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

Interactions
PK
Renal impairment
References

Burosumab

Generic name
Burosumab
Brand name
ATC Code
M05BX05

Pharmacokinetics in children

Cl = 136 ml/day (for a 30 kg child)

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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

X-linked hypophosphataemia
  • Subcutaneous
    • ≥ 1 year
      • Starting dose: 0.8 mg/kg/dose once every 2 weeks. Max: 90 mg/dose. Adjust dose according to fasting serum phosphate level.
        • If fasting serum phosphate levels are below the reference range for age: increase incrementally and no more frequently than every 4 weeks with 0.4 mg/kg to max. 2 mg/kg (max. 90 mg).
        • If fasting serum phosphate are above the age reference range: delay next dose and remeasure fasting serum phosphate within 2 weeks. Half of the previous dose can be restarted if the fasting serum phosphate level is below the reference age range.
        .
Tumour-induced osteomalacia (TIO)
  • Subcutaneous
    • 1 year up to 12 years
      • Starting dose: 0.4 mg/kg/dose once every 2 weeks. Max: 90 mg/dose. Adjust dose according to fasting serum phosphate level.
        • If fasting serum phosphate levels are below the reference range for age: increase incrementally and no more frequently than every 4 weeks with 0.6 mg/kg (as a first increment, next increments at 0,5 mg/kg)  to max. 2 mg/kg (max. 90 mg).
        • If fasting serum phosphate are above the age reference range: delay next dose and remeasure fasting serum phosphate within 2 weeks. Half of the previous dose can be restarted if the fasting serum phosphate level is below the reference age range.
        .
    • 12 years up to 18 years
      • Starting dose: 0.3 mg/kg/dose once every 2 weeks. Max: 180 mg/dose. Adjust dose according to fasting serum phosphate level.
        • If fasting serum phosphate levels are below the reference range for age: increase incrementally and no more frequently than every 4 weeks with 0.3 mg/kg (as a first increment, next increments at 0,2-0,5 mg/kg)  to max. 2 mg/kg (max. 180 mg).
        • If fasting serum phosphate are above the age reference range: delay next dose and remeasure fasting serum phosphate within 2 weeks. Half of the previous dose can be restarted if the fasting serum phosphate level is below the reference age range.
        .

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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

In children with XLH
Very common (> 10%): coughing. Headache, dizziness. Nausea, vomiting, diarrhea, constipation. Tooth abscess, tooth decay. Muscle pain, pain in extremities. Mild or moderate hypersensitivity reactions such as rash, urticaria, facial swelling, and dermatitis. Reaction at the injection site (such as pain, erythema, rash, itching, swelling, urticaria, hematoma, and induration), fever. Decrease in serum vitamin D (25-hydroxycholecalciferol) levels.

The following have also been reported: hyperphosphatemia, increase in parathyroid hormone in blood, hypercalcemia (including severe cases, especially in individuals with tertiary hyperparathyroidism), hypercalciuria.

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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 in children

Elevated serum calcium, including severe hypercalcemia, and/or elevated parathyroid hormone has been observed in patients treated with burosumab. Severe hypercalcemia was mainly reported in individuals with tertiary hyperparathyroidism. Hyperparathyroidism, prolonged immobilization, dehydration, hypervitaminosis D, or renal impairment may increase the risk of hypercalcemia.

Check serum calcium before starting treatment, 1-2 weeks after starting or adjusting the dose, and every 6 months during treatment (every 3 months in children aged 1-2 years). Treat moderate to severe hypercalcemia (> 3.0 mmol/L) before use.

Check alkaline phosphatase, calcium, parathyroid hormone (PTH), and creatinine in plasma at the start of treatment and every 6 months thereafter (every 3 months in children aged 1-2 years).

Check fasting serum phosphate, due to the risk of hyperphosphatemia, every 2 weeks during the first month of treatment, every 4 weeks during the following 2 months, and thereafter as needed. Also check these 4 weeks after each dose adjustment.

[DHPC-SmPC]

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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
M05BX04

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References

  1. Kyowa Kirin Holdings B.V., SmPC Crysvita (EU/1/17/1262/001) Rev 11, 06-07-2023, www.ema.europa.eu
  2. Kyowa Kirin Holdings B.V., SmPC Crysvita (EU/1/17/1262/001) Rev 16, 24-11-2025, www.ema.europa.eu

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Changes

Changes