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Pronunciation:

(VIN de seen)

Synonyms:

DAVA; Deacetyl Vinblastine Carboxamide; Desacetyl Vinblastine Amide Sulfate; DVA; Eldisine Lilly 99094; Lilly CT-3231; NSC-245467; Vindesine Sulfate

Generic Available:

Use - Unlabeled/Investigational:

Investigational: Management of acute lymphocytic leukemia, chronic myelogenous leukemia; breast, head, neck, and lung cancers; lymphomas (Hodgkin's and non-Hodgkin's)

Lactation:

Breast-feeding is not recommended.

Contraindications:

Hypersensitivity to vindesine, vinca alkaloids, or any component of the formulation

Warnings/Precautions:

Vindesine should be used cautiously, if at all in patients with impaired hepatic function or neurologic problems. As with other vinca alkaloids, intrathecal administration may be fatal. Vindesine has been reported to be cross-resistance with vincristine. Vindesine is a moderate vesicant; if extravasation occurs, severe tissue damage leading to ulceration and necrosis, and pain may occur.

Adverse Reactions:

>10%:

Central nervous system: Pyrexia, malaise (up to 60%)

Dermatologic: Alopecia (6% to 92%)

Gastrointestinal: Mild nausea and vomiting (7% to 27%), constipation (10% to 17%) - related to the neurotoxicity

Hematologic: Leukopenia (50%) and thrombocytopenia (14% to 26%), may be dose-limiting; thrombocytosis (20% to 28%)

Nadir: 6-12 days

Recovery: Days 14-18

Neuromuscular & skeletal: Paresthesias (40% to 70%); loss of deep tendon reflexes (35% to 60%, may be dose-limiting); myalgia (up to 60%)

1% to 10%:

Dermatologic: Rashes

Gastrointestinal: Loss of taste

Hematologic: Anemia

Local: Phlebitis

Neuromuscular & skeletal: Facial paralysis

<1%: Acute chest pain, ECG changes, paralytic ileus, jaw pain, photophobia

Stability:

The powder is reconstituted to a concentration of 1 mg/mL. Reconstituted solutions are stable for 30 days under refrigeration (2°C to 8°C/36°F to 46°F). Solutions diluted in dextrose or saline for I.V. infusion are stable for 24 hours at room temperature (15°C to 30°C/59°F to 86°F). The drug will precipitate at pH >6.

Mechanism of Action:

Vindesine is a semisynthetic vinca alkaloid, having a mechanism of action similar to the other vinca derivatives. It arrests cell division in metaphase through inhibition of microtubular formation of the mitotic spindle. The drug is cell-cycle specific for the S phase.

Pharmacodynamics/Kinetics:

Distribution: Vd: 8 L/kg; minimal distribution to adipose tissue or CNS

Metabolism: Hepatic

Half-life elimination:

Triphasic; Alpha: 2 minutes; Beta: 1 hour

Terminal: 24 hours

Excretion: Feces; urine (~3% to 25% of dose as unchanged drug)

Dosage:

Refer to individual protocols. I.V.: Adults:

3-4 mg/m² /week or

1-2 mg/m² days 1 and 2 every 2 weeks or

1-2 mg/m² days 1-5 (continuous infusion) every 2-4 weeks or

1-2 mg/m² days 1-5 every 3-4 weeks

Dosage adjustment in hepatic impairment: Dosage reductions of 50% to 75% have been suggested for "severe" hepatic dysfunction; however, specific guidelines have not been published.

Administration:

Usually administered as a rapid I.V. push (2-3 minutes) or short (15- to 20-minute) infusion; 24-hour continuous infusions are occasionally used

Patient Education:

Hair loss is common but usually reversible. Report any loss of sensation or tingling in hands or feet, constipation, fever, sore throat, bruising, or bleeding.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Loss of taste and facial paralysis.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Oncology: Vesicant:

Yes; see Management of Drug Extravasations.

Dosage Forms:

Injection, powder for reconstitution: 5 mg

International Brand Names:

Eldisine® (AU, BE, CH, DE, FI, FR, GB, HK, IT, LU, NL, RO, SE); Enison® (ES); Fildesin® (JP)

References

Dancey J and Steward WP, "The Role of Vindesine in Oncology - Recommendations After 10 Years' Experience,"Anticancer Drugs, 1995, 6(5):625-36.

Joel S, "The Comparative Clinical Pharmacology of Vincristine and Vindesine: Does Vindesine Offer Any Advantage in Clinical Use?"Cancer Treat Rev, 1996, 21(6):513-25.

Rhomberg W, Eiter H, Soltesz E, et al, "Long-Term Application of Vindesine: Toxicity and Tolerance,"J Cancer Res Clin Oncol, 1990, 116(6):651-3.

Sorenson JB and Hansen HH, "Is There a Role for Vindesine in the Treatment of Nonsmall Cell Lung Cancer?"Invest New Drugs, 1993, 11(2-3):103-33.

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