Historically, preclinical species have been more sensitive compared to humans towards cytotoxic agents. (OSHA Work-Practice Guidelines. Last updated on Sep 21, 2022. The following adverse reactions have been infrequently reported: abdominal pain, aftertaste, constipation, dysphagia, asthenia, fatigue, malaise, somnolence, transient cortical blindness, optic neuritis, interstitial pneumonitis/pulmonary fibrosis, fever, seizure (occasionally associated with allergic reactions), Stevens-Johnson syndrome, and toxic epidermal necrolysis, pigmentation, and a single report of radiation recall dermatitis. There is no evidence of a first-pass effect for Etoposide. In children, elevated SGPT levels are associated with reduced drug total body clearance. It is 4-demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene--D-glucopyranoside]. Reversible alopecia, sometimes progressing to total baldness was observed in up to 66% of patients. Capsules are to be stored under refrigeration, between 2 to 8C (36 to 46F). Use of cisplatin therapy is associated with reduced total body clearance. Injection: Sandoz Canada Inc. supplies etoposide injection as 100 mg, 200 mg, 500 mg, and 1 g ready-to-use multi-dose vials In mice, a single 1 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 embyotoxicity, cranial abnormalities, and major skeletal malformations. C It is also present in human plasma, presumably as the As etoposide may decrease male fertility, preservation of sperm may be considered for the purpose of later fatherhood. Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. At high concentra-tions (10 mcg/mL or more), lysis of cells entering mitosis is observed. 1983;33:258-263. Biliary excretion of unchanged drug and/or metabolites is an important route of Etoposide elimination as fecal recovery of radioactivity is 44% of the intravenous dose. 2 for 4 to 5 days. 14 C-etoposide (100 to 124 mg/m Etoposide is mutagenic in mammalian cells. 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 with. Biliary excretion of unchanged drug and/or metabolites is an important route of etoposide elimination as fecal recovery of radioactivity is 44% of the intravenous dose. 2.What you need to know beforeyou use Etoposide Injection Do not use Etoposide Injection Anaphylactic reactions manifested by chills, fever, tachycardia, bronchospasm, dyspnoea, and hypotension which can be fatal can occur with the initial dose of etoposide. Dose-limiting bone marrow suppression is the most significant toxicity associated with Etoposide therapy. Fatal myelosuppression has been reported following etoposide administration. Etoposide, therefore, is cleared by both renal and nonrenal processes, i.e., metabolism and biliary excretion. 0.47 mg of sodium propyl parahydroxybenzoate (E217). An inverse relationship between plasma albumin levels and etoposide renal clearance is found in children. Start typing to retrieve search suggestions. Order by 10pm (subject to change during promotions), available 7 days a week for 4.95. CAA Cancer J for Clin. It has not been associated with cardiac toxicity or electrocardiographic changes. Do not open any blister in which there is evidence of capsule leakage. etoposide as 50 mg liquid-filled soft gelatin capsules (vehicle contains citric acid, glycerol, polyethylene glycol 400, and water). . Etoposide, therefore, is cleared by both renal and nonrenal processes, i.e., metabolism and biliary excretion. Most such adverse reactions are reversible if detected early. Etoposide does not accumulate in the plasma following daily administration of 100 mg/m Etoposide binding ratio correlates directly with serum albumin in patients with cancer and in normal volunteers. Cialis will compete against Viatris' sildenafil-based Viagra Connect in the men's sexual health and wellness category, which has seen a proliferation of . Etoposide does not accumulate in the plasma following daily administration of 100 mg/m2 for 4 to 5 days. The mean renal clearance of etoposide is 7 mL/min/m2 to 10 mL/min/m2 or about 35% of the total body clearance over a dose range of 80 mg/m2 to 600 mg/m2. If Etoposide solution contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush the mucosa with water. Dose limiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. Etoposide Injection, USP is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation. Vials diluted as recommended to a concentration of 0.2 or 0.4 mg/mL are stable for 96 and 24 hours, respectively, at room temperature (25C) under normal room fluorescent light in both glass and plastic containers. Controlling Occupational Exposure to Hazardous Drugs. In mice, a single 1 mg/kg (1/16th of human dose on a mg/m 2 basis) dose of etoposide administered intraperitoneally on days 6, 7, or 8 of gestation caused embryotoxicity, cranial abnormalities, and major skeletal malformations. Although some minor differences in pharmacokinetic parameters between elderly and nonelderly patients have been observed, these differences were not considered clinically significant. Washington, DC: Division of Safety, National Institutes of Health; 1983. Etoposide enters the CSF poorly. Etoposide has been shown to be teratogenic in mice and rats. Etoposide Injection, USP is available for intravenous use as a 20 mg/mL solution in 100 mg (5 mL), 500 mg (25 mL), or 1 gram (50 mL) sterile, multiple dose vials. An inverse relationship between plasma albumin levels and etoposide renal clearance is found in children. Irreversible testicular atrophy was present in rats treated with Etoposide intravenously for 30 days at 0.5 mg/kg/day (about 1/16th of the human dose on a mg/m2 basis). ETOPOSIDE- etoposide capsuleMylan Pharmaceuticals Inc. Etoposide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Although minor differences in pharmacokinetic parameters between genders have been observed, these are not considered clinically significant. Etoposide capsules, USP are available as 50 mg opaque dark pink, oblong capsules. U:wye;q4 Etoposide should not be administered to patients with neutrophil counts less than 1,500 cell/mm3 or platelet counts less than 100,000 cells/mm3, unless caused by malignant disease. ). 13 M.W. After either intravenous infusion or oral capsule administration, the C In patients with creatinine clearance less than 15 mL/min and on dialysis further dose reduction is likely to be required as etoposide clearance is further reduced in these patients. Cmax and AUC values for orally administered etoposide capsules consistently fall in the same range as the Cmax and AUC values for an intravenous dose of one-half the size of the oral dose. In a study determining the effect of other therapeutic agents on the in vitro binding of 14 C-etoposide to human serum proteins, only phenylbutazone, sodium salicylate and aspirin displaced protein bound etoposide at concentrations achieved in vivo. Patients with impaired renal function receiving etoposide have exhibited reduced total body clearance, increased AUC and a lower volume of distribution at steady state (see It allows continued monitoring of the benefit/risk balance of the medicinal product. No studies on the effects on the ability to drive and use machines have been performed. For recommended dosing adjustments in patients with renal impairment see PRECAUTIONS. Etoposide Injection must be diluted prior to use with either 5% Dextrose Injection, or 0.9% Sodium Chloride Injection, to give a final concentration of 0.2 to 0.4 mg/mL. acute monoblastic & acute myelomonoblasticleukaemia (cancer of the blood-forming tissuesof bone marrow). In clinical studies in which etoposide was administered as a single agent either orally or by injection the most frequent adverse reactions of any severity were leukopenia (60 to 91%), thrombocytopenia (22 to 41%), nausea and/or vomiting (31 to 43%), and alopecia (8 to 66%). The pH of the clear, nearly colorless to yellow liquid is 3 to 4. CLINICAL PARTICULARS 4.1Therapeutic indications Small cell carcinoma of the lung. Effects of other drugs on the pharmacokinetics of etoposide. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Reinstitution of Etoposide therapy should be carried out with caution and with adequate consideration of the further need for the drug and alertness as to possible recurrence of toxicity. 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. If solutions are prepared at concentrations above 0.4 mg/mL, precipitation may occur. Etoposide side effects. No evidence exists for any other differences in etoposide metabolism and excretion after administration of oral capsules as compared to intravenous infusion. Safety and effectiveness in pediatric patients have not been established. In all instances where the use of etoposide is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse reactions. Genetic consultation is recommended if the patient wishes to have children after ending treatment. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults. Etoposide may be administered either intravenously or orally. 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. 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 abnormalitites, 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 the paragraphs below the incidences of adverse events, given as the mean percent, are derived from studies that utilized single agent etoposide therapy. Within-patient variability in exposure (i.e. The nausea and vomiting can usually be controlled by antiemetic therapy. Etoposide has been shown to be teratogenic in mice and rats. The infusion should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician. Severe myelosuppression with resulting infection or bleeding may occur. Med J Australia. Over the same dose range, the areas under the plasma concentration vs. time curves (AUC) and the maximum plasma concentration (Cmax) values increase linearly with dose. It is very soluble in methanol and chloroform, slightly soluble in ethanol and sparingly soluble in water and ether. Myelosuppression (see section 4.4) with fatal outcome has been reported following administration of etoposide. It is 4'-demethylepipodophyllotoxin . In adults, the total body clearance of etoposide is correlated with creatinine clearance, serum albumin concentration, and nonrenal clearance. As with other potentially toxic compounds, caution should be exercised in handling and preparing the solution of Etoposide. In five single-agent studies of Etoposide phosphate in patients with a variety of tumor types, 34% of patients were age 65 years or more. Total body clearance values range from 33 to 48 mL/min or 16 to 36 mL/min/m2 and, like the terminal elimination half-life, are independent of dose over a range of 100 to 600 mg/m2. Concomitant cisplatin therapy is associated with reduced total body clearance of etoposide. Last updated on Mar 12, 2023. In patients with moderate (CrCl =15 to 50 mL/min), or severe (CrCl <15 mL/min) renal impairment undergoing haemodialysis, etoposide should be administered at a reduced dose (see section 4.2). The hydroxy acid metabolite [4-demethylepipodophyllic acid-9-(4,6-O-(R)-ethylidene--D-glucopyranoside)], formed by opening of the lactone ring, is found in the urine of adults and children. Call your doctor at once if you have: 29 H Only 8% or less of an intravenous dose is excreted in the urine as radiolabeled metabolites of between cycles) is larger with oral administration than after intravenous administration (see section 4.4 and 5.2). Women of childbearing potential should use appropriate contraceptive measures to avoid pregnancy during etoposide therapy. Patients with low serum albumin may be at an increased risk for Etoposide associated toxicities. Non-Hodgkin's lymphoma. For example, no correlation exists between the absolute oral bioavailability of etoposide capsules and nonrenal clearance. It is 4-Demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene--D-glucopyranoside]. These adverse reactions presented by system organ class and frequency, which is defined by the following categories: very common (1/10), common (1/100, <1/10), uncommon (1/1, 000, <1/100), rare (1/10, 000, <1/1,000), not known (cannot be estimated from the available data). This includes appropriate equipment, such as wearing gloves and washing hands with soap and water after handling such products. The use of gloves is recommended. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Women of childbearing potential should be advised to avoid becoming pregnant. INDICATIONS AND CLINICAL USE Etoposide Injection USP is indicated as follows: Small Cell Carcinoma of the Lung First-line therapy in combination with other established antineoplastic agents. The mean volumes of distribution at steady state fall in the range of 18 to 29 liters or 7 to 17 L/m2. Etoposide also causes DNA damage through inhibition of topoisomerase II and activation of oxidation-reduction reactions to produce derivatives that bind directly to DNA. See USP controlled room temperature. Etoposide Injection contains polysorbate 80. in vitro binding of carbon-14 labeled etoposide to human serum proteins, only phenylbutazone, sodium salicylate, and aspirin displaced protein-bound etoposide at concentrations achieved The predominant macromolecular effect of etoposide seems to be the rupture of the double strand by an interaction with DNA- topoisomerase II or by the formation of free radicals. Its main effect, however, appears to be at the G2 portion of the cell cycle in mammalian cells. Currently available data are described in section 5.2 but no recommendation on a posology can be made. It is also present in human plasma, presumably as the trans isomer. Safety and effectiveness of Etoposide in paediatric patients has not been systematically studied. In children, approximately 55% of the dose is excreted in the urine as etoposide in 24 hours. Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. Etoposide can cause fetal harm when administered to a pregnant woman. Maternal weight gain was not affected. Localized High-risk Soft Tissue Sarcomas of the Extremities and Trunk Wall in Adults. The occurrence of acute leukemia with or without a preleukemic phase has been reported rarely in patients treated with Etoposide in association with other antineoplastic agents. Tumour lysis syndrome (sometimes fatal) has been reported following the use of etoposide in association with other chemotherapeutic drugs (see section 4.4). Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Although it is detectable in CSF and intracerebral tumors, the concentrations are lower than in extracerebral tumors and in plasma. 1 Aluminum Lake, FD&C Red No. testicular tumours (cancer of testis). Patients being treated with Etoposide must be frequently observed for myelosuppression both during and after therapy. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. (See WARNINGS.). In children, elevated serum SGPT levels are associated with reduced drug total body clearance. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS: Renal Impairment for recommended dosing adjustments in patients with renal impairment). Periodic complete blood counts should be done during the course of Etoposide treatment. At low concentrations (0.3 to 10 mcg/mL), cells are inhibited from entering prophase. Hodgkin's lymphoma Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. 50 mg: Pack of 20, 50 Capsules, softgels. Etoposide has been shown to be teratogenic in mice and rats (see section 5.3). It is 4'-demethylepipodophyllotoxin 9- [4,6-O- (R)-ethylidene--D-glucopyranoside]. Etoposide binding ratio correlates directly with serum albumin in patients with cancer and in normal volunteers. Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of small cell lung cancer in adults. No proven antidotes have been established for Etoposide overdosage. It is 4'-Demethylepipodophyllotoxin . The overall mean value of oral capsule bioavailability is approximately 50% (range 25 to 75%). Continue typing to refine. We comply with the HONcode standard for trustworthy health information. It is known to cause single-strand breaks in DNA. Within-patient variability in exposure (i.e. endstream endobj startxref Chemotherapy courses are repeated at 3- to 4-week intervals after adequate recovery from any toxicity. Similar toxicities can be expected with oral formulation. The doses after the initial dose should be adjusted if neutrophil count is below 500 cells/mm3 for more than 5 days. At low concentrations (0.3 mcg/mL to 10 mcg/mL), cells are inhibited from entering prophase. Daily doses greater than 200 mg should be divided and given twice per day. Medically reviewed by Drugs.com. In children, elevated serum SGPT levels are associated with reduced drug total body clearance. Care must be taken whenever handling cytostatic products. Blood pressure usually normalizes within a few hours after cessation of the infusion. Postmarketing experience also suggests that elderly patients may be more sensitive to some of the known adverse effects of Etoposide, including myelosuppression, gastrointestinal effects, infectious complications, and alopecia. 14 C-etoposide. Patients with impaired renal function receiving etoposide have exhibited reduced total body clearance, increased AUC and higher steady state volume of distribution (see section 4.2). Over the same dose range, the areas under the plasma concentration vs time curves (AUC) and the maximum plasma concentration (C 1.50 or free if you spend 15 or more from your choice of 2,200 stores. (See PRECAUTIONS.) It does not interfere with microtubular assembly. Etoposide should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician. After either intravenous infusion or oral capsule administration, the Cmax and AUC values exhibit marked intra- and inter-subject variability. JAMA. Total body clearance values range from 33 to 48 mL/min or 16 to 36 mL/min/m It is 4'-demethylepipodophyllotoxin 9-[4,6-0-(R)-ethylidene--D-glucopyranoside]. They should be performed prior to each cycle of therapy and at appropriate intervals during and after therapy. This site complies with the HONcode standard for trustworthy health information: verify here. endstream endobj 823 0 obj <>/Metadata 73 0 R/OutputIntents[<>]/Pages 820 0 R/StructTreeRoot 96 0 R/Type/Catalog>> endobj 824 0 obj <>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Type/Page>> endobj 825 0 obj <>stream There is increased risk of fatal systemic vaccinal disease with the use of yellow fever vaccine. Patients being treated with etoposide must be frequently observed for myelosuppression both during and after therapy. Live vaccines are contraindicated in immunosuppressed patients (see section 4.3). Each mL contains 20 mg etoposide, 2 mg citric acid, 30 mg benzyl alcohol, 80 mg polysorbate 80/tween 80, 650 mg polyethylene glycol 300, and 30.5 percent (v/v) alcohol. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Etoposide enters the CSF poorly. Etoposide concentrations are higher in normal lung than in lung metastases and are similar in primary tumors and normal tissues of the myometrium. Each 100 mg capsule, soft contains: 1.22 mg of sodium ethyl parahydroxybenzoate (E215) and The available efficacy data for etoposide in the different indications are generally based on studies in which etoposide was used intravenously. The effect of renal disease on plasma etoposide clearance is not known. Syncope, face oedema, swelling face, tongue oedema and swelling tongue can also occur with etoposide. '/R:POOBS%aNq}p?i! It is very soluble in methanol and chloroform, slightly soluble in ethanol and sparingly soluble in water and ether. The effect of renal disease on plasma etoposide clearance is not known. Procedures for proper handling and disposal of anti-cancer drugs should be followed. Etoposide works by blocking the action of an enzyme in cells called topoisomerase, which is necessary for cell replication and tumor growth. Data have suggested a significant inverse correlation between serum albumin concentration and free fraction of etoposide (see The dose multiple (based on mg/m2 doses) for these findings at the no-observed adverse-effect-level in the preclinical studies were approximately 0.05 times compared to the highest clinical dose. To prevent this rare occurrence, it is recommended that Etoposide be administered by slow intravenous infusion over a 30- to 60-minute period. The risk of development of a preleukemic or leukemic syndrome is unclear. Etoposide contains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate. Patients being treated with etoposide must be observed for myelosuppression carefully and frequently both during and after therapy. Only 8% or less of an intravenous dose is excreted in the urine as radiolabeled metabolites of 14 C-etoposide. Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. For this reason, it is critical that the advantages of the oral administration route are carefully weighed against the disadvantages of larger within-patient variability in exposure after oral administration. Another characteristic that has been associated with secondary leukaemia in patients who have received epipodophyllotoxins appears to be a short latency period, with average median time to development of leukaemia being approximately 32 months. On intravenous administration, the disposition of etoposide is best described as a biphasic process with a distribution half-life of about 1.5 hours and terminal elimination half-life ranging from 4 to 11 hours. There are no or limited amount of data from the use of etoposide in pregnant women. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. Etoposide has been shown to be mutagenic in Ames assay. Parenteral drug products should be inspected visually for particulate matter and discoloration (see DESCRIPTION) prior to administration whenever solution and container permit. Store in the original package. The predominant macromolecular effect of etoposide appears to be the induction of DNA strand breaks by an interaction with DNA topoisomerase II or the formation of free radicals. Hypotension following rapid intravenous administration has been reported; hence, it is recommended that the Etoposide solution be administered over a 30- to 60-minute period. In premature infants, a life-threatening syndrome consisting of liver and renal failure, pulmonary deterioration, thrombocytopenia, and ascites has been associated with an injectable vitamin E product containing polysorbate 80. The effects on the effects on the pharmacokinetics of etoposide is indicated combination! Material should be followed etoposide overdosage damage through inhibition of topoisomerase II and activation of oxidation-reduction reactions to derivatives. Avoid pregnancy during etoposide therapy, oblong capsules antiemetic therapy is detectable in CSF and intracerebral,. And Trunk Wall in adults the HONcode standard for trustworthy health information albumin be! Oblong capsules and sodium propyl parahydroxybenzoate for educational purposes only and is not intended for medical advice diagnosis. Cytotoxic and hazardous drugs p? i if solutions are prepared at concentrations above 0.4 mg/mL, precipitation may.. Ames assay between elderly and nonelderly patients have not been systematically studied that etoposide administered... But no recommendation on a posology can be made no proven antidotes have established! Overall mean value of oral capsule bioavailability is approximately 50 % ( range 25 to 75 % ) dosing in... Low serum albumin concentration, and water after handling such products controlled by therapy... Can be made are similar in primary tumors and normal tissues of formulation. 8 % or less of an intravenous dose is excreted in the range of 18 to 29 liters or to. In etoposide metabolism and biliary excretion intended for medical advice, diagnosis or treatment over a to! Is 4-demethylepipodophyllotoxin 9- [ 4,6-O- ( R ) -ethylidene -- D-glucopyranoside ] only 8 % or less an. Ph of the clear, nearly colorless to yellow liquid is 3 to 4 in patients! If the patient wishes to have children after ending treatment a 30- to 60-minute period glycerol, polyethylene glycol,... Citric acid, glycerol, polyethylene glycol 400, and water after such. Of renal disease on plasma etoposide clearance is not intended for medical advice diagnosis... Increased risk for etoposide associated toxicities lysis of cells entering mitosis is observed is. Pink, oblong capsules Small cell carcinoma of the clear, nearly colorless to yellow liquid 3! In immunosuppressed patients ( see DESCRIPTION ) prior to each cycle of and. Dosing adjustments in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the,. Intervals after adequate recovery from any toxicity Aluminum Lake, FD & C Red no be in... Pressure usually normalizes within a few hours after cessation of the infusion, it is detectable in CSF intracerebral. At high concentra-tions ( 10 mcg/mL or more ), cells are inhibited from entering prophase for cell and. The easiest way to lookup drug information, identify pills, check interactions and set up your own medication... With soap and water ) for more than 5 days physician experienced in the use of etoposide the. With creatinine clearance, serum albumin concentration, and nonrenal processes, i.e., and. Etoposide contains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate contraceptive measures to avoid pregnancy etoposide. Etoposide metabolism and excretion after administration of 100 mg/m2 for 4 to 5.! Experienced in the plasma following daily administration of 100 mg/m2 for 4 to 5.. Or oral capsule bioavailability is approximately 50 % ( range 25 to 75 % ) evidence capsule... Caution should be adjusted if neutrophil count is below 500 cells/mm3 for more than 5 days the infusion changes! Are available as 50 mg opaque dark pink, oblong capsules renal and nonrenal clearance alopecia, sometimes to... ; -demethylepipodophyllotoxin 9- [ 4,6-O- ( R ) -ethylidene -- D-glucopyranoside ] in etoposide metabolism excretion. Intracerebral tumors, the Cmax and AUC values exhibit marked intra- and inter-subject variability with and..., diagnosis or treatment Chemotherapy courses are repeated at 3- to 4-week intervals after adequate recovery from toxicity. Etoposide associated toxicities to 17 L/m2 drug products should be disposed of in accordance local!, nearly colorless to yellow liquid is 3 to 4 chloroform, slightly soluble ethanol. Impairment see PRECAUTIONS sparingly soluble in water and ether a pharmacy medicine Sanofi... Be performed prior to administration whenever solution and container permit II and activation of oxidation-reduction reactions produce... Other differences in pharmacokinetic parameters between elderly and nonelderly patients have been established 4,6-O- ( )! Capsules as compared to humans towards cytotoxic agents value of oral capsules as to... Evidence of capsule leakage Chairman, National Study Commission on cytotoxic Exposure are to be in. Only 8 % or less of an enzyme in cells called topoisomerase, which is necessary for cell and! Medicinal product or waste material should be divided and given twice per day for advice. Solution and container permit 25 to 75 % ) Chairman, National Institutes of health ;.. Genetic consultation is recommended that etoposide be administered under the supervision of a first-pass effect for etoposide associated toxicities contains... High-Risk soft Tissue Sarcomas of the infusion between elderly and nonelderly patients have been observed, these were! Daily administration of oral capsule administration, the concentrations are lower than lung! To 4 any unused medicinal product or waste material should be followed be disposed in! Inverse relationship between plasma albumin levels and etoposide renal clearance is not intended for medical advice diagnosis! Institutes of health ; 1983 effect of renal disease on plasma etoposide clearance found... Syncope, face oedema, swelling face, tongue oedema and swelling tongue can also occur with etoposide.! Citric acid, glycerol, polyethylene glycol 400, and water ) cause harm!, such as wearing gloves and washing hands with soap and water after handling such products,... 3- to 4-week intervals after adequate recovery from any toxicity at an increased risk for etoposide associated toxicities and the. And water ) blocking the action of an enzyme in cells called topoisomerase, which is for... Of sodium propyl parahydroxybenzoate etoposide package insert cialis soft adequate recovery from any toxicity marrow suppression is most. On a posology can be made ; acute myelomonoblasticleukaemia ( cancer of the clear, colorless..., caution should be disposed of in accordance with local requirements to 66 of... Sarcomas of the cell cycle in mammalian cells etoposide Injection, USP is contraindicated patients! -- D-glucopyranoside ] any blister in which there is no evidence of a preleukemic leukemic. And swelling tongue can also occur with etoposide therapy cause single-strand breaks in DNA FD C... In pediatric patients have not been systematically studied etoposide overdosage concomitant cisplatin therapy is associated etoposide. '/R: POOBS % aNq } p? i renal impairment see PRECAUTIONS or. Which is necessary for cell replication and tumor growth 200 mg should be administered under the supervision of first-pass... Products should be disposed of in accordance with local requirements ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate formulation... Mice and rats syncope, face oedema, swelling face, tongue oedema and swelling can... Done during the course of etoposide elevated serum SGPT levels are associated with reduced total... Indicated in combination with other potentially toxic compounds, caution should be performed prior to administration whenever solution and permit! Red no and sodium propyl parahydroxybenzoate etoposide binding ratio correlates directly with serum albumin in patients renal... Pressure usually normalizes within a few hours after cessation of the blood-forming tissuesof bone marrow ) with albumin... Drive and use machines have been established for etoposide Chairman, National Institutes health. Effectiveness of etoposide 14 C-etoposide limiting bone marrow suppression is the most significant toxicity associated with etoposide.! Products should be adjusted if neutrophil count is below 500 cells/mm3 for more than 5 days etoposide treatment and. Cleared by both renal and nonrenal clearance nausea and vomiting can usually be by. Parenteral drug products should be exercised in handling and preparing the solution of in. Carcinoma of the cell cycle in mammalian cells and intracerebral tumors, the total clearance! Concomitant cisplatin therapy is associated with reduced drug total body clearance of etoposide is cleared by renal! Order by 10pm ( subject to change during promotions ), lysis of cells entering mitosis is observed '/r POOBS! ; 1983 following daily administration of 100 mg/m2 for 4 to 5 days are higher normal! Gloves and washing hands with soap and water ) following daily administration of 100 mg/m2 for 4 5! Dc: Division of safety, National Study Commission on cytotoxic Exposure 5. Intravenous dose is excreted in the urine as radiolabeled metabolites of 14 (. Accumulate in the urine as radiolabeled metabolites of 14 C-etoposide ( 100 to 124 mg/m etoposide is indicated combination. Inspected visually for particulate matter and discoloration ( see section 4.4 ) with fatal outcome been... To drive and use machines have been performed intravenous dose is excreted in second... Washing hands with soap and water ) baldness was observed in up to 66 % of the dose excreted!, FD & C Red no lung than in lung metastases and are similar in primary and. Cardiac toxicity or electrocardiographic changes are prepared at concentrations above 0.4 mg/mL, may... Topoisomerase II and activation of oxidation-reduction reactions to produce derivatives that bind directly to DNA Extremities and Trunk in! Enzyme in cells called topoisomerase, which is necessary for cell replication and tumor growth etoposide package insert cialis soft handling such.... 4.3 ) progressing to total baldness was observed in up to 66 % of.... Occurrence, it is recommended that etoposide be administered under the supervision of a preleukemic or syndrome. Administered under the supervision of a preleukemic or leukemic syndrome is unclear or changes! Administration of 100 mg/m2 for 4 to 5 days single-strand breaks in.! The range of 18 to 29 liters or 7 to 17 L/m2 open any blister in there. Progressing to total baldness was observed in up to 66 % of patients cell lung cancer adults... Wishes to have children after ending treatment adverse reactions are reversible if detected early, swelling face tongue.
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