DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Vinorelbine (Vinorelbine Tartrate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Vinorelbine Injection USP is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced nonsmall cell lung cancer (NSCLC). In patients with Stage IV NSCLC, Vinorelbine Injection USP is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, Vinorelbine Injection USP is indicated in combination with cisplatin.

DOSAGE AND ADMINISTRATION

Single-Agent Vinorelbine Injection

The usual initial dose of single-agent vinorelbine injection 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 vinorelbine injection was given weekly until progression or dose-limiting toxicity.

Vinorelbine Injection in Combination with Cisplatin

Vinorelbine injection 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 injection and/or cisplatin are necessary. In the SWOG study, most patients required a 50% dose reduction of vinorelbine injection at day 15 of each cycle and a 50% dose reduction of cisplatin by cycle 3.

Vinorelbine injection 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 at a dose of 120 mg/m2.

Dose Modifications for Vinorelbine Injection

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

Dose Modifications for Hematologic Toxicity

Granulocyte counts should be ≥1000 cells/mm3 prior to the administration of vinorelbine injection. Adjustments in the dosage of vinorelbine injection 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 Vinorelbine Injection
≥1500 100%
1000 to 1499 50%
<1000 Do not administer. Repeat granulocyte count in 1 week. If 3 consecutive weekly doses are held because granulocyte count is <1000 cells/mm3, discontinue vinorelbine injection.
Note: For patients who, during treatment with vinorelbine injection, experienced fever and/or sepsis while granulocytopenic or had 2 consecutive weekly doses held due to granulocytopenia, subsequent doses of vinorelbine injection should be:
≥1500 75%
1000 to 1499 37.5%
<1000 See above

Dose Modifications for Hepatic Insufficiency

Vinorelbine injection should be administered with caution to patients with hepatic insufficiency. In patients who develop hyperbilirubinemia during treatment with vinorelbine injection, 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 Vinorelbine Injection
≤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 vinorelbine injection determined from Table 5 and Table 6 should be administered.

Dose Modifications for Renal Insufficiency

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

Dose Modifications for Neurotoxicity

If grade ≥2 neurotoxicity develops, vinorelbine injection should be discontinued.

Administration Precautions

Caution—vinorelbine injection must be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any vinorelbine injection is injected. Leakage into surrounding tissue during intravenous administration of vinorelbine injection 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 vinorelbine injection, 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 vinorelbine injection. Skin reactions may occur with accidental exposure. 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. Severe irritation of the eye has been reported with accidental contamination of the eye with another vinca alkaloid. If this happens with vinorelbine injection, 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.

Vinorelbine 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, vinorelbine injection should not be administered.

Preparation for Administration

Vinorelbine injection must be diluted in either a syringe or IV bag using one of the recommended solutions. The diluted vinorelbine injection 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 injection 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 vinorelbine injection should be diluted to a concentration between 1.5 and 3 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 vinorelbine injection 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 vinorelbine injection 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 vinorelbine injection are stable at temperatures up to 25°C (77°F) for up to 72 hours. This product should not be frozen.

HOW SUPPLIED

Vinorelbine Injection UPS is a clear, colorless to pale yellow solution in water for injection, containing 10 mg vinorelbine tartrate, USP per mL. Vinorelbine Injection USP is available as follows:

NDC Number Total Contents Package
0703-4182-01 10 mg/1 mL 1 Single-Use Vial per Carton
0703-4183-01 50 mg/5 mL 1 Single-Use Vial per Carton

Store the vials under refrigeration at 2° to 8°C (36° to 46°F) in the carton. Protect from light. DO NOT FREEZE.

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017