From the FDA Drug Label
The recommended starting oral dose of cinacalcet tablets is 30 mg once daily. Cinacalcet tablets should be titrated no more frequently than every 2 to 4 weeks through sequential doses of 30,60,90,120, and 180 mg once daily to target iPTH levels of 150 to 300 pg/mL.
The maximum safe dose of cinacalcet for ESRD dialysis patients who have hyperparathyroidism is 180 mg once daily 1. This dose should be titrated based on serum calcium and phosphorus levels, as well as intact parathyroid hormone (iPTH) levels.
- Key considerations:
- Serum calcium levels should be monitored frequently during dose titration.
- If serum calcium levels decrease below the normal range, appropriate steps should be taken to increase serum calcium levels.
- Cinacalcet tablets can be used alone or in combination with vitamin D sterols and/or phosphate binders.
- Dose adjustment: The dose of cinacalcet tablets should be adjusted based on serum iPTH levels, with a target range of 150 to 300 pg/mL.
From the Research
The maximum safe dose of cinacalcet for ESRD dialysis patients with hyperparathyroidism is typically 180 mg per day, though most patients respond to lower doses. Treatment usually begins at 30 mg once daily, with dose adjustments made every 2-4 weeks based on parathyroid hormone (PTH) levels 2. Dose increases typically follow a progression of 30 mg, 60 mg, 90 mg, 120 mg, and up to 180 mg once daily if needed. Cinacalcet works by increasing the sensitivity of calcium-sensing receptors on parathyroid glands, thereby reducing PTH secretion. Common side effects include nausea, vomiting, and hypocalcemia, so calcium levels should be monitored regularly, especially during dose adjustments 3. If serum calcium falls below 8.4 mg/dL, dose reduction or temporary discontinuation may be necessary. For patients with severe hyperparathyroidism who don't respond to maximum doses, parathyroidectomy may be considered. Cinacalcet should be taken with food or shortly after a meal to improve tolerability and reduce gastrointestinal side effects.
Some key points to consider when using cinacalcet include:
- Monitoring of PTH levels to guide dose adjustments 4
- Regular monitoring of calcium levels to prevent hypocalcemia 2
- Potential for increased risk of hypocalcemia and nausea or vomiting with combination therapy of cinacalcet and vitamin D 3
- Importance of taking cinacalcet with food or shortly after a meal to improve tolerability and reduce gastrointestinal side effects.
It's also important to note that the use of cinacalcet in pediatric patients with ESRD has been studied, and it has been shown to be effective in reducing PTH levels and improving bone mineral density 5. However, the maximum safe dose for pediatric patients may be lower than for adult patients, and dose adjustments should be made based on individual patient response and tolerance.
Overall, cinacalcet is a valuable treatment option for ESRD dialysis patients with hyperparathyroidism, and its use should be guided by careful monitoring of PTH and calcium levels, as well as consideration of potential side effects and interactions with other medications.