Etoposide is administered orally or intravenously iv. Etoposide injection, usp fresenius kabi usa, llc revision. Severe myelosuppression with resulting infection or bleeding may occur. Etopophos etoposide phosphate for injection is an antineoplastic agent which is available for intravenous infusion as a sterile lyophile in singledose vials containing etoposide phosphate equivalent to 100 mg etoposide. In study 1, grade 3 peripheral neuropathy occurred in 8% 40503 of patients, and grade 4 in 0. Product information vepesidtm etoposide description vepesid etoposide. Etopophos etoposide phosphate for injection is an antineoplastic agent which is available for. They must be swallowed whole with a glass of water. Less than 50% of an intravenous dose is excreted in the urine as etoposide with mean recoveries of 8% to 35% within 24 hours. The mean renal clearance of etoposide is 7 mlminm 2 to 10 mlminm 2 or about 35% of the total body clearance over a dose range of 80 mgm 2 to 600 mgm 2. In small cell lung cancer, the recommended dose of etoposide.
Highlights of prescribing information pneumonia pcp pcp. Following completion of 4 cycles of carboplatin and etoposide, administer 840 mg. Temodar temozolomide is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. Etopophos etoposide phosphate for injection is an antineoplastic agent which is available for intravenous infusion as a sterile lyophile in singledose vials containing etoposide phosphate equivalent to 100 mg etoposide, 32. Response rates, response duration, time to progression, and survival are shown in. Etoposide capsules, usp are available as 50 mg opaque dark pink, oblong capsules. It is still unclear, however, if the induction of autophagic processes by etoposide causes cell death or plays a prosurvival function. Etoposide capsule fda prescribing information, side effects. Cytarabine injection, an antineoplastic, is a sterile solution of cytarabine for intravenous and subcutaneous use which contains no preservative and is available in 20 mgml mg50 ml pharmacy bulk package. Etoposide vp16 is the first agent recognized as a topoisomerase ii inhibitor of anticancer drug with ic50 of 59. It is 4demethylepipodophyllotoxin 94,60rethylidene.
Teniposide injection fda prescribing information, side. In small cell lung cancer, the etoposide injection dose in combination with other approved chemotherapeutic drugs ranges from 35 mgm2day for 4 days to 50 mgm2day for 5 days. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively. Etoposide is a topoisomerase ii inhibiting anticancer drug, derived from podophyllotoxin. Teniposide differs from etoposide, another podophyllotoxin derivative, by the substitution of a thenylidene group on the glucopyranoside ring.
Jan 19, 2015 etoposide is a wellknown trigger of apoptotic pathways but recent findings suggest its involvement in autophagic pathways as well. Vepesid fda prescribing information, side effects and uses. Toposar etoposide injection, usp also commonly known as vp16 is a. Etoposide capsule fda prescribing information, side.
Withhold or discontinue imfinzi to manage adverse reactions as described in table 2. Etoposide injection, usp is available for intravenous use as 20 mgml solution in 100 mg 5 ml, 500 mg 25 ml, and 1 g 50 ml sterile, multipledose vials. Each ml contains 20 mg etoposide usp, 2 mg citric acid, 30 mg benzyl alcohol. After intravenous administration of 3hetoposide 70 to 290 mgm2, mean recoveries of radioactivity in the urine range from 42% to 67%, and fecal recoveries range from 0% to 16% of the dose. The mean renal clearance of etoposide is 7 to 10 mlminm 2 or about 35% of the total body clearance over a dose range of 80 to 600 mgm 2. Each liquid filled, soft gelatin capsule contains 50 mg of etoposide, usp in a vehicle consisting of citric acid anhydrous, glycerol and polyethylene glycol.
Etoposide derives from podophyllotoxin, a toxin found in the american mayapple. The product catalog provides you with a full listing of tevas brand and generic product lines. If your skin feels dry, try using an unperfumed moisturising cream every day. You may get mouth sores 7 to 10 days after this drug is given. At high concentrations 10 mcgml or more, lysis of cells entering mitosis is observed. Information for the patient vepesid 50 mg and 100 mg capsules, soft etoposide read all of this leaflet carefully before you start taking this medicine because it contains important. Nov 21, 2019 vepesid etoposide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Gleevec imatinib mesylate tablets, for oral use initial u. Etoposide is highly proteinbound 97%, primarily to albumin. Package when stored under refrigeration 2 to 8c 3646f in the.
Etoposide has been shown to be teratogenic in mice and rats. Toposar etoposide injection, usp also commonly known as vp16 is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. Ifex ifosfamide for injection, usp singledose vials for constitution and administration by intravenous infusion each contain 1 gram or 3 grams of sterile ifosfamide. The usual dose of vepesid is 100 to 200 mg per m2of body surface area for 5 days in a row or 200 mgm2day on days 1, 3 and 5 every 3 to 4 weeks. Vepesid capsules are soft gelatin capsules containing 50 or 100mg etoposide. It has significant therapeutic activity in childhood leukemia, testicular tumors, hodgkins disease, large cell lymphomas and small cell lung cancer sclc. If you have any further questions, ask your doctor or pharmacist. Temodar temozolomide is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with. Elderly patients in this study also had more anorexia, mucositis, dehydration, somnolence, and elevated bun levels than younger patients. Dailymed etopophos etoposide phosphate injection, powder. If the stage of the cancer is limited stage, it can be given along with radiation for the goal of cure. Vepesid etoposide also commonly known as vp16 is a semisynthetic derivative of podophyllotoxin.
It will return to its normal colour after you finish treatment. The ph of the clear, nearly colorless to yellow liquid is 3 to 4. Etoposide has been shown to cause metaphase arrest in chick fibroblasts. Information for the patient vepesid 50 mg and 100 mg capsules, soft etoposide read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Etoposide, therefore, is cleared by both renal and nonrenal processes, i.
The dose of vepesid is based on the recommended dose for the intravenous etoposide medicines, with a 100 mg oral dose being comparable to a 75 mg intravenous one. Oct 12, 2017 the mean renal clearance of etoposide is 7 to 10 mlminm 2 or about 35% of the total body clearance over a dose range of 80 to 600 mgm 2. Oral treatment with etoposide in small cell lung cancer. Important safety information serious and sometimes fatal adverse reactions occurred with tecentriq treatment. Keep them in the original package and at room temperature, away from heat and direct sunlight. It was first synthesized in 1966 and approved for cancer therapy in 1983 by the u.
No proven antidotes have been established for etoposide overdosage. However, if the stage of the cancer is extensive stage or if you have received prior therapy and the cancer has relapsed returned, it is not commonly. Highlights of prescribing information when administering. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each. Mild to moderate exercise can also help you maintain your energy. For recommended dosing adjustments in patients with renal impairment see package insert. Etoposide package insert pdf chemotherapy organic compounds. Etoposide is a prescription medicine used in combination with other chemotherapy drugs to treat certain types of cancer.
Accidental release measures contain spill and collect, as appropriate. Depending on the particular form of the medication being used, this drug can help treat small cell lung cancer or testicular cancer in adults. Emcyt capsules are white and opaque, each containing estramustine phosphate sodium as the disodium salt monohydrate equivalent to 140 mg estramustine phosphate, for oral administration. Highlights of prescribing information these highlights do not. Etoposide fda prescribing information, side effects and uses. Emcyt estramustine phosphate sodium capsules description. Etoposide capsule dosage and administration etoposide capsules. Highlights of prescribing information tafinlar with. A ternary complex with dna is formed by etoposide, and causes dna strands to break 1. Teniposide is a semisynthetic derivative of podophyllotoxin. Etoposide capsules should be taken on an empty stomach. It is very soluble in methanol and chloroform, slightly. Tecentriq, in combination with carboplatin and etoposide, is indicated for the firstline treatment of adult patients with extensivestage small cell lung cancer essclc. Biliary excretion of unchanged drug andor metabolites is an important route of etoposide elimination as fecal recovery of radioactivity is 44% of the intravenous.
Etoposide capsules etoposide dose, indications, adverse. Interrupt empliciti elotuzumab for grade 2 or higher and permanently discontinue for severe infusion reaction. Ifosfamide is a chemotherapeutic agent chemically related to the nitrogen mustards and a synthetic analog of cyclophosphamide. Following completion of 4 cycles of carboplatin and etoposide, administer 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks.
Its main effect, however, appears to be at the g2 portion of the cell cycle in mammalian cells. The activity of the topoisomerase ii enzyme on religation of dna strands is interrupted by etoposide. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Mar 23, 2020 etoposide may be administered either intravenously or orally. Etoposide phosphate is a phosphate ester of etoposide, a semisynthetic derivative of podophyllotoxin. Etoposide injection usp can cause fetal harm when administered to a pregnant woman. Monitor for fever and other signs of infection and treat promptly. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for toposar etoposide. Etopophos is available for intravenous infusion as a sterile lyophilized powder in singledose vials for reconstitution containing 114 mg etoposide phosphate, equivalent to 100 mg etoposide, 32. May 02, 2019 etoposide phosphate is a phosphate ester of etoposide, a semisynthetic derivative of podophyllotoxin. In five singleagent studies of etoposide phos phate in patients with a variety of tumor types, 34% of patients were age 65 years or. Whenadministering with carboplatin and etoposide,administer tecentriq1200mg every 3 weeksprior to chemotherapy. Vepesid, vp16 y etoposide eetopawside is a drug that is used to treat many types of cancers.