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

golden state medical supply, inc. - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol 1 ug - paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4. pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd). pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or hypercalcemia or - vitamin d toxicity [see

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

dr. reddy's laboratories limited - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol 1 ug - paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4.   pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd).   pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or - vitamin d toxicity [see warnings and precautions ( 5.

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

zydus pharmaceuticals usa inc - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol 2 ug - paricalcitol capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4. paricalcitol capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd). paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or - vitamin d toxicity [see warnings and precautions ( 5.1 )] . risk summary limited data with paricalcitol capsules in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see clinical considerations] . in animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered paricalcitol intravenously during the period of organogenesis at doses 2 and 0.5 times, respectively, the maximum recommended human dose (mrhd). adverse reproductive outcomes were observed at doses that caused maternal toxicity [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 estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk chronic kidney disease in pregnancy increases the maternal risk for hypertension, spontaneous abortion, preterm labor, and preeclampsia. chronic kidney disease increases the fetal risk for intrauterine growth restriction (iugr), prematurity, polyhydramnios, still birth, and low birth weight. data animal data pregnant rats and rabbits were treated with paricalcitol by once-daily intravenous (iv) injection during the period of organogenesis (in rats, from gestation day (gd) 6 to 17; in rabbits, from gd 6 to 18). rats were dosed at 0, 0.3, 1.0 or 3.0 mcg/kg/day and rabbits at 0, 0.03, 0.1 or 0.3 mcg/kg/day, representing up to 2 or 0.5 times, respectively, the maximum recommended human dose (mrhd) of 0.24 mcg/kg, based on body surface area (mcg/m2 ). slightly decreased fetal viability was observed in both studies at the highest doses representing 2 and 0.5 times, respectively, the mrhd in the presence of maternal toxicity (decreased body weight and food consumption). pregnant rats were administered paricalcitol by iv injection three times per week at doses of 0, 0.3, 3.0 or 20.0 mcg/kg/day throughout gestation, parturition and lactation (gd 6 to lactation day (ld) 20) representing exposures up to 13 times the mhrd. a small increase in stillbirths and pup deaths from parturition to ld 4 were observed at the high dose when compared to the control group (9.2% versus 3.3% in controls) at 13 times the mrhd, which occurred at a maternally toxic dose known to cause hypercalcemia in rats. surviving pups were not adversely affected; body weight gains, developmental landmarks, reflex ontogeny, learning indices, and locomotor activity were all within normal parameters. f1 reproductive capacity was unaffected. risk summary there is no information available on the presence of paricalcitol in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. studies in rats have shown that paricalcitol and/or its metabolites are present in the milk of lactating rats; however, due to specifies-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk [see data] . because of the potential for serious adverse reactions, including hypercalcemia in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with paricalcitol. data following a single oral administration of 20 mcg/kg of radioactive [3 h] paricalcitol to lactating rats, the concentrations of total radioactivity was determined. lower levels of total radioactivity were present in the milk compared to that in the plasma of the dams indicating that low levels of [3 h] paricalcitol and/or its metabolites are secreted into milk. exposure of the pups to [3 h] paricalcitol through milk was confirmed by the presence of radioactive material in the pups’ stomachs. the safety and effectiveness of paricalcitol capsules have been established in pediatric patients 10 to 16 years of age for the prevention and treatment of secondary hyperparathyroidism associated with stage 3, 4, and 5 ckd. use of paricalcitol capsules in this age group is supported by evidence from adequate and well controlled studies in adults with ckd, a 12-week double-blind placebo-controlled randomized multicenter study in 36 pediatric patients 10 to 16 years of age with ckd stages 3 and 4, and safety data from a 12-week open-label single-arm multicenter study in 13 pediatric patients 10 to 16 years of age with ckd stage 5 receiving peritoneal dialysis or hemodialysis. the pharmacokinetics of paricalcitol in stage 5 ckd pediatric patients appear to be similar to those observed in stage 3 and 4 pediatric patients [see clinical pharmacology ( 12.3 ) and clinical studies ( 14.1 )] . adverse reactions reported in these pediatric studies are consistent with the known safety profile of paricalcitol capsules and with what has been reported in adult clinical studies [see adverse reactions ( 6.1 )] . safety and effectiveness of paricalcitol capsules in pediatric patients under the age of 10 years have not been established. of the total number (n = 220) of ckd stages 3 and 4 patients in clinical studies of paricalcitol capsules, 49% were age 65 and over, while 17% were age 75 and over. of the total number (n = 88) of ckd stage 5 patients in the pivotal study of paricalcitol capsules, 28% were age 65 and over, while 6% were age 75 and over. no overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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

amneal pharmaceuticals llc - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol 1 ug - paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4. pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd). pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or - vitamin d toxicity [see warnings and precautions (5.1)] . risk summary limited data with paricalcitol capsules in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see clinical considerations] . in animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered paricalcitol intravenously during the period of organogenesis at doses 2 and 0.5 times, respectively, the maximum recommended human dose (mrhd). adverse reproductive outcomes were observed at doses that caused maternal toxicity [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 estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. disease-associated maternal and/or embryo/fetal risk chronic kidney disease in pregnancy increases the maternal risk for hypertension, spontaneous abortion, preterm labor, and preeclampsia. chronic kidney disease increases the fetal risk for intrauterine growth restriction (iugr), prematurity, polyhydramnios, still birth, and low birth weight. animal data pregnant rats and rabbits were treated with paricalcitol by once-daily intravenous (iv) injection during the period of organogenesis (in rats, from gestation day (gd) 6 to 17; in rabbits, from gd 6 to 18). rats were dosed at 0, 0.3, 1 or 3 mcg/kg/day and rabbits at 0, 0.03, 0.1 or 0.3 mcg/kg/day, representing up to 2 or 0.5 times, respectively, the maximum recommended human dose (mrhd) of 0.24 mcg/kg, based on body surface area (mg/m2 ). slightly decreased fetal viability was observed in both studies at the highest doses representing 2 and 0.5 times, respectively, the mrhd in the presence of maternal toxicity (decreased body weight and food consumption). pregnant rats were administered paricalcitol by iv injection three times per week at doses of 0, 0.3, 3 or 20 mcg/kg/day throughout gestation, parturition and lactation (gd 6 to lactation day (ld) 20) representing exposures up to 13 times the mhrd. a small increase in stillbirths and pup deaths from parturition to ld 4 were observed at the high dose when compared to the control group (9.2% versus 3.3% in controls) at 13 times the mrhd, which occurred at a maternally toxic dose known to cause hypercalcemia in rats. surviving pups were not adversely affected; body weight gains, developmental landmarks, reflex ontogeny, learning indices, and locomotor activity were all within normal parameters. f1 reproductive capacity was unaffected. risk summary there is no information available on the presence of paricalcitol in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. studies in rats have shown that paricalcitol and/or its metabolites are present in the milk of lactating rats; however, due to specifies-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk [see data] . because of the potential for serious adverse reactions, including hypercalcemia in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with paricalcitol. following a single oral administration of 20 mcg/kg of radioactive [3 h] paricalcitol to lactating rats, the concentrations of total radioactivity was determined. lower levels of total radioactivity were present in the milk compared to that in the plasma of the dams indicating that low levels of [3 h] paricalcitol and/or its metabolites are secreted into milk. exposure of the pups to [3 h] paricalcitol through milk was confirmed by the presence of radioactive material in the pups’ stomachs. safety and effectiveness of paricalcitol capsules in pediatric patients under the age of 10 years have not been established. pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. of the total number (n = 220) of ckd stages 3 and 4 patients in clinical studies of paricalcitol capsules, 49% were age 65 and over, while 17% were age 75 and over. of the total number (n = 88) of ckd stage 5 patients in the pivotal study of paricalcitol capsules, 28% were age 65 and over, while 6% were age 75 and over. no overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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

bionpharma inc. - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol 1 ug - paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4. pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd). pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or hypercalcemia or - vitamin d toxicity [see warnings and precautions ( 5.1) ]. vitamin d toxicity [see warnings and precautions ( 5.1) ]. risk summary limited data with paricalcitol capsules in pregnant women are insufficient to inform a drug‑associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see clinical considerations] . in animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered paricalcitol intravenously during the period of organogenesis at doses 2 and 0.5 times, respectively, the maximum recommended human dose (mrhd). adverse reproductive outcomes were observed at doses that caused maternal toxicity [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 estimated 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 chronic kidney disease in pregnancy increases the maternal risk for hypertension, spontaneous abortion, preterm labor, and preeclampsia. chronic kidney disease increases the fetal risk for intrauterine growth restriction (iugr), prematurity, polyhydramnios, still birth, and low birth weight. data animal data pregnant rats and rabbits were treated with paricalcitol by once-daily intravenous (iv) injection during the period of organogenesis (in rats, from gestation day (gd) 6 to 17; in rabbits, from gd 6 to 18). rats were dosed at 0, 0.3, 1.0 or 3.0 mcg/kg/day and rabbits at 0, 0.03, 0.1 or 0.3 mcg/kg/day, representing up to 2 or 0.5 times, respectively, the maximum recommended human dose (mrhd) of 0.24 mcg/kg, based on body surface area (mg/m 2 ). slightly decreased fetal viability was observed in both studies at the highest doses representing 2 and 0.5 times, respectively, the mrhd in the presence of maternal toxicity (decreased body weight and food consumption). pregnant rats were administered paricalcitol by iv injection three times per week at doses of 0, 0.3, 3.0 or 20.0 mcg/kg/day throughout gestation, parturition and lactation (gd 6 to lactation day (ld) 20) representing exposures up to 13 times the mhrd. a small increase in stillbirths and pup deaths from parturition to ld 4 were observed at the high dose when compared to the control group (9.2% versus 3.3% in controls) at 13 times the mrhd, which occurred at a maternally toxic dose known to cause hypercalcemia in rats. surviving pups were not adversely affected; body weight gains, developmental landmarks, reflex ontogeny, learning indices, and locomotor activity were all within normal parameters. f1 reproductive capacity was unaffected. risk summary there is no information available on the presence of paricalcitol in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. studies in rats have shown that paricalcitol and/or its metabolites are present in the milk of lactating rats; however, due to specifies-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk [see data] . because of the potential for serious adverse reactions, including hypercalcemia in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with paricalcitol. data following a single oral administration of 20 mcg/kg of radioactive [ 3 h] paricalcitol to lactating rats, the concentrations of total radioactivity was determined. lower levels of total radioactivity were present in the milk compared to that in the plasma of the dams indicating that low levels of [ 3 h] paricalcitol and/or its metabolites are secreted into milk. exposure of the pups to [ 3 h] paricalcitol through milk was confirmed by the presence of radioactive material in the pups’ stomachs. safety and effectiveness of paricalcitol capsules in pediatric patients under the age of 10 years have not been established. pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. of the total number (n = 220) of ckd stages 3 and 4 patients in clinical studies of paricalcitol capsules, 49% were age 65 and over, while 17% were age 75 and over. of the total number (n = 88) of ckd stage 5 patients in the pivotal study of paricalcitol capsules, 28% were age 65 and over, while 6% were age 75 and over. no overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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

golden state medical supply, inc. - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol 1 ug - paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4. paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd). paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or - vitamin d toxicity [see warnings and precautions (5.1) ]. pregnancy category c. paricalcitol has been shown to cause minimal decreases in fetal viability (5%) when administered daily to rabbits at a dose 0.5 times a human dose of 14 mcg or 0.24 mcg/kg (based on body surface area, mcg/m 2 ), and when administered to rats at a dose two times the 0.24 mcg/kg human dose (based on body surface area, mcg/m 2 ). at the highest dose tested, 20 mcg/kg administered three times per week in rats (13 times the 14 mcg human dose based on

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

aurobindo pharma limited - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol 1 ug - paricalcitol capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4. paricalcitol capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd). paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or - vitamin d toxicity [see warnings and precautions (5.1)] . risk summary limited data with paricalcitol capsules in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see clinical considerations] . in animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered paricalcitol intravenously during the period of organogenesis at doses 2 and 0.5 times, respectively, the maximum recommended human dose (mrhd). adverse reproductive outcomes were observed at doses that caused maternal toxicity [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 estimated 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 chronic kidney disease in pregnancy increases the maternal risk for hypertension, spontaneous abortion, preterm labor, and preeclampsia. chronic kidney disease increases the fetal risk for intrauterine growth restriction (iugr), prematurity, polyhydramnios, still birth, and low birth weight. data animal data pregnant rats and rabbits were treated with paricalcitol by once-daily intravenous (iv) injection during the period of organogenesis (in rats, from gestation day (gd) 6 to 17; in rabbits, from gd 6 to 18). rats were dosed at 0, 0.3, 1.0 or 3.0 mcg/kg/day and rabbits at 0, 0.03, 0.1 or 0.3 mcg/kg/day, representing up to 2 or 0.5 times, respectively, the maximum recommended human dose (mrhd) of 0.24 mcg/kg, based on body surface area (mg/m2 ). slightly decreased fetal viability was observed in both studies at the highest doses representing 2 and 0.5 times, respectively, the mrhd in the presence of maternal toxicity (decreased body weight and food consumption). pregnant rats were administered paricalcitol by iv injection three times per week at doses of 0, 0.3, 3.0 or 20.0 mcg/kg/day throughout gestation, parturition and lactation (gd 6 to lactation day (ld) 20) representing exposures up to 13 times the mhrd. a small increase in stillbirths and pup deaths from parturition to ld 4 were observed at the high dose when compared to the control group (9.2% versus 3.3% in controls) at 13 times the mrhd, which occurred at a maternally toxic dose known to cause hypercalcemia in rats. surviving pups were not adversely affected; body weight gains, developmental landmarks, reflex ontogeny, learning indices, and locomotor activity were all within normal parameters. f1 reproductive capacity was unaffected. risk summary there is no information available on the presence of paricalcitol in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. studies in rats have shown that paricalcitol and/or its metabolites are present in the milk of lactating rats; however, due to specifies-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk [see data] . because of the potential for serious adverse reactions, including hypercalcemia in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with paricalcitol. data following a single oral administration of 20 mcg/kg of radioactive [3 h] paricalcitol to lactating rats, the concentrations of total radioactivity was determined. lower levels of total radioactivity were present in the milk compared to that in the plasma of the dams indicating that low levels of [3 h] paricalcitol and/or its metabolites are secreted into milk. exposure of the pups to [3 h] paricalcitol through milk was confirmed by the presence of radioactive material in the pups’ stomachs. the safety and effectiveness of paricalcitol capsules have been established in pediatric patients 10 to 16 years of age for the prevention and treatment of secondary hyperparathyroidism associated with stage 3, 4, and 5 ckd. use of paricalcitol capsules in this age group is supported by evidence from adequate and well controlled studies in adults with ckd, a 12-week double-blind placebo-controlled randomized multicenter study in 36 pediatric patients 10 to 16 years of age with ckd stages 3 and 4, and safety data from a 12-week open-label single-arm multicenter study in 13 pediatric patients 10 to 16 years of age with ckd stage 5 receiving peritoneal dialysis or hemodialysis. the pharmacokinetics of paricalcitol in stage 5 ckd pediatric patients appear to be similar to those observed in stage 3 and 4 pediatric patients [see clinical pharmacology (12.3) and clinical studies (14.1)] . adverse reactions reported in these pediatric studies are consistent with the known safety profile of paricalcitol capsules and with what has been reported in adult clinical studies [see adverse reactions (6.1)] . safety and effectiveness of paricalcitol capsules in pediatric patients under the age of 10 years have not been established. of the total number (n = 220) of ckd stages 3 and 4 patients in clinical studies of paricalcitol capsules, 49% were age 65 and over, while 17% were age 75 and over. of the total number (n = 88) of ckd stage 5 patients in the pivotal study of paricalcitol capsules, 28% were age 65 and over, while 6% were age 75 and over. no overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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

banner life sciences llc. - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol 1 mg - paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4. paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd). paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or - vitamin d toxicity [see warnings and precautions (5.1) ]. pregnancy category c. paricalcitol has been shown to cause minimal decreases in fetal viability (5%) when administered daily to rabbits at a dose 0.5 times a human dose of 14 mcg or 0.24 mcg/kg (based on body surface area, mcg/m2 ), and when administered to rats at a dose two times the 0.24 mcg/kg human dose (based on body surface area, mcg/m2 ). at the highest dose tested, 20 mcg/kg administered three times per week in rats (13 times the 14 mcg human dose based on surface area, mcg/m2 ), there was a significant i

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

west-ward pharmaceuticals corp - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol 2 ug in 1 ml - paricalcitol injection is an active vitamin d2 analogue indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stage 5. paricalcitol injection is contraindicated in patients with evidence of: - hypercalcemia [see warnings and precautions (5.1) ] - vitamin d toxicity [see warnings and precautions (5.1) ] or - hypersensitivity to paricalcitol or any inactive ingredient in this product [see adverse reactions (6.2) ] pregnancy category c paricalcitol has been shown to cause minimal decreases in fetal viability (5%) when administered daily to rabbits at a dose 0.5 times the 0.24 mcg/kg human dose (based on surface area, mg/m2 ) and when administered to rats at a dose 2 times the 0.24 mcg/kg human dose (based on plasma levels of exposure). at the highest dose tested (20 mcg/kg 3 times per week in rats, 13 times the 0.24 mcg/kg human dose based on surface area), there was a significant increase of the mortality of newborn rats at doses that were mate

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

banner pharmacaps - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol 1 ug - paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4. paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd). paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or hypercalcemia or - vitamin d toxicity [see warnings and precautions (5.1) ]. vitamin d toxicity [see warnings and precautions (5.1) ]. pregnancy category c. paricalcitol has been shown to cause minimal decreases in fetal viability (5%) when administered daily to rabbits at a dose 0.5 times a human dose of 14 mcg or 0.24 mcg/kg (based on body surface area, mcg/m2 ), and when administered to rats at a dose two times the 0.24 mcg/kg human dose (based on body surface area, mcg/m2 ). at the highest dose tested, 20 mcg/kg administered three times per week in rats (13 times