Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

amneal pharmaceuticals llc - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt) - atovaquone 750 mg in 5 ml - atovaquone oral suspension is indicated for the prevention of pneumocystis jirovecii pneumonia (pcp) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (tmp-smx).  atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate pcp in adults and adolescents (aged 13 years and older) who cannot tolerate tmp-smx.  clinical experience with atovaquone oral suspension for the treatment of pcp has been limited to subjects with mild-to-moderate pcp (alveolar-arterial oxygen diffusion gradient [(a-a)do2 ] ≤45 mm hg). treatment of more severe episodes of pcp with atovaquone oral suspension has not been studied. the efficacy of atovaquone in subjects who are failing therapy with tmp-smx has also not been studied.  atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of atovaquone oral suspension. risk summary available data from postmarketing experience with use of atovaquone in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. pregnant women with hiv who are infected with pcp are at increased risk of adverse pregnancy outcomes (see clinical considerations) . atovaquone given orally by gavage to pregnant rats and rabbits during organogenesis did not cause fetal malformations at plasma concentrations up to 3 times and 0.5 times, respectively, the estimated human exposure based on steady-state plasma concentrations (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk: pregnant women with hiv who are infected with pcp are at increased risk of severe illness and maternal death associated with pcp compared with non-pregnant women. data animal data: atovaquone administered in oral doses of 250 mg/kg/day, 500 mg/kg/day, and 1,000 mg/kg/day to pregnant rats during organogenesis (gestation day [gd] 6 to gd15) did not cause maternal or embryo-fetal toxicity at doses up to 1,000 mg/kg/day corresponding to maternal plasma concentrations approximately 3 times the estimated human exposure during the treatment of pcp based on steady-state plasma concentrations. in pregnant rabbits, atovaquone administered in oral doses of 300 mg/kg/day, 600 mg/kg/day, and 1,200 mg/kg/day during organogenesis (gd6 to gd18) caused decreased fetal body length at a maternally toxic dose of 1,200 mg/kg/day corresponding to a plasma concentration that is approximately 0.5 times the estimated human exposure based on steady-state plasma concentrations. in a pre- and post-natal study in rats, atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day from gd15 until lactation day (ld) 20 did not impair the growth or developmental effects in first generation offspring at doses up to 1,000 mg/kg/day corresponding to approximately 3 times the estimated human exposure based on steady-state plasma concentrations during the treatment of pcp. atovaquone crossed the placenta and was present in fetal rat and rabbit tissue. risk summary the centers for disease control and prevention recommend that hiv-1-infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv-1. there are no data on the presence of atovaquone in human milk, the effects on the breastfed child, or the effects on milk production. atovaquone was detected in rat milk when lactating rats were administered oral atovaquone (see data) . when a drug is present in animal milk, it is likely the drug will be present in human milk. because of the potential for hiv-1 transmission to hiv-negative infants, instruct mothers with hiv-1 not to breastfeed if they are taking atovaquone for the prevention or treatment of pcp. data in a rat study with doses of 10 mg/kg and 250 mg/kg given orally by gavage on postpartum day 11, atovaquone concentrations in the milk were 30% of the concurrent atovaquone concentrations in the maternal plasma at both doses. the concentration of drug in animal milk does not necessarily predict the concentration of drug in human milk. evidence of safety and effectiveness in pediatric patients (aged 12 years and younger) has not been established. in a trial of atovaquone oral suspension administered once daily with food for 12 days to 27 hiv-1-infected, asymptomatic infants and children aged between 1 month and 13 years, the pharmacokinetics of atovaquone were age-dependent. the average steady-state plasma atovaquone concentrations in the 24 subjects with available concentration data are shown in table 5. table 5. average steady-state plasma atovaquone concentrations in pediatric subjects age dose of atovaquone oral suspension 10 mg/kg 30 mg/kg 45 mg/kg average css in mcg/ml (mean ± sd) 1 to 3 months 5.9 (n = 1) 27.8 ± 5.8 (n = 4) _ >3 to 24 months 5.7 ± 5.1 (n = 4) 9.8 ± 3.2 (n = 4) 15.4 ± 6.6 (n = 4) >2 to 13 years 16.8 ± 6.4 (n = 4) 37.1 ± 10.9 (n = 3) _ css = concentration at steady-state. clinical trials of atovaquone did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

jazz pharmaceuticals, inc. - cytarabine (unii: 04079a1rdz) (cytarabine - unii:04079a1rdz), daunorubicin (unii: zs7284e0zp) (daunorubicin - unii:zs7284e0zp) - cytarabine 100 mg in 20 ml - vyxeos is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-aml) or aml with myelodysplasia-related changes (aml-mrc) in adults and pediatric patients 1 year and older. the use of vyxeos is contraindicated in patients with the following: risk summary based on anecdotal data of cytarabine in pregnant women and results of studies of daunorubicin and cytarabine in animals, vyxeos can cause embryo-fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies of vyxeos, daunorubicin, or cytarabine in pregnant women. daunorubicin and cytarabine are reproductive and developmental toxicants in multiple species (mice, rats, and/or dogs), starting at a dose that was approximately 0.02 times the exposure in patients at the recommended human dose on a mg/m2 basis [see animal data] . patients should be advised to avoid becoming pregnant while taking vyxeos. if this drug is used during pregnancy, or if the patient becomes pregnant while taking th

Euroopa Liit - inglise - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - daunorubicin hydrochloride, cytarabine - leukemia, myeloid, acute - antineoplastic agents - vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-aml) or aml with myelodysplasia-related changes (aml-mrc).

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt) - atovaquone oral suspension is indicated for the prevention of pneumocystis jirovecii pneumonia (pcp) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (tmp-smx). atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate pcp in adults and adolescents (aged 13 years and older) who cannot tolerate tmp-smx. clinical experience with atovaquone for the treatment of pcp has been limited to subjects with mild-to-moderate pcp (alveolar-arterial oxygen diffusion gradient [(a-a)do 2 ] ≤45 mm hg). treatment of more severe episodes of pcp with atovaquone has not been studied. the efficacy of atovaquone in subjects who are failing therapy with tmp-smx has also not been studied. atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of atovaquone oral suspension. risk summary available data from postmarketing experience with use of atovaquone in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. pregnant women with hiv who are infected with pcp are at increased risk of adverse pregnancy outcomes (see clinical considerations). atovaquone given orally by gavage to pregnant rats and rabbits during organogenesis did not cause fetal malformations at plasma concentrations up to 3 times and 0.5 times, respectively, the estimated human exposure based on steady-state plasma concentrations (see data) .  the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.  clinical considerations  disease-associated maternal and/or embryo/fetal risk: pregnant women with hiv who are infected with pcp are at increased risk of severe illness and maternal death associated with pcp compared with non-pregnant women. data animal data: atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day to pregnant rats during organogenesis (gestation day [gd] 6 to gd15) did not cause maternal or embryo-fetal toxicity at doses up to 1,000 mg/kg/day corresponding to maternal plasma concentrations approximately 3 times the estimated human exposure during the treatment of pcp based on steady-state plasma concentrations. in pregnant rabbits, atovaquone administered in oral doses of 300, 600, and 1,200 mg/kg/day during organogenesis (gd6 to gd18) caused decreased fetal body length at a maternally toxic dose of 1,200 mg/kg/day corresponding to a plasma concentration that is approximately 0.5 times the estimated human exposure based on steady-state plasma concentrations. in a pre- and post-natal study in rats, atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day from gd15 until lactation day (ld) 20 did not impair the growth or developmental effects in first generation offspring at doses up to 1,000 mg/kg/day corresponding to approximately 3 times the estimated human exposure based on steady-state plasma concentrations during the treatment of pcp. atovaquone crossed the placenta and was present in fetal rat and rabbit tissue. risk summary the centers for disease control and prevention recommend that hiv-1–infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv-1. there are no data on the presence of atovaquone in human milk, the effects on the breastfed child, or the effects on milk production. atovaquone was detected in rat milk when lactating rats were administered oral atovaquone (see data). when a drug is present in animal milk, it is likely the drug will be present in human milk. because of the potential for hiv-1 transmission to hiv-negative infants, instruct mothers with hiv-1 not to breastfeed if they are taking atovaquone for the prevention or treatment of pcp. data in a rat study with doses of 10 and 250 mg/kg given orally by gavage on postpartum day 11, atovaquone concentrations in the milk were 30% of the concurrent atovaquone concentrations in the maternal plasma at both doses. the concentration of drug in animal milk does not necessarily predict the concentration of drug in human milk. evidence of safety and effectiveness in pediatric patients (aged 12 years and younger) has not been established. in a trial of atovaquone oral suspension administered once daily with food for 12 days to 27 hiv-1-infected, asymptomatic infants and children aged between 1 month and 13 years, the pharmacokinetics of atovaquone were age-dependent. the average steady-state plasma atovaquone concentrations in the 24 subjects with available concentration data are shown in table 5. table 5. average steady-state plasma atovaquone concentrations in pediatric subjects c ss = concentration at steady state. clinical trials of atovaquone did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

alnylam pharmaceuticals, inc. - patisiran sodium (unii: wo0ym16lkg) (patisiran - unii:50fkx8cb2y) - onpattro is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to onpattro during pregnancy. physicians are encouraged to enroll pregnant patients, or pregnant women may register themselves in the program by calling 1-877-256-9526 or by contacting alnylampregnancyprogram@iqvia.com. risk summary there are no available data on onpattro use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. onpattro treatment leads to a decrease in serum vitamin a levels, and vitamin a supplementation is advised for patients taking onpattro. vitamin a is essential for normal embryofetal development; however, excessive levels of vitamin a are associated with adverse developmental effects. the effects on the fetus of a reduction in maternal serum ttr caused by onpattro and of vitamin a supplementation are unknown [see

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

eyepoint pharmaceuticals us, inc - dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - dexycu (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation. none. risk summary there are no adequate and well-controlled studies of dexycu (dexamethasone intraocular suspension) 9% in pregnant women. topical ocular administration of dexamethasone in mice and rabbits during the period of organogenesis produced cleft palate and embryofetal death in mice and malformations of abdominal wall/intestines and kidneys in rabbits at doses 7 and 5 times higher than the injected recommended human ophthalmic dose (rhod) of dexycu (517 micrograms dexamethasone), respectively [see data] . in the us 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 topical ocular administration of 0.15% dexamethasone (0.75 mg/kg/day) on gestational days 10 to 13 produced embryofetal lethality and a high incidence of cleft palate in mice. a dose of 0.75 mg/kg/da

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt) - atovaquone oral suspension is indicated for the prevention of pneumocystis jirovecii pneumonia (pcp) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (tmp-smx). atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate pcp in adults and adolescents (aged 13 years and older) who cannot tolerate tmp-smx. clinical experience with atovaquone oral suspension for the treatment of pcp has been limited to subjects with mild-to-moderate pcp (alveolar-arterial oxygen diffusion gradient [(a-a)do2 ] ≤45 mm hg). treatment of more severe episodes of pcp with atovaquone oral suspension has not been studied. the efficacy of atovaquone oral suspension in subjects who are failing therapy with tmp-smx has also not been studied. atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of atovaquone oral suspension. risk summary available data from postmarketing experience with use of atovaquone in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. pregnant women with hiv who are infected with pcp are at increased risk of adverse pregnancy outcomes (see clinical considerations) . atovaquone given orally by gavage to pregnant rats and rabbits during organogenesis did not cause fetal malformations at plasma concentrations up to 3 times and 0.5 times, respectively, the estimated human exposure based on steady-state plasma concentrations (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk: pregnant women with hiv who are infected with pcp are at increased risk of severe illness and maternal death associated with pcp compared with non-pregnant women. data animal data: atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day to pregnant rats during organogenesis (gestation day [gd] 6 to gd15) did not cause maternal or embryo-fetal toxicity at doses up to 1,000 mg/kg/day corresponding to maternal plasma concentrations approximately 3 times the estimated human exposure during the treatment of pcp based on steady-state plasma concentrations. in pregnant rabbits, atovaquone administered in oral doses of 300, 600, and 1,200 mg/kg/day during organogenesis (gd6 to gd18) caused decreased fetal body length at a maternally toxic dose of 1,200 mg/kg/day corresponding to a plasma concentration that is approximately 0.5 times the estimated human exposure based on steady-state plasma concentrations. in a pre- and post-natal study in rats, atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day from gd15 until lactation day (ld) 20 did not impair the growth or developmental effects in first generation offspring at doses up to 1,000 mg/kg/day corresponding to approximately 3 times the estimated human exposure based on steady-state plasma concentrations during the treatment of pcp. atovaquone crossed the placenta and was present in fetal rat and rabbit tissue. risk summary the centers for disease control and prevention recommend that hiv-1-infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv-1. there are no data on the presence of atovaquone in human milk, the effects on the breastfed child, or the effects on milk production. atovaquone was detected in rat milk when lactating rats were administered oral atovaquone (see data) . when a drug is present in animal milk, it is likely the drug will be present in human milk. because of the potential for hiv-1 transmission to hiv-negative infants, instruct mothers with hiv-1 not to breastfeed if they are taking atovaquone oral suspension for the prevention or treatment of pcp. data in a rat study with doses of 10 and 250 mg/kg given orally by gavage on postpartum day 11, atovaquone concentrations in the milk were 30% of the concurrent atovaquone concentrations in the maternal plasma at both doses. the concentration of drug in animal milk does not necessarily predict the concentration of drug in human milk. evidence of safety and effectiveness in pediatric patients (aged 12 years and younger) has not been established. in a trial of atovaquone oral suspension administered once daily with food for 12 days to 27 hiv-1-infected, asymptomatic infants and children aged between 1 month and 13 years, the pharmacokinetics of atovaquone were age-dependent. the average steady-state plasma atovaquone concentrations in the 24 subjects with available concentration data are shown in table 5. age dose of atovaquone oral suspension 10 mg/kg 30 mg/kg 45 mg/kg average css in mcg/ml (mean ± sd) 1 to 3 months 5.9 (n = 1) 27.8 ± 5.8 (n = 4) _ >3 to 24 months 5.7 ± 5.1 (n = 4) 9.8 ± 3.2 (n = 4) 15.4 ± 6.6 (n = 4) >2 to 13 years 16.8 ± 6.4 (n = 4) 37.1 ± 10.9 (n = 3) _ clinical trials of atovaquone did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt) - atovaquone oral suspension usp is indicated for the prevention of pneumocystis jirovecii pneumonia (pcp) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (tmp-smx). atovaquone oral suspension usp is indicated for the acute oral treatment of mild-to-moderate pcp in adults and adolescents (aged 13 years and older) who cannot tolerate tmp-smx. clinical experience with atovaquone oral suspension usp for the treatment of pcp has been limited to subjects with mild-to-moderate pcp (alveolar-arterial oxygen diffusion gradient     [(a-a)do2 ] ≤45 mm hg). treatment of more severe episodes of pcp with atovaquone oral suspension usp has not been studied. the efficacy of atovaquone oral suspension usp in subjects who are failing therapy with tmp-smx has also not been studied. atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

major pharmaceuticals - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt) - atovaquone oral suspension is indicated for the prevention of pneumocystis jirovecii pneumonia (pcp) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (tmp-smx). atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate pcp in adults and adolescents (aged 13 years and older) who cannot tolerate tmp-smx. clinical experience with atovaquone for the treatment of pcp has been limited to subjects with mild-to-moderate pcp (alveolar-arterial oxygen diffusion gradient [(a-a)do2 ] ≤45 mm hg). treatment of more severe episodes of pcp with atovaquone has not been studied. the efficacy of atovaquone in subjects who are failing therapy with tmp-smx has also not been studied. atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of atovaquone oral suspension. pregnancy category

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt) - atovaquone oral suspension is indicated for the prevention of pneumocystis jirovecii pneumonia (pcp) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (tmp-smx). atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate pcp in adults and adolescents (aged 13 years and older) who cannot tolerate tmp-smx. clinical experience with atovaquone for the treatment of pcp has been limited to subjects with mild-to-moderate pcp (alveolar-arterial oxygen diffusion gradient [(a-a)do2 ] ≤45 mm hg). treatment of more severe episodes of pcp with atovaquone has not been studied. the efficacy of atovaquone in subjects who are failing therapy with tmp-smx has also not been studied. atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of atovaquone oral suspension. pregnancy category