Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Amgen
 
NNPS:  FALSE
 
-
-