevation, asthenia, injection site reaction and peripheral neuropathy

Contraindications

  • None

Special Precautions

  • Dose reductions should be considered in patients with decreased neutrophil counts or elevated serum total bilirubin
  • Monitor liver function during treatment to determine hepatic toxicity
  • Patients should be monitored for abdominal pain and constipation and a prophylactic bowel regimen should be initiated in cases of severe constipation and bowel obstruction
  • Discontinue vinorelbine use, if extravasations occurs, as it can result in severe tissue injury, necrosis and/or thrombophlebitis
  • Observe patients for the symptoms of new or worsening neuropathy, as neurologic toxicity: severe sensory and motor neuropathies can occur
  • Vinorelbine can cause pulmonary toxicity and respiratory failure, so monitor patients for respiratory disorders such as dyspnea and bronchospasm and discontinue use in patients who develop unexplained dyspnea
  • Avoid concomitant use of CYP3A4 inhibitors with vinorelbine to reduce severity of adverse reactions
  • Females of reproductive potential should be advised to use effective contraceptives to avoid pregnancy as it can cause potential risk to the fetus
  • Discontinue use of vinorelbine in nursing mothers
Vinolee 10/50 Injection - ADMAC Life Science