Blastovin PF

/ Salomon, Levin & Elstein Ltd

FATAL IF GIVEN BY OTHER ROUTES. FOR INTRAVENOUS USE ONLY
Before each administration a monitoring of neutrophil count is necessary.
Starting dose
Adults: It is sensible to start the therapy with a single dose of 0.1 mg/kg (of 3.7 mg/m2 ) i.v. once per week, followed by a leukocyte count to be performed in order to establish the sensitivity of the patient to the product.
Children: It is sensible to start the therapy with a single dose of 2.5 mg/m2
i.v., followed by a leukocyte count in order to establish the sensitivity of the patient to the product.
Maintenance dose: The leukopenia as a reaction to Vinblastine is variable. Therefore it is recommended not to give the product more often than once per seven days. The daily use of low doses of Vinblastine is not recommended, even if the total weekly dose would be the same as the recommended dose since frequency and severity of toxicities may be increased. The starting dose can be increased weekly by 0.05 mg/kg (or 1.8 mg/m2 ) for adults and 1.25 mg/m2
for children. Usual dose is 5.5 – 7.5 mg/m², with an average dose of 0.15 to 0.2 mg/kg or 4 to 6 mg/m2 in adults. Do not further increase the dose after reaching this maximum dose which reduces the number of leucocytes to approximately 3,000/mm3. In some patients 0.1 mg/kg (or 3.7 mg/m2) can already result in
leukopenia, others require more than 0.3 mg/kg (or 11.1 mg/m2) and very rarely 0.5 mg/kg (18.5mg/m2). However, for most patients the weekly dose will be between 0.15 and 0.2 mg/kg. When the dose of Vinblastine that will cause the above mentioned leukopenia has been established, a quantity equal to the previous dose in the schedule should be administered as a maintenance dose with weekly intervals. Thus the patient receives the maximum dose that does not cause leukopenia. The maximum dose is 0.5 mg/kg (or 18.5 mg/m2) for adults. The usual dose for children is 7.5 mg/m2, 12.5 mg/m2 has been given as a single agent.
A next dose of Vinblastine may only be administered when the number of leukocytes has increased to at least 4,000/mm3 , also if the dose interval of seven days has passed already. In some cases the oncolytic activity can already be noticed before the leucopoenic effect. If this is the case, then there will be no need to increase the next dose. The maintenance therapy with an indeterminate duration should consist of the maximum dose that can be administered on an
outpatient basis once every seven to fourteen days without reducing the leukocyte count to a dangerous level.
Dose with liver function disorders: If the liver function is abnormal on the first day of treatment, then the dose of vinblastine is 100% with a bilirubin concentrate of < 25 µmol/l (or <1.5 mg/dL),, 50% if this is 25-50 µmol/l (or 1.5-3.0 mg/dL) Vinblastine should not be administered when bilirubin is >50 μmol/l (or >3 mg/dL).
Dose with renal function disorders: Because the metabolism and excretion are primarily hepatic a dose adjustment does not have to be recommended for patients with a reduced renal function.
Combination therapy: In the combination schedules the doses and frequencies can differ from the above mentioned weekly standard doses. For the correct dosing in the combination schedules is referred to the actual medical literature.
See prescribing information for full details.

Treatment of the following neoplasms, either alone or in conjunction with other oncolytic drugs:
Frequently responsive malignancies:
– Generalized Hodgkin’s disease (stages III and IV, Ann Arbor modification of Rye staging system);
– Non-Hodgkin’s lymphoma: Reticulum-cell sarcoma; Lymphosarcoma
– Mycosis fungoides
– Neuroblastoma
– Histiocytosis X
Less frequently responsive malignancies:
– Choriocarcinoma resistant to other chemotherapeutic agents
– Embryonal carcinoma of the testis
– Carcinoma of the breast, unresponsive to appropriate endocrine surgery and hormonal therapy.

Hypersensitivity to vinblastine or to one of the other vinca-alkaloids and to any of the excipients. Leukopenia not related to the tumor. Severe uncontrolled infection (such infections must first be controlled with antiseptics or antibiotics before administering vinblastine). Intrathecal administration of vinblastine.

Contact distributing company for full details.

Contact distributing company for full details.

Contact distributing company for full details.