Label Changes for:

Sensipar (cinacalcet) Tablets

February 2008

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS

  • Hypotension and/or Worsening Heart Failure

PRECAUTIONS

  • General
    • Hypocalcemia
      • Sensipar is not indicated for CKD patients not on dialysis...
      • ...In a phase 3 study of 32 weeks duration and including 404 subjects...

ADVERSE REACTIONS

  • Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease
    on Dialysis
    • In 3 double-blind placebo-controlled clinical trials, 1126 CKD patients on dialysis received study drug...
  • Table 2. Adverse Event Incidence (> 5%) in Patients on DialysisTable 2 Adverse Event Incidence
  • Postmarketing Experience with Sensipar

WARNINGS

Hypotension and/or Worsening Heart Failure

In postmarketing safety surveillance, isolated, idiosyncratic cases of hypotension and/or worsening heart failure have been reported in patients with impaired cardiac function, in which a causal relationship to Sensipar could not be completely excluded and may be mediated by reductions in serum calcium levels. Clinical trial data showed hypotension occurred in 7% of Sensipar-treated patients, 12% of placebo-treated patients, and heart failure occurred in 2% of patients receiving Sensipar or placebo.

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