Guidance on Cinacalcet Use in Pediatric Dialysis

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Before starting cinacalcet, Monitor serum calcium, phosphate, parathyroid hormone (PTH) and 25-hydroxyvitamin D levels regularly and make treatment decisions based on all of the trends. Use albumin-corrected calcium levels (ionized calcium levels are more accurate). Keep serum calcium and phosphate levels within age-appropriate normal range. Consider calcium intake from diet, medications, and dialysate.

Benefits and Contraindications

Use cinacalcet in children older than 3 years on dialysis who have persistent and severe hyperparathyroidism in the presence of high or high-normal calcium levels, despite optimized conventional management, including active vitamin D. There is no clear threshold level of PTH above which cinacalcet therapy should be started. Do not start cinacalcet in patients with albumin-corrected calcium levels less than 2.40 mmol/L. Do not start cinacalcet in patients with prolonged QT interval. Use cinacalcet with caution in patients with history of seizures, cardiac arrhythmia, significant liver disease or poor adherence to medications. Use drugs that prolong the QTc interval or interact with cinacalcet with caution.

Monitoring cinacalcet therapy

• Monitor serum calcium levels within 1 week of starting cinacalcet therapy, weekly during the titration phase, and at least monthly when maintenance dose has been established in a patient.
• Check serum PTH levels monthly.
• Inform children and their caregivers of hypocalcemia symptoms, the importance of medication adherence, and instructions on serum calcium monitoring. Caution about other medications which may prolong QTc interval or interact with cinacalcet.
• Withhold cinacalcet when albumin-corrected serum calcium levels are less than 2.0 mmol/L and/or ionized calcium levels are less than 1.0 mmol/L. Cinacalcet may be restarted in a lower dose when serum calcium levels return to the higher end of the normal range.
• Withdraw cinacalcet in case of symptomatic hypocalcemia, including paresthesia, myalgia, cramps, tetany and convulsions, long QT interval or severe side effects.

Treating a pediatric patient with persistent severe SHPT despite conventional therapy

The guideline authors suggest that parathyroidectomy be considered in case of severe and persistent SHPT despite optimized cinacalcet and conventional therapy, including active vitamin D. “Given the limited available evidence, the strength of these statements are weak to moderate, and must be carefully considered by the treating physician and adapted to individual patient needs as appropriate,” the authors concluded. The working group highlighted that use of cinacalcet in children requires further research including studies with key patient level outcomes, such as bone pain, parathyroidectomy, cardiovascular events, bone fractures, or mortality.

Contact details

Alex Stewart
Managing Editor
Journal of Nephrology and Urology