Vinorelbine
Generic Name: vinorelbine
Brand Names:
Vinorelbine
11 DESCRIPTION Vinorelbine Injection, USP contains vinorelbine, a semi-synthetic vinca alkaloid. The molecular formula for vinorelbine tartrate is C 45 H 54 N 4 O 8 •2C 4 H 6 O 6. It has a molecular weight of 1079.11. The structural formula is as follows: Vinorelbine tartrate is a white to light yellow amorphous powder. It is easily soluble in water, very soluble in methanol and practically insoluble in hexane.
Overview
11 DESCRIPTION Vinorelbine Injection, USP contains vinorelbine, a semi-synthetic vinca alkaloid. The molecular formula for vinorelbine tartrate is C 45 H 54 N 4 O 8 •2C 4 H 6 O 6. It has a molecular weight of 1079.11. The structural formula is as follows: Vinorelbine tartrate is a white to light yellow amorphous powder. It is easily soluble in water, very soluble in methanol and practically insoluble in hexane.
Uses
1 INDICATIONS AND USAGE Vinorelbine Injection is indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) As a single agent for the treatment of patients with metastatic NSCLC Vinorelbine Injection is a vinca alkaloid indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) ( 1 ) As a single agent for first-line treatment of patients with metastatic NSCLC ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION In combination with cisplatin: 25 to 30 mg/m 2 as an intravenous injection or infusion once weekly ( 2.1 ) Single agent: 30 mg/m 2 as intravenously once a week ( 2.1 ) Adjust dose in patients with decreased neutrophil counts or elevated serum total bilirubin ( 2.2 ) 2.1 Recommended Dosage In Combination with Cisplatin 100 mg/m 2 The recommended dosage of Vinorelbine Injection is 25 mg/m 2 administered as an intravenous injection or infusion over 6 to 10 minutes on Days 1, 8, 15 and 22 of a 28-day cycle in combination with cisplatin 100 mg/m 2 on Day 1 only of each 28-day cycle.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.1 )] Hepatic Toxicity [see Warnings and Precautions ( 5.2 )] Severe Constipation and Bowel Obstruction [see Warnings and Precautions ( 5.3 )] Extravasation and Tissue Injury [see Warnings and Precautions ( 5.4 )] Neurologic Toxicity [see Warnings and Precautions ( 5.5 )] Pulmonary Toxicity and Respiratory Failure [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (incidence ≥ 20%) are leukopenia, neutropenia, anemia, increased aspartate aminotransferase, nausea, vomiting, constipation, asthenia, injection site reaction and peripheral neuropathy ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Ph...
Interactions
7 DRUG INTERACTIONS Inhibitors of CYP3A4: May cause earlier onset and/or increased severity of adverse reactions ( 7.1 ) 7.1 CYP3A Inhibitors Exercise caution in patients concurrently taking drugs known to inhibit CYP3A. Concurrent administration of vinorelbine with a CYP3A inhibitor may cause an earlier onset and/or an increased severity of adverse reactions.
Warnings
WARNING: MYELOSUPPRESSION Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death can occur [see Warnings and Precautions ( 5.1 )]. Decrease the dose or withhold vinorelbine in accord with recommended dose modifications [see Dosage and Administration ( 2.2 )]. WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. Severe myelosuppression resulting in serious infection, septic shock, and death can occur ( 5.1 ). 5 WARNINGS AND PRECAUTIONS Hepatic Toxicity: Monitor hepatic function prior to initiation and during treatment ( 5.2 ) Severe constipation and bowel obstruction, including necrosis and perforation, occur. Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction and/or paralytic ileus ( 5.3 ) Extravasation can result in severe tissue injury, local tissue necrosis and/or thrombophlebitis. Immediately stop vinorelbine and institute recommended management procedures ( 5.4 ) Neurologic Toxicity: Severe sensory and motor neuropathies occur. Monitor patients for new or worsening signs and symptoms of neuropathy. Discontinue for Grade 2 or greater neuropathy ( 5.5 ) Pulmonary toxicity and respiratory failure occur. 4 CONTRAINDICATIONS None None
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , vinorelbine can cause fetal harm when administered to a pregnant woman. Available human data are insufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively (see Data ) .
Storage
Storage Conditions Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Protect from light. Retain in carton until time of use. Discard unused portion. Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours. Store diluted solutions of Vinorelbine Injection, USP at 5° to 30°C (41° to 86°F) [see Dosage and Administration ( 2.3 )] .
Frequently Asked Questions
What is Vinorelbine used for?▼
1 INDICATIONS AND USAGE Vinorelbine Injection is indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) As a single agent for the treatment of patients with metastatic NSCLC Vinorelbine Injection is a vinca alkaloid indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) ( 1 ) As a single agent for first-line treatment of patients with metastatic NSCLC ( 1 )
What are the side effects of Vinorelbine?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.1 )] Hepatic Toxicity [see Warnings and Precautions ( 5.2 )] Severe Constipation and Bowel Obstruction [see Warnings and Precautions ( 5.3 )] Extravasation and Tissue Injury [see Warnings and Precautions ( 5.4 )] Neurologic Toxicity [see Warnings and Precautions ( 5.5 )] Pulmonary Toxicity and Respiratory Failure [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (incidence ≥ 20%) are leukopenia, neutropenia, anemia, increased aspartate aminotransferase, nausea, vomiting, constipation, asthenia, injection site reaction and peripheral neuropathy ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Ph...
Can I take Vinorelbine during pregnancy?▼
8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , vinorelbine can cause fetal harm when administered to a pregnant woman. Available human data are insufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively (see Data ) .
What are the important warnings for Vinorelbine?▼
WARNING: MYELOSUPPRESSION Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death can occur [see Warnings and Precautions ( 5.1 )]. Decrease the dose or withhold vinorelbine in accord with recommended dose modifications [see Dosage and Administration ( 2.2 )]. WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. Severe myelosuppression resulting in serious infection, septic shock, and death can occur ( 5.1 ). 5 WARNINGS AND PRECAUTIONS Hepatic Toxicity: Monitor hepatic function prior to initiation and during treatment ( 5.2 ) Severe constipation and bowel obstruction, including necrosis and perforation, occur. Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction and/or paralytic ileus ( 5.3 ) Extravasation can result in severe tissue injury, local tissue necrosis and/or thrombophlebitis. Immediately stop vinorelbine and institute recommended management procedures ( 5.4 ) Neurologic Toxicity: Severe sensory and motor neuropathies occur. Monitor patients for new or worsening signs and symptoms of neuropathy. Discontinue for Grade 2 or greater neuropathy ( 5.5 ) Pulmonary toxicity and respiratory failure occur. 4 CONTRAINDICATIONS None None
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.