Malta - inglés - Malta Medicines Authority

accord healthcare limited - cinacalcet hydrochloride - film-coated tablet - cinacalcet hydrochloride 90 mg - calcium homeostasis

Malta - inglés - Malta Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - cinacalcet hydrochloride - film-coated tablet - cinacalcet hydrochloride 30 mg - calcium homeostasis

Malta - inglés - Malta Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - cinacalcet hydrochloride - film-coated tablet - cinacalcet hydrochloride 60 mg - calcium homeostasis

Malta - inglés - Malta Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - cinacalcet hydrochloride - film-coated tablet - cinacalcet hydrochloride 90 mg - calcium homeostasis

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

arrotex pharmaceuticals pty ltd - cinacalcet hydrochloride, quantity: 66.12 mg (equivalent: cinacalcet, qty mg) - tablet, film coated - excipient ingredients: iron oxide yellow; macrogol 8000; magnesium stearate; sodium starch glycollate type b; silicon dioxide; iron oxide black; brilliant blue fcf aluminium lake; mannitol; croscarmellose sodium; polyvinyl alcohol; microcrystalline cellulose; titanium dioxide; purified talc - cinacalcet may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease, receiving dialysis (see clinical trials). cinacalcet should be used as adjunctive therapy. cinacalcet is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma. cinacalcet may be used to treat the biochemical manifestations of primary hyperparathyroidism in patients for whom parathyroidectomy is not a treatment option.

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

arrotex pharmaceuticals pty ltd - cinacalcet hydrochloride, quantity: 99.18 mg (equivalent: cinacalcet, qty mg) - tablet, film coated - excipient ingredients: iron oxide black; titanium dioxide; iron oxide yellow; magnesium stearate; croscarmellose sodium; silicon dioxide; brilliant blue fcf aluminium lake; mannitol; macrogol 8000; purified talc; microcrystalline cellulose; polyvinyl alcohol; sodium starch glycollate type b - cinacalcet may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease, receiving dialysis (see clinical trials). cinacalcet should be used as adjunctive therapy. cinacalcet is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma. cinacalcet may be used to treat the biochemical manifestations of primary hyperparathyroidism in patients for whom parathyroidectomy is not a treatment option.

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

arrotex pharmaceuticals pty ltd - cinacalcet hydrochloride, quantity: 33.06 mg (equivalent: cinacalcet, qty mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; silicon dioxide; mannitol; macrogol 8000; polyvinyl alcohol; magnesium stearate; iron oxide black; brilliant blue fcf aluminium lake; iron oxide yellow; purified talc; titanium dioxide; sodium starch glycollate type b - cinacalcet may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease, receiving dialysis (see clinical trials). cinacalcet should be used as adjunctive therapy. cinacalcet is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma. cinacalcet may be used to treat the biochemical manifestations of primary hyperparathyroidism in patients for whom parathyroidectomy is not a treatment option.

Estados Unidos - inglés - NLM (National Library of Medicine)

aurobindo pharma limited - cinacalcet hydrochloride (unii: 1k860wsg25) (cinacalcet - unii:uaz6v7728s) - cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (hpt) in adult patients with chronic kidney disease (ckd) on dialysis [see clinical studies (14.1)]. limitations of use: cinacalcet tablets are not indicated for use in patients with ckd who are not on dialysis because of an increased risk of hypocalcemia [see warnings and precautions (5.1)] . cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with parathyroid carcinoma [see clinical studies (14.2)] . cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with primary hpt for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy [see clinical studies (14.3)]. cinacalcet tablets treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [see warnings and precautions (5.1)] . risk summary limited case reports of cinacalcet use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. in animal reproduction studies, when female rats were exposed to cinacalcet during the period of organogenesis through to weaning at 2 to 3 times the systemic drug levels (based on auc) at the maximum recommended human dose (mrhd) of 180 mg/day, peripartum and early postnatal pup loss and reduced pup body weight gain were observed in the presence of maternal hypocalcemia [see data] . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in pregnant female rats given oral gavage doses of 2, 25, 50 mg/kg/day cinacalcet during gestation, no teratogenicity was observed at doses up to 50 mg/kg/day (exposure 4 times those resulting with a human oral dose of 180 mg/day based on auc comparison). decreased fetal body weights were observed at all doses (less than 1 to 4 times a human oral dose of 180 mg/day based on auc comparison) in conjunction with maternal toxicity (decreased food consumption and body weight gain). in pregnant female rabbits given oral gavage doses of 2, 12, 25 mg/kg/day cinacalcet during gestation, no adverse fetal effects were observed (exposures less than with a human oral dose of 180 mg/day based on auc comparisons). reductions in maternal food consumption and body weight gain were seen at doses of 12 and 25 mg/kg/day. cinacalcet has been shown to cross the placental barrier in rabbits. in pregnant rats given oral gavage doses of 5, 15, 25 mg/kg/day cinacalcet during gestation through lactation, no adverse fetal or pup (post-weaning) effects were observed at 5 mg/kg/day (exposures less than with a human therapeutic dose of 180 mg/day based on auc comparisons). higher doses of 15 and 25 mg/kg/day cinacalcet (exposures 2 to 3 times a human oral dose of 180 mg/day based on auc comparisons) were accompanied by maternal signs of hypocalcemia (periparturient mortality and early postnatal pup loss), and reductions in postnatal maternal and pup body weight gain. risk summary there are no data regarding the presence of cinacalcet in human milk or effects on the breastfed infant or on milk production. studies in rats showed that cinacalcet was excreted in the milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cinacalcet and any potential adverse effects on the breastfed infant from cinacalcet or from the underlying maternal condition. the safety and efficacy of cinacalcet have not been established in pediatric patients. the use of cinacalcet for the treatment of secondary hpt in pediatric patients with ckd on dialysis was evaluated in two randomized, controlled studies (pediatric study 1 and study 2) where 47 pediatric patients aged 6 years to less than 18 years received at least one dose of cinacalcet and in one single-arm study (pediatric study 3) where 17 pediatric patients aged 28 days to less than 6 years received at least one dose of cinacalcet. dosing with cinacalcet in pediatric study 1 was stopped because of a fatality in a cinacalcet-treated individual. the individual was noted to be severely hypocalcemic at the time of death. the cause of death was multifactorial and a contribution of cinacalcet to the death could not be excluded [see warnings and precautions (5.1)]. study 1 was terminated and changes to cinacalcet dosing after the fatality were implemented in pediatric study 2 and study 3 to minimize the risk of severe hypocalcemia. the data in pediatric studies 2 and 3 were insufficient to establish the safety and efficacy of cinacalcet for the treatment of secondary hpt in pediatric patients with ckd on dialysis. in aggregate, the pediatric studies did not establish a safe and effective cinacalcet dosing regimen for the pediatric population. of the total number of subjects (n = 1136) in clinical studies of cinacalcet, 26 percent were 65 and over, and 9 percent were 75 and over. no overall differences in the safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out [see clinical studies (14) and clinical pharmacology (12.3)] . no dosage adjustment is necessary for renal impairment [see clinical pharmacology (12.3)] . patients with moderate and severe hepatic impairment should have serum calcium, serum phosphorus, and ipth levels monitored closely throughout treatment with cinacalcet because cinacalcet exposure (auc0-infinite ) is increased by 2.4 and 4.2 fold, respectively, in these patients [see clinical pharmacology (12.3)] .

Estados Unidos - inglés - NLM (National Library of Medicine)

dr. reddys laboratories inc - cinacalcet hydrochloride (unii: 1k860wsg25) (cinacalcet - unii:uaz6v7728s) - cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (hpt) in adult patients with chronic kidney disease (ckd) on dialysis [see clinical studies (14.1)] .   limitations of use: cinacalcet tablets are not indicated for use in patients with ckd who are not on dialysis because of an increased risk of hypocalcemia [see warnings and precautions ( 5.1)] . cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with parathyroid carcinoma [see clinical studies ( 14.2)] . cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with primary hpt for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy [see clinical studies (14.3)] . cinacalcet treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [see warnings and precautions (5.1)]. risk summary limited case reports of cinacalcet use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. in animal reproduction studies, when female rats were exposed to cinacalcet during the period of organogenesis through to weaning at 2 to 3 times the systemic drug levels (based on auc) at the maximum recommended human dose (mrhd) of 180 mg/day, peripartum and early postnatal pup loss and reduced pup body weight gain were observed in the presence of maternal hypocalcemia [see data] .   the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.   data animal data in pregnant female rats given oral gavage doses of 2, 25, 50 mg/kg/day cinacalcet during gestation, no teratogenicity was observed at doses up to 50 mg/kg/day (exposure 4 times those resulting with a human oral dose of 180 mg/day based on auc comparison). decreased fetal body weights were observed at all doses (less than 1 to 4 times a human oral dose of 180 mg/day based on auc comparison) in conjunction with maternal toxicity (decreased food consumption and body weight gain). in pregnant female rabbits given oral gavage doses of 2, 12, 25 mg/kg/day cinacalcet during gestation, no adverse fetal effects were observed (exposures less than with a human oral dose of 180 mg/day based on auc comparisons). reductions in maternal food consumption and body weight gain were seen at doses of 12 and 25 mg/kg/day. cinacalcet has been shown to cross the placental barrier in rabbits. in pregnant rats given oral gavage doses of 5, 15, 25 mg/kg/day cinacalcet during gestation through lactation, no adverse fetal or pup (post-weaning) effects were observed at 5 mg/kg/day (exposures less than with a human therapeutic dose of 180 mg/day based on auc comparisons). higher doses of 15 and 25 mg/kg/day cinacalcet (exposures 2 to 3 times a human oral dose of 180 mg/day based on auc comparisons) were accompanied by maternal signs of hypocalcemia (periparturient mortality and early postnatal pup loss), and reductions in postnatal maternal and pup body weight gain. risk summary there are no data regarding the presence of cinacalcet in human milk or effects on the breastfed infant or on milk production. studies in rats showed that cinacalcet was excreted in the milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cinacalcet and any potential adverse effects on the breastfed infant from cinacalcet or from the underlying maternal condition. the safety and efficacy of cinacalcet have not been established in pediatric patients. the use of cinacalcet for the treatment of secondary hpt in pediatric patients with ckd on dialysis was evaluated in two randomized, controlled studies (pediatric study 1 and study 2) where 47 pediatric patients aged 6 years to less than 18 years received at least one dose of cinacalcet and in one single-arm study (pediatric study 3) where 17 pediatric patients aged 28 days to less than 6 years received at least one dose of cinacalcet. dosing with cinacalcet in pediatric study 1 was stopped because of a fatality in a cinacalcet-treated individual. the individual was noted to be severely hypocalcemic at the time of death. the cause of death was multifactorial and a contribution of cinacalcet to the death could not be excluded [see warnings and precautions (5.1)]. study 1 was terminated and changes to cinacalcet dosing after the fatality were implemented in pediatric study 2 and study 3 to minimize the risk of severe hypocalcemia. the data in pediatric studies 2 and 3 were insufficient to establish the safety and efficacy of cinacalcet for the treatment of secondary hpt in pediatric patients with ckd on dialysis. in aggregate, the pediatric studies did not establish a safe and effective cinacalcet dosing regimen for the pediatric population.  of the total number of subjects (n=1136) in clinical studies of cinacalcet, 26 percent were 65 and over, and 9 percent were 75 and over. no overall differences in the safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out [see clinical studies (14) and clinical pharmacology (12.3)]. no dosage adjustment is necessary for renal impairment [see clinical pharmacology (12.3)]. patients with moderate and severe hepatic impairment should have serum calcium, serum phosphorus, and ipth levels monitored closely throughout treatment with cinacalcet because cinacalcet exposure (auc0-infinite ) is increased by 2.4 and 4.2 fold, respectively, in these patients [see clinical pharmacology (12.3)] .

Estados Unidos - inglés - NLM (National Library of Medicine)

avkare - cinacalcet hydrochloride (unii: 1k860wsg25) (cinacalcet - unii:uaz6v7728s) - cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (hpt) in adult patients with chronic kidney disease (ckd) on dialysis [see clinical studies (14.1)]. limitations of use: cinacalcet tablets are not indicated for use in patients with ckd who are not on dialysis because of an increased risk of hypocalcemia [see warnings and precautions (5.1)] . cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with parathyroid carcinoma [see clinical studies (14.2)] . cinacalcet tablets are indicated for the treatment of severe hypercalcemia in adult patients with primary hpt who are unable to undergo parathyroidectomy [see clinical studies (14.3)] . cinacalcet tablets treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [see warnings and precautions (5.1)] . risk summary limited case reports of cinacalcet use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. in animal reproduction studies, when female rats were exposed to cinacalcet during the period of organogenesis through to weaning at 2 to 3 times the systemic drug levels (based on auc) at the maximum recommended human dose (mrhd) of 180 mg/day, peripartum and early postnatal pup loss and reduced pup body weight gain were observed in the presence of maternal hypocalcemia [see data] . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in pregnant female rats given oral gavage doses of 2, 25, 50 mg/kg/day cinacalcet during gestation, no teratogenicity was observed at doses up to 50 mg/kg/day (exposure 4 times those resulting with a human oral dose of 180 mg/day based on auc comparison). decreased fetal body weights were observed at all doses (less than 1 to 4 times a human oral dose of 180 mg/day based on auc comparison) in conjunction with maternal toxicity (decreased food consumption and body weight gain). in pregnant female rabbits given oral gavage doses of 2, 12, 25 mg/kg/day cinacalcet during gestation, no adverse fetal effects were observed (exposures less than with a human oral dose of 180 mg/day based on auc comparisons). reductions in maternal food consumption and body weight gain were seen at doses of 12 and 25 mg/kg/day. cinacalcet has been shown to cross the placental barrier in rabbits. in pregnant rats given oral gavage doses of 5, 15, 25 mg/kg/day cinacalcet during gestation through lactation, no adverse fetal or pup (post-weaning) effects were observed at 5 mg/kg/day (exposures less than with a human therapeutic dose of 180 mg/day based on auc comparisons). higher doses of 15 and 25 mg/kg/day cinacalcet (exposures 2 to 3 times a human oral dose of 180 mg/day based on auc comparisons) were accompanied by maternal signs of hypocalcemia (periparturient mortality and early postnatal pup loss), and reductions in postnatal maternal and pup body weight gain. risk summary there are no data regarding the presence of cinacalcet in human milk or effects on the breastfed infant or on milk production. studies in rats showed that cinacalcet was excreted in the milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cinacalcet and any potential adverse effects on the breastfed infant from cinacalcet or from the underlying maternal condition. the safety and efficacy of cinacalcet have not been established in pediatric patients. the use of cinacalcet for the treatment of secondary hpt in pediatric patients with ckd on dialysis was evaluated in two randomized, controlled studies (pediatric study 1 and study 2) where 47 pediatric patients aged 6 years to less than 18 years received at least one dose of cinacalcet and in one single-arm study (pediatric study 3) where 17 pediatric patients aged 28 days to less than 6 years received at least one dose of cinacalcet. dosing with cinacalcet in pediatric study 1 was stopped because of a fatality in a cinacalcet-treated individual. the individual was noted to be severely hypocalcemic at the time of death. the cause of death was multifactorial and a contribution of cinacalcet to the death could not be excluded [see warnings and precautions (5.1)]. study 1 was terminated and changes to cinacalcet dosing after the fatality were implemented in pediatric study 2 and study 3 to minimize the risk of severe hypocalcemia. the data in pediatric studies 2 and 3 were insufficient to establish the safety and efficacy of cinacalcet for the treatment of secondary hpt in pediatric patients with ckd on dialysis. in aggregate, the pediatric studies did not establish a safe and effective cinacalcet dosing regimen for the pediatric population. of the total number of subjects (n = 1136) in clinical studies of cinacalcet, 26 percent were 65 and over, and 9 percent were 75 and over. no overall differences in the safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out [see  clinical studies (14) and clinical pharmacology (12.3)] . no dosage adjustment is necessary for renal impairment [see clinical pharmacology (12.3)] . patients with moderate and severe hepatic impairment should have serum calcium, serum phosphorus, and ipth levels monitored closely throughout treatment with cinacalcet because cinacalcet exposure (auc 0-infinite ) is increased by 2.4 and 4.2 fold, respectively, in these patients [see clinical pharmacology (12.3)] .