Navelbine Injection Dosage

Generic name: vinorelbine tartrate
Dosage form: injection

This dosage information does not include all the information needed to use Navelbine Injection safely and effectively. See full prescribing information for Navelbine Injection.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Single-Agent NAVELBINE

The usual initial dose of single-agent NAVELBINE is 30 mg/m2 administered weekly. The recommended method of administration is an intravenous injection over 6 to 10 minutes. In controlled trials, single-agent NAVELBINE was given weekly until progression or dose-limiting toxicity.

NAVELBINE in Combination with Cisplatin

NAVELBINE may be administered weekly at a dose of 25 mg/m2 in combination with cisplatin given every 4 weeks at a dose of 100 mg/m2.

Blood counts should be checked weekly to determine whether dose reductions of vinorelbine and/or cisplatin are necessary. In the SWOG study, most patients required a 50% dose reduction of NAVELBINE at day 15 of each cycle and a 50% dose reduction of cisplatin by cycle 3.

NAVELBINE may also be administered weekly at a dose of 30 mg/m2 in combination with cisplatin, given on days 1 and 29, then every 6 weeks with cisplatin at a dose of 120 mg/m2.

Dose Modifications for NAVELBINE

The dosage should be adjusted according to hematologic toxicity or hepatic insufficiency, whichever results in the lower dose for the corresponding starling dose of NAVELBINE (see Table 5).

Dose Modifications for Hematologic Toxicity

Granulocyte counts should be ≥1,000 cells/mm3 prior to the administration of NAVELBINE. Adjustments in the dosage of NAVELBINE should be based on granulocyte counts obtained on the day of treatment according to Table 5.

Table 5: Dose Adjustments Based on Granulocyte Counts
Granulocytes on Day of Treatment (Cells/mm3)
Percentage of Starting Dose of NAVELBINE
≥1,500 100%
1,000 to 1,499 50%
<1,000 count Do not administer. Repeat granulocyte count in 1 week.
If 3 consecutive weekly doses are held because granulocyte is <1,000 cells/mm3, discontinue NAVELBINE.
Note: For patients who, during treatment with vinorelbine, experienced fever and/or sepsis while granulocytopenic or had 2 consecutive weekly doses held due to granulocytopenia, subsequent doses of vinorelbine should be:
>1,500 75
1,000 to 1,499 37.5%
<1,000 See above

Dose Modifications for Hepatic Insufficiency

NAVELBINE should be administered with caution to patients with hepatic insufficiency. In patients who develop hyperbilirubinemia during treatment with NAVELBINE, the dose should be adjusted for total bilirubin according to Table 6.

Table 6: Dose Modification Based on Total Bilirubin
Total Bilirubin
(mg/dL)
Percentage of Starting Dose of NAVELBINE
≤2.0 100%
2.1 to 3.0 50%
>3.0 25%

Dose Modifications for Concurrent Hematologic Toxicity and Hepatic Insufficiency

In patients with both hematologic toxicity and hepatic insufficiency, the lower of the doses based on the corresponding starting dose of NAVELBINE determined from Table 5 and Table 6 should be administered.

Dose Modifications for Renal Insufficiency

No dose adjustments for NAVELBINE are required for renal insufficiency. Appropriate dose reductions for cisplatin should be made when NAVELBINE is used in combination.

Dose Modifications for Neurotoxicity

If Grade ≥2 neurotoxicity develops, NAVELBINE should be discontinued.

Administration Precautions

Caution - NAVELBINE must be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any NAVELBINE is injected. Leakage into surrounding tissue during intravenous administration of NAVELBINE may cause considerable irritation, local tissue necrosis, and/or thrombophlebitis. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Since there are no established guidelines for the treatment of extravasation injuries with NAVELBINE, institutional guidelines may be used. The ONS Chemotherapy Guidelines provide additional recommendations for the prevention of extravasation injuries.1

As with other toxic compounds, caution should be exercised in handling and preparing the solution of NAVELBINE. Skin reactions may occur with accidental exposure. 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. Severe irritation of the eye has been reported with accidental contamination of the eye with another vinca alkaloid. If this happens with NAVELBINE, the eye should be flushed with water immediately and thoroughly.

Procedures for proper handling and disposal of anticancer drugs should be used. Several guidelines on this subject have been published.2-8

There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

NAVELBINE Injection is a clear, colorless to pale yellow solution. 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.

Preparation for Administration

NAVELBINE Injection must be diluted in either a syringe or IV bag using one of the recommended solutions. The diluted NAVELBINE should be administered over 6 to 10 minutes into the side port of a free-flowing IV closest to the IV bag followed by flushing with at least 75 to 125 mL of one of the solutions. Diluted vinorelbine may be used for up to 24 hours under normal room light when stored in polypropylene syringes or polyvinyl chloride bags at 5° to 30°C (41° to 86°F).

Syringe: The calculated dose of NAVELBINE should be diluted to a concentration between 1.5 and 3.0 mg/mL.

The following solutions may be used for dilution:

 
5% Dextrose Injection, USP
 
0.9% Sodium Chloride Injection, USP

IV Bag:The calculated dose of NAVELBINE should be diluted to a concentration between 0.5 and 2 mg/mL.

The following solutions may be used 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

Unopened vials of NAVELBINE are stable until the date indicated on the package when stored under refrigeration at 2° to 8°C (36° to 46°F) and protected from light in the carton. Unopened vials of NAVELBINE are stable at temperatures up to 25°C (77°F) for up to 72 hours. This product should not be frozen.

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