Vinblastine Sulfate — Active Pharmaceutical Ingredient

Vinblastine Sulfate is an active pharmaceutical ingredient found in 2 FDA-approved drug products. Forms: Injectable. Routes: Injection.

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Vinblastine Sulfate (2 brand names, 1 dosage form, 1 route)

Available dosage forms: Injectable.

Routes of administration: Injection.

Brand Names

  • VELBAN
  • VINBLASTINE SULFATE

Boxed Warning

Caution: This preparation should be administered by individuals experienced in the administration of vinblastine sulfate. It is extremely important that the intravenous needle or catheter be properly positioned before any vinblastine sulfate is injected. Leakage into surrounding tissue during intravenous administration of vinblastine sulfate 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 sulfate injection.

Indications and Usage

Vinblastine Sulfate 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 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.

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.

Adverse Reactions

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 sulfate 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 sulfate 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 acci

Drug Interactions

The simultaneous oral or intravenous administration of phenytoin and antineoplastic chemotherapy combinations that included vinblastine sulfate has been reported to have reduced blood levels of the anticonvulsant and to have increased seizure activity. Dosage adjustment should be based on serial blood level monitoring. The contribution of vinblastine sulfate to this interaction is not certain. The interaction may result from either reduced absorption of phenytoin or an increase in the rate of its metabolism and elimination. Caution should be exercised in patients concurrently taking drugs known to inhibit drug metabolism by hepatic cytochrome P450 isoenzymes in the CYP 3A subfamily, or in patients with hepatic dysfunction. Concurrent administration of vinblastine sulfate with an inhibitor of this metabolic pathway may cause an earlier onset and/or an increased severity of side effects. Enhanced toxicity has been reported in patients receiving concomitant erythromycin (see ADVERSE REACTIONS ).

⚠ Caution
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