Vindesine: Uses, Dosage, Side Effects and More

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

Intravenous
Blastic phase chronic myeloid leukaemia

Adult: As monotherapy or in combination with other chemotherapeutic agents: Initially, 3 mg/m². Dose may be increased in increments of 0.5 mg/m² at weekly intervals if granulocyte count is ≥1,500 cells/mm³, platelet count is ≥100,000 cells/mm³, and no acute abdominal pain occurs. Avoid sustained granulocyte count of <2,500 cells/mm³. Doses may be given via IV infusion over 5-10 minutes or inj over 1-3 minutes into a freely running infusion. Usual weekly dose: 3-4 mg/m². Max weekly dose: 4 mg/m².

Intravenous
Advanced breast cancer

Adult: For cases unresponsive to appropriate endocrine surgery and/or hormonal treatment: As monotherapy or in combination with other chemotherapeutic agents: Initially, 3 mg/m². Dose may be increased in increments of 0.5 mg/m² at weekly intervals if granulocyte count is ≥1,500 cells/mm³, platelet count is ≥100,000 cells/mm³, and no acute abdominal pain occurs. Avoid sustained granulocyte count of <2,500 cells/mm³. Doses may be given via IV infusion over 5-10 minutes or inj over 1-3 minutes into a freely running infusion. Usual weekly dose: 3-4 mg/m². Max weekly dose: 4 mg/m².

Intravenous
Malignant melanoma

Adult: For cases unresponsive to other forms of treatment: As monotherapy or in combination with other chemotherapeutic agents: Initially, 3 mg/m². Dose may be increased in increments of 0.5 mg/m² at weekly intervals if granulocyte count is ≥1,500 cells/mm³, platelet count is ≥100,000 cells/mm³, and no acute abdominal pain occurs. Avoid sustained granulocyte count of <2,500 cells/mm³. Doses may be given via IV infusion over 5-10 minutes or inj over 1-3 minutes into a freely running infusion. Usual weekly dose: 3-4 mg/m². Max weekly dose: 4 mg/m².

Intravenous
Acute lymphoblastic leukaemia

Child: For cases resistant to other drugs: As monotherapy or in combination with other chemotherapeutic agents: Initially, 4 mg/m². Dose may be increased in increments of 0.5 mg/m² at weekly intervals if granulocyte count is ≥1,500 cells/mm³, platelet count is ≥100,000 cells/mm³, and no acute abdominal pain occurs. Avoid sustained granulocyte count of <2,500 cells/mm³. Doses may be given via IV infusion over 5-10 minutes or inj over 1-3 minutes into a freely running infusion. Usual weekly dose: 4-5 mg/m².

Hepatic Impairment

Significant hepatic or biliary impairment: Dose reduction may be needed.

Reconstitution

Reconstitute a 5 mg vial with 5 mL of NaCl 0.9% solution to prepare a concentration of 1 mg/mL; use NaCl 0.9% preserved with 2% benzyl alcohol to reconstitute the vial if it will be stored for >24 hours. For IV infusion, may further dilute the reconstituted solution in a 25-50 mL NaCl 0.9% or dextrose 5% in water infusion bag.

Contraindications

Demyelinating form of Charcot-Marie-Tooth syndrome; severe granulocytopenia (<1,500 cells/mm³), severe thrombocytopenia; severe bacterial infection. Administration via intrathecal route.

Special Precautions

Patient with pre-existing neuromuscular disease. If given in conjunction with radiation therapy through portals that include the liver, delay vindesine until after completion of the radiation therapy. Consider prophylactic measures to prevent obstipation due to decreased bowel motility. Avoid extravasation or contamination of the eyes. Children. Hepatic impairment. Pregnancy and lactation.

Adverse Reactions

Significant: Bone marrow suppression (e.g. granulocytopenia, thrombocytopenia); neurotoxicity (e.g. headache, jaw pain, foot drop, paraesthesia, loss of deep tendon reflex, convulsion); gastrointestinal effects (e.g. nausea, vomiting, constipation, stomatitis, diarrhoea, abdominal pain, paralytic ileus); acute shortness of breath and severe bronchospasm (particularly in combination with mitomycin); inj site reactions, including significant irritation, phlebitis or cellulitis (if extravasation occurs).
Blood and lymphatic system disorders: Mild anaemia, thrombocytosis.
Ear and labyrinth disorders: Hearing impairment (e.g. deafness), vertigo.
Gastrointestinal disorders: Dyspepsia, dysphagia, localised vesiculation of the mouth.
General disorders and administration site conditions: Malaise, chills, fever, asthenia.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Musculoskeletal pain.
Psychiatric disorders: Depression.
Skin and subcutaneous tissue disorders: Alopecia, maculopapular rash.

Patient Counseling Information

Women of childbearing potential and men with female partners of childbearing potential must use proven birth control methods during therapy.

Monitoring Parameters

Monitor CBC with differential (before each dose) and LFTs. Hepatitis B virus screening with HBsAg, hepatitis B core antibody, total Ig or IgG, and antibody to HBsAg is recommended before or at the beginning of systemic chemotherapy. Closely monitor the infusion site. Assess for signs and symptoms of infection (especially if granulocytes are <1,000 cells/mm³), neurotoxicity, pulmonary toxicity, and gastrointestinal effects (particularly constipation and acute abdominal pain).

Drug Interactions

Additive neurotoxicity when given with other agents that have neurotoxic potential. Increased risk of acute shortness of breath and severe bronchospasm with mitomycin. May decrease the serum concentrations of phenytoin leading to increased seizure activity. May result in earlier onset or increased adverse effect severity with CYP3A inhibitors.

Action

Description:
Mechanism of Action: Vindesine, a semisynthetic vinca alkaloid derived from vinblastine, is an antineoplastic agent. It binds to tubulin which results in the disruption of mitotic spindle formation and the arrest of the cell cycle at metaphase.
Pharmacokinetics:
Distribution: Rapidly distributed to body tissues.
Metabolism: Metabolised mainly in the liver.
Excretion: Via faeces and urine. Terminal elimination half-life: Approx 20 hours.

Chemical Structure

Storage

Intact vial: Store between 2-8°C. Solution reconstituted using preservative-free NaCl 0.9%: May store under refrigeration for up to 24 hours. Solution reconstituted using NaCl 0.9% with 2% benzyl alcohol: May store under refrigeration for up to 28 days. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.

MIMS Class

Cytotoxic Chemotherapy

ATC Classification

L01CA03 - vindesine ; Belongs to the class of plant alkaloids and other natural products, vinca alkaloids and analogues. Used in the treatment of cancer.

References

Brayfield A, Cadart C (eds). Vindesine Sulfate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/12/2024.

Eldisine Powder for Solution for Injection 5 mg (Genus Pharmaceuticals Limited). MHRA. https://products.mhra.gov.uk. Accessed 11/12/2024.

Joint Formulary Committee. Vindesine Sulfate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/12/2024.

Vindesine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 11/12/2024.

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