Drug Detail:Navelbine (Vinorelbine [ vin-or-el-been ])
Generic Name: VINORELBINE TARTRATE 10mg in 1mL
Dosage Form: injection
Drug Class: Mitotic inhibitors
Recommended Dosage
In Combination with Cisplatin 100 mg/m2
- The recommended dose of NAVELBINE is 25 mg/m 2 administered as an intravenous injection or infusion over 6 to 10 minutes on Days 1, 8, 15, and 21 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/m2
- The recommended dose of NAVELBINE 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 dose of NAVELBINE is 30 mg/m 2 administered intravenously over 6 to 10 minutes once a week.
Dose Modifications
Myelosuppression
[see Warnings and Precautions (5.1)]
Hold or decrease the dose of NAVELBINE in patients with decreased neutrophil counts using the following schema.
|
Neutrophils on Day of Treatment (Cells/mm 3) |
Percentage of Starting Dose of NAVELBINE |
|
≥ 1,500 |
100% |
|
1,000 to 1,499 |
50% |
|
< 1,000 |
Do not administer NAVELBINE. |
|
Repeat neutrophil count in one week. |
|
|
If three consecutive weekly doses are held because |
|
| Neutrophil count is < 1,000 cells/mm3, discontinue NAVELBINE | |
|
Note : For patients who experience fever and/or sepsis while neutrophil count is < 1,500 or had 2 consecutive weekly doses held due to neutropenia, subsequent doses of NAVELBINE should be: |
|
|
> 1,500 |
75% |
|
1,000 to 1,499 |
37.5% |
|
< 1,000 |
Do not administer NAVELBINE. Repeat neutrophil count in one week. |
Hepatic Impairment/Toxicity
[seeWarnings and Precautions (5.2) and Use in Specific Populations(8.6)]
Reduce NAVELBINE dose in patients with elevated serum total bilirubin concentration according to the following schema:
|
Serum total bilirubin concentration (mg/dl) |
Percentage of Starting Dose of NAVELBINE |
|
< 2.0 |
100% |
|
2.1 to 3.0 |
50% |
|
> 3.0 |
25% |
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 NAVELBINE determined from the above schemas.
Neurologic Toxicity
[see Warnings and Precautions (5.5)]
Discontinue NAVELBINE for for Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher peripheral neuropathy or autonomic neuropathy causing constipation.
Preparation and Administration
Preparation
Dilute NAVELBINE 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 NAVELBINE 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).
Administration
Administer diluted NAVELBINE 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.
NAVELBINE must only be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any NAVELBINE 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, NAVELBINE should not be administered.
Management of Suspected Extravasation
- If NAVELBINE leakage into surrounding tissue occurs or is suspected, immediately stop administration of NAVELBINE and initiate appropriate management measures in accordance with institutional policies [see Warnings and Precautions (5.4)].
Procedures for Proper Handling and Disposal
NAVELBINE is a cytotoxic drug. Follow applicable special handling and disposal procedures 1.
Exercise caution in handling and preparing the solution of NAVELBINE. The use of gloves is recommended. If the solution of NAVELBINE contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water.
Avoid contamination of the eye with NAVELBINE. If exposure occurs, flush the eyes with water immediately and thoroughly.
Discard unused portion.
