Cinacalcet

Generic name
Cinacalcet
Brand name
ATC Code
H05BX01
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Cinacalcet

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The pharmacokinetics was studied in paediatric patients with ESRD receiving dialysis aged 3 to 17 years of age. After single and multiple once daily oral doses of cinacalcet, plasma cinacalcet concentrations (Cmax and AUC values after normalisation by dose and weight) were similar to those observed in adult patients.

Tmax (adults): 2 - 6 h

[EPAR Mimpara]

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Secondary hyperparathyroidism in severe renal failure
  • Oral
    • 3 years up to 18 years
      • Initial dose: 0.2 mg/kg/day in 1 dose
      • Maintenance dose: increase the dose every 4 weeks if necessary based on the intact parathyroid hormone (iPTH) concentration or the serum calcium concentration up to a maximum of 2.5 mg/kg/day in 1 dose. Max: 180 mg/day.

      • Calculate dosing based on the patients dry weight.

Renal impaiment in children > 3 months

Application is not recommended in patients with chronic renal disease who are not undergoing dialysis due to an increased risk of hypocalcaemia.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

One case of severe hypocalcaemia with fatal outcome has been reported.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

Hypocalcaemia.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Monitor the serum calcium concentrations and the therapy compliance carefully during treatment with cinacalcet.

Check the serum calcium concentration weekly within one week of starting treatment, after dose adjustment and after the maintenance dose has been established. When treatment is discontinued, serum calcium should be determined within 5 to 7 days. Check the PTH concentration one to four weeks after starting treatment or after a dose adjustment, no earlier than 12 hours after a dose intake.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTI-PARATHYROID AGENTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Other anti-parathyroid agents
H05BX02

Reference

  1. Amgen Europe B.V., SmPC Mimpara (EU/1/04/292/013) Rev 26, 06-06-2024, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose