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Class: Vinca alkaloid
- Solution for Injection 10 mg/mL
Vinorelbine interferes with microtubule assembly primarily by inhibiting mitosis at metaphase through its interaction with tubulin.
Vd is 25 to 40.1 L/kg.
One metabolite, deacetylvinorelbine, has been shown to possess antitumor activity.
T ½ is 28 to 44 h. Mean plasma clearance is about 1 to 1.26 L/h/kg. Substantial hepatic elimination in humans, with large amounts recovered in feces after IV administration.
Special PopulationsHepatic Function Impairment
Based on experience with other anticancer vinca alkaloids, dosage adjustments are recommended for patients with impaired hepatic function taking vinorelbine.
Indications and Usage
Unresectable, advanced non-small cell lung cancer.
Breast cancer, cisplatin-resistant ovarian cancer, Hodgkin lymphoma.
Pretreatment granulocyte counts less than 1,000 cells/mm 3 .
Dosage and AdministrationUnresectable, Advanced Non-Small Cell Lung Cancer
IV 30 mg/m 2 once weekly until either disease progression or dose-limiting toxicity occur.Dosage Adjustment for Hematologic Toxicity
Granulocyte counts should be at least 1,000 cells/mm 3 prior to the administration of vinorelbine. Base dosage adjustments on granulocyte counts. See manufacturer's recommendations.Dosage Adjustment in Hepatic Dysfunction
IV Reduce dose 50% if total bilirubin is 2.1 to 3 mg/dL. Reduce dose 25% if total bilirubin is more than 3 mg/dL.
- Vinorelbine must be further diluted prior to administration.
- Administer by IV infusion
- Infuse IV over 6 to 10 min into the side port of a freely flowing IV line closest to the IV bag. Follow injection with at least 75 to 125 mL dextrose 5% or sodium chloride 0.9%.
Refrigerate but do not freeze. Protect from light. Unopened vials may be stored at room temperature up to 25°C (77°F) for up to 72 h. Diluted solutions may be stored at room temperature or under refrigeration for up to 24 h in polypropylene syringes or PVC bags. Solutions are preservative-free and should be discarded within 24 h of preparation.
Incidence of granulocytopenia increases when vinorelbine is used in combination with cisplatin.CYP-450 3A enzyme inhibitors (eg ketoconazole, itraconazole, macrolides)
May increase vinorelbine serum levels and toxicity.Mitomycin
Acute pulmonary reactions were noted when vinca alkaloids were given with mitomycin.Paclitaxel
Monitor for signs and symptoms of neuropathy with concomitant use of vinorelbine and paclitaxel.Radiation
Radiation recall reactions may occur.
Laboratory Test Interactions
None well documented.
Fatigue; mild to moderate peripheral neuropathy.
Mild alopecia; rash and injection site reactions; pain at injection site.
Transient elevations in LFTs; constipation; paralytic ileus; mild stomatitis; anorexia; diarrhea.
Dose-limiting granulocytopenia occurs with a nadir of 7 to 10 days.
Anaphylaxis; angioedema; pruritus.
Jaw pain; myalgia; arthralgia.
WarningsIV use only
Intrathecal use of other vinca alkaloids has been fatal. Label syringe “Warning - For IV Use Only; fatal if given intrathecally.”Granulocytopenia
May be severe and predispose to infection. Do not administer to patients with granulocyte counts less than 1,000 cells/mm 3 .Avoid extravasation
Proper placement of needle/catheter prior to administration. Extravasation can cause severe local necrosis.
Category D .
Safety and efficacy in children have not been established.
Administer with caution to patients with hepatic insufficiency.
May cause severe constipation, paralytic ileus, intestinal obstruction, necrosis, and perforation.
Interstitial pulmonary changes
Cases of interstitial pulmonary changes and ARDS, most of which were fatal, occurred in patients.
Paralytic ileus, stomatitis, esophagitis, bone marrow aplasia, sepsis, paresis.
- Advise patients to report fever or chills immediately.
- Advise women of childbearing potential to avoid pregnancy during treatment.
- Advise patients to contact the health care provider if experiencing increased shortness of breath, cough, or other new pulmonary symptoms, or if experiencing symptoms of abdominal pain or constipation.
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