Vinorelbine 10 mg/mL
Vinorelbine · INJECTION, SOLUTION · Actavis Pharma, Inc.
Vinorelbine is a chemotherapy medication given by injection into a vein that is used to treat certain types of cancer, including lung cancer and breast cancer. It works by interfering with cancer cell growth and division.
Key Facts
- Brand Name
- Vinorelbine
- Generic Name
- Vinorelbine
- NDC Code (Product)
45963-607- Manufacturer
- Actavis Pharma, Inc.
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA078011
- Marketing Start
- 03/01/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & Administration
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. In Combination with Cisplatin 120 mg/m 2 The recommended dosage of Vinorelbine Injection is 30 mg/m 2 administered as an intravenous injection or infusion over 6 to 10 minutes once a week in combination with cisplatin 120 mg/m 2 on Days 1 and 29, then every 6 weeks. Single Agent The recommended dosage of Vinorelbine Injection is 30 mg/m 2 administered intravenously over 6 to 10 minutes once a week. 2.2 Dosage Modifications Myelosuppression Hold or decrease the dose of Vinorelbine Injection in patients with decreased neutrophil counts according to the following schema [see Warnings…
Contraindications
4 CONTRAINDICATIONS None None
Drug 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.
Adverse Reactions
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 Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under varying designs and in different patient populations, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial and may not reflect the rates actually observed in cl…
Frequently Asked Questions
What is Vinorelbine used for?
Vinorelbine is a chemotherapy medication given by injection into a vein that is used to treat certain types of cancer, including lung cancer and breast cancer. It works by interfering with cancer cell growth and division.
Is Vinorelbine a controlled substance?
Vinorelbine is not classified as a controlled substance by the DEA.
What is the generic name for Vinorelbine?
The generic name for Vinorelbine is Vinorelbine. There are no other listed brand versions of Vinorelbine.
What is the NDC code for Vinorelbine 10 mg/mL?
The NDC (National Drug Code) for Vinorelbine 10 mg/mL is 45963-607, listed by Actavis Pharma, Inc..
Other Vinorelbine Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)