What is the maximum dose of Cinacalcet (Cinacalcet hydrochloride) for a patient with secondary hyperparathyroidism?

Maximum Dose of Cinacalcet for Secondary Hyperparathyroidism

The maximum dose of cinacalcet for secondary hyperparathyroidism in patients with chronic kidney disease on dialysis is 180 mg once daily. 1

Dosing Algorithm for Secondary Hyperparathyroidism

Starting Dose and Titration Schedule

• Begin with 30 mg once daily, taken with food or shortly after a meal 1
• Titrate no more frequently than every 2 to 4 weeks through sequential doses: 30 mg → 60 mg → 90 mg → 120 mg → 180 mg once daily 1
• Target iPTH levels of 150 to 300 pg/mL 1
• The dose range of 30-180 mg demonstrates dose-proportional pharmacokinetics 2

Monitoring Requirements During Titration

• Measure serum calcium and phosphorus within 1 week of initiation or dose adjustment 1
• Measure iPTH 1 to 4 weeks after initiation or dose adjustment 1
• Assess iPTH levels no earlier than 12 hours after dosing 1
• Once maintenance dose is established, monitor serum calcium approximately monthly 1

Important Distinction: Primary Hyperparathyroidism and Parathyroid Carcinoma

For patients with parathyroid carcinoma or primary hyperparathyroidism, the dosing differs substantially:

• Start at 30 mg twice daily 1
• Titrate every 2 to 4 weeks through: 30 mg twice daily → 60 mg twice daily → 90 mg twice daily → 90 mg three or four times daily 1
• This can result in a maximum total daily dose of 360 mg (90 mg four times daily) 1, 3

Critical Safety Considerations

Hypocalcemia Management

• Cinacalcet increases hypocalcemia risk 7.38-fold, which is the most significant adverse effect 4, 5, 6
• If serum calcium falls below 8.4 mg/dL but remains above 7.5 mg/dL, increase calcium-containing phosphate binders and/or vitamin D sterols 1
• If serum calcium falls below 7.5 mg/dL or symptoms of hypocalcemia persist, withhold cinacalcet until serum calcium reaches 8 mg/dL, then restart at the next lowest dose 1

Common Gastrointestinal Effects

• Nausea occurs with a relative risk of 2.05, typically mild to moderate and transient 4, 5
• Vomiting (RR 1.95) and diarrhea (RR 1.15) are also common 4, 5
• These gastrointestinal effects were the most frequent adverse events in clinical trials 7, 3

Clinical Context and Efficacy

Mortality and Morbidity Outcomes

• Cinacalcet has little to no effect on all-cause mortality (RR 0.97) 4, 5
• The primary benefit is preventing parathyroidectomy (RR 0.49) 4
• Treating 1,000 patients for 1 year prevents approximately 3 parathyroidectomies but causes 60 cases of hypocalcemia and 150 cases of nausea 4

Long-Term Effectiveness

• The 180 mg once daily maximum dose has been studied for up to 3 years, demonstrating sustained PTH reduction without increasing calcium or phosphorus levels 8
• Approximately 55% of patients achieved PTH ≤300 pg/mL at 100 weeks of treatment 8