Clinical medicine profile
Vincristine
Therapeutic agent (verify pharmacological class)
- Route
- INTRAVENOUS
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
WARNINGS 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. WARNINGS 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.
Contraindications
- CONTRAINDICATIONS 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 .
Precautions
- WARNINGS 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.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
DOSAGE AND ADMINISTRATION 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. Preparation for flexible plastic container Vincristine Sulfate Injection when diluted with 0.9% Sodium Chloride Injection in concentrations from 0.0015 mg/mL to 0.08 mg/mL is stable for up to 24 hours when protected from light or 8 hours under normal light at 25°C. Caution: 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 will help disperse the drug and may minimize discomfort and the possibility of cellulitis. Vincristine Sulfate Injection must be administered via an intact, free–flowing intravenous needle or catheter. Care should be taken that there is no leakage or swelling occurring during administration (see boxed WARNINGS ). The diluted Vincristine Sulfate Injection may be infused via a flexible plastic container directly into an intravenous catheter/needle or into a running intravenous infusion (see Drug Interactions below). Patients Receiving Radiation Therapy Vincristine Sulfate Injection should not be given to patients while they are receiving radiation therapy through ports that include the liver. When Vincristine Sulfate Injection is used in combination with L–asparaginase, Vincristine Sulfate Injection should be given 12 to 24 hours before administration of the enzyme in order to minimize toxicity; administering L–asparaginase before Vincristine Sulfate Injection may reduce hepatic clearance of vincristine. Drug Interactions Vincristine Sulfate Injection should not be diluted in solutions that raise or lower the pH outside the range of 3.5 to 5.5. It should not be mixed with anything other than 0.9% Sodium Chloride Injection USP. Whenever solution and container permit, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Handling and Disposal Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 1 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
Pediatric Use See DOSAGE AND ADMINISTRATION section.
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Use, effects & interactions
Indications
- INDICATIONS AND USAGE 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.
Adverse effects
- ADVERSE REACTIONS 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.
Drug interactions
Open multi-drug checker ↗- ///A vinca alkaloid isolated from Cantharanthus roseus.
- ///Drug interactions: It may raise the concentration of blood uric acid hence interacts with allopurinol, colchicine, probenecid and sulfinpyrazone.
Mechanism & disposition
of vincristine sulfate has been related to the inhibition of microtubule formation in mitotic spindle, resulting in an arrest of dividing cells at the metaphase stage.
Read complete mechanism
of vincristine sulfate has been related to the inhibition of microtubule formation in mitotic spindle, resulting in an arrest of dividing cells at the metaphase stage. Central nervous system leukemia has been reported in patients undergoing otherwise successful therapy with vincristine sulfate. This suggests that vincristine does not penetrate well into the cerebrospinal fluid. Pharmacokinetic studies in patients with cancer have shown a triphasic serum decay pattern following rapid intravenous injection. The initial, middle and terminal half–lives are 5 minutes,
Product-specific
Product-specific
INTRAVENOUS
of vinca alkaloids has been shown to be mediated by hepatic cytochrome P450 isoenzymes in the CYP 3A subfamily. This metabolic pathway may be impaired in patients with hepatic dysfunction or who are taking concomitant potent inhibitors of these isoenzymes (see PRECAUTIONS ). Abou...
Pregnancy, lactation & diet
Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist.
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions due to vincristine sulfate in nursing infants, a decision should be made either to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Brands & loaded prices
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Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.