ion, seizure (occasionally associated with allergic reactions), Stevens-Johnson syndrome, toxic epidermal necrolysis, and radiation recall dermatitis. Hepatic toxicity may be seen.
Local soft tissue toxicity has been reported following extravasation of Etopophos. Infiltration of Etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis.
The incidences of adverse reactions in the table that follows are derived from multiple databases from studies in 2081 patients when VePesid was used either orally or by injection as a single agent.
Adverse Drug Effects Observed With Single-Agent VePesid Percent Range of Reported
Incidence
Hematologic toxicity
Leukopenia (<1000/mm3) 3-17
Leukopenia (<4000/mm3) 60-91
Thrombocytopenia (<50,000/mm3) 1-20
Thrombocytopenia (<100,000/mm3) 22-41
Anemia 0-33
Gastrointestinal toxicity
Nausea and vomiting 31-43
Abdominal pain 0-2
Anorexia 10-13
Diarrhea 1-13
Stomatitis 1-6
Hepatic 0-3
Alopecia 8-66
Peripheral neurotoxicity 1-2
Hypotension 1-2
Allergic Reaction 1-2
Overdosage
No proven antidotes have been established for Etopophos overdosage in humans. In mice, a single intravenous dose of rapidly administered Etopophos was lethal at or above 120 mg/kg (about 7 times human dose on a mg/m2 basis) and was associated with clinical signs of neurotoxicity.
Etopophos Dosage and Administration
The usual dose of VePesid for Injection in testicular cancer in combination with other approved chemotherapeutic agents ranges from 50 to 100 mg/m2/day on days 1 through 5 to 100 mg/m2/day on days 1, 3, and 5. Equivalent doses of Etopophos should be used.
In small cell lung cancer, the VePesid for Injection dose in combination with other approved chemotherapeutic drugs ranges from 35 mg/m2/day for 4 days to 50 mg/m2/day for 5 days. Equivalent doses of Etopophos should be used.
For recommended dosing adjustments in patients with renal impairment, see PRECAUTIONS.
Etopophos SHOULD NOT BE GIVEN BY BOLUS INTRAVENOUS INJECTION. Etopophos solutions may be administered at infusion rates from 5 to 210 minutes. Chemotherapy courses are repeated at 3- to 4-week intervals after adequate recovery from any toxicity.
The dosage should be modified to take into account the myelosuppressive effect of other drugs in the combination or the effects of prior x-ray therapy or chemotherapy which may have compromised bone marrow reserve.
Administration Precautions
As with other potentially toxic compounds, caution should be exercised in handling and preparing the solution of Etopophos. Skin reactions associated with accidental exposure to Etopophos may occur. The use of gloves is recommended. If Etopophos solution contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush the mucosa with water.
Preparation for Intravenous Administration
Prior to use, the content of each vial must be reconstituted with Sterile Water for Injection, USP; 5% Dextrose Injection, USP; 0.9% Sodium Chloride Injection, USP; Bacteriostatic Water for Injection with Benzyl Alcohol; or Bacteriostatic Sodium Chloride for Injection with Benzyl Alcohol to a concentration equivalent to 20 mg/mL or 10 mg/mL etoposide (22.7 or 11.4 mg/mL e |
