DBL™ VINBLASTINE INJECTION [SIN07944P]

Product Info

DBL™ VINBLASTINE INJECTION

[SIN07944P]

4.1 Therapeutic indications
Vinblastine is effective as a single agent, but its therapeutic effect is enhanced when used in combination with other antineoplastic drugs.

Vinblastine has been used in the treatment of Hodgkin’s disease (Stages III and IV) in combination therapy [with adriamycin (doxorubicin), bleomycin and dacarbazine as ABVD] and in the treatment of advanced testicular carcinoma (with cisplatin and bleomycin).

Vinblastine has been used in the palliative treatment of lymphocytic lymphoma, histiocytic lymphoma, advanced stages of mycosis fungoides, Kaposi’s sarcoma and Histiocytosis X.

Vinblastine may be used in the treatment of choriocarcinoma resistant to other chemotherapeutic agents; and carcinoma of the breast, unresponsive to appropriate endocrine surgery and hormonal therapy.

One of the most effective single agents for the treatment of Hodgkin’s disease is vinblastine. A protocol substituting cyclophosphamide for nitrogen mustard and vinblastine for vincristine in MOPP [mechlorethamine hydrochloride (nitrogen mustard), vincristine sulfate, prednisone and procarbazine] is an alternative therapy for previously untreated patients with advanced Hodgkin’s disease. Patients suffering relapse have also responded to combination therapy that included vinblastine.

Advanced testicular germ-cell cancers are sensitive to vinblastine alone but the administration of vinblastine concomitantly with other antineoplastic agents, produces better clinical results. Bleomycin effectiveness is enhanced when vinblastine is administered 6 to 8 hours prior to bleomycin administration; this schedule permits more cells to be arrested during metaphase, in which bleomycin is active.

4.2 Dose and method of administration
Dosage
DBL Vinblastine Injection is for intravenous use only. Fatal if given by any other route. Vinblastine should not be given intramuscularly, subcutaneously or intrathecally. In order to avoid the risk of extravasation, it is extremely important that the needle be properly positioned in the vein before the product is infused.

It is recommended that DBL Vinblastine Injection be administered ONCE EVERY 7 DAYS. Therapy is initiated in adults by the administration of a single intravenous dose of 3.7 mg/m² bsa (body surface area). Thereafter white blood cell counts should be made to determine the patient’s sensitivity to vinblastine.

The recommended incremental approach to dosage at WEEKLY INTERVALS is as follows:

Dosage increase may be continued but must not exceed 18.5 mg/m² bsa for adults and 12.5 mg/m² bsa for children. Dosage should not be increased after the dose which reduces white cell count to approximately 3.0 x 10⁹/L (3000/mm³).

For most adult patients the dosage will be 5.5 to 7.4 mg/m² bsa. However, leukopenia can be produced at 3.7 mg/m² bsa; others may require 11.1 mg/m² bsa, and very rarely 18.5 mg/m² bsa.

A maintenance dosage is administered ONCE WEEKLY, one increment smaller than the dosage to produce the above degree of leukopenia. Hence, the patient is receiving the maximum dosage that does not cause leukopenia.

IT SHOULD BE EMPHASIZED THAT, EVEN THOUGH 7 DAYS HAVE ELAPSED, THE NEXT DOSE OF DBL VINBLASTINE INJECTION SHOULD NOT BE GIVEN UNTIL THE WHITE CELL COUNT HAS RETURNED TO AT LEAST 4.0 x 10⁹/L (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 subsequent doses.

Maintenance therapy duration is dependent upon the disease being treated and the antineoplastic agent combination. Maintenance therapy for the treatment of Hodgkin’s disease is subject to varying opinions as to duration. 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.

Method of administration
DBL Vinblastine Injection is a sterile solution of vinblastine sulfate in sodium chloride 0.9% injection.

The calculated dose of the solution may be infused via a flexible plastic container either directly into the vein or into the injection site of a running intravenous infusion.

FOR INTRAVENOUS USE ONLY. FATAL IF GIVEN BY OTHER ROUTES (see Section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In case of mistaken administration by intrathecal route, see Section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Care should be taken to avoid infiltration of subcutaneous tissues (see Section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

DBL Vinblastine Injection may be further diluted with compatible solutions (0.9% saline or 5% glucose) for the purpose of IV infusion. However, dilution in large volumes of diluent (100 to 250 mL) or prolonged infusion, is not recommended, since this may cause irritation and increase the risk of extravasation. To avoid microbial contamination hazards, infusion should be commenced as soon as practicable after preparation of the mixture. Infusion should be completed within 24 hours of preparation of the solution and any residue discarded.

Diluted solutions which are not clear or show evidence of particulate matter should be discarded.

Caution is advised when intravenously administering vinblastine into extremities. If the circulation is impaired, the risk of thrombosis is increased.

Syringes should not be used for DBL Vinblastine Sulfate Injection administration.
Preparation must be by dilution in small volume intravenous bags (the ‘minibag’ technique), rather than in a syringe, to protect against accidental administration via a spinal route.

Compatibilities
DBL Vinblastine Injection has been found to be compatible when added to sodium chloride 0.9% injection and glucose 5% injection.

4.3 Contraindications
Vinblastine is contraindicated in patients who have experienced hypersensitivity reactions with this medicine.

Vinblastine is contraindicated in patients who are leukopenic.

It should not be used in the presence of bacterial infection. Such infections should be brought under control with antiseptics or antibiotics before the initiation of therapy with vinblastine.