VINORELBINE- vinorelbine tartrate injection, solution
Actavis Pharma, Inc.
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
In Combination with Cisplatin 100 mg/m 2
The recommended dose of vinorelbine is 25 mg/m2 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/m2 on Day 1 only of each 28 day cycle.
In Combination with Cisplatin 120 mg/m 2
- The recommended dose of vinorelbine is 30 mg/m2 administered as an intravenous injection or infusion over 6 to 10 minutes once a week in combination with cisplatin 120 mg/m2 on Days 1 and 29, then every 6 weeks.
- The recommended dose of vinorelbine is 30 mg/m2 administered intravenously over 6 to 10 minutes once a week.
Hold or decrease the dose of vinorelbine in patients with decreased neutrophil counts according to the following schema [see Warnings and Precautions (5.1)]:
|Neutrophils on Day of Treatment (cells/mm 3 )||Percentage of Starting Dose of Vinorelbine|
|1,000 to 1,499||50%|
|< 1,000||Do not administer vinorelbine. Repeat neutrophil count in one week. If three consecutive weekly doses are held because neutrophil count is < 1,000 cells/mm3 , discontinue vinorelbine|
|Note: For patients who experience fever and/or sepsis while neutrophil count is < 1,500 cells/mm3 or had 2 consecutive weekly doses held due to neutropenia, subsequent doses of vinorelbine should be:|
|1,000 to 1,499||37.5%|
|< 1,000||Do not administer vinorelbine.|
|Repeat neutrophil count in one week.|
|Serum Total Bilirubin Concentration (mg/dl)||Percentage of Starting Dose of Vinorelbine|
|2.1 to 3.0||50%|
Concurrent Myelosuppression and Hepatic Impairment/Toxicity
In patients with both myelosuppression and hepatic impairment/toxicity, administer the lower of the doses based on the corresponding starting dose of vinorelbine determined from the above schemas.
Discontinue vinorelbine for Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher peripheral neuropathy or autonomic neuropathy causing constipation [see Warnings and Precautions (5.5)].
Dilute vinorelbine injection in an intravenous bag to a concentration between 0.5 mg/mL and 2 mg/mL. Use one of the following recommended solutions for dilution:
- 5% Dextrose Injection, USP
- 0.9% Sodium Chloride Injection, USP
- 0.45% Sodium Chloride Injection, USP
- 5% Dextrose and 0.45% Sodium Chloride Injection, USP
- Ringer’s Injection, USP
- Lactated Ringer’s Injection, USP
Stability and Storage Conditions of Diluted Solutions
Diluted vinorelbine injection may be used for up to 24 hours under normal room light when stored in polyvinyl chloride bags at 5° to 30°C (41° to 86°F).
Administer diluted vinorelbine injection over 6 to 10 minutes into the side port of a free-flowing intravenous line followed by flushing with at least 75 to 125 mL of one of the solutions.
Vinorelbine Injection must only be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any vinorelbine is injected.
Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. If particulate matter is seen, vinorelbine injection should not be administered.
Management of Suspected Extravasation
If vinorelbine leakage into surrounding tissue occurs or is suspected, immediately stop administration of vinorelbine and initiate appropriate management measures in accordance with institutional policies [see Warnings and Precautions (5.4)].
Vinorelbine is a cytotoxic drug. Follow applicable special handling and disposal procedures1 .
Exercise caution in handling and preparing the solution of vinorelbine injection. The use of gloves is recommended. If the solution of vinorelbine injection contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water.
Avoid contamination of the eye with vinorelbine injection. If exposure occurs, flush the eyes with water immediately and thoroughly.
Discard unused portion.
Injection: 1 mL (10 mg/mL) and 5 mL (50 mg/ 5 mL) clear colorless to pale yellow solution in single-dose vials:
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