pharmacopeia

Boxed warning

Caution–This preparation should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. It is extremely important that the intravenous needle or catheter be properly positioned before any vincristine is injected. Leakage into surrounding tissue during intravenous administration of Vincristine Sulfate Injection 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 OVERDOSAGE section for the treatment of patients given intrathecal Vincristine Sulfate Injection.

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Tubulin Interactions.

Indications

Sourced from openFDA
  • Vincristine Sulfate Injection is indicated in acute leukemia. Vincristine Sulfate Injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin's disease, non–Hodgkin's malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms' tumor.ICD-10: C95.90

Contraindications

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  • Patients with the demyelinating form of Charcot–Marie–Tooth syndrome should not be given Vincristine Sulfate Injection. Careful attention should be given to those conditions listed under WARNINGS and PRECAUTIONS .contraindicated

Dosage & administration

Sourced from openFDA

This preparation is for intravenous use only (see WARNINGS ). Neurotoxicity appears to be dose related. Extreme care must be used in calculating and administering the dose of Vincristine Sulfate Injection since overdosage may have a very serious or fatal outcome. The usual dose of Vincristine Sulfate Injection for pediatric patients is 1.5–2 mg/m 2 . For pediatric patients weighing 10 kg or less, the starting dose should be 0.05 mg/kg, administered once a week. The usual dose of Vincristine Sulfate Injection for adults is 1.4 mg/m 2 . A 50% reduction in the dose of Vincristine Sulfate Injection is recommended for patients having a direct serum bilirubin value above 3 mg/100 mL. The drug is administered intravenously at weekly intervals. TO REDUCE THE POTENTIAL FOR FATAL MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION, VINCRISTINE 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 ). The concentration of Vincristine Sulfate Injection is 1 mg/mL. Do not add extra fluid to the vial prior to removal of the dose. Withdraw the solution of Vincristine Sulfate Injection into an accurate dry syringe, measuring the dose carefully. Do not add extra fluid to the vial in an attempt to empty it completely.

Warnings & precautions

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This preparation is for intravenous use only. It should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. The intrathecal administration of Vincristine Sulfate Injection usually results in death. To reduce the potential for fatal medication errors due to incorrect route of administration, Vincristine 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 OVERDOSAGE section for the treatment of patients given intrathecal Vincristine Sulfate Injection. Pregnancy Vincristine sulfate can cause fetal harm when administered to a pregnant woman. When pregnant mice and hamsters were given doses of vincristine sulfate that caused resorption of 23% to 85% of fetuses, fetal malformations were produced in those that survived. Five monkeys were given single doses of vincristine sulfate between days 27 and 34 of their pregnancies; 3 of the fetuses were normal at term, and 2 viable fetuses had grossly evident malformations at term. In several animal species, vincristine sulfate can induce teratogenesis as well as embryo death at doses that are nontoxic to the pregnant animal. There are no adequate and well–controlled studies in pregnant women. If this drug is used during pregnancy or if the patient becomes pregnant while receiving this drug, she should be apprised of the potential hazard to the fetus. Women of child–bearing potential should be advised to avoid becoming pregnant.

Adverse reactions

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Prior to the use of this drug, patients and/or their parents/guardian should be advised of the possibility of untoward symptoms. In general, adverse reactions are reversible and are related to dosage. The most common adverse reaction is hair loss; the most troublesome adverse reactions are neuromuscular in origin. When single, weekly doses of the drug are employed, the adverse reactions of leukopenia, neuritic pain, and constipation occur but are usually of short duration (ie., less than 7 days). When the dosage is reduced, these reactions may lessen or disappear. The severity of such reactions seems to increase when the calculated amount of drug is given in divided doses. Other adverse reactions, such as hair loss, sensory loss, paresthesia, difficulty in walking, slapping gait, loss of deep–tendon reflexes, and muscle wasting, may persist for at least as long as therapy is continued. Generalized sensorimotor dysfunction may become progressively more severe with continued treatment. Although most such symptoms usually disappear by about the sixth week after discontinuance of treatment, some neuromuscular difficulties may persist for prolonged periods in some patients. Regrowth of hair may occur while maintenance therapy continues. The following adverse reactions have been reported: Hepatic veno-occlusive disease has been reported in patients receiving vincristine, particularly in pediatric patients, as part of standard combination chemotherapy regimens. Some of the patients had fatal outcomes; some who survived had undergone liver transplantation.

Use in specific populations

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Usage in Pregnancy See WARNINGS .

Overdosage

Sourced from openFDA

Side effects following the use of Vincristine Sulfate Injection are dose related. In pediatric patients under 13 years of age, death has occurred following doses of vincristine sulfate that were 10 times those recommended for therapy. Severe symptoms may occur in this patient group following dosages of 3 to 4 mg/m 2 . Adults can be expected to experience severe symptoms after single doses of 3 mg/m 2 or more (see ADVERSE REACTIONS ). Therefore, following administration of doses higher than those recommended, patients can be expected to experience exaggerated side effects. Supportive care should include the following: (1) prevention of side effects resulting from the syndrome of inappropriate antidiuretic hormone secretion (preventive treatment would include restriction of fluid intake and perhaps the administration of a diuretic affecting the function of Henle's loop and the distal tubule); (2) administration of anticonvulsants; (3) use of enemas or cathartics to prevent ileus (in some instances, decompression of the gastrointestinal tract may be necessary); (4) monitoring the cardiovascular system; (5) determining daily blood counts for guidance in transfusion requirements.

Approval history

Sourced from openFDA
  • Apr 19, 1988ANDAANDA071484Hospira

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
28,660 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Febrile Neutropenia4,31515%
  2. 2Pyrexia1,8756.5%
  3. 3Neutropenia1,7196.0%
  4. 4Off Label Use1,6905.9%
  5. 5Sepsis1,0853.8%
  6. 6Vomiting1,0123.5%
  7. 7Disease Progression9993.5%
  8. 8Nausea9413.3%
  9. 9Pancytopenia9183.2%
  10. 10Pneumonia9133.2%
  11. 11Hypotension8703.0%
  12. 12Thrombocytopenia8342.9%
  13. 13Death8242.9%
  14. 14Drug Ineffective8242.9%
  15. 15Anaemia8062.8%

Literature

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Recent PubMed references pinned to Vincristine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 1,393 ClinicalTrials.gov registrations naming Vincristine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Vincristine work?
Mechanism-of-action class: Tubulin Interactions.
What is Vincristine used for?
According to FDA labeling, Vincristine carries indications including: Vincristine Sulfate Injection is indicated in acute leukemia. Vincristine Sulfate Injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin's disease, non–Hodgkin's malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms' tumor.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Vincristine?
Vincristine is classified as Vinca alkaloids and analogues, Vinca Alkaloid, Tubulin Interactions, Cellular Growth Phase Arrest, Decreased Mitosis, Increased Cellular Death.
What are the brand names for Vincristine?
Vincristine is marketed under brand names including Marqibo, Vincasar.
What are the contraindications for Vincristine?
Vincristine labeling lists contraindications including: Patients with the demyelinating form of Charcot–Marie–Tooth syndrome should not be given Vincristine Sulfate Injection. Careful attention should be given to those conditions listed under WARNINGS and PRECAUTIONS .. Always consult the full prescribing information and a clinician.
Note. Data for vincristine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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