VINBLASTINE SULFATE Solution for injection Ref.[8715] Active ingredients: Vinblastine

Posology

The recommended dose for adults, the elderly and children is 6 mg/m², usually administered no more frequently than once every seven days. For testicular tumours, the dosage may be increased to 0.2 mg/kg administered on each of two consecutive days every three weeks.

To minimise the possibility of extravascular spillage, it is suggested that the syringe and needle be rinsed with venous blood before withdrawal. The dose should not be diluted in large volumes of diluent (ie, 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 into an extremity in which the circulation is impaired, or potentially impaired, by such conditions as compressing or invading neoplasm, phlebitis or varicosity.

Patients with hepatic impairment

As vinblastine is excreted principally by the liver, toxicity may be increased when there is hepatic insufficiency and it may be necessary to reduce initial doses in the presence of significantly impaired hepatic or biliary function. A reduction of 50% in the dose is recommended for patients having a direct serum bilirubin value above 3 mg/100 ml.

Patients with renal impairment

Since metabolism and excretion are primarily hepatic, no modification is recommended for patients with impaired renal function.

Vinblastine should not be given intramuscularly, subcutaneously or intrathecally.

Method of administration

The solution may be injected either directly into the vein or into the injection site of a running intravenous infusion. Injection of vinblastine sulfate may be completed in about one minute.

FOR INTRAVENOUS USE ONLY. FATAL IF GIVEN BY OTHER ROUTES (see Warnings)

In case of mistaken administration by intrathecal route, see section 4.4.

Syringes containing this product should be overlabelled with the intrathecal warning label provided - ‘FOR INTRAVENOUS USE ONLY. FATAL IF GIVEN BY OTHER ROUTES’.

Side effects following the use of vinblastine are dose related. Therefore, following administration of more than the recommended dose, patients can be expected to experience these effects in an exaggerated fashion.

In addition, neurotoxicity similar to that seen with vincristine sulfate may be observed.

Treatment

Supportive care should include: (1) prevention of the side effects that result from the syndrome of inappropriate secretion of antidiuretic hormone. This includes restriction of fluid intake and perhaps the use of a diuretic acting on the loop of Henle and distal tubule function; (2) administration of an anticonvulsant; (3) prevention and treatment of ileus; (4) monitoring the patient’s cardiovascular system; and (5) daily blood counts for guidance in transfusion requirement.

The major effect of excessive doses of vinblastine will be on granulocytopoeisis, and this may be life-threatening.

Shelf life: 2 years.

Store in a refrigerator (2°C-8°C). Keep vial in outer carton in order to protect from light.

10 ml, Type I clear conventional glass vial, West Type 1888 rubber closure, aluminium spun cap ring, in packs of 5 vials.

10 ml, Type I clear Onco-Tain vials, West Type 1888 rubber closure, aluminium spun cap ring, in packs of 5 vials.

Not all above presentations and pack sizes may be marketed.

Cytotoxic Handling Guidelines

Administration

Should be administered only by or under the direct supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic agents.

Preparation (Guidelines)

1. Chemotherapeutic agents should be prepared for administration only by professionals who have been trained in the safe use of the preparation.
2. Operations such as reconstitution of powder and transfer to syringes should be carried out only in the designated area.
3. The personnel carrying out these procedures should be adequately protected with clothing, gloves and eye shield.
4. Pregnant personnel are advised not to handle chemotherapeutic agents.

Contamination

1. In the event of contact with the skin or eyes, the affected area should be washed with copious amounts of water or normal saline. A bland cream may be used to treat the transient stinging of skin. Medical advice should be sought if the eyes are affected.
2. In the event of spillage, operators should put on gloves and mop up the spilled material with a sponge kept in the area for that purpose. Rinse the area twice with water. Put all solutions and sponges into a plastic bag and seal it.

Disposal

Syringes, containers, absorbent materials, solution and any other contaminated material should be placed in a thick plastic bag or other impervious container and incinerated.