Denosumab

Generic name
Denosumab
Brand name
ATC Code
M05BX04
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

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

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

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

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.

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.

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.

Interactions

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

DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION

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

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

Reference

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

Changes

Therapeutic Drug Monitoring


Overdose