Anaphylactic reactions have been reported in pediatric patients (see Mild to severe mucositis/esophagitis may occur. If severe hematologic toxicity occurs, consider supportive therapy, antibiotics for complicating infections, and blood product transfusions. Mild to severe mucositis/esophagitis may occur. 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. Etoposide Injection USP is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Patients being treated with etoposide Injection USP must be frequently observed for myelosuppression both during and after therapy. Component of various combination chemotherapeutic regimens for treatment of refractory testicular tumors in patients who have already received appropriate surgery, chemotherapy, and radiation therapy. 2 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. Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported. Procedures for proper handling and disposal of anticancer drugs should be considered. In rats, an intravenous etoposide dose of 0.4 mg/kg/day (about 1/20th of the human dose on a mg/m Stable for 2 years refrigerated at 28C. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. May be useful for treatment of hepatoma. Glucoronide and/or sulfate conjugates of etoposide are also excreted in human urine. Although some minor differences in pharmacokinetic parameters between age and gender have been observed, these differences were not considered clinically significant. For solution and drug compatibility information, see Compatibility under Stability. Twice the IV dosage rounded to the nearest 50 mg is recommended. Bavla Road, Ta. Files, All Mapping Commonly used brand name (s) In the U.S. Etopophos Vepesid In Canada Dom-Etoposide Eposin Etoposide Pms-Etoposide Available Dosage Forms: Etoposide, therefore, is cleared by both renal and nonrenal processes, i.e., metabolism and biliary excretion. Etoposide Injection USP should be considered a potential carcinogen in humans. At high concentrations (10 mcg/mL or more), lysis of cells entering mitosis is observed. is this? It has not been associated with cardiac toxicity or electrocardiographic changes. Several guidelines on this subject have been published1-8. Total body clearance values range from 33 mL/min to 48 mL/min or 16 mL/min/m2 to 36 mL/min/m2 and, like the terminal elimination half-life, are independent of dose over a range 100 mg/m2 to 600 mg/m2. Following oral administration, about 525% of the dose is excreted in urine within 2448 hours. It has a molecular weight of 588.58 and a molecular formula of C Observe closely for possible hypotensive reactions. This patient information sheet applies only to approved uses of the drug. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: Arm A (HLX10): HLX10 + chemotherapy (carboplatin-etoposide) Get Label RSS Feed, Base dosage on the clinical and hematologic response and tolerance of the patient and whether or not other chemotherapy or radiation therapy has been or is also being used in order to obtain optimum therapeutic results with minimum adverse effects. 16729-114-32, Teratogenic Effects: Pregnancy Category D, 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, Procedures for proper handling and disposal, All Drug Rarely extravasation has been associated with necrosis and venous induration. Dosage adjustments may be required. It is not known whether this drug is excreted in human milk. The unbound fraction of etoposide significantly correlated with bilirubin in a population of cancer patients. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Exact mechanism(s) of action is not known; apparently produces cytotoxic effects by damaging DNA and thereby inhibiting or altering DNA synthesis. It has a molecular weight of 588.56 and a molecular formula of C29H32O13. Issued - March 2014 Etoposide Injection USP in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. WARNINGS.). Etoposide enters the CSF poorly. 14C-etoposide. Component of combination chemotherapeutic regimens (e.g., etoposide, ifosfamide, and methotrexate) for treatment of advanced diffuse lymphomas of unfavorable histology (e.g., diffuse histiocytic lymphoma) [off-label]. It is used to treat small cell lung cancer and other cancers. In children, approximately 55% of the dose is excreted in the urine as etoposide in 24 hours. being able to get an erection, but not having it last long enough for sex. Files, Presentations In adults, the total body clearance of etoposide is correlated with creatinine clearance, serum albumin concentration, and nonrenal clearance. Reconstitute vial containing 100 mg of etoposide phosphate powder with 5 or 10 mL sterile water for injection, 5% dextrose injection, 0.9% sodium chloride, bacteriostatic water for injection (with benzyl alcohol), or bacteriostatic sodium chloride for injection (with benzyl alcohol) to provide a solution containing 20 mg etoposide per mL (22.7 etoposide phosphate per mL) or 10 mg etoposide per mL (11.4 mg etoposide phosphate per mL), respectively. Call your doctor for medical advice about side effects. Presence in Breast Milk, Medline Plus, These reactions have usually responded promptly to the cessation of the infusion and administration of pressor agents, corticosteroids, antihistamines, or volume expanders as appropriate; however, the reactions can be fatal. In children, elevated serum SGPT levels are associated with reduced drug total body clearance. Data have suggested a significant Inverse correlation between serum albumin concentration and free fraction of etoposide. Nausea and vomiting are the major gastrointestinal toxicities. Presence in Breast Milk, Medline Plus, After intravenous administration of 3 is an indication to withhold further therapy until the blood counts have sufficiently recovered. 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 PRECAUTIONS). Nausea and vomiting are the major gastrointestinal toxicities. You may report side effects to the FDA at 1-800-FDA-1088. When the consecutive-day dosage regimen is employed, some clinicians administer etoposide for 35 days, depending on the patients hematologic tolerance. Most such adverse reactions are reversible if detected early. Jones RB, et al. Blood pressure usually normalizes within a few hours after cessation of the infusion. It is 4'-demethylepipodophyllotoxin . Bone marrow recovery is usually complete within 20 days after administration, but may occasionally require longer periods. In mice, a single 1 mg/kg (1/16th of human dose on a mg/m Official Label (Printer Friendly) View All Sections BOXED WARNING (What is this?) In a study determining the effect of other therapeutic agents on the Component of a combination chemotherapeutic regimen (e.g., carboplatin with etoposide) as second-line (salvage) therapy for treatment of recurrent (relapsed or refractory) Wilms tumor including recurrent tumors of unfavorable histology, abdominal recurrence after radiation therapy, or recurrence within 6 months of nephrectomy or after initial combination chemotherapy. Death associated with myelosuppression has been reported. 83-2621. The use of gloves is recommended. Rash, urticaria, and/or pruritus have infrequently been reported at recommended doses. At investigational doses, a generalized pruritic erythematous maculopapular rash, consistent with perivasculitis, has been reported. Treatment is symptomatic. Component of a chemotherapeutic regimen with methotrexate, dactinomycin, cyclophosphamide, and vincristine (EMA-CO), or with cisplatin as second-line therapy for gestational trophoblastic tumors (choriocarcinoma). Following IV infusion, excreted principally (4060%) in urine as unchanged drug (2030% within 24 hours, 3045% within 48 hours) and metabolites in 4872 hours. in vivo. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. It is used with cisplatin as first-line therapy. The severity of such nausea and vomiting is generally mild to moderate with treatment discontinuation required in 1% of patients. The incidences of adverse reactions in the table that follows are derived from multiple databases from studies in 2,081 patients when etoposide was used either orally or by injection as a single agent. Vardenafil (marketed as Levitra) Healthcare Professional Sheet (7/2005) FDA Updates Labeling for Viagra, Cialis and Levitra for Rare Post-Marketing Reports of Eye Problems Content current as of: Reinstitute therapy with caution, considering further need for the drug and possible toxicity recurrence. It is a topoisomerase II inhibitor and appears to cause DNA strand breaks. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. In addition, an apparent hypersensitivity-associated apnea has been reported rarely. Other side effects not listed may also occur in some patients. Files, Presentations 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. Has been used alone and in combination chemotherapy for remission induction in refractory acute lymphocytic (lymphoblastic) leukemia (ALL) in a limited number of children; little, if any, activity in adults. Highly toxic drug with a low therapeutic index; therapeutic response is not likely to occur without some evidence of toxicity. The severity of such nausea and vomiting is generally mild to moderate with treatment discontinuation required in 1% of patients. Data are not available in patients with creatinine clearances <15 mL/min and further dose reduction should be considered in these patients. The unbound fraction of etoposide significantly correlated with bilirubin in a population of cancer patients. When restarting the infusion, a slower administration rate should be used. Manufactured by: Geriatric patients may be particularly susceptible to etoposide-induced adverse effects. They should be performed prior to each cycle of therapy and at appropriate intervals during and after therapy. If solutions are prepared at concentrations above 0.4 mg/mL, precipitation may occur. Etoposide does not accumulate in the plasma following daily administration of 100 mg/m2 for 4 to 5 days. Two different dose-dependent responses are seen. Non-Hodgkin's lymphoma. At investigational doses, a generalized pruritic erythematous maculopapular rash, consistent with perivasculitis, has been reported. An IP dose of 1.5 mg/kg (about 1/10th of human dose on a mg/m For example, no correlation exists between the absolute oral bioavailability of etoposide capsules and nonrenal clearance. However, much of the information may also apply to unapproved uses that are being studied. Etoposide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. After treatment with etoposide has ended, normal hair growth should return. It is made more miscible with water by means of organic solvents. Component of a combination chemotherapeutic regimen (ifosfamide, cisplatin, and either etoposide or vinblastine) as second-line therapy for recurrent nonseminomatous testicular carcinoma. No evidence exists for any other differences in etoposide metabolism and excretion after administration of oral capsules as compared to intravenous infusion. WARNINGS). 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 mg/kg/day 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. 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. Drug Interactions High-dose cyclosporin A resulting in concentrations above 2000 ng/mL administered with oral etoposide has led to an 80% increase in etoposide exposure with a 38% decrease in total body clearance of etoposide compared to etoposide . Anaphylactoid reactions consisting principally of chills, rigors, diaphoresis, pruritus, loss of consciousness, nausea, vomiting, fever, bronchospasm, dyspnea, tachycardia, hypertension, and/or hypotension reported. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. After either intravenous infusion or oral capsule administration, the Cmax and AUC values exhibit marked intra- and inter-subject variability. FDA label information for this drug is available at DailyMed. 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. In addition, 0-demethylation of the dimethoxyphenol ring occurs through the CYP450 3A4 isoenzyme pathway to produce the corresponding catechol. 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 (see WARNINGS). View Labeling Archives, 29H A longer duration of administration may be used if the volume of fluid to be infused is a concern. being able to get an erection sometimes, but not every time you want to have sex. Antineoplastic agents (cisplatin, carmustine, cytarabine, cyclophosphamide), Potential additive or synergistic antineoplastic activity, Limited data, further documentation needed; consider potential effect when administering etoposide to patients who received prior cisplatin therapy, Possible decreased total body clearance of etoposide with concomitant use of oral etoposide and high-dose cyclosporine, Inhibitors of phosphatase activity (e.g., levamisole HCl). This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. In addition, an apparent hypersensitivity-associated apnea has been reported rarely. Use of cisplatin therapy is associated with reduced total body clearance. 16729-114-11, 17 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. 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. Two different dose-dependent responses are seen. Thrombocytopenia (less than 50,000 platelets/mm3), Thrombocytopenia (less than 100,000 platelets/mm3). In children, approximately 55% of the dose is excreted in the urine as etoposide in 24 hours. The occurrence of a platelet count below 50,000/mm NDC 16729-114-32250 mg/12.5 mL Sterile, Multiple Dose Vial. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. It has not been associated with cardiac toxicity or electrocardiographic changes. This page contains brief information about etoposide and a collection of links to more information about the use of this drug, research results, and ongoing clinical trials. 150 mg/m2 daily for 3 consecutive days every 4 weeks; repeat cycles of therapy and reduce dosage as necessary depending on the patients response and the myelosuppressive effect of the drug. Dilute required dose of concentrate for injection to a final concentration of 0.2 or 0.4 mg/mL in 0.9% sodium chloride or 5% dextrose injection. In combination with cyclophosphamide and doxorubicin (or vincristine) for treatment of extensive-stage disease. Dose-limiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. 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). ), More about getting RSS News & Updates from DailyMed, Thrombocytopenia (less than 50,000 platelets/mm, Thrombocytopenia (less than 100,000 platelets/mm, 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product, 12.5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product, 25 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product, 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product, manufacture(16729-114) , analysis(16729-114), 5 Events, (What April 19, 2016. It is 4-Demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene--D-glucopyranoside]. Biphasic, may exhibit triphasic elimination with a prolonged terminal phase. To prevent this rare occurrence, it is recommended that etoposide be administered by slow intravenous infusion over a 30- to 60-minute period. Etoposide injection is an chemotherapy anticancer medication used in combination with other chemotherapy medications to treat testicular cancer or small cell lung cancer. (See Renal Impairment under Dosage and Administration.). 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 the oral capsules. Safety and effectiveness in pediatric patients have not been established. Gastrointestinal toxicities are slightly more frequent after oral administration than after intravenous infusion. For more information, see the Drug Information Summary for Etoposide Phosphate. Call your doctor for medical advice about side effects. 4. 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