Vinorelbine Tartrate
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Questions & Answers
Side Effects & Adverse Reactions
Vinorelbine should be administered in carefully adjusted doses by or under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
Patients treated with vinorelbine should be frequently monitored for myelosuppression both during and after therapy. Granulocytopenia is dose-limiting. Granulocyte nadirs occur between 7 and 10 days after dosing with granulocyte count recovery usually within the following 7 to 14 days.
Complete blood counts with differentials should be performed and results reviewed prior to administering each dose of vinorelbine. Vinorelbine should not be administered to patients with granulocyte counts <1,000 cells/mm3. Patients developing severe granulocytopenia should be monitored carefully for evidence of infection and/or fever. See DOSAGE AND ADMINISTRATION for recommended dose adjustments for granulocytopenia.
Acute shortness of breath and severe bronchospasm have been reported infrequently, following the administration of vinorelbine and other vinca alkaloids, most commonly when the vinca alkaloid was used in combination with mitomycin. These adverse events may require treatment with supplemental oxygen, bronchodilators, and/or corticosteroids, particularly when there is pre-existing pulmonary dysfunction.
Reported cases of interstitial pulmonary changes and acute respiratory distress syndrome (ARDS), most of which were fatal, occurred in patients treated with single-agent vinorelbine. The mean time to onset of these symptoms after vinorelbine administration was 1 week (range 3 to 8 days). Patients with alterations in their baseline pulmonary symptoms or with new onset of dyspnea, cough, hypoxia, or other symptoms should be evaluated promptly.
Vinorelbine has been reported to cause severe constipation (e.g., Grade 3-4), paralytic ileus, intestinal obstruction, necrosis, and/or perforation. Some events have been fatal.
Vinorelbine may cause fetal harm if administered to a pregnant woman. A single dose of vinorelbine has been shown to be embryo- and/or fetotoxic in mice and rabbits at doses of 9 mg/m2 and 5.5 mg/m2, respectively (one third and one sixth the human dose). At nonmaternotoxic doses, fetal weight was reduced and ossification was delayed. There are no studies in pregnant women. If vinorelbine is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with vinorelbine.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Vinorelbine is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced non-small cell lung cancer (NSCLC). In patients with Stage IV NSCLC, vinorelbine is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, vinorelbine is indicated in combination with cisplatin.
History
There is currently no drug history available for this drug.
Other Information
Vinorelbine Injection USP is for intravenous administration. Each vial contains vinorelbine tartrate equivalent to 10 mg (1-mL vial) or 50 mg (5-mL vial) vinorelbine in Water for Injection. No preservatives or other additives are present. The aqueous solution is sterile and nonpyrogenic.
Vinorelbine tartrate is a semi-synthetic vinca alkaloid with antitumor activity. The chemical name 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(R*,R*)-2,3-dihydroxybutanedioate (1:2)(salt)].
Vinorelbine tartrate has the following structure:
Vinorelbine tartrate is a white to yellow or light brown amorphous powder with the molecular formula C45H54N4O8•2C4H6O6 and molecular weight of 1079.12. The aqueous solubility is >1,000 mg/mL in distilled water. The pH of Vinorelbine Injection USP is approximately 3.5.
Sources
Vinorelbine Tartrate Manufacturers
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Sandoz Inc.
![Vinorelbine Tartrate Injection, Solution [Sandoz Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Vinorelbine Tartrate | Sandoz Inc.
Single-Agent Vinorelbine Injection USPThe usual initial dose of single-agent Vinorelbine Injection USP 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 USP was given weekly until progression or dose-limiting toxicity.
Vinorelbine Injection USP in Combination with CisplatinVinorelbine Injection USP 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 USP and/or cisplatin are necessary. In the SWOG study, most patients required a 50% dose reduction of Vinorelbine Injection USP at day 15 of each cycle and a 50% dose reduction of cisplatin by cycle 3.
Vinorelbine Injection USP 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 USPThe 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 USP (see Table 5).
Dose Modifications for Hematologic ToxicityGranulocyte counts should be ≥1,000 cells/mm3 prior to the administration of Vinorelbine Injection USP. Adjustments in the dosage of Vinorelbine Injection USP 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 ≥1,500 100% 1,000 to 1,499 50% <1,000 Do not administer. Repeat granulocyte count in 1 week. If 3 consecutive weekly doses are held because granulocyte count is <1,000 cells/mm3, discontinue VINORELBINE. 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 InsufficiencyVinorelbine Injection USP should be administered with caution to patients with hepatic insufficiency. In patients who develop hyperbilirubinemia during treatment with Vinorelbine Injection USP, 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 ≤2.0 100% 2.1 to 3.0 50% >3.0 25% Dose Modifications for Concurrent Hematologic Toxicity and Hepatic InsufficiencyIn patients with both hematologic toxicity and hepatic insufficiency, the lower of the doses based on the corresponding starting dose of Vinorelbine Injection USP determined from Table 5 and Table 6 should be administered.
Dose Modifications for Renal InsufficiencyNo dose adjustments for Vinorelbine Injection USP are required for renal insufficiency. Appropriate dose reductions for cisplatin should be made when Vinorelbine Injection USP is used in combination.
Dose Modifications for NeurotoxicityIf Grade ≥2 neurotoxicity develops, Vinorelbine Injection USP should be discontinued.
Administration PrecautionsCaution - Vinorelbine Injection USP must be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any Vinorelbine Injection USP is injected. Leakage into surrounding tissue during intravenous administration of Vinorelbine Injection USP 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 USP, 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 USP. Skin reactions may occur with accidental exposure. The use of gloves is recommended. If the solution of Vinorelbine Injection USP 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 USP, 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 USP 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 USP should not be administered.
Preparation for AdministrationVinorelbine Injection USP must be diluted in either a syringe or IV bag using one of the recommended solutions. The diluted Vinorelbine Injection USP 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 USP 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).
SyringeThe calculated dose of Vinorelbine Injection USP should be diluted to a concentration between 1.5 and 3.0 mg/mL. The following solutions may be used for dilution:
IV Bag
5% Dextrose Injection, USP
0.9% Sodium Chloride Injection, USPThe calculated dose of Vinorelbine Injection USP should be diluted to a concentration between 0.5 and 2 mg/mL. The following solutions may be used for dilution:
Stability
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, USPUnopened vials of Vinorelbine Injection USP 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 USP 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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Hospira Worldwide, Inc.
Vinorelbine Tartrate | Hospira Worldwide, Inc.
2.1 Recommended DoseIn Combination with Cisplatin 100 mg/m2
• The recommended dose of Vinorelbine 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 Vinorelbine 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 Vinorelbine is 30 mg/m 2 administered intravenously over 6 to 10 minutes once a week. 2.2 Dose ModificationsHematologic Toxicity
[see Warnings and Precautions (5.1)].
Hold or decrease the dose of Vinorelbine in patients with decreased neutrophil counts using the following schema.
Neutrophils on Day of Treatment
(Cells/mm3)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 VinorelbineNote: 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 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
[see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)].
Reduce Vinorelbine 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 Vinorelbine
≤ 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 Vinorelbine determined from the above schemas.
Neurologic Toxicity
[see Warnings and Precautions (5.5)]
Discontinue Vinorelbine for NCI CTCAE Grade 2 or higher peripheral neuropathy or autonomic neuropathy causing constipation.
2.3 Preparation and AdministrationVinorelbine Injection must be diluted in either a syringe or IV bag using one of the recommended solutions.
Syringe
The calculated dose of Vinorelbine 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, USPIV Bag
The calculated dose of Vinorelbine 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, USPStability
Unopened vials of Vinorelbine 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 are stable at temperatures up to 25°C (77°F) for up to 72 hours.
This product should not be frozen.
Administration
The diluted Vinorelbine 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.
Vinorelbine 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 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 DisposalHandle and dispose Vinorelbine consistent with recommendations for the handling and disposal of hazardous drugs.2
Exercise caution in handling and preparing the solution of Vinorelbine. The use of gloves is recommended. If the solution of Vinorelbine contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water.
Avoid contamination of the eye with Vinorelbine. If exposure occurs, flush the eyes with water immediately and thoroughly.
![Vinorelbine Tartrate Injection, Solution [Hospira Worldwide, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=06eeaab8-a00d-4b41-b46b-40163f09ecb8&name=434519.jpg)
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