been reported.
Neurotoxicity:
Neurotoxicity has been reported including severe cases of neuropathy in patients due to an interaction of vincristine sulphate and VUMON (teniposide). Central nervous system depression has been observed in patients receiving higher than recommended doses.
Hypotension:
Transient hypotension may occur following rapid intravenous administration of VUMON (see Preparation and Administration). Sudden death due to probable arrhythmia and hypotension has been reported.
Other toxicities:
The following reactions have been rarely reported:
Headache and confusion, infection, renal dysfunction, hypertension, asthenia.
Urinary bladder irritation has occasionally been observed, but only in patients with an infiltrative form of bladder carcinoma where the drug was administered intravesically.
PRECAUTIONS:
VUMON (teniposide) should be administered with care to patients with marrow involvement by tumour and to patients with impaired renal or hepatic function.
Regular monitoring of white blood cell and platelet counts should be performed during treatment with VUMON (teniposide). If white blood cell count is below 2000cell/mm³ or platelets below 75,000cell/mm³, unless caused by malignant disease, treatment should be postponed until bone marrow recovery is complete.
Care should be taken to ensure that VUMON (teniposide) infusions are given intravenously with indwelling catheter in proper position prior to infusion as extravasation, necrosis and/or thrombophlebitis may result with improper administration.
Instances of hypotension have been reported during VUMON (teniposide) infusion. Therefore, vital signs should be monitored during the first 30minutes.
Paediatrics:
Benzyl alcohol has been associated with toxicity in newborns. A syndrome characterized by gasping respirations, kernicterus, metabolic acidosis, neurologic deterioration, hematologic abnormalities and death have been reported to occur following administration of benzyl alcohol containing flush solutions to low birth weight, preterm infants.
Acute central nervous system depression and hypotension have been observed in patients who were receiving higher than recommended doses of VUMON, and who were also pre-treated with antiemetic medicines.
VUMON should not be given intra-arterially, intrapleural or intraperitonially.
Interactions:
Anticonvulsants such as phenobarbital and phenytoin increase the clearance rate of teniposide resulting in lower systemic exposure for a given teniposide dose. Increased doses may be required in patients receiving anticonvulsant therapy.
Tolbutamide, sodium salicylate and sulfamethiazole have been shown in vitro to displace teniposide from plasma proteins. Because of extremely high binding of teniposide to proteins, small decreases in binding could result in substantial increases in free drug with associated increased drug effect and toxicity.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage:
No proven antidotes have been established for VUMON (teniposide) overdosage.
IDENTIFICATION:
Clear glass ampoule with a clear, slightly yellow to yellow liquid.
PRESENTATION:
Ampoules: 50mg/5mL in single packs.
STORAGE INSTRUCTIONS:
When stored at temperature not exceeding (25°C), VUMON packaged in flint glass ampoules will remain stable until expiration date ind
