Vinorelbine
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Questions & Answers
Side Effects & Adverse Reactions
For external use only.
Do not use on broken skin
Ask a doctor before use if you have kidney disease
Stop use if rash or irritation occurs
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Do not use on broken skin
Ask a doctor before use if you have kidney disease
Stop use if rash or irritation occurs
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
reduces underarm wetness
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Vinorelbine Manufacturers
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Mylan Institutional Llc
![Vinorelbine Injection, Solution [Mylan Institutional Llc ]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Vinorelbine | Procter & Gamble Manufacturing Company
apply to underarms only
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Pfizer Laboratories Div Pfizer Inc.
Vinorelbine | Pfizer Laboratories Div Pfizer Inc.
Single-Agent Vinorelbine Injection USP:The 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 Cisplatin:Vinorelbine 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 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 with cisplatin at a dose of 120 mg/m2.
Dose Modifications for Vinorelbine Injection USP: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 USP (see Table 5).
Dose Modifications for Hematologic Toxicity: Granulocyte 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 Injection USP
≥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 Injection USP.
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: Vinorelbine 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 Injection USP
< 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 USP determined from Table 5 and Table 6 should be administered.
Dose Modifications for Renal Insufficiency: No 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 Neurotoxicity: If Grade ≥2 neurotoxicity develops Vinorelbine Injection USP should be discontinued.
Administration Precautions:Caution - 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 injuries1.
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 published2-8.
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 Administration:Vinorelbine 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 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 USP 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 Vinorelbine Injection USP 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 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.
-
Pfizer Laboratories Div Pfizer Inc.
Vinorelbine | Pfizer Laboratories Div Pfizer Inc.
Single-Agent Vinorelbine Injection USP:The 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 Cisplatin:Vinorelbine 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 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 with cisplatin at a dose of 120 mg/m2.
Dose Modifications for Vinorelbine Injection USP: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 USP (see Table 5).
Dose Modifications for Hematologic Toxicity: Granulocyte 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 Injection USP
≥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 Injection USP.
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: Vinorelbine 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 Injection USP
< 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 USP determined from Table 5 and Table 6 should be administered.
Dose Modifications for Renal Insufficiency: No 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 Neurotoxicity: If Grade ≥2 neurotoxicity develops Vinorelbine Injection USP should be discontinued.
Administration Precautions:Caution - 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 injuries1.
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 published2-8.
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 Administration:Vinorelbine 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 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 USP 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 Vinorelbine Injection USP 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 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.
-
Teva Parenteral Medicines, Inc.
Vinorelbine | Teva Parenteral Medicines, Inc.
Single-Agent Vinorelbine InjectionThe 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 CisplatinVinorelbine 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 InjectionThe 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 ToxicityGranulocyte 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 InsufficiencyVinorelbine 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 toTable 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 InsufficiencyIn patients with both hematologic toxicity and hepatic insufficiency, the lower of the doses based on the corresponding starting dose of vinorelbine injection determined fromTable 5andTable 6should be administered.
Dose Modifications for Renal InsufficiencyNo 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 NeurotoxicityIf grade ≥2 neurotoxicity develops, vinorelbine injection should be discontinued.
Administration PrecautionsCaution—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 AdministrationVinorelbine 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)
SyringeThe 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 BagThe 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
StabilityUnopened 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.
-
Mylan Institutional Llc
Vinorelbine | Mylan Institutional Llc
2.1 Recommended DoseIn Combination with Cisplatin 100 mg/m2
The recommended dose of Vinorelbine Injection, USP 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 Vinorelbine Injection, USP 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 Vinorelbine Injection, USP is 30 mg/m2 administered intravenously over 6 to 10 minutes once a week. 2.2 Dose Modifications Hematologic Toxicity[see Warnings and Precautions (5.1)]
Hold or decrease the dose of Vinorelbine Injection, USP in patients with decreased neutrophil counts using the following schema.
Neutrophils on Day of Treatment (Cells/mm3)
Percentage of Starting Dose of Vinorelbine Injection, USP
≥ 1,500
100%
1,000 to 1,499
50%
< 1,000
Do not administer Vinorelbine Injection USP.
Repeat neutrophil count in one week.
If three consecutive weekly doses are held because
Neutrophil count is < 1,000 cells/mm3, discontinue
Vinorelbine Injection, USP
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 Vinorelbine
Injection, USP should be:
> 1,500
75%
1,000 to 1,499
37.5%
< 1,000
Do not administer Vinorelbine Injection, USP.
Repeat neutrophil count in one week.
Hepatic Impairment/Toxicity[see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)]
Reduce Vinorelbine Injection, USP 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 Injection, USP
≤ 2.0
100%
2.1 to 3.0
50%
> 3.0
25%
Concurrent Hematologic Toxicity and Hepatic ImpairmentIn patients with both hematologic toxicity and hepatic impairment, administer the lower of the doses based on the corresponding starting dose of Vinorelbine Injection, USP determined from the above schemas.
Neurologic Toxicity[see Warnings and Precautions (5.5) ]
Discontinue Vinorelbine Injection, USP for NCI CTCAE Grade 2 or higher peripheral neuropathy or autonomic neuropathy causing constipation.
2.3 Preparation and AdministrationPreparation of Vinorelbine Injection, USP
Dilute Vinorelbine Injection, USP 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, USPIntravenous 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, USPStabiliy
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).
Administration
Administer diluted Vinorelbine Injection, USP 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, USP must only be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any Vinorelbine Injection, USP 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, USP should not be administered.
Management of Suspected Extravasation
If Vinorelbine Injection, USP leakage into surrounding tissue occurs or is suspected, immediately stop administration of Vinorelbine Injection, USP 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 Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs2.
Exercise caution in handling and preparing the solution of Vinorelbine Injection, USP. 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.
Avoid contamination of the eye with Vinorelbine Injection, USP. If exposure occurs, flush the eyes with water immediately and thoroughly.
-
Sagent Pharmaceuticals
Vinorelbine | Sagent Pharmaceuticals
2.1 Recommended DoseIn Combination with Cisplatin 100 mg/m2
The recommended dose of Vinorelbine Injection, USP 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 Vinorelbine Injection, USP 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 Vinorelbine Injection, USP is 30 mg/m2 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 Injection, USP in patients with decreased neutrophil counts using the following schema.
Neutrophils on Day of Treatment (Cells/mm3) Percentage of Starting Dose of Vinorelbine Injection, USP ≥ 1,500 100% 1,000 to 1,499 50% < 1,000 Do not administer Vinorelbine Injection, USP.
Repeat neutrophil count in one week.
If three consecutive weekly doses are held because
Neutrophil count is < 1,000 cells/mm3, discontinue Vinorelbine Injection, USP 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 Vinorelbine Injection, USP should be: > 1,500 75% 1,000 to 1,499 37.5% < 1,000 Do not administer Vinorelbine Injection, USP. Repeat neutrophil count in one week.Hepatic Impairment/Toxicity
[see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)]
Reduce Vinorelbine Injection, USP 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 Injection, USP ≤ 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 Injection, USP determined from the above schemas.
Neurologic Toxicity
[see Warnings and Precautions (5.5)]
Discontinue Vinorelbine Injection, USP for NCI CTCAE Grade 2 or higher peripheral neuropathy or autonomic neuropathy causing constipation.
2.3 Preparation and AdministrationPreparation of Vinorelbine Injection, USP
Dilute Vinorelbine Injection, USP 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, USPIntravenous 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, USPStability
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).
Administration
Administer diluted Vinorelbine Injection, USP 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, USP must only be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any Vinorelbine Injection, USP 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, USP should not be administered.
Management of Suspected Extravasation
If Vinorelbine Injection, USP leakage into surrounding tissue occurs or is suspected, immediately stop administration of Vinorelbine Injection, USP 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 Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs.1
Exercise caution in handling and preparing the solution of Vinorelbine Injection, USP. 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.
Avoid contamination of the eye with Vinorelbine Injection, USP. If exposure occurs, flush the eyes with water immediately and thoroughly.
![Vinorelbine Injection, Solution [Pfizer Laboratories Div Pfizer Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=deac0e4c-91fd-40ac-b478-0236291af3c0&name=vinorel-inj-pfizer-figure-02.jpg)
![Vinorelbine Injection, Solution [Pfizer Laboratories Div Pfizer Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=831c2287-e7d1-41ff-90ed-1ddd38350590&name=vino-inj-novaplus-figure-05.jpg)
![Vinorelbine Injection [Teva Parenteral Medicines, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fa49b48c-49ce-4a95-8d3f-70ca304926fb&name=64b26cd8-7d44-4677-bd80-b5d6716e43a3-04.jpg)
![Vinorelbine Injection, Solution [Mylan Institutional Llc ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6a4d9c3b-1db8-4090-810c-3794b3ca59a4&name=vinorelbine-inj-mylan-figure-03.jpg)
![Vinorelbine Injection, Solution [Sagent Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=10a70995-e04d-4044-b1dc-c9aa27460397&name=vin00-0001-03.jpg)
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