1 Guidance

1.1 Cinacalcet is not recommended for the routine treatment of secondary hyperparathyroidism in patients with end-stage renal disease on maintenance dialysis therapy.

1.2 Cinacalcet is recommended for the treatment of refractory secondary hyperparathyroidism in patients with end-stage renal disease (including those with calciphylaxis) only in those:

  • who have 'very uncontrolled' plasma levels of intact parathyroid hormone (defined as greater than 85 pmol/litre [800 pg/ml]) that are refractory to standard therapy, and a normal or high adjusted serum calcium level, and

  • in whom surgical parathyroidectomy is contraindicated, in that the risks of surgery are considered to outweigh the benefits.

1.3 Response to treatment should be monitored regularly and treatment should be continued only if a reduction in the plasma levels of intact parathyroid hormone of 30% or more is seen within 4 months of treatment, including dose escalation as appropriate.