Version May 2024
Note: Patients should be on a prophylactic bowel regimen to prevent obstipation.
Adult T-cell leukemia/lymphoma (off-label use): IV: 2.4 mg/m2 on day 15 (as part of the VCAP-AMP-VECP multi-agent chemotherapy regimen) (Tsukasaki 2007).
Breast cancer, advanced: IV: Initial: 3 mg/m2; if no toxicity and granulocyte count is acceptable (avoid sustained granulocyte counts <2,500/mm3), may increase dose in 0.5 mg/m2 increments at weekly intervals (do not increase dose if granulocyte count <1,500/mm3, platelet count <100,000/mm3, or if acute abdominal pain is present). Usual range: 3 to 4 mg/m2; maximum dose/week: 4 mg/m2.
Chronic myeloid leukemia (blast crisis): IV: Initial: 3 mg/m2; if no toxicity and granulocyte count is acceptable (avoid sustained granulocyte counts <2,500/mm3), may increase dose in 0.5 mg/m2 increments at weekly intervals (do not increase dose if granulocyte count <1,500/mm3, platelet count <100,000/mm3, or if acute abdominal pain is present). Usual range: 3 to 4 mg/m2; maximum dose/week: 4 mg/m2.
Melanoma, malignant, unresponsive: IV: Initial: 3 mg/m2; if no toxicity and granulocyte count is acceptable (avoid sustained granulocyte counts <2,500/mm3), may increase dose in 0.5 mg/m2 increments at weekly intervals (do not increase dose if granulocyte count <1,500/mm3, platelet count <100,000/mm3, or if acute abdominal pain is present). Usual range: 3 to 4 mg/m2; maximum dose/week: 4 mg/m2.
Non-Hodgkin lymphoma, diffuse large B-cell (off-label use):
≤59 years of age: IV: 2 mg/m2 on days 1 and 5 every 2 weeks (in combination with doxorubicin, cyclophosphamide, bleomycin, prednisone, and rituximab [R-ACVBP regimen]) for 4 cycles (with growth factor support), followed by sequential consolidation therapy (Molina 2014; Recher 2011).
<61 years of age: IV: 2 mg/m2 on days 1 and 5 every 2 weeks (in combination with doxorubicin, cyclophosphamide, bleomycin, and prednisone [ACVBP regimen]) for 3 cycles, followed by sequential consolidation therapy (Reyes 2005).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
Dosage reductions may be necessary for significant hepatic or biliary impairment, however the manufacturer’s labeling does not provide specific adjustment recommendations.
American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2 : Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (ASCO [Griggs 2021]).
Gastrointestinal toxicity (acute abdominal pain): Withhold dose. After treatment is resumed, do not increase dose above the dose where acute abdominal pain occurred.
Neurotoxicity: May require dose reduction or temporary discontinuation.
Pulmonary toxicity (progressive dyspnea requiring chronic therapy): Permanently discontinue.
Refer to adult dosing.
Acute lymphoblastic leukemia, resistant: Pediatric: IV: Initial: 4 mg/m2; if no toxicity and granulocyte count is acceptable (avoid sustained granulocyte counts <2,500/mm3), may increase dose in 0.5 mg/m2 increments at weekly intervals (do not increase dose if granulocyte count <1,500/mm3, platelet count <100,000/mm3, or if acute abdominal pain is present). Usual range: 4 to 5 mg/m2.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing adjustment for toxicity: Pediatric:
Gastrointestinal toxicity (acute abdominal pain): Withhold dose. After treatment is resumed, do not increase dose above the dose where acute abdominal pain occurred.
Neurotoxicity: May require dose reduction or temporary discontinuation.
Pulmonary toxicity (progressive dyspnea requiring chronic therapy): Permanently discontinue.
There are no dosage adjustments provided in the manufacturer’s labeling.
Dosage reductions may be necessary for significant hepatic or biliary impairment, however the manufacturer’s labeling does not provide specific adjustment recommendations.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Central nervous system: Chills, convulsions, decreased deep tendon reflex, depression, headache, malaise, neurotoxicity, peripheral neuritis, tingling sensation of hands or feet
Dermatologic: Alopecia, cellulitis (with extravasation), localized vesiculation mouth, maculopapular rash
Gastrointestinal: Abdominal pain, anorexia, constipation, diarrhea, dyspepsia, dysphagia, intestinal obstruction, nausea, paralytic ileus, perforated duodenal ulcer, stomatitis, vomiting
Hematologic & oncologic: Granulocytopenia (nadir: 3 to 5 days; recovery: 7 to 10 days), mild anemia, thrombocythemia, thrombocytopenia
Local: Injection site reaction
Neuromuscular & skeletal: Foot-drop, jaw pain, musculoskeletal pain, weakness
Respiratory: Bronchospasm, dyspnea
Miscellaneous: Fever
Hypersensitivity to vindesine sulphate or any component of the formulation; intrathecal administration (fatal); demyelinating form of Charcot-Marie-Tooth syndrome; severe granulocytopenia (<1,500/mm3) or severe thrombocytopenia; severe bacterial infection.
Concerns related to adverse effects:
• Bone marrow suppression: Granulocytopenia is the dose-limiting toxicity; the nadir is generally 3 to 5 days after administration and recovery is rapid and usually complete within 7 to 10 days after the vindesine dose. Thrombocytopenia may occur if administered more frequently than once weekly, although platelets are usually unaffected or may increase when vindesine is administered weekly; thrombocytopenia is more likely when platelets are already low prior to treatment. Mild anemia may occur (rare).
• Extravasation: Vindesine is a vesicant; ensure proper needle or catheter placement prior to and during infusion. Avoid extravasation. Extravasation may cause significant irritation.
• Gastrointestinal effects: Nausea, vomiting, constipation, ileus, stomatitis, diarrhea, and/or abdominal pain may occur. Vindesine may cause acute abdominal pain; paralytic ileus may be a risk if further doses are administered. Patients should be on a prophylactic bowel regimen to prevent obstipation.
• Neurotoxicity: Neurotoxicity (eg, paresthesias, jaw pain, loss of deep tendon reflexes, foot drop, headache, convulsions) may occur; may require dose reduction. Use with caution in patients with preexisting neuromuscular disease; neurotoxicity may be additive. Neurotoxicity associated with vindesine may typically be less severe/progressive than that seen with other vinca alkaloids.
• Respiratory effects: Acute shortness of breath and severe bronchospasm have been reported with vinca alkaloids, usually when used in combination with mitomycin (may be severe in patients with preexisting pulmonary toxicity). Onset may be several minutes to hours after vinca administration and up to 2 weeks after mitomycin. Progressive dyspnea may occur.
Special handling:
• Hazardous agent: Avoid eye contamination; severe irritation or corneal ulceration may occur. If eye exposure occurs, wash eye immediately and thoroughly with water or saline.
Other warnings/precautions:
• For IV use only: For IV use only. Administration by other routes may be fatal. To prevent administration errors, the World Health Organization strongly recommends dispensing vinca alkaloids diluted in a minibag (WHO 2007), if not dispensed in a minibag, affix an auxiliary label stating “For intravenous use only - fatal if given by other routes” and also place in an overwrap labeled “Do not remove covering until moment of injection.” Vindesine should be administered by individuals experienced in administering vinca alkaloids. Vinca alkaloids should NOT be prepared during the preparation of any intrathecal medications. After preparation, keep vindesine in a location away from the separate storage location recommended for intrathecal medications. Vindesine should NOT be delivered to the patient at the same time with any medications intended for central nervous system administration (ASCO/ONS [Neuss 2016]).
• Radiation therapy recipients: If radiation therapy is through portals that include the liver, delay vindesine until after completion of radiation therapy.
Not available in the US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Injection, as sulphate: Eldisine: 5 mg [contains mannitol]
No
IV: For IV administration only. Fatal if given by other routes.
The World Health Organization strongly recommends dispensing vinca alkaloids in a minibag (NOT in a syringe). Vindesine should NOT be delivered to the patient at the same time with any medications intended for CNS administration.
Administer IV over 1 to 3 minutes into a free-flowing IV line. The preferred vinca alkaloid administration is as a short 5- to 10-minute infusion in a 25 to 50 mL minibag (ISMP 2020).
Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.
Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); initiate hyaluronidase antidote; remove needle/cannula; apply dry warm compresses for 20 minutes 4 times a day for 1 to 2 days; elevate extremity (ESMO/EONS [Perez Fidalgo 2012]). Remaining portion of the vindesine dose should be infused through a separate vein.
Hyaluronidase: If needle/cannula still in place, administer 1 to 6 mL hyaluronidase (150 units/mL) into the existing IV line; the usual dose is 1 mL hyaluronidase for each 1 mL of extravasated drug (ESMO/EONS [Perez Fidalgo 2012]; Schulmeister 2011). If needle/cannula was removed, inject 1 to 6 mL (150 units/mL) SubQ in a clockwise manner using 1 mL for each 1 mL of drug extravasated (Schulmeister 2011) or administer 1 mL (150 units/mL) as 5 separate 0.2 mL injections (using a 25-gauge needle) SubQ into the extravasation site (Polovich 2009).
IV: For IV administration only. Fatal if given by other routes.
The World Health Organization strongly recommends dispensing vinca alkaloids in a minibag (NOT in a syringe). Vindesine should NOT be delivered to the patient at the same time with any medications intended for central nervous system administration.
Administer IV over 1 to 3 minutes into a free-flowing IV line. The preferred vinca alkaloid administration is as a short 5- to 10-minute infusion in a 25 to 50 mL minibag (ISMP 2020).
Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation. If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); initiate hyaluronidase (see Management of Drug Extravasations for more details); remove needle/cannula; apply dry warm compresses for 20 minutes 4 times a day for 1 to 2 days; elevate extremity (ESMO/EONS [Perez Fidalgo 2012]). Remaining portion of the vindesine dose should be infused through a separate vein.
This medication is not on the NIOSH (2016) list; however, it may meet the criteria for a hazardous drug. Vindesine is a cytotoxic drug (per product labeling).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016).
Note: Not approved in the US and/or Canada.
Acute lymphoblastic leukemia, resistant: Treatment of resistant childhood acute lymphoblastic leukemia.
Breast cancer, advanced: Treatment of advanced breast cancer unresponsive to appropriate endocrine surgery and/or hormonal therapy (if indicated).
Chronic myeloid leukemia: Treatment of blast crisis of chronic myeloid leukemia.
Melanoma, malignant: Treatment of unresponsive malignant melanoma.
Adult T-cell leukemia/lymphoma; Non-Hodgkin lymphoma (diffuse large B-cell)
Vindesine may be confused with vinblastine, vincristine, vinorelbine.
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
For IV use only. Fatal if administered by other routes. To prevent fatal inadvertent intrathecal injection, it is recommended by the World Health Organization (WHO) that vinca alkaloid doses be dispensed in a small minibag.
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Vindesine. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Vindesine. Risk C: Monitor therapy
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification
Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification
MitoMYcin (Systemic): Antineoplastic Agents (Vinca Alkaloids) may enhance the adverse/toxic effect of MitoMYcin (Systemic). Specifically, the risk of pulmonary toxicity may be increased. Risk C: Monitor therapy
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider therapy modification
Phenytoin: Vindesine may decrease the serum concentration of Phenytoin. Risk C: Monitor therapy
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification
Patients who could become pregnant and patients with partners who could become pregnant should use effective contraception during vindesine treatment.
Based on data from animal reproduction studies, in utero exposure to vindesine may cause fetal harm.
Use during breastfeeding is not recommended.
CBC with differential, LFTs. Monitor infusion site. Monitor for signs/symptoms of infection (particularly if granulocytes are <1,000/mm3), neurotoxicity, pulmonary toxicity, and/or for constipation (including acute abdominal pain).
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Vindesine is a semisynthetic vinca alkaloid derived from vinblastine; it binds to and stabilizes tubulin, thus disrupting the formation of the mitotic spindle and arresting the cell cycle at metaphase.
Metabolism: Primarily hepatic.
Excretion: Feces; urine.
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