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Navelbine

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Navelbine

Navelbine

INDICATIONS

NAVELBINE 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

DOSAGE AND ADMINISTRATION

Recommended Dose

In Combination with Cisplatin 100 mg/m²
  • The recommended dose of NAVELBINE is 25 mg/m² 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/m² on day 1 only of each 28 day cycle.
In Combination with Cisplatin 120 mg/m²
  • The recommended dose of NAVELBINE 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.
Single-Agent

The recommended dose of NAVELBINE is 30 mg/m² administered intravenously over 6 to 10 minutes once a week.

Dose Modifications

Hematologic Toxicity

[see WARNINGS AND PRECAUTIONS]

Hold or decrease the dose of NAVELBINE in patients with decreased neutrophil counts using the following schema.

Neutrophils on Day of Treatment (Cells/mm³) 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

[see WARNINGS AND PRECAUTIONS and Use In Specific Populations]

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 Hematologic Toxicity and Hepatic Impairment

In patients with both hematologic toxicity and hepatic impairment, 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] Discontinue NAVELBINE for NCI CTCAE Grade 2 or higher peripheral neuropathy or autonomic neuropathy causing constipation.

Preparation And Administration

Preparation of NAVELBINE

Dilute NAVELBINE in either a syringe or intravenous bag using one of the recommended solutions.

Syringe

Dilute 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
Intravenous Bag

Dilute 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

Diluted NAVELBINE 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).

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]

Procedures For Proper Handling And Disposal

Handle and dispose NAVELBINE consistent with recommendations for the handling and disposal of hazardous drugs2 .

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.

HOW SUPPLIED

Dosage Forms And Strengths

NAVELBINE Injection

Clear colorless to pale yellow solution in single use vials:

1 mL (10 mg/ 1 mL)
5 mL (50 mg/ 5 mL)

Storage And Handling

NAVELBINE Injection is a clear, colorless to pale yellow aqueous solution available in single-dose vials with royal blue caps, individually packaged in a carton as:

10 mg/1 mL (NDC 64370-532-01).
50 mg/5 mL (NDC 64370-532-02).

Store the vials at 2° to 8°C (36° to 46°F) in the carton. Protect from light. DO NOT FREEZE. Unopened vials of NAVELBINE are stable at 25°C (77°F) for up to 72 hours.

NAVELBINE is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

REFERENCES

1. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

Manufactured by: Pierre Fabre Médicament 45 place Abel Gance -92100 Boulogne –FRANCE. Distributed by: Pierre Fabre Pharmaceuticals, Inc. Parsippany, NJ 07054. Revised: 03/2014

Last reviewed on RxList: 4/7/2014
This monograph has been modified to include the generic and brand name in many instances.

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