United States - English - NLM (National Library of Medicine)

e.r. squibb & sons, l.l.c. - etoposide phosphate (unii: 528xyj8l1n) (etoposide - unii:6plq3cp4p3) - etoposide 100 mg - etopophos is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors. etopophos is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer. etopophos is contraindicated in patients with a history of a severe hypersensitivity reaction to etoposide products [see warnings and precautions (5.3)] . risk summary based on animal data and its mechanism of action, etopophos can cause fetal harm when administered to a pregnant woman. etoposide, the active moiety of etoposide phosphate is teratogenic in mice and rats (see data) . advise pregnant women of the potential hazard to a fetus. advise women of childbearing potential to avoid becoming pregnant. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in rats, an intravenous etoposide dose of 0.4 m

Israel - English - Ministry of Health

abic marketing ltd, israel - etoposide - concentrate for solution for infusion - etoposide 20 mg/ml - etoposide - etoposide - hodgkin's disease. malignant (non-hodgkin's) lymphomas, especially of the histiocytic variety.acute non-lymphocytic leukemia. management of refractory testicular tumors and of small cell lung cancer.

Australia - English - Department of Health (Therapeutic Goods Administration)

link medical products pty ltd t/a link pharmaceuticals - etoposide phosphate, quantity: 1136 mg (equivalent: etoposide, qty 1000 mg) - injection, powder for - excipient ingredients: sodium citrate dihydrate; dextran 40 - indications: for use in the treatment of: *small cell carcinoma of the lung *acute monocytic and myelomonocytic leukaemia *hodgkin's disease *non-hodgkin's lymphoma *testicular tumours.

Australia - English - Department of Health (Therapeutic Goods Administration)

link medical products pty ltd t/a link pharmaceuticals - etoposide phosphate, quantity: 567.8 mg (equivalent: etoposide, qty 500 mg) - injection, powder for - excipient ingredients: sodium citrate dihydrate; dextran 40 - indications: for use in the treatment of: *small cell carcinoma of the lung *acute monocytic and myelomonocytic leukaemia *hodgkin's disease *non-hodgkin's lymphoma *testicular tumours.

Australia - English - Department of Health (Therapeutic Goods Administration)

link medical products pty ltd t/a link pharmaceuticals - etoposide phosphate, quantity: 113.6 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; dextran 40 - for use in the treatment of: small cell carcinoma of the lung; acute monocytic and myelomonocytic leukaemia; hodgkin's disease; non- hodgkin's lymphoma and testicular tumours.

United States - English - NLM (National Library of Medicine)

h2-pharma, llc - etoposide phosphate (unii: 528xyj8l1n) (etoposide - unii:6plq3cp4p3) - etopophos is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors. etopophos is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer. etopophos is contraindicated in patients with a history of a severe hypersensitivity reaction to etoposide products [see warnings and precautions (5.3)] . risk summary based on animal data and its mechanism of action, etopophos can cause fetal harm when administered to a pregnant woman. etoposide, the active moiety of etoposide phosphate is teratogenic in mice and rats (see data) . advise pregnant women of the potential hazard to a fetus. advise women of childbearing potential to avoid becoming pregnant. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in rats, an intravenous etoposide dose of 0.4 mg/kg/day (about 0.05 times of the 50 mg/m2 human dose based on body surface area [bsa]) during organogenesis caused maternal toxicity, embryotoxicity, and teratogenicity (skeletal abnormalities, exencephaly, encephalocele, and anophthalmia); higher doses of 1.2 and 3.6 mg/kg/day (about 0.14 and 0.5 times the 50 mg/m2 human dose based on bsa) resulted in 90% and 100% embryonic resorptions. in mice, a single etoposide dose of 1.0 mg/kg (approximately 0.06 times the 50 mg/m2 human dose based on bsa) administered intraperitoneally on days 6, 7, or 8 of gestation caused embryotoxicity, cranial abnormalities, and major skeletal malformations. an intraperitoneal dose of 1.5 mg/kg (about 0.1 times the 50 mg/m2 human based on bsa) 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 [see nonclinical toxicology (13.1)] . there is no information regarding the presence of etoposide in human milk or its effects on breastfed infant milk production. because of the potential for serious adverse reactions in nursing infants from etopophos, advise women not to breastfeed during treatment with etopophos. contraception females advise females of reproductive potential to use effective contraception during treatment with etopophos and for 6 months after the final dose. males etopophos may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. males with female sexual partners of reproductive potential should use effective contraception during treatment with etopophos and for 4 months after the final dose. infertility females in females of reproductive potential, etopophos may cause infertility and result in amenorrhea. premature menopause can occur with etopophos. recovery of menses and ovulation is related to age at treatment. males in male patients, etopophos may result in oligospermia, azoospermia, and permanent loss of fertility. sperm counts have been reported to return to normal levels in some men, and in some cases, have occurred several years after the end of therapy [see nonclinical toxicology (13.1)] . safety and effectiveness in pediatric patients have not been established. clinical studies of etoposide did not include sufficient numbers (n=71) of patients aged 65 years and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between elderly and younger patients.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - etoposide, quantity: 20 mg/ml - injection, concentrated - excipient ingredients: ethanol; citric acid; polysorbate 80; macrogol 300; benzyl alcohol - small cell carcinoma of the lung. acute monocytic and myelomonocytic leukaemia; hodgkin's disease non-hodgkin's lymphoma.

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - etoposide (unii: 6plq3cp4p3) (etoposide - unii:6plq3cp4p3) - etoposide 20 mg in 1 ml - etoposide injection, usp is indicated in the management of the following neoplasms: etoposide injection, usp in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy. adequate data on the use of etoposide capsules in the treatment of testicular cancer are not available. etoposide injection, usp and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. etoposide injection, usp is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - etoposide (unii: 6plq3cp4p3) (etoposide - unii:6plq3cp4p3) - etoposide 50 mg - etoposide capsules are indicated in the management of the following neoplasms: etoposide capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. etoposide capsules are contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.

United States - English - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - etoposide (unii: 6plq3cp4p3) (etoposide - unii:6plq3cp4p3) - etoposide 20 mg in 1 ml - etoposide injection, usp is indicated in the management of the following neoplasms: etoposide injection in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy. etoposide injection and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. etoposide is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.