Active Ingredient: Cinacalcet
Cinacalcet is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
30 - 180 mg
From 30 To 180 mg once every day
The recommended starting dose for adults is 30 mg once per day. Cinacalcet should be titrated every 2 to 4 weeks to a maximum dose of 180 mg once daily to achieve a target parathyroid hormone (PTH) in dialysis patients of between 150-300 pg/mL (15.9-31.8 pmol/L) in the intact PTH (iPTH) assay.
PTH levels should be assessed at least 12 hours after dosing with cinacalcet. Reference should be made to current treatment guidelines.
PTH should be measured 1 to 4 weeks after initiation or dose adjustment of cinacalcet. PTH should be monitored approximately every 1-3 months during maintenance. Either the intact PTH (iPTH) or bio-intact PTH (biPTH) may be used to measure PTH levels; treatment with cinacalcet does not alter the relationship between iPTH and biPTH.
Corrected serum calcium should be measured and monitored and should be at or above the lower limit of the normal range prior to administration of first dose of cinacalcet. The normal calcium range may differ depending on the methods used by your local laboratory.
During dose titration, serum calcium levels should be monitored frequently, and within 1 week of initiation or dose adjustment of cinacalcet. Once the maintenance dose has been established, serum calcium should be measured approximately monthly.
In the event that corrected serum calcium levels fall below 8.4 mg/dL (2.1 mmol/L) and/or symptoms of hypocalcaemia occur the following management is recommended:
| Corrected Serum calcium level or clinical symptoms of hypocalcaemia | Recommendations |
|---|---|
| 8.4 mg/dL (2.1 mmol/L) and >7.5 mg/dL (1.9 mmol/L), or in the presence of clinical symptoms of hypocalcaemia | Calcium-containing phosphate binders, vitamin D sterols and/or adjustment of dialysis fluid calcium concentrations can be used to raise serum calcium according to clinical judgment. |
| 8.4 mg/dL (2.1 mmol/L) and >7.5 mg/dL (1.9 mmol/L) or persistent symptoms of hypocalcaemia despite attempts to increase serum calcium | Reduce or withhold dose of cinacalcet. |
| ≤7.5 mg/dL (1.9 mmol/L) or persistent symptoms of hypocalcaemia and Vitamin D cannot be increased | Withhold administration of cinacalcet until serum calcium levels reach 8.0 mg/dL (2.0 mmol/L) and/or symptoms of hypocalcaemia have resolved. Treatment should be reinitiated using the next lowest dose of cinacalcet. |
It is recommended that cinacalcet be taken with food or shortly after a meal, as studies have shown that bioavailability of cinacalcet is increased when taken with food.
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