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Vinblastine Sulfate

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Vinblastine Sulfate

INDICATIONS

Vinblastine sulfate (vinblastine sulfate injection) 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 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 sulfate (vinblastine sulfate injection) 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 sulfate (vinblastine sulfate injection) 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 sulfate (vinblastine sulfate injection) . 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 sulfate (vinblastine sulfate injection) . A protocol using cyclophosphamide in place of nitrogen mustard and vinblastine sulfate (vinblastine sulfate injection) instead of vincristine sulfate is an alternative therapy for previously untreated patients with advanced Hodgkin's disease.

Advanced testicular germinal-cell cancers (embryonal carcinoma, teratocarcinoma, and choriocarcinoma) are sensitive to vinblastine sulfate (vinblastine sulfate injection) alone, but better clinical results are achieved when vinblastine sulfate (vinblastine sulfate injection) is administered concomitantly with other antineoplastic agents. The effect of bleomycin is significantly enhanced if vinblastine sulfate (vinblastine sulfate injection) is administered 6 to 8 hours prior to the administration of bleomycin; this schedule permits more cells to be arrested during metaphase, the stage of the cell cycle in which bleomycin is active.

DOSAGE AND ADMINISTRATION

This preparation is for intravenous use only (see WARNINGS).

Special Dispensing Information: WHEN DISPENSING VINBLASTINE SULFATE (vinblastine sulfate injection) IN OTHER THAN THE ORIGINAL CONTAINER, IT IS IMPERATIVE THAT IT BE PACKAGED IN THE PROVIDED OVERWRAP WHICH BEARS THE FOLLOWING STATEMENT: “DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION. FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS USE ONLY” (see WARNINGS). A syringe containing a specific dose must be labeled, using the auxiliary sticker provided, to state: “FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS USE ONLY”.

Caution: It is extremely important that the intravenous needle or catheter be properly positioned before any vinblastine sulfate (vinblastine sulfate injection) is injected. Leakage into surrounding tissue during intravenous administration of vinblastine sulfate (vinblastine sulfate injection) 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 minimize discomfort and the possibility of cellulitis.

There are variations in the depth of the leukopenic response which follows therapy with vinblastine sulfate (vinblastine sulfate injection) . For this reason, it is recommended that the drug be given no more frequently than once every 7 days.

Adult patients: It is wise to initiate therapy for adults by administering a single intravenous dose of 3.7 mg/m2 of body surface area (bsa). Thereafter, white-blood-cell counts should be made to determine the patient's sensitivity to vinblastine sulfate (vinblastine sulfate injection) .

A simplified and conservative incremental approach to dosage at weekly intervals for adults may be outlined as follows:

First dose ........................... 3.7 mg/m2 bsa

Second dose ...................... 5.5 mg/m2 bsa

Third dose .......................... 7.4 mg/m2 bsa

Fourth dose ........................ 9.25 mg/m2 bsa

Fifth dose ........................... 11.1 mg/m2 bsa

The above-mentioned increases may be used until a maximum dose not exceeding 18.5 mg/m2 bsa for adults is reached. The dose should not be increased after that dose which reduces the white-cell count to approximately 3000 cells/mm3. In some adults, 3.7 mg/m2 bsa may produce this leukopenia; other adults may require more than 11.1 mg/m2 bsa; and, very rarely, as much as 18.5 mg/m2 bsa may be necessary. For most adult patients, however, the weekly dosage will prove to be 5.5 to 7.4 mg/m2 bsa.

When the dose of vinblastine sulfate (vinblastine sulfate injection) which will produce the above degree of leukopenia has been established, a dose of 1 increment smaller than this should be administered at weekly intervals for maintenance. Thus, the patient is receiving the maximum dose that does not cause leukopenia. It should be emphasized that, even though 7 days have elapsed, the next dose of vinblastine sulfate should not be given until the white-cell count has returned to at least 4000/mm3. In some cases, oncolytic activity may be encountered before leukopenic effect. When this occurs, there is no need to increase the size of the subsequent doses (See PRECAUTIONS).

Pediatric Patients: A review of published literature from 1993 to 1995 showed that initial doses of vinblastine sulfate (vinblastine sulfate injection) in pediatric patients varied depending on the schedule used and whether vinblastine sulfate (vinblastine sulfate injection) was administered as a single agent or incorporated within a particular chemotherapeutic regimen. As a single agent for Letterer-Siwe disease (histiocytosis X), the initial dose of vinblastine sulfate (vinblastine sulfate injection) was reported as 6.5 mg/m2. When vinblastine sulfate was used in combination with other chemotherapeutic agents for the treatment of Hodgkin's disease, the initial dose was reported as 6 mg/m2. For testicular germ cell carcinomas, the initial dose of vinblastine sulfate (vinblastine sulfate injection) was reported as 3 mg/m2 in a combination regimen. Dose modifications should be guided by hematologic tolerance.

Patients with Renal or Hepatic Impairment: A reduction of 50% in the dose of vinblastine sulfate (vinblastine sulfate injection) is recommended for patients having a direct serum bilirubin value above 3 mg/100 mL. Since metabolism and excretion are primarily hepatic, no modification is recommended for patients with impaired renal function.

The duration of maintenance therapy varies according to the disease being treated and the combination of antineoplastic agents being used. There are differences of opinion regarding the duration of maintenance therapy with the same protocol for a particular disease; for example, various durations have been used with the MOPP program in treating Hodgkin's disease. Prolonged chemotherapy for maintaining remissions involves several risks, among which are life-threatening infectious diseases, sterility, and possibly the appearance of other cancers through suppression of immune surveillance.

In some disorders, survival following complete remission may not be as prolonged as that achieved with shorter periods of maintenance therapy. On the other hand, failure to provide maintenance therapy in some patients may lead to unnecessary relapse; complete remissions in patients with testicular cancer, unless maintained for at least 2 years, often result in early relapse.

To prepare a solution containing 1 mg/mL of vinblastine sulfate (vinblastine sulfate injection) , add 10 mL of Bacteriostatic Sodium Chloride Injection (preserved with benzyl alcohol) or 10 mL of Sodium Chloride Injection (unpreserved) to the 10 mg of Vinblastine Sulfate (vinblastine sulfate injection) for Injection in the sterile vial. Do not use other solutions. The drug dissolves instantly to give a clear solution.

Unused portions of the remaining solutions made with normal saline that do not contain preservatives should be discarded immediately. Unused preservative-containing solutions made with normal saline may be stored in a refrigerator for future use for a maximum of 28 days.

The dose of vinblastine sulfate (vinblastine sulfate injection) (calculated to provide the desired amount) may be injected either into the tubing of a running intravenous infusion or directly into a vein. The latter procedure is readily adaptable to outpatient therapy. In either case, the injection may be completed in about 1 minute. If care is taken to insure that the needle is securely within the vein and that no solution containing vinblastine sulfate (vinblastine sulfate injection) is spilled extravascularly, cellulitis and/or phlebitis will not occur. To minimize further the possibility of extravascular spillage, it is suggested that the syringe and needle be rinsed with venous blood before withdrawal of the needle. The dose should not be diluted in large volumes of diluent (i.e., 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 (vinblastine sulfate injection) into an extremity in which the circulation is impaired or potentially impaired by such conditions as compressing or invading neoplasm, phlebitis, or varicosity.

Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published.1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

HOW SUPPLIED

Vinblastine Sulfate for Injection USP (vinblastine sulfate (vinblastine sulfate injection) injection) is supplied in packs of ten individually-boxed vials containing 10 mg lyophilized vinblastine sulfate (vinblastine sulfate injection) .

NDC 55390-091-10.

Store vials in refrigerator, 2° to 8°C (36° to 46°F) to assure extended stability.

REFERENCES

1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.

2. AMA Council Report, Guidelines for Handling Parenteral Antineoplastics. JAMA,1985; 253 (11) :1590-1592.

3. National Study Commission on Cytotoxic Exposure – Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.

4. Clinical Oncological Society of Australia, Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia, 1983; 1:426-428.

5. Jones RB, et al: Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA – A Cancer Journal for Clinicians,1983; (Sept/Oct) 258-263.

6. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J. Hosp Pharm,1990; 47:1033-1049.

7. OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs. Am J. Hosp Pharm, 1986; 43:1193-1204.

Manufactured by: Ben Venue Laboratories Bedford, OH 44146. Manufactured for: Bedford Laboratories Bedford, Ohio 44146. FDA Rev date: 8/22/2002

Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.

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