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Vindesine Drug Information Provided by Lexi-Comp

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Pronunciation

(VIN de seen)

Generic Available (U.S.)

No

Index Terms

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

Prescribing and Access Restrictions

Investigational agent in the U.S.

Pharmacologic Category

  • Antineoplastic Agent, Vinca Alkaloid

Use: Unlabeled

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

Special handling:

• Hazardous agent: Use appropriate precautions for handling and disposal.

Disease-related concerns:

• Hepatic impairment: Use with caution (if at all) in patients with hepatic impairment.

• Neurologic impairment: Use with caution (if at all) in patients with neurologic problems.

Other warnings/precautions:

• Cross-resistance: Vindesine has been reported to be cross-resistance with vincristine.

• Not for intrathecal administration: Intrathecal administration may be fatal.

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: Paresthesia (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

Storage

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.

Reconstitution

The powder is reconstituted to a concentration of 1 mg/mL.

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: I.V.

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

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

Mental Health: Effects on Mental Status

Malaise is common

Mental Health: Effects on Psychiatric Treatment

Hematological side effects are common; use caution with clozapine, carbamazepine, and valproic acid.

Mental Health: Comment

Paresthesias are common.

Oncology: Vesicant

Vesicant

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, powder for reconstitution: 5 mg

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.

International Brand Names

  • Eldisin (AT)
  • Eldisine (AR, AU, BE, CH, DE, FI, FR, GB, IT, LU, NL, SE, ZA)
  • Enisan (ES)
  • Fildesin (JP)
  • Gesidine (PT)
  • XI AI KE (CL)

Lexi-Comp.com

Last full review/revision February 2012

Content last modified February 2012

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