- 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]
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Secondary hyperparathyroidism in severe renal failure |
|---|
|
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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.
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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.
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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.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Other anti-parathyroid agents | ||
|---|---|---|
| H05BX02 | ||
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Reference
- Amgen Europe B.V., SmPC Mimpara (EU/1/04/292/013) Rev 26, 06-06-2024, www.ema.europa.eu
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Changes
Changes
