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Basic Drug Info
Drug Name:Vinblastine Sulfate
Manufacturer:Bedford Laboratories
Other Info:Manufactured by:                                                                                  Manufactured for: Ben Venue Laboratories                                                                        Bedford Laboratories™ Bedford, OH 44146                                                                              Bedford, Ohio 44146 December 2001                                                                                    VIN-P02



Clinical Trials:


Indications and Usage

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.
Malignant Neoplasms -- A term for diseases in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread through the bloodstream and lymphatic system to other parts of the body.

Hodgkins Disease -- A malignant disease characterized by progressive enlargement of the lymph nodes, spleen, and general lymphoid tissue. In the classical variant, giant usually multinucleate Hodgkin's and REED-STERNBERG CELLS are present; in the nodular lymphocyte predominant variant, lymphocytic and histiocytic cells are seen.

Small Cell Lymphoma --

Small Lymphocytic Lymphoma -- A non-Hodgkin lymphoma composed of monomorphic small, round B-lymphocytes in the lymph nodes. When the lymphoid process predominantly involves the bone marrow and the peripheral blood it is called chronic lymphocytic leukemia. (WHO, 2001)

Carcinoma -- A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)

Choriocarcinoma -- A malignant metastatic form of trophoblastic tumors. Unlike the HYDATIDIFORM MOLE, choriocarcinoma contains no CHORIONIC VILLI but rather sheets of undifferentiated cytotrophoblasts and syncytiotrophoblasts (TROPHOBLASTS). It is characterized by the large amounts of CHORIONIC GONADOTROPIN produced. Tissue origins can be determined by DNA analyses: placental (fetal) origin or non-placental origin (CHORIOCARCINOMA, NON-GESTATIONAL).

Primary malignant neoplasm --

Contraindications

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.
Agranulocytosis -- A decrease in the number of GRANULOCYTES; (BASOPHILS; EOSINOPHILS; and NEUTROPHILS).

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Bacterial Infections -- Infections by bacteria, general or unspecified.

Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Warnings

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.
Branded Drugs
The following US Branded drugs contain Vinblastine Sulfate


VELBAN -- ELI LILLY AND CO


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