adder carcinoma:
Initial treatment:
a. Cyclic regime consisting of 30mg/m²/day for five consecutive days, and followed by a rest period of ten days (this constitutes one treatment cycle). Six to ten such treatment cycles are necessary. This dosage schedule was successful in cases of malignant lymphoma and urinary bladder carcinoma.
b. Twice weekly administration at a dose of 40-50mg/m² over a period of at least six to nine weeks. In patients with good bone marrow reserve this dose may be given carefully three times a week. This dosage schedule was successful in cases of malignant lymphomas.
Maintenance treatment:
A single dose of 150mg of VUMON given every ten to fourteen days for a prolonged period of several months is indicated in order to maintain the remission, as shown in cases of malignant lymphomas.
Cerebral malignancy:
The following dosage schedule was successful in brain tumours:
A high single dose of 100-130mg/m² is given once weekly.
One treatment course consists of six to eight such doses followed by a rest period of 14days. Depending on the evolution, a total of six to nine treatment courses are recommended.
Hodgkin's disease:
A dose of 40mg/m² of VUMON on the 1st, 4th, 8th, 11th and 14th day of treatment, and then followed by a rest period of 14days, has been shown to be safe and efficacious in combination with procarbazine and prednisone.
Relapsed and resistant acute lymphocytic leukaemia. The following dosage regimen has been used: Vumon 165mg/m² in combination with cytarabine 300mg/m² twice weekly for 8doses.
Neuroblastoma in children:
130-180mg/m² weekly.
Dosage should be adjusted according to individual patient variability and toxicity, when employed as a single agent or in combination with other antineoplastic agents.
Combination Therapy:
VUMON has been used in combination with several other approved chemotherapeutic agents. When it is used in combination with other myelosuppressive drugs, the dose should be appropriately reduced. Peripheral blood counts should be monitored and, if necessary, marrow eva luations performed regularly.
NOTE:
Patients with Down's Syndrome may be especially sensitive to myelosuppressive chemotherapy, therefore, dose modification may need to be considered in these patients.
METHOD OF ADMINISTRATION
Hard plastic devices made of ABS (a polymer composed of acronitrile, butadine and styrene) have been reported to decompose when exposed to N,N-dimethylacetamide, one of the solvents present in the VUMON formulation. This effect has not been reported for VUMON itself, or for diluted solutions of VUMON.
In order to prevent extraction of the plasticizer DEHP (di(2-ethylhexyl)phthalate) from polyvinyl chloride (PVC) containers, solutions of VUMON should be prepared in non-DEHP containing large volume parenteral containers such as glass or polyolefin containers. VUMON solutions should be administered with non-DEHP containing administration sets.
Immediately before administration, each 5mL ampule of VUMON containing 50mg of teniposide must be diluted with 50, 125, 250 or 500mL of either 5percent Dextrose Injection or 0.9 percent Sodium Chloride Injection. Such dilution provides final teniposide concentrations of 1, 0,4, 0,2 and 0,1mg/mL, respectively. The diluted solution should then be administered by intravenous infusion over a minimum of thirty minutes. To reduce the possibility of hypotensi
