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

cipla usa inc. - cinacalcet hydrochloride (unii: 1k860wsg25) (cinacalcet - unii:uaz6v7728s) - cinacalcet 30 mg - cinacalcet hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 l

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

slate run pharmaceuticals - cinacalcet hydrochloride (unii: 1k860wsg25) (cinacalcet - unii:uaz6v7728s) - cinacalcet hydrochloride 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 hydrochloride 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 hydrochloride tablets are indicated for the treatment of hypercalcemia in adult patients with parathyroid carcinoma [see clinical studies (14.2)] . cinacalcet hydrochloride 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 hydrochloride 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 hydrochloride tablets use in pregn

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

actavis pharma, inc. - cinacalcet hydrochloride (unii: 1k860wsg25) (cinacalcet - unii:uaz6v7728s) - cinacalcet hydrochloride 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 hydrochloride 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 hydrochloride tablets are indicated for the treatment of hypercalcemia in adult patients with parathyroid carcinoma [see clinical studies (14.2)] . cinacalcet hydrochloride 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 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 dr

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

cadila healthcare limited - cinacalcet hydrochloride (unii: 1k860wsg25) (cinacalcet - unii:uaz6v7728s) - cinacalcet hydrochloride 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 hydrochloride 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 hydrochloride tablets are indicated for the treatment of hypercalcemia in adult patients with parathyroid carcinoma [see clinical studies (14.2)]. cinacalcet hydrochloride 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 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 d

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

zydus pharmaceuticals (usa) inc. - cinacalcet hydrochloride (unii: 1k860wsg25) (cinacalcet - unii:uaz6v7728s) - cinacalcet hydrochloride 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 hydrochloride 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 hydrochloride tablets are indicated for the treatment of hypercalcemia in adult patients with parathyroid carcinoma [see clinical studies (14.2)]. cinacalcet hydrochloride 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 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 d

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

exelan pharmaceuticals inc. - cinacalcet hydrochloride (unii: 1k860wsg25) (cinacalcet - unii:uaz6v7728s) - cinacalcet hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride use in pregnant women are insuffic

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

amneal pharmaceuticals llc - 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 hcl 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 hcl use in pregn

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

physicians total care, inc. - cinacalcet hydrochloride (unii: 1k860wsg25) (cinacalcet - unii:uaz6v7728s) - cinacalcet hydrochloride 30 mg - sensipar is indicated for the treatment of secondary hyperparathyroidism (hpt) in patients with chronic kidney disease (ckd) on dialysis [see clinical studies (14.1)]. sensipar is indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma [see clinical studies (14.2)]. sensipar is indicated for the treatment of severe hypercalcemia in patients with primary hpt who are unable to undergo parathyroidectomy [see clinical studies (14.3)]. hypocalcemia: sensipar treatment should not be initiated if serum calcium is less than the lower limit of the normal range [see warnings and precautions (5.1)] . 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 area under the curve [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

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

aci healthcare usa, inc - cinacalcet hydrochloride (unii: 1k860wsg25) (cinacalcet - unii:uaz6v7728s) - cinacalcet tablets is 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 is 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 is indicated for the treatment of hypercalcemia in adult patients with parathyroid carcinoma [see clinical studies (14.2)] . cinacalcet tablets is 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.

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

avpak - 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 (auc 0-infinite ) is increased by 2.4 and 4.2 fold, respectively, in these patients [see clinical pharmacology ( 12.3) ] .