Uniblastin 10mg Injection

Vinblastine Injection is indicated in the palliative treatment of the following: I. Frequently Responsive Malignancies - Generalized Hodgkin’s disease (Stages III and IV, Ann Arbor modification of Rye staging system) - Lymphocytic lymphoma (nodular and diffuse, poorly and well differentiated) - Histiocytic lymphoma - Mycosis fungoides (advanced stages) - Advanced carcinoma of the testis - Kaposi’s sarcoma - Letterer-Siwe disease (histiocytosis X) II. Less Frequently Responsive Malignancies - Choriocarcinoma resistant to other chemotherapeutic agents - Carcinoma of the breast, unresponsive to appropriate endocrine surgery and hormonal therapy Current principles of chemotherapy for many types of cancer include the concurrent administration of several antineoplastic agents. For enhanced therapeutic effect without additive toxicity, agents with different dose-limiting clinical toxicities and different mechanisms of action are generally selected. Therefore, although Vinblastine is effective as a single agent in the aforementioned indications, it is usually administered in combination with other antineoplastic drugs. Such combination therapy produces a greater percentage of response than does a single-agent regimen. These principles have been applied, for example, in the chemotherapy of Hodgkin’s disease. Hodgkin's Disease Vinblastine has been shown to be one of the most effective single agents for the treatment of Hodgkin’s disease. Advanced Hodgkin’s disease has also been successfully treated with several multiple-drug regimens that included Vinblastine. Patients who had relapses after treatment with the MOPP program - mechlorethamine hydrochloride (nitrogen mustard), vincristine sulfate, prednisone and procarbazine - have likewise responded to combination-drug therapy that included Vinblastine. A protocol using cyclophosphamide in place of nitrogen mustard and Vinblastine instead of vincristine sulfate is an alternative therapy for previously untreated patients with advanced Hodgkin’s disease. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Boxed warning. Caution: This preparation should be administered by individuals experienced in the administration of Vinblastine. It is extremely important that the intravenous needle or catheter be properly positioned before any Vinblastine is injected. Leakage into surrounding tissue during intravenous administration of Vinblastine 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 WARNINGS for the treatment of patients given intrathecal Vinblastine injection. This preparation is for intravenous use only. It should be administered by individuals experienced in the administration of Vinblastine. The intrathecal administration of Vinblastine usually results in death. To reduce the potential for fatal medication errors due to incorrect route of administration, Vinblastine injection should be diluted in a flexible plastic container and prominently labeled (as indicated) “FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES.’’ 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. There are no published cases of survival following intrathecal administration of Vinblastine to base treatment on. However, based on the published management of survival cases involving the related vinca alkaloid vincristine sulfate 1-3, if Vinblastine is mistakenly given by the intrathecal route, the following treatment should be initiated immediately after the injection: 1. Removal of as much 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 liter 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. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Prior to the use of the drug, patients should be advised of the possibility of untoward symptoms. In general, the incidence of adverse reactions attending the use of Vinblastine appears to be related to the size of the dose employed. With the exception of epilation, leukopenia and neurologic side effects, adverse reactions generally have not persisted for longer than 24 hours. Neurologic side effects are not common; but when they do occur, they often last for more than 24 hours. Leukopenia, the most common adverse reaction, is usually the dose-limiting factor. The following are manifestations that have been reported as adverse reactions, in decreasing order of frequency. The most common adverse reactions are underlined: Hematologic - Leukopenia (granulocytopenia), anemia, thrombocytopenia (myelosuppression). Dermatologic - Alopecia is common. A single case of light sensitivity associated with this product has been reported. Gastrointestinal - Constipation, anorexia, nausea, vomiting, abdominal pain, ileus, vesiculation of the mouth, pharyngitis, diarrhea, hemorrhagic enterocolitis, bleeding from an old peptic ulcer and rectal bleeding. Neurologic - Numbness of digits (paresthesias), loss of deep tendon reflexes, peripheral neuritis, mental depression, headache, convulsions. 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 is used in combination with other agents known to be ototoxic such as the platinum-containing oncolytics. Cardiovascular - Hypertension —Cardiac effects such as myocardial infarction, angina pectoris and transient abnormalities of ECG related to coronary ischemia have been reported very rarely. Cases of unexpected myocardial infarction and cerebrovascular accidents have occurred in patients undergoing combination chemotherapy with vinblastine, bleomycin and cisplatin. Raynaud’s phenomenon has also been reported with this combination. Pulmonary - See PRECAUTIONS. Miscellaneous - Malaise, bone pain, weakness, pain in tumor-containing tissue, dizziness, jaw pain, skin vesiculation, hypertension, Raynaud’s phenomenon when patients are being treated with Vinblastine in combination with bleomycin and cis-platinum for testicular cancer. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.