What is the recommended dosing for cinacalcet (Sensipar) in patients with secondary hyperparathyroidism and chronic kidney disease (CKD) on dialysis?

Cinacalcet Dosing for Secondary Hyperparathyroidism in CKD Patients on Dialysis

For patients with secondary hyperparathyroidism and chronic kidney disease on dialysis, the recommended starting dose of cinacalcet is 30 mg once daily, with titration every 2-4 weeks through sequential doses of 30,60,90,120, and 180 mg once daily to target iPTH levels of 150-300 pg/mL. 1

Initial Dosing and Administration

• Start with 30 mg once daily, taken with food or shortly after a meal
• Cinacalcet tablets should always be taken whole, not chewed, crushed, or divided
• Cinacalcet is indicated only for CKD patients on dialysis, not for those with CKD who are not on dialysis 1

Monitoring and Dose Titration

After initiation or dose adjustment:

• Measure serum calcium and phosphorus within 1 week
• Measure intact PTH (iPTH) within 1-4 weeks
• Titrate dose no more frequently than every 2-4 weeks
• Assess iPTH levels no earlier than 12 hours after dosing 1

Target Levels and Combination Therapy

• Target iPTH level: 150-300 pg/mL
• Cinacalcet can be used alone or in combination with vitamin D sterols and/or phosphate binders 1
• The 2017 KDIGO guidelines suggest calcimimetics, calcitriol, or vitamin D analogues, or a combination as acceptable treatment options for CKD G5D patients requiring PTH-lowering therapy 2

Safety Monitoring and Hypocalcemia Management

• Once maintenance dose is established, measure serum calcium approximately monthly 1
• If serum calcium falls below 8.4 mg/dL but remains above 7.5 mg/dL, or if symptoms of hypocalcemia occur:
  • Increase calcium-containing phosphate binders
  • Increase vitamin D sterol doses
• If serum calcium falls below 7.5 mg/dL, or if symptoms of hypocalcemia persist:
  • Withhold cinacalcet until calcium levels reach 8 mg/dL and symptoms resolve
  • Restart at the next lowest dose 1

Efficacy and Side Effects

Cinacalcet effectively reduces PTH levels in dialysis patients with secondary hyperparathyroidism:

• Clinical trials show 43% of patients achieve target PTH levels (≤250 pg/mL) compared to 5% with placebo 3
• Mean PTH reductions of approximately 43% can be expected 3

Common side effects include:

• Hypocalcemia (7.38 times higher risk compared to placebo) 2
• Nausea (2.05 times higher risk) 2
• Vomiting (1.95 times higher risk) 2

Important Considerations and Contraindications

• Cinacalcet is contraindicated if serum calcium is below the lower limit of normal 1
• Treatment should not be initiated in patients with CKD who are not on dialysis due to increased risk of hypocalcemia 1
• Routine use of cinacalcet in all CKD patients is not warranted; benefits may be limited to preventing parathyroidectomy in patients for whom surgery is contraindicated 2

Clinical Pearls

• Cinacalcet provides small reductions in the risk of surgical parathyroidectomy but has little or no effect on all-cause mortality 2
• Effects on cardiovascular mortality remain uncertain 2
• When choosing between treatment options (calcimimetics, vitamin D analogs, or combination), consider the patient's current calcium and phosphate levels 2
• Cinacalcet lowers serum calcium-phosphorus product by approximately 15% 3

By following this dosing regimen and monitoring protocol, clinicians can effectively manage secondary hyperparathyroidism in CKD patients on dialysis while minimizing the risk of adverse effects.