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VINBLASTINE SULPHATE is a brand name for Vinblastine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vinblastine sulfate is a cytotoxic drug that arrests cell growth at the metaphase. Its actions are more pronounced on the rapidly dividing cell than on the normal cell. It appears to act, like vincristine, by binding to the microtubular proteins of the mitotic spindle, preventing polymerisation. Information available…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The recommended dose for adults, the elderly and children is 6 mg/m2, usually administered no more frequently than once every seven days. 2 mg/kg administered on each of two consecutive days every three weeks. To minimise the possibility of extravascular spillage, it is suggested that the syringe and needle be rinsed with venous blood before withdrawal.
The dose should not be diluted in large volumes of diluent (ie, 100 to 250 ml) or given intravenously for prolonged periods (ranging from 30 to 60 minutes or more), since this frequently results in irritation of the vein and increases the chance of extravasation.
Because of the enhanced possibility of thrombosis, it is considered inadvisable to inject a solution of vinblastine sulfate into an extremity in which the circulation is impaired, or potentially impaired, by such conditions as compressing or invading neoplasm, phlebitis or varicosity.
Patients with hepatic impairment As vinblastine is excreted principally by the liver, toxicity may be increased when there is hepatic insufficiency and it may be necessary to reduce initial doses in the presence of significantly impaired hepatic or biliary function.
A reduction of 50% in the dose is recommended for patients having a direct serum bilirubin value above 3 mg/100 ml. Patients with renal impairment Since metabolism and excretion are primarily hepatic, no modification is recommended for patients with impaired renal function.
Vinblastine should not be given intramuscularly, subcutaneously or intrathecally. Method of administration The solution may be injected either directly into the vein or into the injection site of a running intravenous infusion. Injection of vinblastine sulfate may be completed in about one minute.
FOR INTRAVENOUS USE ONLY. 4) In case of mistaken administration by intrathecal route, see section
The use of small amounts of vinblastine daily for long periods is not advisable, even though the resulting total dosage may be similar to the recommended dosage. Little or no therapeutic advantage has been demonstrated when such regimens have been used and side-effects are increased.
The incidence of side effects with vinblastine sulfate appears to be dose related and most do not persist longer than 24 hours. Neurological effects are uncommon but can occur and may last longer than 24 hours.
The frequency grouping is defined using the following convention:
Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Infections and infestations Not known Pharyngitis Neoplasms benign, malignant and unspecified (incl.
cysts and polys) Not known Tumour pain Blood and lymphatic system disorders Not known Neutropenia, Leucopeniaa, Thrombocytopenia, Anaemia Endocrine disorders Not known Inappropriate anti-diuretic hormone secretionb Metabolism and nutrition disorders Not known Anorexia Psychiatric disorders: Not known Depression Nervous system disorders Not known Cerebrovascular accidentc Convulsions, Numbness, Neuropathy peripheral, Loss of deep tendon reflexes, Paraesthesia Headache, Dizziness Ear and labyrinth disorders Not known VIIIth nerve injuryd Cardiac disorders Not known Myocardial infarctionc Vascular disorders Not known Hypertension, Raynaud’s phenomenone Respiratory, thoracic and mediastinal disorders Not known Dyspnoeaf, Acute respiratory distressf Gastrointestinal disorders Not known Haemorrhagic enterocolitis, Rectal bleeding, Peptic ulcer haemorrhage, Ileus, Nauseag, Vomitingg, Constipation, Oral mucosal blistering, Diarrhoea, Abdominal pain, Stomatitis Skin and subcutaneous tissue disorders: Not known Blister, Alopeciah Musculosketetal and connective tissue disorders Not known Myalgia, Bone pain, Jaw pain Reproductive system and breast disorders Not known Aspermia General disorders and administration site conditions Not known Injection site phlebitis, Injection site cellulitis (and in extreme cases skin exfoliation), Extravasation, Malaise, Asthenia a Leucopoenia is the most common side effect and dose limiting factor.
4. Syringes containing this product should be overlabelled with the intrathecal warning label provided - 'FOR INTRAVENOUS USE ONLY. FATAL IF GIVEN BY OTHER ROUTES'. 1. For intravenous use only. 4). Vinblastine sulfate is contraindicated in patients who are leucopenic.
Vinblastine sulfate should not be used in the presence of bacterial infection. Such infections should be brought under control with antiseptics or antibiotics before the initiation of therapy with vinblastine sulfate. 4 Special warnings and precautions for use Vinblastine sulfate is for intravenous use only.
6). 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 1litre 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 may cause a severe local reaction on extravasation.
1. For intravenous use only. 4). Vinblastine sulfate is contraindicated in patients who are leucopenic. Vinblastine sulfate should not be used in the presence of bacterial infection. Such infections should be brought under control with antiseptics or antibiotics before the initiation of therapy with vinblastine sulfate.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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b Syndrome of inappropriate ADH secretion has been reported with higher than recommended doses. c In combination chemotherapy with vinblastine sulfate, bleomycin and cisplatin. d Treatment with vinca alkaloids has resulted rarely in both vestibular and auditory damage to the eighth cranial nerve.
Manifestations include partial or total deafness, which may be temporary or permanent, and difficulties with balance including dizziness, nystagmus, and vertigo. Particular caution is warranted when vinblastine sulfate is used in combination with other agents known to be ototoxic, such as the platinum-containing oncolytics.
e Raynaud’s phenomenon has occurred when patients are being treated with vinblastine in combination with bleomycin and cisplatin for testicular cancer. 5). g antiemetics may be used to control nausea and vomiting. h usually not total and in some cases the hair regrows during maintenance therapy).
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
If leakage into the surrounding tissue should occur during intravenous administration of vinblastine sulfate, 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 drug 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 the white cell count has returned to normal levels, if leucopoenia with less than 2000 white blood cells per mm3 occurs following a dose of vinblastine sulfate. When cachexia or ulcerated areas of the skin 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 vinblastine sulfate, 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 hemoglobin 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 vinblastine sulfate 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 […]