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

Interactions
PK
Renal impairment
References

Denosumab

Generic name
Denosumab
Brand name
ATC Code
M05BX04

Pharmacokinetics in children

Bioavailability after subcutaneous administration: 62% 
T1/2: mean 28 days (14-55 days)

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

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Giant cell tumour of bone
  • Subcutaneous
    • ≥ 12 years
      • 120 mg/dose day 1,8,15 and 29 and afterwards every 4 weeks.

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Renal impaiment in children > 3 months

Dose adjustment is not required in renal impairment.

Monitoring of serum calcium concentration is recommended in severe renal impairment (creatinine clearance less than 30 ml / min) and in dialysis due to the increased risk of hypocalcaemia in these patients.

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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

The side effect profile in children (12-18 years) is similar to the side effect profile in adults. Clinically significant hypercalcaemia after treatment discontinuation has been reported in the post-marketing setting in pediatric patients.

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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

No information available on specific contra indications in children.

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

Warnings & precautions

No information available on specific warnings and precautions in children.

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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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Bisphosphonates
M05BA04
M05BA03
M05BA07
Other drugs affecting bone structure and mineralization
M05BX05

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Reference

  1. Amgen Europe B.V., SmPC Xgeva (EU/1/11/703/001 -003) 24-03-2020, www.geneesmiddeleninformatiebank.nl

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Changes

Changes