Prescription Drug Information: Vinorelbine

VINORELBINE- vinorelbine tartrate injection, solution
Actavis Pharma, Inc.

WARNING: MYELOSUPPRESSION

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

In Combination with Cisplatin 100 mg/m2

  • The recommended dosage 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/m2

  • The recommended dosage 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.

Single Agent

  • The recommended dosage of vinorelbine is 30 mg/m2 administered intravenously over 6 to 10 minutes once a week.

2.2 Dosage Modifications

Myelosuppression

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
≥ 1,500 100%
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:
> 1,500 75%
1,000 to 1,499 37.5%
< 1,000 Do not administer vinorelbine.
Repeat neutrophil count in one week.

Hepatic Impairment/Toxicity

Reduce vinorelbine dose in patients with elevated serum total bilirubin concentration according to the following schema [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)]:

Serum Total Bilirubin Concentration (mg/dl) Percentage of Starting Dose of Vinorelbine
≤ 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 vinorelbine determined from the above schemas.

Neurologic Toxicity

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)].

2.3 Preparation and Administration

Preparation

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).

Administration

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)].

2.4 Procedures for Proper Handling and Disposal

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.

3 DOSAGE FORMS AND STRENGTHS

Injection: 1 mL (10 mg/mL) and 5 mL (50 mg/ 5 mL) clear colorless to pale yellow solution in single-dose vial

4 CONTRAINDICATIONS

None

5 WARNINGS AND PRECAUTIONS

5.1 Myelosuppression

Myelosuppression, manifested by neutropenia, anemia and thrombocytopenia, occur in patients receiving vinorelbine as a single agent and in combination with cisplatin [see Adverse Reactions (6.1, 6.2)]. Neutropenia is the major dose-limiting toxicity with vinorelbine. Grade 3 to 4 neutropenia occurred in 53% of patients treated with vinorelbine at 30 mg/m2 per week. Dose adjustment due to myelosuppression occurred in 51% of patients (Study 2). In clinical trials with vinorelbine administered at 30 mg/m2 per week, neutropenia resulted in hospitalizations for pyrexia and/or sepsis in 8% of patients. Death due to sepsis occurred in 1% of patients. Neutropenia nadirs occur between 7 and 10 days after dosing with neutropenia count recovery usually occurring within the following 7 to 14 days.

Monitor complete blood counts prior to each dose of vinorelbine. Do not administer vinorelbine to patients with neutrophil counts < 1,000 cells/mm3. Adjustments in the dosage of vinorelbine should be based on neutrophil counts obtained on the day of treatment [see Dosage and Administration (2.2)].

5.2 Hepatic Toxicity

Drug-induced liver injury manifest by elevated aspartate aminotransferase (AST) and bilirubin occur in patients receiving vinorelbine as a single agent and in combination with cytotoxic agents. Assess hepatic function prior to initiation of vinorelbine and periodically during treatment. Reduce the dose of vinorelbine for patients who develop elevations in total bilirubin ≥2 times upper limit of normal [see Dosage and Administration (2.2) and Use in Specific Populations (8.6)].

5.3 Severe Constipation and Bowel Obstruction

Severe and fatal paralytic ileus, constipation, intestinal obstruction, necrosis, and perforation occur in patients receiving vinorelbine. Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction and/or paralytic ileus, considering adequate dietary fiber intake, hydration and routine use of stool softeners.

5.4 Extravasation and Tissue Injury

Extravasation of vinorelbine can result in severe irritation, local tissue necrosis and/or thrombophlebitis. If signs or symptoms of extravasation occur, immediately stop administration of vinorelbine and institute recommended management procedures [see Dosage and Administration (2.2) and Adverse Reaction (6.1)].

5.5 Neurologic Toxicity

Sensory and motor neuropathies, including severe neuropathies, occur in patients receiving vinorelbine. Monitor patients for new or worsening signs and symptoms of neuropathy, such as paresthesia, hyperesthesia, hyporeflexia and muscle weakness while receiving vinorelbine. Discontinue vinorelbine for CTCAE Grade 2 or greater neuropathy [see Dosage and Administration (2.2) and Adverse Reaction (6.1)].

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