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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
05/23/2017
Trade Name:
Sensipar
Generic Name or Proper Name (*):
cinacalcet
Indications Studied:
Treatment of secondary HPT in pediatric patients with Chronic Kidney Disease on dialysis
Label Changes Summary:
*Safety and efficacy for the pediatric population have not been established. *Use for the treatment of secondary HPT in pediatric patients with CKD on dialysis was evaluated in two randomized, controlled studies in 47 pediatric patients aged 6 years to less than 18 years and in one single-arm study in 17 pediatric patients aged 28 days to less than 6 years. *Dosing with Sensipar in pediatric study 1 was stopped because of a fatality in a Sensipar-treated individual who was noted to be severely hypocalcemic at the time of death. The cause of death was multifactorial and a contribution of Sensipar to the death could not be excluded. *Life threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with Sensipar, including in pediatric patients. *Pediatric studies did not establish a safe and effective Sensipar dosing regimen for the pediatric population. *Information on safety, and clinical trials.
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Amgen
NNPS:
FALSE
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