From the FDA Drug Label
Patients initially received 30 mg cinacalcet twice daily and then were titrated every 2 weeks to a maximum dose of 90 mg four times daily Daily dose during the study ranged from 30 mg twice daily to 90 mg four times daily. Daily dose during the study ranged from 30 mg twice a day to 90 mg four times a day. The maximum dosing of cinacalcet is 90 mg four times daily 1.
- The dose can be titrated every 2 weeks to achieve the desired serum calcium concentration.
- The median dose of cinacalcet at the completion of one study was 60 mg/day.
From the Research
The maximum recommended dose of cinacalcet is 180 mg per day, typically administered in divided doses. Treatment usually begins at 30 mg once daily, with dose titration every 2-4 weeks based on parathyroid hormone (PTH) levels and calcium levels 2. Dose increases should follow a sequence of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and up to 90 mg three times daily if needed. Cinacalcet should be taken with food or shortly after a meal to improve absorption and reduce gastrointestinal side effects. Regular monitoring of serum calcium and PTH levels is essential during treatment, particularly after dose adjustments. If hypocalcemia develops (calcium below 8.4 mg/dL), dose reduction or temporary discontinuation may be necessary. In patients with hepatic impairment, careful dose titration is recommended.
Key Considerations
- Cinacalcet works by increasing the sensitivity of calcium-sensing receptors on the parathyroid gland, thereby reducing PTH secretion and helping to normalize calcium levels in conditions like secondary hyperparathyroidism in chronic kidney disease or parathyroid carcinoma 3.
- The pharmacodynamic effect of cinacalcet throughout the daily dosing interval in controlled patients is characterized by a transient reduction in PTH and phosphorus, with return to baseline at 24 hours 2.
- After discontinuation of cinacalcet, PTH levels were significantly increased at 48 hours, highlighting the need for regular monitoring and dose adjustments 2.
Dosing and Administration
- Treatment should begin at 30 mg once daily, with dose titration every 2-4 weeks based on PTH and calcium levels 2.
- Dose increases should follow a sequence of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and up to 90 mg three times daily if needed.
- Cinacalcet should be taken with food or shortly after a meal to improve absorption and reduce gastrointestinal side effects.
Monitoring and Safety
- Regular monitoring of serum calcium and PTH levels is essential during treatment, particularly after dose adjustments 2.
- If hypocalcemia develops (calcium below 8.4 mg/dL), dose reduction or temporary discontinuation may be necessary.
- In patients with hepatic impairment, careful dose titration is recommended. Some of the evidence provided, such as the study on etelcalcetide vs cinacalcet 4, may not be directly relevant to the question of cinacalcet max dosing, but it is worth noting that etelcalcetide was found to be noninferior to cinacalcet in reducing serum PTH concentrations over 26 weeks. However, this information does not impact the recommended max dosing of cinacalcet.