Loading…
VINCRISTINE SULFATE is a brand name for Vincristine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vincristine sulfate is used either alone or in conjunction with other oncolytic drugs for the treatment of: 1. Leukaemias, including acute lymphocytic leukaemia, chronic lymphocytic leukaemia, acute myelogenous leukaemia and blastic crisis of chronic myelogenous leukaemia. 2. Malignant lymphomas, including Hodgkin's…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The following dosage regimens have been used:
Adults: The drug is administered intravenously at weekly intervals. 5 mg/m2 up to a maximum weekly dose of 2 mg. 4 to 2 mg/m2 given on a weekly basis with a maximum weekly dose of 2 mg. 05 mg/kg administered as a weekly intravenous injection.
Elderly:
The normal adult dose is still appropriate in the elderly.
Hepatic Impairment:
Because of the hepatic metabolism and biliary excretion of vincristine sulfate, reduced doses are recommended in patients with obstructive jaundice or other hepatic impairment. Patients with liver disease sufficient to decrease biliary excretion may experience an increase in the severity of side-effects.
4). Method of administration Precautions to be taken before handling or administering the medicinal product. This preparation is for intravenous (IV) use only. It should only be administered by individuals experienced in vincristine administration.
4). 4 for use for the treatment of patients accidentally given intrathecal vincristine sulfate. Vincristine sulfate is administered by intravenous infusion at weekly intervals. Great care should be exercised in calculating and administering the dose, as overdosage may be extremely serious or even fatal.
The calculated dose of the vincristine solution should be administered ONLY through a vein either by intravenous injection or infusion (IV) according to the treatment protocol and under constant supervision for signs of extravasation.
The dose should not be increased beyond the level which produces therapeutic benefit. Individual doses should not exceed 2 mg; and white cell counts should be carried out before and after giving each dose. Intravenous injection Direct injection into the vein may be completed in about one minute.
2). 9%) solution for injection or glucose 50 mg/ml (5%) solution for injection). After administration the vein must be flushed through thoroughly. Care should be taken to avoid extravasation as this may cause local ulceration.
Caution:
If leakage into surrounding tissue should occur during intravenous administration of vincristine sulfate, it may cause considerable irritation. The injection should be discontinued immediately and any remaining portion of the dose should then be introduced into another vein.
In general, adverse reactions are reversible and are related to dosage size and cumulative dosage. The use of small amounts of vincristine daily for long periods is not advised. The most common adverse reaction is alopecia; the most troublesome adverse reactions are neuromuscular in origin.
, less than 7 days). When the dosage is reduced, these reactions may lessen or disappear. They seem to be increased when the calculated amount of medicinal product is given in divided doses. Other adverse reactions, such as alopecia, sensory loss, paraesthesia, difficulty in walking, slapping gait, loss of deep-tendon reflexes and muscle wasting may persist for at least as long as therapy is continued.
Generalised sensorimotor dysfunction may become progressively more severe with continued treatment, but the neuromuscular difficulties may persist for prolonged periods in some patients. Re-growth of hair may occur while maintenance therapy continues.
The reported adverse reactions are listed below by MedDRA system Organ Class and by frequency.
Frequencies are defined as:
Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), and Frequency not known (cannot be estimated from available data). 2) Investigations Weight decrease a.
If thrombocytopenia is present when treatment begins, it may actually improve before the appearance of marrow remission. b. Reported in patients receiving vincristine sulfate as part of a multi-drug chemotherapy regimen. c. There is a high urinary sodium excretion in the presence of hyponatraemia, renal or adrenal disease, hypotension, dehydration, azotaemia and clinical oedema are absent.
With fluid deprivation, improvement occurs in the hyponatraemia and in the renal loss of sodium. d. Often dose limiting. e. Frequently with hypertension. Several instances of convulsions followed by coma have been reported in children. f.
3). Can be fatal if administered intrathecally. It should be administered by physicians experienced in the administration of vincristine sulfate. Vincristine sulfate should not be given by intrathecal, intramuscular or subcutaneous injection.
Syringes containing this product should be labelled ‘VINCRISTINE FOR INTRAVENOUS USE ONLY. FATAL IF GIVEN BY OTHER ROUTES’.
Emergency Treatment of accidental intrathecal administration:
After inadvertent intrathecal administration, 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.
Based on the published management of these survival cases, if vincristine sulfate is mistakenly given by the intrathecal route, the following treatment should be initiated immediately after the injection: 1. Removal of as much cerebrospinal fluid (CSF) as is safely possible through the lumbar access.
2. Insertion of an epidural catheter into the subarachnoid space via the intervertebral space above initial lumbar access and CSF irrigation with lactated Ringer’s solution. Fresh frozen plasma should be requested and, when available, 25 ml should be added to every 1 litre of lactated Ringer’s solution.
3. Insertion of an intraventricular drain or catheter by a neurosurgeon and continuation of CSF irrigation with fluid removal through the lumbar access connected to a closed drainage system. Lactated Ringer’s solution should be given by continuous infusion at 150 ml/h, or at a rate of 75 ml/h when fresh frozen plasma has been added as above.
The rate of infusion should be adjusted to maintain a spinal fluid protein level of 150 mg/dl.
4). 1. Patients with the demyelinating form of Charcot-Marie-Tooth syndrome should not be given vincristine sulfate. 4.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Local injection of hyaluronidase and the application of moderate heat to the area of leakage help to disperse the drug and are thought to minimise discomfort and the possibility of cellulitis. With the vial presentations, do not add extra fluid to the vial prior to removal of the dose.
Withdraw the solution of vincristine sulfate into an accurate dry syringe, measuring the dose carefully. Do not add extra fluid to the vial in an attempt to empty it completely. 4). Because of the narrow range between therapeutic and toxic levels and variations in response, the dosage must always be adjusted to the individual.
6.
Especially affecting the extra-ocular and laryngeal muscles. g. With blindness. h. Partial or total, temporary or permanent. Manifestations also include difficulties with balance, including dizziness, nystagmus and vertigo. Particular caution is warranted when vincristine sulfate is used in combination with other agents known to be ototoxic, such as platinum-based drugs.
i. Reported in association with chemotherapy combinations that included vincristine sulfate when given to patients previously treated with mediastinal radiation. Causality has not been established. j. Constipation may take the form of upper colon impaction and the rectum may be found to be empty on physical examination.
k. Paralytic ileus may occur particularly in young children. The ileus will reverse itself upon temporary discontinuance of vincristine sulfate and with symptomatic care. l. Especially in children. m. Other drugs known to cause urinary retention (particularly in the elderly) should, if possible, be discontinued for the first few days following administration of vincristine sulfate.
Neoplasms benign, malignant and unspecified (including cysts and polyps):
The occurrence of secondary malignancies has been reported rarely in patients treated with vincristine sulfate in association with other anticancer drugs known to be carcinogenic.
Blood and lymphatic system disorders:
Granulocytopenia and neutropenia; vincristine does not appear to have any constant or significant effect upon the platelets or the red blood cells, however, anaemia, haemolytic anaemia and thrombocytopenia have been reported. Clinical consequences of granulocytopenia may be fever, infections and sepsis.
There have been occasional reports of fatal infections during vincristine therapy.
Nervous system disorders:
Frequently, there appears to be a sequence in the development of neuromuscular side effects. Initially, one may encounter only sensory impairment and paraesthesia. With continued treatment, neuritic pain may appear and later, motor difficulties.
No reports have yet been made of any agent that can reverse the […]
The following measures have also been used in addition but may not be essential:
Folinic acid has been administered intravenously as a 100 mg bolus and then infused at a rate of 25 mg/h for 24 hours, then bolus doses of 25 mg 6-hourly for 1 week. Intravenous administration of glutamic acid 10 g over 24 hours, followed by 500 mg three times daily by mouth for one month.
Pyridoxine has been given at a dose of 50 mg 8 hourly by intravenous infusion over 30 minutes. Their roles in the reduction of neurotoxicity are unclear. 2. Interaction with azole antifungals Concomitant administration of azole antifungals with vincristine has been associated with neurotoxicity and other serious adverse reactions, including seizures, peripheral neuropathy, syndrome of inappropriate antidiuretic hormone secretion (SIADH), and paralytic ileus.
5). Haematological Granulocytopenia is less likely following therapy with vincristine sulfate than is the case with other oncolytic agents. It is usually neuromuscular rather than bone marrow toxicity that limits dosage. However, because of the possibility of granulocytopenia, both physician and patient should remain alert for signs of any complicating infection.
If granulocytopenia or a complicating infection is present, then administration of the next dose of vincristine sulfate warrants careful consideration. On occasions, these infections may prove fatal. 2). Urate nephropathy Acute uric acid nephropathy, which may occur after administration of oncolytic agents, has also been reported with vincristine sulfate.
Neurological As vincristine sulfate penetrates the blood-brain barrier poorly, additional agents and routes of administration may be required for central nervous system leukaemias. The neurotoxic effect of vincristine sulfate may be additive with other neurotoxic agents or increased by spinal cord irradiation and neurological disease.
Elderly patients may be more susceptible to the neurotoxic effects of vincristine sulfate. Respiratory Acute shortness of breath and severe bronchospasm have been reported following the administration of vinca alkaloids. 5). Mutagenicity Both in vivo and in vitro laboratory tests have failed to demonstrate conclusively that this product is mutagenic.
Fertility following treatment with vincristine sulfate 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 sulfate indicate that azoospermia and amenorrhoea can occur in post pubertal patients.
Recovery occurred many months after completion of chemotherapy in some but not all patients. When the same treatment is administered to prepubertal patients, it is much less likely to cause permanent azoospermia and amenorrhoea. Secondary malignancies Patients who received vincristine sulfate chemotherapy in combination with anticancer drugs known to be carcinogenic have developed second malignancies.
The contributing role of vincristine sulfate in this development has not been determined. No evidence of carcinogenicity was found following intraperitoneal administration in rats and mice, although this study was limited. Eyes disorders Care should be exercised to avoid accidental contamination of the eyes as vincristine sulfate is highly irritant and can cause corneal ulceration.
The eye should be washed immediately and thoroughly.