Dizziness 5
Extravasation/Phlebitis 5
Since etoposide phosphate is converted to etoposide, those adverse experiences that are associated with VePesid can be expected to occur with Etopophos.
Hematologic Toxicity
Myelosuppression after Etopophos administration is dose related and dose limiting with the leukocyte nadir counts occurring from day 15 to day 22 after initiation of drug therapy, granulocyte nadir counts occurring day 12 to 19 after initiation of drug therapy, and platelet nadirs occurring from day 10 to 15. Bone marrow recovery usually occurs by day 21 but may be delayed, and no cumulative toxicity has been reported. Fever and infection have also been reported in patients with neutropenia. Death associated with myelosuppression has been reported following etoposide administration.
Gastrointestinal Toxicity
Nausea and vomiting are the major gastrointestinal toxicities. The severity of such nausea and vomiting is generally mild to moderate with treatment discontinuation required in 1% of patients. Nausea and vomiting can usually be controlled with standard antiemetic therapy.
Blood Pressure Changes
In clinical studies, 151 patients were treated with Etopophos with infusion times ranging from 30 minutes to 3.5 hours. Sixty-three patients received Etopophos as a 5-minute bolus infusion. Four patients experienced one or more episodes of hypertension and eight patients experienced one or more episodes of hypotension, which may or may not be drug related. One episode of hypotension was reported among those patients who received a 5-minute bolus infusion. If clinically significant hypotension or hypertension occurs with Etopophos, appropriate supportive therapy should be initiated.
Allergic Reactions
Anaphylactic-type reactions characterized by chills, rigors, tachycardia, bronchospasm, dyspnea, diaphoresis, fever, pruritus, hypertension or hypotension, loss of consciousness, nausea, and vomiting have been reported to occur in 3% (7/245) of all patients treated with Etopophos. Facial flushing was reported in 2% and skin rashes in 3% of patients receiving Etopophos. These reactions have usually responded promptly to the cessation of the infusion and administration of pressor agents, corticosteroids, antihistamines, or volume expanders as appropriate; however, the reactions can be fatal. Hypertension and/or flushing have also been reported. Blood pressure usually normalizes within a few hours after cessation of the initial infusion.
Anaphylactic-like reactions have occurred during the initial infusion of Etopophos (see WARNINGS). Facial/tongue swelling, coughing, diaphoresis, cyanosis, tightness in throat, laryngospasm, back pain, and/or loss of consciousness have sometimes occurred in association with the above reactions. In addition, an apparent hypersensitivity-associated apnea has been reported.
Rash, urticaria, and/or pruritus have been reported at recommended doses. At investigational doses, a generalized pruritic erythematous maculopapular rash, consistent with perivasculitis, has been reported.
Alopecia
Reversible alopecia, sometimes progressing to total baldness, was observed in up to 44% of patients.
Other Toxicities
The following adverse reactions have been reported: abdominal pain, aftertaste, constipation, dysphagia, fever, transient cortical blindness, interstitial pneumonitis/pulmonary fibrosis, optic neuritis, pigmentat |
