ve reactions, VUMON should not be administered by bolus injection or rapid infusion. Greatest care should be taken to ensure that the catheter tip remains in the vein during administration, to avoid extravasation and possible tissue irritation.
When diluted as recommended above, solutions that contain teniposide 0,1mg, 0,2mg or 0.4mg/mL, are stable under normal fluorescent lighting for 24 hours in the recommended large volume glass or polyolefin parenteral containers. Refrigeration is not recommended. VUMON solutions prepared at a final teniposide concentration of 1mg/mL, and stored at room temperature under normal fluorescent lighting are less stable, and should be administered within 4 hours of preparation to reduce the potential or precipitation.
NOTE:
This product may precipitate when diluted in any manner, with any diluent or to any concentration other than those described above. If evidence of precipitation does appear, the solution should not be administered. Likewise, precipitation has occurred when prolonged infusions of teniposide (24hour) were administered through a variety of infusion devices. These infusions, and their delivery systems, should be inspected frequently during administration. Heparin solution can cause precipitation of teniposide, therefore, administration sets/tubing, etc., should be flushed thoroughly with 5% Dextrose Injection or 0.9% Sodium Chloride Injection, before and after administration of VUMON. Diluted VUMON solutions should be subjected to as little agitation as is necessary to prepare the solution, since excessive agitation can result in precipitation. No other drugs should be mixed with VUMON infusion.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Haematological Toxicity:
Myelosuppression is often dose-limiting, with leukopenia and thrombocytopenia occurring 7-14days after VUMON (teniposide) treatment. Bone marrow recovery is usually complete within 2-3weeks. Leukopenia is more frequent and more severe than thrombocytopenia.
Anemia also occurs and immune haemolytic anemia has been reported.
The occurrence of acute nonlymphocytic leukaemia has been reported in patients treated with VUMON in association with other antineoplastic agents.
Gastrointestinal Toxicity:
Nausea and vomiting are the major gastrointestinal toxicities. The nausea and vomiting can usually be controlled by antiemetic therapy. Stomatitis/mucositis, hepatic dysfunction, anorexia, diarrhoea and abdominal pain may occur.
Alopecia:
A high incidence of alopecia has been reported, especially in patients receiving multiple courses of therapy.
Hypersensitivity:
Anaphylactic-like reactions characterized by chills, fever, tachycardia, bronchospasm, dyspnoea and hypotension have been reported to occur during or immediately after VUMON (teniposide) administration. They may be due to the Cremophor EL component of the vehicle or to teniposide itself. These reactions may occur on the first dose and may occur more commonly in patients with brain tumors or in patients with neuroblastoma. The risk of having a reaction may be related to repeated exposure and cumulative dose. These reactions have usually responded promptly to cessation of the infusion and administration of pressor agents, corticosteroids, antihistamines or volume expanders as appropriate. Flushing, sweating, hypertension and oedema have also been reported.
Dermatologic
Urticaria, with or without pruritus have |
