Neurotoxicity has been reported, including severe cases of neuropathy in patients due to an interaction of vincristine sulfate and VUMON when administered concomitantly.
Acute central nervous system depressionand hypotension have been observed in patients receiving investigational infusionsof high-dose VUMON who were pretreated with antiemetic drugs. The depressanteffects of the antiemetic agents and the alcohol content of the VUMON formulationmay place patients receiving higher than recommended doses of VUMON at riskfor central nervous system depression.
Alopecia, sometimes progressing to total baldness, was observedin 9% of eva luable pediatric patients who received VUMON as single-agent therapy.It was usually reversible.
The following reactions have been reported: headache, confusion, and asthenia.
Acute central nervous system depression, hypotension, and metabolic acidosis have been observed in patients who were receiving higher than recommended doses of VUMON, and who were also pretreated with antiemetic drugs.
There is no known antidote for VUMON overdosage. The anticipatedcomplications of overdosage are secondary to bone marrow suppression. Treatmentshould consist of supportive care, including blood products and antibioticsas indicated.
NOTE: Contact of undilutedVUMON with plastic equipment or devices used to prepare solutions for infusionmay result in softening or cracking and possible drug product leakage. Thiseffect has not been reported with diluted solutions ofVUMON.
In order to prevent extraction of the plasticizerDEHP [di(2-ethylhexyl) phthalate], solutions of VUMON should be prepared innon-DEHP containing LVP containers such as glass or polyolefin plastic bagsor containers.
VUMON solutions should be administeredwith non-DEHP containing intravenous administration sets.
Inone study, childhood ALL patients failing induction therapy with a cytarabine-containingregimen were treated with the combination of VUMON 165 mg/m andcytarabine 300 mg/m intravenously, twice weeklyfor 8 to 9 doses. In another study, patients with childhood ALL refractoryto vincristine/prednisone-containing regimens were treated with the combinationof VUMON 250 mg/m and vincristine 1.5 mg/m intravenously,weekly for 4 to 8 weeks and prednisone 40 mg/m orallyfor 28 days.
Adequate data in patients with hepaticinsufficiency and/or renal insufficiency are lacking, but dose adjustmentsmay be necessary for patients with significant renal or hepatic impairment.
Caution should be exercised in handlingand preparing the solution of VUMON. Several guidelines on proper handlingand disposal of anticancer drugs have been published. Skinreactions associated with accidental exposure to VUMON may occur. To minimizethe risk of dermal exposure, always wear impervious gloves when handling ampulescontaining VUMON. If VUMON solution contacts the skin, immediately wash theskin thoroughly with soap and water. If VUMON contacts mucous membranes, themembranes should be flushed immediately and thoroughly with water. More informationis available in the references listed below.
VUMON must be diluted with either 5%Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP, to give finalteniposide concentrations of 0.1 mg/mL, 0.2 mg/mL, 0.4 mg/mL, or 1.0 mg/mL.Solutions prepared in 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection,USP at teniposide concentrations o
