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

novadoz pharmaceuticals llc - thiotepa (unii: 905z5w3gkh) (thiotepa - unii:905z5w3gkh) - thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary. thiotepa for injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. thiotepa for injection is indicated for treatment of superficial papillary carcinoma of the urinary bladder. pediatric use information is approved for adienne sa 's tepadina (thiotepa) for injection. however, due to adienne sa 's marketing exclusivity rights, the drug product is not labeled with that information. thiotepa for injection is contraindicated in: - patients with severe hypersensitivity to thiotepa [see warnings and precautions (5.2)] - concomitant use with live or attenuated vaccines [see warnings and precautions (5.4)] risk summary thiotepa can cause fetal harm when administered to a pregnant woman based on findings from animals and the drug’s mechanism of action [see clinical pharmacology (12.1)] . limited available data with thiotepa use in pr

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

gland pharma limited - thiotepa (unii: 905z5w3gkh) (thiotepa - unii:905z5w3gkh) - thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary. thiotepa for injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. thiotepa for injection is indicated for treatment of superficial papillary carcinoma of the urinary bladder. pediatric use information is approved for adienne sa' s tepadina (thiotepa) for injection. however, due to adienne sa's marketing exclusivity rights, the drug product is not labeled with that information. thiotepa for injection is contraindicated in: • patients with severe hypersensitivity to thiotepa [see warnings and precautions (5.2)]   • concomitant use with live or attenuated vaccines [see warnings and precautions (5.4)] risk summary thiotepa can cause fetal harm when administered to a pregnant woman based on findings from animals and the drug’s mechanism of action [see clinical pharmacology (12.1)]. limited available data with thiotepa use in

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

fresenius kabi usa, llc - thiotepa (unii: 905z5w3gkh) (thiotepa - unii:905z5w3gkh) - thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary. thiotepa for injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. thiotepa for injection is indicated for treatment of superficial papillary carcinoma of the urinary bladder. pediatric use information is approved for adienne sa' s tepadina (thiotepa) for injection. however, due to adienne sa's marketing exclusivity rights, the drug product is not labeled with that information. thiotepa for injection is contraindicated in: • patients with severe hypersensitivity to thiotepa [see warnings and precautions (5.2)]   • concomitant use with live or attenuated vaccines [see warnings and precautions (5.4)] risk summary thiotepa can cause fetal harm when administered to a pregnant woman based on findings from animals and the drug’s mechanism of action [see clinical pharmacology (12.1)]. limited available data with thiotepa use in

Israel - English - Ministry of Health

medomie pharma ltd, israel - thiotepa - powder for concentrate for solution for infusion - thiotepa 100 mg/vial - thiotepa - indicated in combination with other chemotherapy medicinal products:1. with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients.2. when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.

Israel - English - Ministry of Health

medomie pharma ltd, israel - thiotepa - powder for concentrate for solution for infusion - thiotepa 15 mg/vial - thiotepa - indicated in combination with other chemotherapy medicinal products:1. with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients.2. when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - thiotepa 15mg;   - powder for injection - 15 mg - active: thiotepa 15mg  

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

amneal pharmaceuticals llc - thiotepa (unii: 905z5w3gkh) (thiotepa - unii:905z5w3gkh) - thiotepa 15 mg - tepadina is indicated to reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (hsct) for pediatric patients with class 3 beta-thalassemia [see clinical studies (14)]. tepadina is indicated for treatment of adenocarcinoma of the breast or ovary. tepadina is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. tepadina is indicated for treatment of superficial papillary carcinoma of the urinary bladder. tepadina is contraindicated in: - patients with severe hypersensitivity to thiotepa [ see warnings and precautions (5.2)] - concomitant use with live or attenuated vaccines [ see warnings and precautions (5.4)]. risk summary tepadina can cause fetal harm when administered to a pregnant woman based on findings from animals and the drug’s mechanism of action [ see clinical pharmacology ( 12.1 ) ]. limited available data with tepadina use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. in animal reproduction studies, administration of thiotepa to pregnant rats and rabbits during organogenesis produced teratogenic effects (alterations in embryo development, anomalies of the skeletal system of the fetus) at doses approximately 0.125 and 1 times, respectively, the maximum recommended human daily dose on a mg/m 2 basis. thiotepa was lethal to rabbit fetuses at approximately 2 times the maximum recommended human therapeutic dose based on body-surface area [ see data]. consider the benefits and risks of tepadina for the mother and possible risks to the fetus when prescribing tepadina to a pregnant woman. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data thiotepa given by the ip route in mice at doses ≥ 1 mg/kg (3.2 mg/m 2 ), approximately 8-fold less than the maximum recommended human therapeutic dose based on body-surface area, and in rats at doses ≥ 3 mg/kg (21 mg/m 2 ), approximately equal to the maximum recommended human therapeutic dose based on body-surface area, resulted in various malformations including neural tube defects, omphalocele, renal agenesis, atresia ani, limb and digit defects, cleft palate, micrognathia, other skeletal anomalies in the skull, vertebrae and ribs, and reduced skeletal ossification. thiotepa was lethal to rabbit fetuses at a dose of 3 mg/kg (41 mg/m 2 ), approximately 2 times the maximum recommended human therapeutic dose based on bodysurface area. risk summary there is no information regarding the presence of thiotepa in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions, including the potential for tumorigenicity shown for thiotepa in animal studies, advise patients not to breastfeed during tepadina treatment. pregnancy testing tepadina can cause fetal harm when administered to a pregnant female. verify the pregnancy status of females of reproductive potential prior to initiating tepadina therapy. contraception females advise females of reproductive potential to avoid pregnancy during tepadina treatment and for at least 6 months after the final dose of tepadina. advise females to immediately report pregnancy [ see use in specific populations (8.1)] . males tepadina may damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities. males with female sexual partners of reproductive potential should use effective contraception during tepadina treatment and for at least 1 year after the final dose of tepadina [ see nonclinical toxicology ( 13.1 ) ]. infertility based on nonclinical findings, male and female fertility may be compromised by treatment with tepadina. inform male patients about the possibility of sperm conservation before the start of therapy [ see nonclinical toxicology (13.1)]. the safety and effectiveness of tepadina for prevention of graft rejection in pediatric patients undergoing allogeneic hsct for class 3 beta-thalassemia was established in one prospective study and one retrospective study [ see clinical studies (14) ] that included 1 infant (1 month to 1 year), 23 children (2 to 11 years) and 13 adolescents (12 to 16 years) who received tepadina as part of their preparative regimen. safety and effectiveness of tepadina in neonates have not been established. safety and effectiveness of tepadina for treatment of adenocarcinoma of the breast, adenocarcinoma of the ovary, malignant effusions and superficial papillary carcinoma of the urinary bladder in pediatric patients have not been established. the safety and effectiveness of tepadina as a preparative regimen prior to allogeneic hematopoietic progenitor (stem) cell transplantation (hsct) for patients with class 3 beta-thalassemia have not been established in geriatric patients. clinical studies of tepadina for this indication did not include subjects aged 65 and over. clinical studies of tepadina for treatment of adenocarcinoma of the breast, adenocarcinoma of the ovary, malignant effusions and superficial papillary carcinoma of the urinary bladder did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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 decreasing hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. in patients with moderate (creatinine clearance (clcr) of 30 ml/min to 59 ml/min) renal impairment, decreased renal excretion may result in increased plasma levels of thiotepa and tepa [see clinical pharmacology ( 12.2 )] . this may result in increased toxicity. monitor patients with moderate to severe (clcr < 30 ml/min) renal impairment for signs and symptoms of toxicity following treatment with tepadina for an extended period of time. thiotepa is extensively metabolized in the liver. patients with moderate (bilirubin levels greater than 1.5 times to 3 times the upper limit of normal and any ast) hepatic impairment may have increased plasma levels of thiotepa [ see clinical pharmacology ( 12.2 ) ] . this may result in toxicity. monitor patients with moderate to severe (bilirubin levels greater than 3 times upper limit of normal and any ast) hepatic impairment for signs and symptoms of toxicity following treatment with tepadina for an extended period of time.

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

aspen pharma pty ltd - thiotepa -

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

meitheal pharmaceuticals inc - thiotepa (unii: 905z5w3gkh) (thiotepa - unii:905z5w3gkh) - thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary. thiotepa for injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. thiotepa for injection is indicated for treatment of superficial papillary carcinoma of the urinary bladder. pediatric use information is approved for adienne sa’s tepadina (thiotepa) for injection. however, due to adienne sa’s marketing exclusivity rights, the drug product is not labeled with that information. thiotepa is contraindicated in: - patients with severe hypersensitivity to thiotepa [see warnings and precautions (5.2)] - concomitant use with live or attenuated vaccines [see warnings and precautions (5.4)] thiotepa can cause fetal harm when administered to a pregnant woman based on findings from animals and the drug’s mechanism of action [see clinical pharmacology (12.1)] . limited available data with thiotepa use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. in animal reproduction studies, administration of thiotepa to pregnant mice and rats during organogenesis produced teratogenic effects (neural tube defects and malformations of the skeletal system of the fetus) at doses approximately 0.125 and 1 times, respectively, the maximum recommended human daily dose on a mg/m2 basis. thiotepa was lethal to rabbit fetuses at approximately 2 times the maximum recommended human therapeutic dose based on body-surface area [see data] . consider the benefits and risks of thiotepa for the mother and possible risks to the fetus when prescribing thiotepa to a pregnant woman. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. animal data thiotepa given by the ip route in mice at doses ≥ 1 mg/kg (3.2 mg/m2 ), approximately 8-fold less than the maximum recommended human therapeutic dose based on body-surface area, and in rats at doses ≥ 3 mg/kg (21 mg/m2 ), approximately equal to the maximum recommended human therapeutic dose based on body-surface area, resulted in various malformations including neural tube defects, omphalocele, renal agenesis, atresia ani, limb and digit defects, cleft palate, micrognathia, other skeletal anomalies in the skull, vertebrae and ribs, and reduced skeletal ossification. thiotepa was lethal to rabbit fetuses at a dose of 3 mg/kg (41 mg/m2 ), approximately 2 times the maximum recommended human therapeutic dose based on body-surface area. risk summary there is no information regarding the presence of thiotepa in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions, including the potential for tumorigenicity shown for thiotepa in animal studies, advise patients not to breastfeed during thiotepa treatment. pregnancy testing thiotepa can cause fetal harm when administered to a pregnant female. verify the pregnancy status of females of reproductive potential prior to initiating thiotepa therapy. contraception females advise females of reproductive potential to avoid pregnancy during thiotepa treatment and for at least 6 months after the final dose of thiotepa. advise females to immediately report pregnancy [see use in specific populations (8.1)] . males thiotepa may damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities. males with female sexual partners of reproductive potential should use effective contraception during thiotepa treatment and for at least 1 year after the final dose of thiotepa [see nonclinical toxicology (13.1)] . infertility based on nonclinical findings, male and female fertility may be compromised by treatment with thiotepa. inform male patients about the possibility of sperm conservation before the start of therapy [see nonclinical toxicology (13.1)] . safety and effectiveness of thiotepa in neonates have not been established. safety and effectiveness of thiotepa for treatment of adenocarcinoma of the breast, adenocarcinoma of the ovary, malignant effusions and superficial papillary carcinoma of the urinary bladder in pediatric patients have not been established. pediatric use information is approved for adienne sa’s tepadina (thiotepa) for injection. however, due to adienne sa’s marketing exclusivity rights, the drug product is not labeled with that information. clinical studies of thiotepa for treatment of adenocarcinoma of the breast, adenocarcinoma of the ovary, malignant effusions and superficial papillary carcinoma of the urinary bladder did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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 decreasing hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. in patients with moderate (creatinine clearance (clcr) of 30 ml/min to 59 ml/min) renal impairment, decreased renal excretion may result in increased plasma levels of thiotepa and tepa [see clinical pharmacology (12.2)] . this may result in increased toxicity. monitor patients with moderate to severe (clcr < 30 ml/min) renal impairment for signs and symptoms of toxicity following treatment with thiotepa for an extended period of time. thiotepa is extensively metabolized in the liver. patients with moderate (bilirubin levels greater than 1.5 times to 3 times the upper limit of normal and any ast) hepatic impairment may have increased plasma levels of thiotepa [see clinical pharmacology (12.2)] . this may result in toxicity. monitor patients with moderate to severe (bilirubin levels greater than 3 times upper limit of normal and any ast) hepatic impairment for signs and symptoms of toxicity following treatment with thiotepa for an extended period of time.

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

hikma pharmaceuticals usa inc. - thiotepa (unii: 905z5w3gkh) (thiotepa - unii:905z5w3gkh) - thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary. thiotepa for injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. thiotepa for injection is indicated for treatment of superficial papillary carcinoma of the urinary bladder. pediatric use information is approved for adienne sa’s tepadina (thiotepa) for injection. however, due to adienne sa’s marketing exclusivity rights, the drug product is not labeled with that information. thiotepa for injection is contraindicated in: - patients with severe hypersensitivity to thiotepa [see warnings and precautions (5.2)] - concomitant use with live or attenuated vaccines [see warnings and precautions (5.4)] thiotepa for injection can cause fetal harm when administered to a pregnant woman based on findings from animals and the drug’s mechanism of action [see clinical pharmacology (12.1) ]. limited available data with thiotepa for injection u