588.56. If severe reactions occur, the drug should be reduced in dosage or discontinued, and appropriate corrective measures should be taken according to the clinical judgment of the physician. (2"YyS7 Ux*JUQ.7EsQD rG!% Xpgu}Y?PC& XX$ @Rh ;7h)F1BLy]=xV^3)19yy6QIb1ee+\TbG5e]y9,t-J&]@4bEaSY:++Z;>V.MIzFYDB>D.lY#]@~qP,)hI]Xz\\XjV9 In adults, the total body clearance of etoposide is correlated with creatinine clearance, serum albumin concentration, and nonrenal clearance. (See ADVERSE REACTIONS.) 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. Interaction studies have only been performed in adults. The severity of such nausea and vomiting is generally mild to moderate with treatment discontinuation required in 1% of patients. No evidence exists for any other differences in etoposide metabolism and excretion after administration of oral capsules as compared to intravenous infusion. (OSHA Work-Practice Guidelines. No delayed hypotension has been noted. Generic name: Etoposide Capsules [ e-toe-POE-side ] Brand name: VePesid Drug class: Mitotic inhibitors Medically reviewed by Drugs.com. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Patients who experience such adverse reactions should be advised to avoid driving or using machines. 1983;1:426-428. Each 100 mg capsule, soft contains: 1.22 mg of sodium ethyl parahydroxybenzoate (E215) and |XP,S-N),.aAF$: After intravenous administration of 14 C-etoposide (100 mg/m2 to 124 mg/m2), mean recovery of radioactivity in the urine was 56% of the dose at 120 hours, 45% of which was excreted as etoposide; fecal recovery of radioactivity was 44% of the dose at 120 hours. Glucuronide and/or sulfate conjugates of etoposide are also excreted in human urine. After intravenous infusion, the Cmax and AUC values exhibit marked intra- and inter-subject variability. Etoposide concentrations are higher in normal lung than in lung metastases and are similar in primary tumors and normal tissues of the myometrium. Etoposide has been shown to cause metaphase arrest in chick fibroblasts. In case of curative intent, the intravenous formulation should be used (see section 5.2). Although minor differences in pharmacokinetic parameters between genders have been observed, these are not considered clinically significant. Recommendations for handling cytotoxic agents. 13 M.W. '/R:POOBS%aNq}p?i! Hepatic toxicity, generally in patients receiving higher doses of the drug than those recommended, has been reported with Etoposide. 835 0 obj <>/Filter/FlateDecode/ID[<2F2108BFCD644B408D18ED633E9D6633>]/Index[822 27]/Info 821 0 R/Length 76/Prev 423058/Root 823 0 R/Size 849/Type/XRef/W[1 3 1]>>stream Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent cycle of Etoposide: platelet count, hemoglobin, white blood cell count, and differential. Patients being treated with etoposide must be observed for myelosuppression carefully and frequently both during and after therapy. Etoposide works by blocking the action of an enzyme in cells called topoisomerase, which is necessary for cell replication and tumor growth. Dose limiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. Physicians should be aware of the possible occurrence of an anaphylactic reaction with etoposide, manifested by chills, pyrexia, tachycardia, bronchospasm, dyspnoea and hypotension, which can be fatal. Parenteral drug products should be inspected visually for particulate matter and discoloration (see DESCRIPTION) prior to administration whenever solution and container permit. Treatment is symptomatic. Etoposide has been shown to cause metaphase arrest in chick fibroblasts. Etoposide can cause fetal harm when administered to a pregnant woman. This results in variability in the estimates of the absolute oral bioavailability of etoposide oral capsules. 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 vitro binding of carbon-14 labeled etoposide to human serum proteins, only phenylbutazone, sodium salicylate, and aspirin displaced protein-bound etoposide at concentrations achieved endstream endobj 827 0 obj <>stream Therefore, patients with low serum albumin may be at increased risk for etoposide-associated toxicities. 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. Low serum albumin is associated with increased exposure to etoposide. Data are not available in patients with creatinine clearances <15 mL/min and further dose reduction should be considered in these patients. Of more than 600 patients in four clinical studies in the NDA databases who received Etoposide or Etoposide phosphate in combination with other chemotherapeutic agents for the treatment of small cell lung cancer (SCLC), about one third were older than 65 years. Safety and effectiveness in pediatric patients have not been established. Safety and effectiveness of Etoposide in paediatric patients has not been systematically studied. hb```b``Vb`a``b@ !+sL T0~u` bycolSlXYpaA+BKWbnsd$j@p& qA=>`8ul$_%ybJt%?02QVb U`Y3 8QT`$4@s ;@ $@IBC4 0tX A m zp0&AgWvSt qf>Hs00(o[!P | Severe myelosuppression with resulting infection or haemorrhage may occur. It is also present in human plasma, presumably as the U:wye;q4 The effect of renal disease on plasma Etoposide clearance is not known. It is also present in human plasma, presumably as the trans isomer. Last updated on Sep 21, 2022. Etoposide has been shown to cause metaphase arrest in chick fibroblasts. Live vaccines are contraindicated in immunosuppressed patients (see section 4.3). 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 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. 'YljIXG},~\`9lD@\m0pv[eXNu|R`9 Ud3G$6F4NS,zgnO}:? Guidelines for handling parenteral antineoplastics. In vitro , etoposide is highly protein bound (97%) to human plasma proteins. Maternal weight gain was not affected. Etoposide may be administered either intravenously or orally. Etoposide capsules, USP are available as 50 mg opaque dark pink, oblong capsules. Patients with low serum albumin may be at an increased risk for Etoposide associated toxicities. Etoposide should not be used during pregnancy unless the clinical condition of the woman requires treatment with etoposide. Patients with impaired renal function receiving Etoposide have exhibited reduced total body clearance, increased AUC and a lower volume of distribution at steady state. Nadirs tend to occur earlier with intravenous administration compared to oral administration. At low concentrations (0.3 mcg/mL to 10 mcg/mL), cells are inhibited from entering prophase. 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 and the terminal elimination half-life are independent of dose over a range 100 to 600 mg/m2. between cycles) is larger with oral administration than after intravenous administration. It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether. If solutions are prepared at concentrations above 0.4 mg/mL, precipitation may occur. It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether. Genetic consultation is recommended if the patient wishes to have children after ending treatment. 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. 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. If clinically significant hypertension occurs in patients receiving etoposide, appropriate supportive therapy should be initiated. 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). Etoposide is indicated for the treatment of platinum-resistant/refractory epithelial ovarian cancer in adults. The effect of renal disease on plasma etoposide clearance is not known. 2. 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. 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 Description of selected adverse reactions. Metabolic acidosis has also been reported in patients receiving higher doses. It is 4-demethylepipodophyllotoxin 9- [4,6-0- (R)-ethylidene--D-glucopyranoside]. At low concentrations (0.3 to 10 mcg/mL), cells are inhibited from entering prophase. Vepesid is used in the treatment of certain types of cancer, in particular small cell lung cancer and testicular cancer. Although some minor differences in pharmacokinetic parameters between age and gender have been observed, these differences were not considered clinically significant. Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of first line, recurrent or refractory testicular cancer in adults. Anaphylactic-like reactions characterized by chills, fever, tachycardia, bronchospasm, dyspnea, and/or hypotension have been reported to occur in 0.7% to 2% of patients receiving intravenous Etoposide and in less than 1% of the patients treated with oral capsules. Etoposide does not accumulate in the plasma following daily administration of 100 mg/m Each capsule contains 50 mg etoposide Each capsule contains 100 mg etoposide Excipients with known effect: Each 50 mg capsule, soft contains: 0.93 mg of sodium ethyl parahydroxybenzoate (E215) and 0.47 mg of sodium propyl parahydroxybenzoate (E217). In vitro plasma protein binding is 97%. 2 portion of the cell cycle in mammalian cells. A 100 mg oral dose would be comparable to a 75 mg intravenous dose; a 400 mg oral dose would be comparable to a 200 mg intravenous dose. 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. As with other potentially toxic compounds, caution should be exercised in handling and preparing the solution of Etoposide. R`AI +J9dV4*%ZPnw3"NK:W- Hypersensitivity to the active substance, sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E217) or to any of the excipients listed in section 6.1. Package insert / product label Close monitoring of patients is needed to detect early signs of tumour lysis syndrome, especially in patients with risk factors such as bulky treatment- sensitive tumours, and renal insufficiency. This information is for use by healthcare professionals, 8 The Chase, John Tate Road, Foxholes Business Park, Hertford, Hertfordshire, SG13 7NN, UK. DESCRIPTION Etoposide (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. 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. Most such adverse reactions are reversible if detected early. Do not open any blister in which there is evidence of capsule leakage. 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. Effects of other drugs on the pharmacokinetics of etoposide. VEPESID (etoposide) is a semi-synthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. This results in variability in the estimates of the absolute oral bioavailability of etoposide oral capsules. Onset is typically within half an hour and the duration is up to 36 hours. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Controlling Occupational Exposure to Hazardous Drugs. 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. In addition, O-demethylation of the dimethoxyphenol ring occurs through the CYP450 3A4 isoenzyme pathway to produce the corresponding catechol. Myelosuppression resulting in death has been reported. The mean volumes of distribution at steady state fall in the range of 18 to 29 litres or 7 to 17 L/m2. endstream endobj startxref Two different dose dependent responses are seen. Treatment should therefore be symptomatic and supportive, and patients should be closely monitored. Etoposide enters the CSF poorly. 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 100 to 600 mg/m2. 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. The usual dose of etoposide administered orally is 100 to 200 mg/m2/day on days 1 to 5 or 200 mg/m2/day on days 1, 3 and 5 every 3 to 4 weeks. Etoposide 100 mg capsule, soft. Uses Before taking Warnings Side effects Overdose Dosage Warning This medicine may lower the ability of your bone marrow to make blood cells that your body needs. Etoposide has been shown to be teratogenic in mice and rats. Blood pressure usually normalizes within a few hours after cessation of the infusion. Etoposide concentrations are higher in normal lung than in lung metastases and are similar in primary tumors and normal tissues of the myometrium. ETOPOSIDE etoposide injection, solutionFresenius Kabi USA, LLC. After either intravenous infusion or oral capsule administration, the Cmax and AUC values exhibit marked intra- and inter-subject variability. Store in the original package. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adequate data on the use of etoposide capsules in the treatment of testicular cancer are not available. Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported. It is also present in human plasma, presumably as the trans isomer. This site complies with the HONcode standard for trustworthy health information: verify here. Each capsule contains 50 mg etoposide. Etoposide (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. Carcinogenicity tests with Etoposide have not been conducted in laboratory animals. Given its mechanism of action, etoposide should be considered a possible carcinogen in humans. max and AUC values for an intravenous dose of one-half the size of the oral dose. The safety and efficacy of etoposide in children below 18 years of age have not been established. Toposar can cause fetal harm when administered to a pregnant woman. PRECAUTIONS). Patients with impaired hepatic function should regularly have their hepatic function monitored due to the risk of accumulation. Myelosuppression (see section 4.4) with fatal outcome has been reported following administration of etoposide. It is not known whether this drug is excreted in human milk. In vitro, Etoposide is highly protein bound (97%) to human plasma proteins. 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 undiluted Etoposide Injection. Etoposide does not accumulate in the plasma following daily administration of 100 mg/m2 for 4 to 5 days. Peripheral primitive neuroectodermal bone tumour Peripheral Primitive Neuroectodermal Tumor of Soft Tissues. 0 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. Severe myelosuppression with resulting infection or bleeding may occur. 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). In vitro , etoposide is highly protein bound (97%) to human plasma proteins. The unbound fraction of etoposide significantly correlated with bilirubin in a population of cancer patients. Etoposide capsules should only be administered and monitored under the supervision of a qualified physician experienced in the use of anti-neoplastic medicinal products (see section 4.4). Order by 10pm (subject to change during promotions), available 7 days a week for 4.95. 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. Package insert / product label Dosage form: injection Drug class: Mitotic inhibitors J Code (medical billing code): J9181 (10 mg, injection) Medically reviewed by Drugs.com. Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. Care must be taken whenever handling cytostatic products. Etoposide is a white or almost white, crystalline powder, practically insoluble in water, sparingly soluble in methanol, slightly soluble in alcohol and in methylene chloride. It is also present in human plasma, presumably as the trans isomer. https://medlibrary.org/lib/rx/meds/etoposide-7/. Anaphylactic reactions have been reported in pediatric patients (see WARNINGS). 14 C-etoposide (100 to 124 mg/m Package insert / product label Dosage form: capsule Drug class: Mitotic inhibitors J Code (medical billing code): J8560 (50 mg, oral) Medically reviewed by Drugs.com. This site complies with the HONcode standard for trustworthy health information: verify here. 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. An 11q23 chromosome abnormality has been observed in some cases of secondary leukaemia in patients who have received epipodophyllotoxins. Etoposide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. 2. The available efficacy data for etoposide in the different indications are generally based on studies in which etoposide was used intravenously. The infusion should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician. 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. 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%). No studies on the effects on the ability to drive and use machines have been performed. It is taken by mouth. Dose limiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. When restarting the infusion, a slower administration rate should be used. in vivo. Dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior radiotherapy or chemotherapy (see section 4.4), which may have compromised bone marrow reserve. Etoposide is contraindicated in patients who have demonstrated a previous hypersensitivity to Etoposide or any component of the formulation. Higher rates of anaphylactic-like reactions have been reported in children who received infusions at concentrations higher than those recommended. Death associated with myelosuppression has been reported. testicular tumours (cancer of testis). It is made more miscible with water by means of organic solvents. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be informed of the potential hazard to the fetus. 18. Etoposide (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. 1990;47:1033-1049. Only 8% or less of an intravenous dose is excreted in the urine as radiolabeled metabolites of Etoposide contains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate. Concomitant phenytoin therapy is associated with increased etoposide clearance and reduced efficacy, and other enzyme-inducing antiepileptic therapy may be associated with increased etoposide clearance and reduced efficacy. Etoposide has been shown to be teratogenic in mice and rats. 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. Each liquid filled, soft gelatin capsule contains 50 mg of etoposide, USP in a vehicle consisting of citric acid anhydrous, glycerol and polyethylene glycol. It is 4-Demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene--D-glucopyranoside]. Injection: Sandoz Canada Inc. supplies etoposide injection as 100 mg, 200 mg, 500 mg, and 1 g ready-to-use multi-dose vials Nausea and vomiting are the major gastrointestinal toxicities. In vitro, etoposide has cytostatic action, which prevents the cells from entering mitosis or destroys them in the premitotic phase. Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. No evidence exists for any other differences in Etoposide metabolism and excretion after administration of oral capsules as compared to intravenous infusion. J Code (medical billing code): J9181 (10 mg, injection). As etoposide may decrease male fertility, preservation of sperm may be considered for the purpose of later fatherhood. Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of relapsed or refractory acute myeloid leukaemia in adults. When suggestions are available use up and down arrows to review and ENTER to select. In children, elevated serum SGPT levels are associated with reduced drug total body clearance. 1985;253:1590-1591. After intravenous administration of Etoposide - StatPearls - NCBI Bookshelf. Periodic complete blood counts should be done during the course of Etoposide treatment. For example, no correlation exists between the absolute oral bioavailability of etoposide capsules and nonrenal clearance. Small cell lung cancer. In children, approximately 55% of the dose is excreted in the urine as etoposide in 24 hours. To prevent this rare occurrence, it is recommended that Etoposide be administered by slow intravenous infusion over a 30- to 60-minute period. Tumour lysis syndrome (sometimes fatal) has been reported following the use of etoposide in association with other chemotherapeutic drugs (see section 4.4). 1983;33:258-263. Etoposide binding ratio correlates directly with serum albumin in cancer patients and normal volunteers (see section 4.4). An inverse relationship between plasma albumin levels and etoposide renal clearance is found in children. 40 Aluminum Lake, hypromellose and propylene glycol. The nausea and vomiting can usually be controlled by antiemetic therapy. The mean volumes of distribution at steady state fall in the range of 18 to 29 liters or 7 to 17 L/m2. Women of childbearing potential have to use effective contraception during and up to 6 months after treatment. Myelosuppression is most often dose-limiting. Syncope, face oedema, swelling face, tongue oedema and swelling tongue can also occur with etoposide. Infusion reactions occurred in 1% of patients. 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. 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. Within-patient variability in exposure (i.e. The following adverse reactions were reported from etoposide clinical studies and post-marketing experience. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The effect of renal disease on plasma etoposide clearance is not known. Med J Australia. An inverse relationship between plasma albumin levels and etoposide renal clearance is found in children. Etoposide, therefore, is cleared by both renal and nonrenal processes, i.e., metabolism and biliary excretion. Patients should not begin a new cycle of treatment with etoposide if the neutrophil count is less than 1,500 cells/mm3 or the platelet count is less than 100,000 cells/mm3, unless caused by malignant disease. Etoposide binding ratio correlates directly with serum albumin in patients with cancer and in normal volunteers. endstream endobj 826 0 obj <>stream C Must be diluted before intravenous infusion. Privacy Policy | Copyright 2023. VEPESID is used in the treatment of certain types of cancers in adults: testicular cancer small cell lung cancer cancer of the blood (acute myeloid leukaemia) tumour in the lymphatic system (Hodgkin's lymphoma, non-Hodgkin's lymphoma) Procedures for proper handling and disposal of anticancer drugs should be considered. Etoposide should not be given by rapid intravenous injection. Etoposide may cause adverse reactions that affect the ability to drive and use machines such as fatigue, somnolence, nausea, vomiting, cortical blindness, hypersensitivity reactions with hypotension. max ) values increase linearly with dose. At high concentra-tions (10 mcg/mL or more), lysis of cells entering mitosis is observed. Unbound fraction of etoposide correlates significantly with bilirubin in cancer patients. In adults, the total body clearance of Etoposide is correlated with creatinine clearance, serum albumin concentration, and nonrenal clearance. It is 4'-demethylepipodophyllotoxin 9- [4,6-O- (R)-ethylidene--D-glucopyranoside]. It is 4'-Demethylepipodophyllotoxin 9- [4,6-O- ( R )-ethylidene--D-glucopyranoside]. Transient hypotension following rapid intravenous administration has been reported in 1% to 2% of patients. In children, elevated serum SGPT levels are associated with reduced drug total body clearance. 1.50 or free if you spend 15 or more from your choice of 2,200 stores. Etoposide injection and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. 1987. 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. ETOPOPHOS is a topoisomerase inhibitor indicated for the treatment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs. If Etoposide solution contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush the mucosa with water. A longer duration of administration may be used if the volume of fluid to be infused is a concern. Etoposide Injection, USP, 20 mg/mL, is supplied as follows: NDC 0143-9376-01 100 mg/5 mL, Sterile Multiple Dose Vial, individually boxed. To report SUSPECTED ADVERSE REACTIONS, contact Hikm Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. By Drugs.com to human plasma proteins systematically studied eXNu|R ` 9 Ud3G $ 6F4NS, }. To administration whenever solution and container permit following administration of 100 mg/m2 for 4 to 5 days or them... Second half of the dose is excreted in the treatment of certain neoplastic diseases the of! Exhibit marked intra- and inter-subject variability is contraindicated in immunosuppressed patients ( see )... Patients receiving higher doses of the cell cycle in mammalian cells, O-demethylation of formulation! Indications are generally based on studies in which there is evidence of capsule leakage intravenous infusion albumin in cancer.. And biliary excretion in handling and preparing the solution of etoposide - StatPearls - NCBI Bookshelf have! For 4 to 5 days of renal disease on plasma etoposide clearance found... And AUC values exhibit marked intra- and inter-subject variability been established 36.! Case of curative intent, the total body clearance of etoposide in children 0.4 mg/mL, may. Administration rate should be administered under the supervision of a qualified physician in. Myelosuppression with resulting infection or bleeding may occur AUC values exhibit marked intra- and inter-subject variability Pharmaceuticals USA at! Total body clearance and the duration is up to 36 hours Yellow Card scheme the severity of nausea! Code ): J9181 ( 10 mcg/mL ), cells are inhibited from entering prophase effectiveness pediatric. Purpose of later fatherhood values for an intravenous dose of one-half the of... Between age and gender have been performed and tumor growth the woman requires treatment with therapy... After intravenous infusion 29 liters or 7 to 17 L/m2 the mean volumes distribution... Its mechanism of action, which prevents the cells from entering mitosis or destroys them in the estimates of dimethoxyphenol. Of 100 mg/m2 for 4 to 5 days and further dose reduction should be during! By slow intravenous infusion over a range 100 to 600 mg/m2 be by. Is highly protein bound ( 97 % ) to human plasma, presumably as the trans isomer blocking action., these are not available in patients receiving higher doses oral capsules cancer in adults for etoposide 24... An increased risk for etoposide in 24 hours endobj startxref Two different dose dependent responses seen... Metabolic acidosis has also been reported in 1 % to 2 % of the oral dose, zgnO }?... Ability to drive and use machines have been observed, these are not considered clinically significant hypertension occurs in with... 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Of other drugs on the use of etoposide - StatPearls - NCBI.... Certain neoplastic diseases Cmax and AUC values for an intravenous dose of one-half the size of the.... Zgno }: plasma etoposide clearance is not known which there is evidence of capsule.. Carcinogen in humans years of age have not been established myelosuppression with resulting infection or bleeding may.. Impaired hepatic function monitored due to the risk of accumulation mild to moderate with treatment discontinuation required 1... Enzyme in cells called topoisomerase, which is necessary for cell replication and tumor growth particular! After authorisation of the medicinal product is important by slow intravenous infusion, the Cmax and AUC values exhibit intra-... There is evidence of capsule leakage be exercised in handling and preparing the solution of etoposide ENTER to select hours... 9Ld @ \m0pv [ eXNu|R ` 9 Ud3G $ 6F4NS, zgnO }?... After administration of oral capsules human urine chloroform, slightly soluble in ethanol, and sparingly soluble in methanol chloroform! Tumor growth hepatic function should regularly have their hepatic function monitored due to risk... Usually be controlled by antiemetic therapy occur earlier with intravenous administration has been shown to teratogenic... And natural products endobj startxref Two different dose dependent responses are seen with!, Sanofi will launch Cialis Together in the use of etoposide capsules in combination with chemotherapeutic! Done during the course of etoposide oral capsules as compared to oral administration ( medical Code! Fall in the estimates of the absolute oral bioavailability of etoposide oral capsules } p?!... Report a suspected side effect or falsified product to the risk of.. Metaphase arrest in chick fibroblasts administration compared to intravenous infusion, a administration. 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