Etopophos
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Questions & Answers
Side Effects & Adverse Reactions
Patients being treated with ETOPOPHOS must be frequently observed for myelosuppression both during and after therapy. Myelosuppression resulting in death has been reported following etoposide administration. Dose-limiting bone marrow suppression is the most significant toxicity associated with ETOPOPHOS therapy. Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent cycle of ETOPOPHOS: platelet count, hemoglobin, white blood cell count, and differential. The occurrence of a platelet count below 50,000/mm3 or an absolute neutrophil count below 500/mm3 is an indication to withhold further therapy until the blood counts have sufficiently recovered. The toxicity of rapidly infused ETOPOPHOS in patients with impaired renal or hepatic function has not been adequately evaluated. The toxicity profile of ETOPOPHOS when infused at doses >175 mg/m2 has not been delineated.
Physicians should be aware of the possible occurrence of an anaphylactic reaction manifested by chills, fever, tachycardia, bronchospasm, dyspnea, and hypotension. Higher rates of anaphylactic-like reactions have been reported in children who received infusions of etoposide at concentrations higher than those recommended. The role that concentration of infusion (or rate of infusion) plays in the development of anaphylactic-like reactions is uncertain. (See ADVERSE REACTIONS.) Treatment is symptomatic. The infusion should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician.
Injection site reactions may occur during the administration of ETOPOPHOS (see ADVERSE REACTIONS). Closely monitor the infusion site for possible infiltration during drug administration. No specific treatment for extravasation reactions is known.
ETOPOPHOS can cause fetal harm when administered to a pregnant woman. Etoposide has been shown to be teratogenic in mice and rats, and it is therefore likely that ETOPOPHOS is also teratogenic.
In rats, an intravenous etoposide dose of 0.4 mg/kg/day (about 1/20 of the human dose on a mg/m2 basis) during organogenesis caused maternal toxicity, embryotoxicity, and teratogenicity (skeletal abnormalities, exencephaly, encephalocele, and anophthalmia); higher doses of 1.2 and 3.6 mg/kg/day (about 1/7 and 1/2 of the human dose on a mg/m2 basis) resulted in 90% and 100% embryonic resorptions. In mice, a single 1.0 mg/kg (1/16 of the human dose on a mg/m2 basis) dose of etoposide administered intraperitoneally on days 6, 7, or 8 of gestation caused embryotoxicity, cranial abnormalities, and major skeletal malformations. An intraperitoneal dose of 1.5 mg/kg (about 1/10 of the human dose on a mg/m2 basis) on day 7 of gestation caused an increase in the incidence of intrauterine death and fetal malformations and a significant decrease in the average fetal body weight.
If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be warned of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
ETOPOPHOS should be considered a potential carcinogen in humans. The occurrence of acute leukemia with or without a preleukemic phase has been reported in rare instances in patients treated with etoposide alone or in association with other neoplastic agents. The risk of development of a preleukemic or leukemic syndrome is unclear. Carcinogenicity tests with ETOPOPHOS have not been conducted in laboratory animals.
Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
ETOPOPHOS for Injection is indicated in the management of the following neoplasms:
Refractory Testicular Tumors-ETOPOPHOS for Injection in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy.
Small Cell Lung Cancer-ETOPOPHOS for Injection in combination with other approved chemotherapeutic agents as first-line treatment in patients with small cell lung cancer.
History
There is currently no drug history available for this drug.
Other Information
ETOPOPHOS (etoposide phosphate) for Injection is an antineoplastic agent which is available for intravenous infusion as a sterile lyophile in single-dose vials containing etoposide phosphate equivalent to 100 mg etoposide, 32.7 mg sodium citrate USP, and 300 mg dextran 40.
Etoposide phosphate is a water soluble ester of etoposide (commonly known as VP-16), a semi-synthetic derivative of podophyllotoxin. The water solubility of etoposide phosphate lessens the potential for precipitation following dilution and during intravenous administration.
The chemical name for etoposide phosphate is:
4'-Demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside], 4'-(dihydrogen phosphate).
Etoposide phosphate has the following structure:
Sources
Etopophos Manufacturers
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E.r. Squibb & Sons, L.l.c.
![Etopophos (Etoposide Phosphate) Injection, Powder, Lyophilized, For Solution [E.r. Squibb & Sons, L.l.c.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Etopophos | E.r. Squibb & Sons, L.l.c.
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 PrecautionsAs 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 AdministrationPrior 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 etoposide phosphate, respectively). Use the quantity of diluent shown below to reconstitute the product.
Vial Strength Volume of Diluent Final Concentration 100 mg 5 mL 20 mg/mL 10 mL 10 mg/mLFollowing reconstitution, ETOPOPHOS can be further diluted to concentrations as low as 0.1 mg/mL etoposide with either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.
Solutions of ETOPOPHOS should be prepared in an aseptic manner. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
StabilityUnopened vials of ETOPOPHOS for Injection are stable until the date indicated on the package when stored under refrigeration 2° to 8°C (36°-46°F) in the original package. When reconstituted as directed, ETOPOPHOS solutions can be stored in glass or plastic containers under refrigeration 2° to 8°C (36°-46°F) for 7 days; at controlled room temperature 20° to 25°C (68°-77°F) for 24 hours following reconstitution with Sterile Water for Injection, USP, 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP; or at controlled room temperature 20° to 25°C (68°-77°F) for 48 hours following reconstitution with Bacteriostatic Water for Injection with Benzyl Alcohol or Bacteriostatic Sodium Chloride for Injection with Benzyl Alcohol. ETOPOPHOS solutions further diluted as directed can be stored under refrigeration 2° to 8°C (36°-46°F) or at controlled room temperature 20° to 25°C (68°-77°F) for 24 hours.
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