Toposar
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Questions & Answers
Side Effects & Adverse Reactions
Patients being treated with TOPOSAR must be frequently observed for myelosuppression both during and after therapy. Myelosuppression resulting in death has been reported. Dose-limiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent cycle of TOPOSAR: 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.
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 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 section.) 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.
For parenteral administration, TOPOSAR should be given only by slow intravenous infusion (usually over a 30- to 60-minute period) since hypotension has been reported as a possible side effect of rapid intravenous injection.
Etoposide can cause fetal harm when administered to a pregnant woman. Etoposide has been shown to be teratogenic in mice and rats.
In rats, an intravenous etoposide dose of 0.4 mg/kg/day (about 1/20th 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 1/7th and 1/2 of human dose on a mg/m2 basis) resulted in 90 and 100% embryonic resorptions. In mice, a single 1.0 mg/kg (1/16th of 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 I.P. dose of 1.5 mg/kg (about 1/10th of 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.
Women of childbearing potential should be advised to avoid becoming pregnant. 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.
Etoposide 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 etoposide have not been conducted in laboratory animals.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
TOPOSAR is indicated in the management of the following neoplasms:
TOPOSAR in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy.
Etoposide injection and/or capsules 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
TOPOSAR (etoposide injection, USP) (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4'-demethylepipodophyllotoxin 9-[4,6-0-(R)-ethylidene-β-D-glucopyranoside]. It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether. It is made more miscible with water by means of organic solvents. It has a molecular weight of 588.58 and a molecular formula of C29H32O13.
TOPOSAR is available for intravenous use as a sterile 20 mg/mL solution in 100 mg (5 mL), 500 mg (25 mL), or 1 g (50 mL) sterile multiple dose vials. The pH of the clear, yellow liquid is 3.0 to 4.0.
Each mL contains: 20 mg etoposide, 2 mg citric acid anhydrous, 80 mg polysorbate 80, 650 mg polyethylene glycol 300, dehydrated alcohol 33.2% (v/v).
The structural formula is:
Sources
Toposar Manufacturers
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Teva Parenteral Medicines, Inc
![Toposar (Etoposide) Injection [Teva Parenteral Medicines, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Toposar | Teva Parenteral Medicines, Inc
Note: Plastic devices made of acrylic or ABS (a polymer composed of acrylonitrile, butadiene, and styrene) have been reported to crack and leak when used withundiluted etoposide injection.
TOPOSARThe usual dose of TOPOSAR 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.
In small cell lung cancer, the TOPOSAR 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.
For recommended dosing adjustments in patients with renal impairment see PRECAUTIONS section.
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 effects 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 TOPOSAR. Skin reactions associated with accidental exposure to etoposide may occur. The use of gloves is recommended. If TOPOSAR 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 AdministrationTOPOSAR must be diluted prior to use with either 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, to give a final concentration of 0.2 to 0.4 mg/mL. If solutions are prepared at concentrations above 0.4 mg/mL, precipitation may occur. Hypotension following rapid intravenous administration has been reported, hence, it is recommended that the TOPOSAR solution be administered over a 30- to 60-minute period. A longer duration of administration may be used if the volume of fluid to be infused is a concern. TOPOSAR should not be given by rapid intravenous injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration (see DESCRIPTION section) prior to administration whenever solution and container permit.
StabilityUnopened vials of TOPOSAR are stable until the date indicated on the package at room temperature (25°C). Vials diluted as recommended to a concentration of 0.2 to 0.4 mg/mL are stable for 96 and 24 hours, respectively, at room temperature (25°C) under normal room fluorescent light in both glass and plastic containers.
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
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Teva Parenteral Medicines, Inc.
Toposar | Teva Parenteral Medicines, Inc.
Note: Plastic devices made of acrylic or ABS (a polymer composed of acrylonitrile, butadiene, and styrene) have been reported to crack and leak when used withundiluted etoposide injection.
TOPOSARThe usual dose of TOPOSAR 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.
In small cell lung cancer, the TOPOSAR 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.
For recommended dosing adjustments in patients with renal impairment see PRECAUTIONS section.
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 effects 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 TOPOSAR. Skin reactions associated with accidental exposure to etoposide may occur. The use of gloves is recommended. If TOPOSAR 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 AdministrationTOPOSAR must be diluted prior to use with either 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, to give a final concentration of 0.2 to 0.4 mg/mL. If solutions are prepared at concentrations above 0.4 mg/mL, precipitation may occur. Hypotension following rapid intravenous administration has been reported, hence, it is recommended that the TOPOSAR solution be administered over a 30- to 60-minute period. A longer duration of administration may be used if the volume of fluid to be infused is a concern. TOPOSAR should not be given by rapid intravenous injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration (see DESCRIPTION section) prior to administration whenever solution and container permit.
StabilityUnopened vials of TOPOSAR are stable until the date indicated on the package at room temperature (25°C). Vials diluted as recommended to a concentration of 0.2 to 0.4 mg/mL are stable for 96 and 24 hours, respectively, at room temperature (25°C) under normal room fluorescent light in both glass and plastic containers.
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
![Toposar (Etoposide) Injection [Teva Parenteral Medicines, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=17e94672-4f1c-443b-8da6-bfa6cc96e485&name=f2bb6be5-76fb-408b-bfb5-a0607070baa8-02.jpg)
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