From the Guidelines
Cinacalcet (Sensipar) is indicated for starting in patients with chronic kidney disease (CKD) stage 5D who have secondary hyperparathyroidism and are at risk of parathyroidectomy, but not for routine treatment of elevated serum parathyroid hormone (PTH) levels.
Key Indications
- Secondary hyperparathyroidism: Cinacalcet is used to treat secondary hyperparathyroidism in patients with CKD stage 5D, which can lead to hypercalcemia, bone disease, and other complications 1.
- Parathyroidectomy prevention: The primary benefit of cinacalcet is the prevention of surgical parathyroidectomy in patients with CKD stage 5D who are at risk of this procedure 1.
Important Considerations
- Limited benefits: Cinacalcet has little or no effect on all-cause mortality, cardiovascular mortality, or fracture prevention in patients with CKD stage 5D 1.
- Adverse effects: Cinacalcet is commonly associated with adverse effects such as hypocalcemia, nausea, vomiting, and diarrhea, which can affect nutrition and quality of life 1.
- Restricted use: The US Food and Drug Administration approval for cinacalcet is restricted to patients with CKD stage 5D who have secondary hyperparathyroidism, and the UK National Health Service National Institute for Health and Clinical Excellence guidance recommends limiting cinacalcet use to patients with elevated PTH concentrations refractory to standard therapy and in whom surgical parathyroidectomy is contraindicated 1.
From the FDA Drug Label
Cinacalcet tablet is a positive modulator of the calcium sensing receptor indicated for: • Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. • Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). • 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.
The indications for starting Cinacalcet (Sensipar) are:
- Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis
- Hypercalcemia in adult patients with Parathyroid Carcinoma (PC)
- 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 2 2 2
From the Research
Indications for Starting Cinacalcet (Sensipar)
The indications for starting Cinacalcet (Sensipar) include:
- Secondary hyperparathyroidism (HPT) associated with chronic kidney disease requiring dialysis 3, 4, 5
- Primary hyperparathyroidism, including parathyroid carcinoma 3, 5, 6
- Hypercalcemia in patients with primary HPT or parathyroid carcinoma 3, 6
Key Considerations
- Cinacalcet is effective in reducing parathyroid hormone (PTH) levels, serum calcium, and phosphorus levels in patients with secondary HPT 3, 4, 5
- Cinacalcet has been shown to improve achievement of National Kidney Foundation's-Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) treatment goals for PTH, calcium, and phosphorus levels 3, 5
- However, in patients with primary HPT, cinacalcet may not provide symptom relief and may accelerate bone loss with prolonged use 7