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. SeeDOSAGE AND ADMINISTRATIONfor 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.
报道了间质肺变化和急性呼吸窘迫综合征（ARDS）的病例，其中大部分是致命的，发生在接受单药乙烯宾替宾治疗的患者中。在葡萄链球菌给药后，这些症状发作的平均时间为1周（范围3至8天）。应立即评估其基线肺症状改变或呼吸困难，咳嗽，缺氧或其他症状的新患者。
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和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
目前还没有生产informa的警告tion available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
用途
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酒石酸是一种半合成的长春花碱aloid 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和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 TartrateManufacturers
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Sandoz Inc.
![Vinorelbine Tartrate注入，溶液[Sandoz Inc.]](//www.lbxkm.com/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注射USP可以每周以25 mg/m2的剂量与顺铂一起服用每4周以100 mg/m2的剂量给药。
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.
剂量Vinorelbine注入USP的修改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 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 Insufficiency肾脏功能不全不需要葡萄链球菌注射USP的剂量调整。当Vinorelbine注入USP结合使用时，应进行合适的顺铂减少。
Dose Modifications for NeurotoxicityIf Grade ≥2 neurotoxicity develops, Vinorelbine Injection USP should be discontinued.
Administration Precautions谨慎 - Vinorelbine注射USP必须静脉注射。在注入任何Vinorelbine注射USP之前，将静脉注射针或导管正确放置在非常重要的情况下。静脉注射葡萄球菌注射USP期间，渗入周围组织中的组织可能会引起相当大的刺激，局部组织坏死和/或血栓质量。如果发生渗出，则应立即停止注射，然后应将剂量的其余部分引入另一个静脉。由于没有既定的指南用于用Vinorelbine注射USP治疗溢beplay体验出损伤，因此可以使用机构指南。《 ONS化学疗法指南》为预防渗出损伤提供beplay体验了其他建议。1
与其他有毒化合物一样，应在处理和准备Vinorelbine注入USP的溶液时谨慎行事。意外暴露可能会发生皮肤反应。建议使用手套。如果Vinorelbine注入USP的溶液接触皮肤或粘膜，请立即用肥皂和水彻底清洗皮肤或粘膜。据报道，眼睛意外污染了眼睛的严重刺激，另一种Vinca生物碱。如果在Vinorelbine注入USP中发生这种情况，则应立即并彻底地用水冲洗眼睛。
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％葡萄糖和0.45％氯化钠注射，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.结合顺铂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 Modifications血液学毒性
[see Warnings and Precautions (5.1)].
Hold or decrease the dose of Vinorelbine in patients with decreased neutrophil counts using the following schema.
当天中性粒细胞
(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
3.7.5%
< 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%
同时血液学毒性和肝损害
在血液学毒性和肝损伤的患者中，根据从上述方has确定的乙烯苯甲胺的相应起始剂量来施用剂量的较低剂量。
神经毒性
[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％葡萄糖和0.45％氯化钠注射，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.
该产品不应冷冻。
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
•如果Vinorelbine泄漏到周围的组织中发生或被怀疑，请立即停止使用Vinorelbine，并根据机构政策启动适当的管理措施[请参阅警告和预防措施（5.4）]。2.4适当处理和处置的程序Handle 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 TartrateInjection, 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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