Alcavixin Special Precautions

It is extremely important that the intravenous needle be properly positioned before vincristine is injected. Leakage into surrounding tissue during intravenous administration of vincristine may cause considerable irritation. If extravasations occur, 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. Whenever solution and container permit, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Vincristine should be administered cautiously in the following: Patients with liver impairment, renal dysfunction, bone marrow suppression, patients with complicating infection, a history of neuromuscular disease, chickenpox (fatal systemic disorder may occur).
Acute uric acid nephropathy, which may occur after the administration of oncolytic agents, has also been reported with Vincristine. In the presence of leukopenia or a complicating infection, administration of the next dose of vincristine warrants careful consideration.
Vincristine is administered cautiously because infection, manifestation of bleeding tendency, and exacerbation has occurred occasionally.
The children having Hodgkin's disease under the MOPP therapy including vincristine sulfate have been reported to develop gonadal disorder such as irreversible azoospermia, and administration to children and patients under reproductive age should be carried out considering its potential effect on gonad.
Because dose limiting clinical toxicity is manifested as neurotoxicity, clinical evaluation (eg. history, physical examination) is necessary to detect the need for dosage modification. Following administration of vincristine, some individuals may have a fall in the white blood cell count or platelet count, particularly when previous therapy or the disease itself has reduced bone marrow function. Therefore, a complete blood count should be done before administration of each dose. Acute elevation of serum uric acid may also occur during induction of remission in acute leukemia, thus such levels should be determined frequently during the first 3 to 4 weeks of treatment or appropriate measures taken to prevent uric acid nephropathy. The laboratory performing these tests should be consulted for its range of normal values.
Precautions in Administration: This preparation is for intravenous use only. It should be administered by individuals experienced in the administration of vincristine. The intrathecal administration of vincristine usually results in death. Treatment of patients following intrathecal administration of vincristine has included immediate removal of spinal fluid and flushing with Lactated Ringer's, as well as other solutions and has not prevented ascending paralysis and death. In one case, progressive paralysis in an adult was arrested by the following treatment initiated immediately after the intrathecal injection: As much spinal fluid was removed as could be safely done through lumbar access.
The sub-arachnoids space was flushed with Lactated Ringer’s solution infused continuously through a catheter in a cerebral lateral ventricle at the rate of 150 mL/h. The fluid was removed through a lumbar access.
As soon as fresh frozen plasma became available, the fresh frozen plasma, 25 mL, diluted in 1 L of Lactated Ringer's solution was infused through the cerebral ventricular catheter at the rate of 75 mL/h with removal through the lumbar access. The rate of infusion was adjusted to maintain a protein level in the spinal fluid of 150 mL/dL.
Glutamic acid, 10 g, was given intravenously over 24 hours followed by 500 mg 3 times daily by mouth for 1 month or until neurological dysfunction stabilized. The role of glutamic acid in this treatment is not certain and may not be essential.
Leakage into surrounding tissue during intravenous administration of vincristine sulfate may cause necrosis in injection site. Therefore, vincristine sulfate is administered cautiously.
Care must be taken to avoid contamination of the eye with concentrations of vincristine used clinically.
If accidental contamination occurs, severe irritation (or, if the drug was delivered under pressure, even corneal ulceration) may result. The eye should be washed immediately and thoroughly.
Vincristine should never be mixed with any other drug and 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 normal saline or glucose in water. After preparation, vincristine should be administered within a few hours.
Others: Neither in vivo nor in vitro laboratory tests have conclusively demonstrated the mutagenicity of this product. Fertility following treatment with vincristine alone for malignant disease has not been studied in humans. Clinical reports of both male and female patients who received multiple agent chemotherapy that included vincristine indicate that azoospermia and amenorrhea can occur in postpubertal patients.
Recovery occurred many months after completion of chemotherapy in some but not all patients. When the same treatment is administered to prepubertal patients, permanent azoospermia and amenorrhea are much less likely. Patients who received chemotherapy with vincristine in combination with anticancer drugs known to be carcinogenic have developed second malignancies. The contributing role of vincristine in this development has not been determined. No evidence of carcinogenicity was found following intraperitoneal administration of vincristine in rats and mice, although this study was limited.
If central nervous system leukemia is diagnosed, additional agents may be required, because vincristine does not appear to cross the blood brain barrier in adequate amounts.
Chemotherapy combinations which have included vincristine or vinca alkaloid single administration have been reported to cause myocardial infarction and cerebral infarction.
Use in pregnancy & lactation: Vincristine can cause fetal harm when administered to a pregnant woman. When pregnant mice and hamster were given doses of vincristine that caused the resorption of 23% to 85% of fetuses, fetal malformations were produced in those that survived. Five monkeys were given single doses of vincristine 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 can induce teratogenesis as well as embryo death that are nontoxic to the pregnant animal. There are no adequate and well-controlled studies in pregnant woman. 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.
Woman of childbearing potential should be advised to avoid becoming pregnant.
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 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.