|Drug Name:||Vinblastine Sulfate|
|Other Info:||Manufactured by: Manufactured for: Ben Venue Laboratories Bedford Laboratories™ Bedford, OH 44146 Bedford, Ohio 44146 December 2001 VIN-P02|
Vinblastine sulfate is indicated in the palliative treatment of the following: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)Less Frequently Responsive Malignancies: Choriocarcinoma resistant to other chemotherapeutic agents Carcinoma of the breast, unresponsive to appropriate endocrine surgery and hormonal therapyCurrent 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 sulfate 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.
Vinblastine sulfate is contraindicated in patients who have significant granulocytopenia unless this is a result of the disease being treated.
It should not be used in the presence of bacterial infections.Such infections must be brought under control prior to the initiation of therapy with vinblastine sulfate.
This product is for intravenous use only.
It should be administered by individuals experienced in the administration of vinblastine sulfate.
The intrathecal administration of vinblastine sulfate usually results in death.
Syringes containing this product should be labeled, using the auxiliary sticker provided to state ‘‘FATAL IF GIVEN INTRATHECALLY.
FOR INTRAVENOUS USE ONLY.”Extemporaneously prepared syringes containing this product must be packaged in an overwrap which is labeled “DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION.
FATAL IF GIVEN INTRATHECALLY.
FOR INTRAVENOUS USE ONLY.”After inadvertent intrathecal administration of vinca alkaloids, immediate neurosurgical intervention is required in order to prevent ascending paralysis leading to death.
In a vey 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 sulfate to base treatment on.
However, based on the published management of survival cases involving the related vinca alkaloid vincristine sulfate, if vinblastine sulfate is mistakenly given by the intrathecal route, the following treatment should be initiated immediately after the injection:Remove as much CSF as is safely possible through the lumbar access.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.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/hour, or a rate of 75 mL/hour 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.The following measures have also been used in addition but may not be essential:Glutamic acid, 10 grams, has been given intravenously over 24 hours, followed by 500 mg three times daily by mouth for 1 month.
Folinic acid has been administered intravenously as a 100 mg bolus and then infused at a rate of 25 mg/hour for 24 hours, then bolus doses of 25 mg every 6 hours for 1 week.
Pyridoxine has been given at a dose of 50 mg every 8 hours by intravenous infusion over 30 minutes.Their roles in the reduction of neurotoxicity are unclear.