Vinblastine

FDA label, Fresenius Kabi USA, LLC, intravenous, effective 2025-04-15. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Boxed warning

Caution: This preparation should be administered by individuals experienced in the administration of vinblastine sulfate. It is extremely important that the intravenous needle or catheter be properly positioned before any vinblastine sulfate is injected. Leakage into surrounding tissue during intravenous administration of vinblastine sulfate may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein.

Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis. FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES. See WARNINGS for the treatment of patients given intrathecal vinblastine sulfate injection.

Handling and access

NIOSH hazardous drug

Table 1

NIOSH lists vinblastine as a hazardous drug. AHFS class: 10:00 antineoplastic agents.

  • The package insert includes manufacturer's special handling information (MSHI). Follow it when preparing, administering, and disposing of this drug.

Handle with the precautions your facility uses for hazardous drugs (USP <800>). NIOSH's Managing Hazardous Drug Exposures lists controls by drug form and activity.

Source: NIOSH List of Hazardous Drugs in Healthcare Settings, 2024December 2024, updates through Jul 17, 2025

Dosing in kidney impairment

Dose modifications should be guided by hematologic tolerance. Patients with Renal or Hepatic Impairment A reduction of 50% in the dose of vinblastine sulfate is recommended for patients having a direct serum bilirubin value above 3 mg/100 mL. Since metabolism and excretion are primarily hepatic, no modification is recommended for patients with impaired renal function.

Preparation and administration

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Basis

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DOSAGE AND ADMINISTRATION: This preparation is for intravenous use only (see WARNINGS ). Special Dispensing Information - To reduce the potential for fatal medication errors due to incorrect route of administration, vinblastine sulfate injection should be diluted in a flexible plastic container and prominently labeled (as indicated), “FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES.” (see WARNINGS ).

Preparation for flexible plastic container Vinblastine sulfate injection when diluted with 0.9% sodium chloride injection to concentrations of 0.1 mg/mL to 0.4 mg/mL is stable at room temperature for up to 24 hours when protected from light or 8 hours in normal light. Caution–It is extremely important that the intravenous needle or catheter be properly positioned before any vinblastine sulfate is injected.

On the other hand, failure to provide maintenance therapy in some patients may lead to unnecessary relapse; complete remissions in patients with testicular cancer, unless maintained for at least two years, often result in early relapse. The calculated dose of vinblastine sulfate may be infused from a flexible plastic container directly into an intravenous catheter/needle or into a running intravenous infusion.

If care is taken to ensure that the needle is securely within the vein and that no solution containing vinblastine sulfate is spilled extravascularly, cellulitis and/or phlebitis will not occur. To minimize further the possibility of extravascular spillage, flush the infusion line with normal saline prior to removal of the intravenous catheter or needle.

The dose should not be diluted in large volumes of diluent (i.e. greater than 100 mL) or given intravenously for prolonged periods (longer than 30 minutes), since this frequently results in irritation of the vein and increases the chance of extravasation. Because of the enhanced possibility of thrombosis, it is considered inadvisable to inject a solution of vinblastine sulfate into an extremity in which the circulation is impaired or potentially impaired by such conditions as compressing or invading neoplasm, phlebitis or varicosity.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published. 4-10 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

Drug interactions

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Label text (2 paragraphs)

Drug Interactions The simultaneous oral or intravenous administration of phenytoin and antineoplastic chemotherapy combinations that included vinblastine sulfate has been reported to have reduced blood levels of the anticonvulsant and to have increased seizure activity. Dosage adjustment should be based on serial blood level monitoring. The contribution of vinblastine sulfate to this interaction is not certain. The interaction may result from either reduced absorption of phenytoin or an increase in the rate of its metabolism and elimination.

Caution should be exercised in patients concurrently taking drugs known to inhibit drug metabolism by hepatic cytochrome P450 isoenzymes in the CYP 3A subfamily, or in patients with hepatic dysfunction. Concurrent administration of vinblastine sulfate with an inhibitor of this metabolic pathway may cause an earlier onset and/or an increased severity of side effects. Enhanced toxicity has been reported in patients receiving concomitant erythromycin (see ADVERSE REACTIONS ).

Contraindications

CONTRAINDICATIONS: Vinblastine sulfate is contraindicated in patients who have significant granulocytopenia unless this is a result of the disease being treated. It should not be used in the presence of bacterial infections. Such infections must be brought under control prior to the initiation of therapy with vinblastine sulfate.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

E*

Likelihood score E*: Unproven but suspected rare cause of clinically apparent liver injury. (Score for vinblastine.)

The vinca alkaloids include vincristine, vinblastine and vinorelbine which are important antineoplastic agents used in many chemotherapeutic regimens for a wide variety of cancers. Despite their cytotoxic activity against cancer cells, the vinca alkaloids have rarely been implicated in causing clinically apparent acute liver injury.

ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.

Source: LiverTox: Vinca Alkaloids (NIDDK, public domain)Chapter updated Sep 12, 2020

Pregnancy and lactation

Pregnancy

Usage in Pregnancy Pregnancy Category D - (See WARNINGS ). Vinblastine sulfate should be given to a pregnant woman only if clearly needed. Animal studies suggest that teratogenic effects may occur.

Lactation

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from vinblastine sulfate in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.

Breastfeeding (LactMed)

Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. It is probably impractical to resume breastfeeding after vinblastine therapy because of the drug's long half-life. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk. Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.

Source: LactMed: Vinblastine (NICHD, public domain)Revised Aug 15, 2024

Supply and cost

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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