DBL Vinblastine Special Precautions

DBL Vinblastine Injection is for intravenous use only. DBL Vinblastine Injection must be used only by physicians experienced in cytotoxic chemotherapy.
After inadvertent intrathecal administration of vinca alkaloids, immediate neurosurgical intervention is required in order to prevent ascending paralysis leading to death. In a very small number of patients, life-threatening paralysis and subsequent death was averted but resulted in devastating neurological sequelae, with limited recovery afterwards.
The following treatment successfully arrested progressive paralysis in a single patient mistakenly given the related vincristine sulfate, intrathecally. This treatment should be initiated immediately: 1. Removal of as much CSF as is safely possible through the lumbar access.
2. Flushing with Lactated Ringer's solution by continuous infusion at 150 mL/h, through a catheter in a cerebral lateral ventricle and removed through lumbar access, until fresh plasma became available.
3. Fresh frozen plasma, 25 mL, diluted with 1 litre of Lactated Ringer's was then infused similarly at 75 mL/h. The rate of infusion should be adjusted to maintain a spinal fluid protein level of 150 mg/dL.
4. Glutamic acid, 10 g, was given IV over 24 hours, followed by 500 mg tds by mouth for 1 month. Glutamic acid may not be essential.
Vinblastine SHOULD NOT BE GIVEN intramuscularly, subcutaneously or intrathecally.
Syringes containing this product should be over labelled with the intrathecal warning label provided - 'FOR INTRAVENOUS USE ONLY. FATAL IF GIVEN BY OTHER ROUTES'.
As with other antineoplastic agents, Vinblastine Injection may cause a severe local reaction on extravasation. If leakage into the surrounding tissue should occur during intravenous administration of DBL Vinblastine Injection, the injection should be discontinued immediately and any remaining portion of the dose should be introduced into another vein. Local injection of hyaluronidase with the application of heat has been used to disperse the medicine in order to minimise discomfort and the possibility of tissue damage. Cases of phlebitis and cellulitis have been reported.
Liver disease may alter the elimination of vinblastine in the bile, markedly increasing toxicity to peripheral nerves and necessitating a dosage modification in affected patients.
The dose-limiting factor is myelosuppression. In general, the larger the dose employed, the more profound and longer lasting the leucopenia will be. The fact that the granulocyte count returns to normal levels after drug-induced leucopenia is an indication that the granulocyte-producing mechanism is not permanently depressed.
Following therapy with vinblastine sulfate, the nadir in the granulocyte count may be expected to occur five to ten days after the last day of drug administration. Recovery of the granulocyte count is fairly rapid thereafter and is usually complete within another seven to fourteen days. If granulocytopenia with less than 1,000 granulocytes/mm³ occurs following a dose of vinblastine sulfate, the patient should be watched carefully for evidence of infection until the granulocyte count has returned to a safe level. Any infection must be brought under control immediately.
Patients should be carefully monitored for infection until white cell count has returned to normal levels if leucopenia with less than 2,000 white blood cells per mm³ occurs following a dose of vinblastine sulfate.
When cachexia or ulcerated areas of the skin surface are present, a more profound granulocytopenic response may be produced by vinblastine. Therefore, its use should be avoided in older persons suffering from either of these conditions.
Although the thrombocyte count is not usually significantly lowered by therapy with DBL Vinblastine Injection, patients whose bone marrow has been recently impaired by prior therapy with radiation or with other oncolytic drugs may show thrombocytopenia (less than 150,000 platelets/mm³). When other chemotherapy or radiation has not been employed previously, thrombocyte reduction below the level of 150,000/mm³ is rarely encountered, even when vinblastine sulfate may be causing significant granulocytopenia. Rapid recovery from thrombocytopenia within a few days is the rule.
The effect of vinblastine sulfate upon the red blood cell count and haemoglobin is usually insignificant when other treatment does not complicate the picture.
In patients with malignant-cell infiltration of the bone marrow, the granulocyte and platelet counts have sometimes fallen drastically after moderate doses of vinblastine sulfate. Further use of the drug in such patients is inadvisable.
Breaks and aberrations were not observed on chromosome analysis of marrow cells from patients treated with DBL Vinblastine Injection although chromosomal changes have been noted in some hamster lung cell in vitro tests.
Granulocytes and platelet counts have sometimes fallen precipitously after moderate doses of vinblastine sulfate in patients with malignant cell infiltration of the bone marrow. Further use of the drug in such patients is inadvisable.
Avoid contamination of the eye with vinblastine sulfate solution for injection. If accidental contamination occurs, severe irritation or corneal ulceration may result. The affected eye should be thoroughly irrigated with water immediately.
DBL Vinblastine Injection contains sodium: DBL Vinblastine Injection contains 35.42 mg sodium in each vial, equivalent to 1.77% of the WHO maximum recommended daily intake (RDI) of 2 g sodium for an adult.
Effects on Ability to Drive and Use Machines: Effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration. However, adverse effects of vinblastine sulfate (with unknown frequency) may include dizziness and motor dysfunction which could affect the ability to drive or use machines (see Adverse Reactions). Patients should refrain from driving or using machines until they know that the medicinal product does not negatively affect these abilities.