Active Ingredient: Cinacalcet
Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
0.2 - 2.5 mg per kg of body weight
From 0.2 To 2.5 mg per kg of body weight once every day
0.2 mg per kg of body weight
Corrected serum calcium should be in the upper range of, or above, the age-specified reference interval prior to administration of first dose of cinacalcet, and closely monitored. The normal calcium range differs depending on the methods used by your local laboratory and the age of the child/patient.
The recommended starting dose for children aged ≥3 years to <18 years is ≤0.20 mg/kg once daily based on the patient’s dry weight (see table).
The dose can be increased to achieve a desired target iPTH range. The dose should be increased sequentially through available dose levels (see table) no more frequently than every 4 weeks. The dose can be increased up to a maximum dose of 2.5 mg/kg/day, not to exceed a total daily dose of 180 mg.
Cinacalcet daily dose in paediatric patients:
| Patient dry weight (kg) | Starting dose (mg) | Available sequential dose levels (mg) |
|---|---|---|
| 10 to <12.5 | 1 | 1, 2.5, 5, 7.5, 10 and 15 |
| ≥12.5 to <25 | 2.5 | 2.5, 5, 7.5, 10, 15, and 30 |
| ≥25 to <36 | 5 | 5, 10, 15, 30, and 60 |
| ≥36 to <50 | 5, 10, 15, 30, 60, and 90 | |
| ≥50 to <75 | 10 | 10, 15, 30, 60, 90, and 120 |
| ≥75 | 15 | 15, 30, 60, 90, 120, and 180 |
PTH levels should be assessed at least 12 hours after dosing with cinacalcet and iPTH should be measured 1 to 4 weeks after initiation or dose adjustment of cinacalcet.
The dose should be adjusted based on iPTH as shown below:
Serum calcium should be measured within 1 week after initiation or dose adjustment of cinacalcet.
Once the maintenance dose has been established, weekly measurement of serum calcium is recommended. Serum calcium levels in paediatric patients should be maintained within the normal range. If serum calcium levels decrease below the normal range or symptoms of hypocalcaemia occur, appropriate dose adjustment steps should be taken as shown in table 2 below:
Dose adjustment in paediatric patients ≥3 to <18 years of age:
| Corrected Serum calcium value or clinical symptoms of hypocalcaemia | Dosing recommendations |
|---|---|
| Corrected serum calcium is at or below age-specified lower limit of normal or if symptoms of hypocalcaemia occur, regardless of calcium level. | Stop treatment with cinacalcet.* Administer calcium supplements, calcium-containing phosphate binders and/or vitamin D sterols, as clinically indicated. |
| Corrected total serum calcium is above age-specified lower limit of normal, and Symptoms of hypocalcaemia have resolved. | Restart at the next lower dose. If cinacalcet treatment has been stopped for more than 14 days, restart at the recommended starting dose. If patient was receiving the lowest dose (1 mg/day) prior to discontinuation, restart at the same dose (1 mg/day). |
* If the dose has been stopped, corrected serum calcium should be measured within 5 to 7 days.
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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