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

rebel distributors corp - aprepitant (unii: 1nf15yr6uy) (aprepitant - unii:1nf15yr6uy) - aprepitant 40 mg - emend1, in combination with other antiemetic agents, is indicated for the: - prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (hec) including high-dose cisplatin - prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec) [see dosage and administration (2.1)] . registered trademark of merck sharp & dohme corp., a subsidiary of merck & co., inc. copyright © 2003, 2005, 2006 merck sharp & dohme corp., a subsidiary of merck & co., inc. all rights reserved emend is indicated for the prevention of postoperative nausea and vomiting [see dosage and administration (2.2)] . emend has not been studied for the treatment of established nausea and vomiting. chronic continuous administration is not recommended [see warnings and precautions (5.5)]. emend is contraindicated in patients who are hypersensitive to any component of the product. emend is a dose-dependen

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

hepalink usa inc. - fosaprepitant dimeglumine (unii: d35fm8t64x) (aprepitant - unii:1nf15yr6uy) - fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (hec) including high-dose cisplatin. - delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). limitations of use - fosaprepitant has not been studied for the treatment of established nausea and vomiting. pediatric use information is approved for merck sharp & dohme corp., a subsidiary of merck & co., inc.’s emend (fosaprepitant) for injection. however, due to merck sharp & dohme corp., a subsidiary of merck & co., inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. fosaprepitant is contraindicated in patients: - who are hypersensitive to any component of the product. hypersensitivity reactions including anaphylactic reactions, flushing, erythema, and dy

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

heron therapeutics, inc. - aprepitant (unii: 1nf15yr6uy) (aprepitant - unii:1nf15yr6uy) - cinvanti, in combination with other antiemetic agents, is indicated in adults for the prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (hec) including high-dose cisplatin as a single-dose regimen. - delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec) as a single-dose regimen. - nausea and vomiting associated with initial and repeat courses of mec as a 3-day regimen. limitations of use - cinvanti has not been studied for the treatment of established nausea and vomiting. cinvanti is contraindicated in patients: - who are hypersensitive to any component of the product [see description (11)] . hypersensitivity reactions including anaphylaxis have been reported [see warnings and precautions (5.2), adverse reactions (6.2)] . - taking pimozide. inhibition of cyp3a4 by aprepitant could result in elevated plasma concentrations of pimozide, which is a cyp3a4 substrate, potentially causing serious or life-threatening reactions, such as qt prolongation, a known adverse reaction of pimozide [see warnings and precautions (5.1)] . risk summary there are no available data on cinvanti use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. avoid use of cinvanti in pregnant women due to the alcohol content (see clinical considerations). in animal reproduction studies, no adverse developmental effects were observed in rats or rabbits exposed during the period of organogenesis to systemic drug concentrations (area under the plasma-concentration time curve [auc]) of aprepitant approximately equivalent to the exposure at the recommended human dose (rhd) of cinvanti 130 mg (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. clinical considerations fetal/neonatal adverse reactions cinvanti contains alcohol. published studies have demonstrated that alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development. there is no safe level of alcohol exposure in pregnancy; therefore, avoid use of cinvanti in pregnant women. data animal data in embryofetal development studies in rats and rabbits, aprepitant was administered during the period of organogenesis at oral doses up to 1000 mg/kg twice daily (rats) and up to the maximum tolerated dose of 25 mg/kg/day (rabbits). no embryofetal lethality or malformations were observed at any dose level in either species. the exposures (auc) in pregnant rats at 1000 mg/kg twice daily and in pregnant rabbits at 125 mg/kg/day were approximately equivalent to the exposure at the rhd of cinvanti 130 mg. aprepitant crosses the placenta in rats and rabbits. risk summary there are no data on the presence of aprepitant in human milk, the effects on the breastfed infant, or the effects on milk production. aprepitant is present in rat milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for cinvanti and any potential adverse effects on the breastfed infant from cinvanti or from the underlying maternal condition. contraception upon administration of cinvanti, the efficacy of hormonal contraceptives may be reduced. advise females of reproductive potential using hormonal contraceptives to use an effective alternative or back-up non-hormonal contraceptive (such as condoms or spermicides) during treatment with cinvanti and for 1 month following the last dose of cinvanti or oral aprepitant, whichever is administered last [see warnings and precautions (5.4), drug interactions (7.1), clinical pharmacology (12.3)] . the safety and effectiveness of cinvanti have not been established in pediatric patients. of the 1649 adult cancer patients treated with intravenous fosaprepitant in hec and mec clinical studies, 27% were aged 65 and over, while 5% were aged 75 and over. other reported clinical experience with fosaprepitant and/or oral aprepitant has not identified differences in responses between elderly and younger patients. in general, use caution when dosing elderly patients as they have a greater frequency of decreased hepatic, renal or cardiac function and concomitant disease or other drug therapy [see clinical pharmacology (12.3)] . the pharmacokinetics of aprepitant in patients with mild and moderate hepatic impairment were similar to those of healthy subjects with normal hepatic function. no dosage adjustment is necessary for patients with mild to moderate hepatic impairment (child-pugh score 5 to 9). there are no clinical or pharmacokinetic data in patients with severe hepatic impairment (child-pugh score greater than 9). therefore, additional monitoring for adverse reactions in these patients may be warranted when cinvanti is administered [see clinical pharmacology (12.3)] .

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

heron therapeutics, inc. - aprepitant (unii: 1nf15yr6uy) (aprepitant - unii:1nf15yr6uy) - aponvie is indicated for the prevention of postoperative nausea and vomiting (ponv) in adults. limitations of use aponvie has not been studied for the treatment of established nausea and vomiting. aponvie is contraindicated in patients: - with a history of hypersensitivity to aprepitant or any component of the product [see description (11)] . hypersensitivity reactions have included anaphylaxis [see warnings and precautions (5.1)] . - taking pimozide. inhibition of cyp3a4 by aprepitant could result in elevated plasma concentrations of pimozide, which is a cyp3a4 substrate, potentially causing serious or life-threatening reactions, such as qt prolongation, a known adverse reaction of pimozide [see drug interactions (7.1)] . risk summary there are insufficient data on aprepitant use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. avoid use of aponvie in pregnant women due to the alcohol content (see clinical considerations) . in animal reproduction studies, no adverse developmental effects were observed in rats or rabbits exposed during the period of organogenesis to systemic drug concentrations (area under the plasma-concentration time curve [auc]) of oral aprepitant approximately 4.8 times the exposure at the recommended human dose of aponvie (see data) . the background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. clinical considerations fetal/neonatal adverse reactions aponvie contains alcohol. published studies have demonstrated that alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development. there is no safe level of alcohol exposure in pregnancy; therefore, avoid use of aponvie in pregnant women. data animal data in embryofetal development studies in rats and rabbits, aprepitant was administered during the period of organogenesis at oral doses up to 1000 mg/kg twice daily (rats) and up to the maximum tolerated dose of 125 mg/kg/day (rabbits). no embryofetal lethality or malformations were observed at any dose level in either species. the exposures (auc) in pregnant rats at 1000 mg/kg twice daily and in pregnant rabbits at 125 mg/kg/day were approximately 4.8 times the exposure at the recommended human dose of aponvie. aprepitant crosses the placenta in rats and rabbits. risk summary there are no data on the presence of aprepitant in human milk, the effects on the breastfed infant, or the effects on milk production. aprepitant is present in rat milk. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for aponvie and any potential adverse effects on the breastfed infant from aponvie or from the underlying maternal condition. contraception upon administration of aponvie, the efficacy of hormonal contraceptives may be reduced. advise females of reproductive potential using hormonal contraceptives to use an effective alternative or back-up non-hormonal contraceptive (such as condoms or spermicides) for 1 month following administration of aponvie [see warnings and precautions (5.4), drug interactions (7.1), and clinical pharmacology (12.3)] . the safety and effectiveness of aponvie have not been established in pediatric patients. juvenile animal study a study was conducted in young rats to evaluate the effects of aprepitant on growth and on neurobehavioral and sexual development. rats were treated at oral doses up to the maximum feasible dose of 1000 mg/kg twice daily from the early postnatal period (postnatal day 10) through postnatal day 58. slight changes in the onset of sexual maturation were observed in female and male rats; however, there were no effects on mating, fertility, embryonic-fetal survival, or histomorphology of the reproductive organs. there were no effects in neurobehavioral tests of sensory function, motor function, and learning and memory. of the 1120 adult patients treated with oral aprepitant in ponv clinical studies, 7% were aged 65 and over, while 2% were aged 75 and over. clinical studies of aprepitant did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. no clinically meaningful differences in the pharmacokinetics of oral aprepitant were observed in healthy geriatric subjects compared to younger adult subjects [see clinical pharmacology (12.3)] .

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

merck sharp & dohme corp. - fosaprepitant dimeglumine (unii: d35fm8t64x) (aprepitant - unii:1nf15yr6uy) - emend® for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (hec) including high-dose cisplatin. - delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). limitations of use - emend has not been studied for the treatment of established nausea and vomiting. emend is contraindicated in patients: - who are hypersensitive to any component of the product. hypersensitivity reactions including anaphylactic reactions, flushing, erythema, and dyspnea have been reported [see warnings and precautions (5.2), adverse reactions (6.2)] . - taking pimozide. inhibition of cyp3a4 by aprepitant, the active moiety, could result in elevated plasma concentrations of this drug, which is a cyp3a4 substrate, potentially causing serious or life-threatening reactions, such as qt prolongation, a

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

merck sharp & dohme corp. - fosaprepitant dimeglumine (unii: d35fm8t64x) (aprepitant - unii:1nf15yr6uy) - emend® for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (hec) including high-dose cisplatin. - delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). limitations of use - emend has not been studied for the treatment of established nausea and vomiting. emend is contraindicated in patients: - who are hypersensitive to any component of the product. hypersensitivity reactions including anaphylactic reactions, flushing, erythema, and dyspnea have been reported [see warnings and precautions (5.2), adverse reactions (6.2)] . - taking pimozide. inhibition of cyp3a4 by aprepitant, the active moiety, could result in elevated plasma concentrations of this drug, which is a cyp3a4 substrate, potentially causing serious or life-t

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

merck sharp & dohme corp. - fosaprepitant dimeglumine (unii: d35fm8t64x) (aprepitant - unii:1nf15yr6uy) - emend® for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (hec) including high-dose cisplatin. - delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). limitations of use - emend has not been studied for the treatment of established nausea and vomiting. emend is contraindicated in patients: - who are hypersensitive to any component of the product. hypersensitivity reactions including anaphylactic reactions, flushing, erythema, and dyspnea have been reported [see warnings and precautions (5.2), adverse reactions (6.2)] . - taking pimozide. inhibition of cyp3a4 by aprepitant, the active moiety, could result in elevated plasma concentrations of this drug, which is a cyp3a4 substrate, potentially causing serious or life-t

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

athenex pharmaceutical division, llc. - fosaprepitant dimeglumine (unii: d35fm8t64x) (aprepitant - unii:1nf15yr6uy) - fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (hec) including high-dose cisplatin. - delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). limitations of use - fosaprepitant for injection has not been studied for the treatment of established nausea and vomiting. pediatric use information is approved for merck sharp & dohme corp., a subsidiary of merck & co., inc.'s emend (fosaprepitant) for injection. however, due to merck sharp & dohme corp., a subsidiary of merck & co., inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. fosaprepitant for injection is contraindicated in patients: - who are hypersensitive to any component of the product. hypersensitivity reactions including anaphylactic reactions

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

spes pharmaceuticals inc. - fosaprepitant dimeglumine (unii: d35fm8t64x) (aprepitant - unii:1nf15yr6uy) - focinvez, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (hec) including high-dose cisplatin. - delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). limitations of use  - focinvez has not been studied for treatment of established nausea and vomiting. focinvez is contraindicated in patients: - who are hypersensitive to any component of the product. hypersensitivity reactions including anaphylactic reactions, flushing, erythema, and dyspnea have been reported [see warnings and precautions (5.2), and adverse reactions ( 6.2)] . - taking pimozide. inhibition of cyp3a4 by aprepitant, the active moiety, could result in elevated plasma concentrations of this drug, which is a cyp3a4 substrate, potentially c

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

arrotex pharmaceuticals pty ltd - aprepitant, quantity: 165 mg - capsule - excipient ingredients: hypromellose; poloxamer; sucrose; microcrystalline cellulose; gelatin; sodium lauryl sulfate; titanium dioxide; indigo carmine aluminium lake; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - aprepitant, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of: - highly emetogenic cancer chemotherapy. - moderately emetogenic cancer chemotherapy. aprepitant is indicated for the prevention of postoperative nausea and vomiting.