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

Interactions
PK
Renal impairment
References

Vandetanib

Generic name
Vandetanib
Brand name
ATC Code
L01EX04

Pharmacokinetics in children

The pharmacokinetic parameters of vandetanib in paediatric MTC patients aged 9 to 17 years were the same as those for adults.  The exposure to vandetanib in children aged 5 to 8 years who showed indications of gliomas was comparable to that in MTC patients aged 9 to 18 years. 

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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

Medullar thyroid carcinoma
  • Oral
    • ≥ 5 years
      • BSAStarting doseafter 8 weeks – if well toleratedDose reduction
        0.7 – < 0.9 m² 100 mg every other day increase to 100 mg/day -
        0.9 – < 1.2 m² 100 mg/day 7-day pattern: 100 mg/day on days 1, 3, 5 and 7; 200 mg/day on days 2, 4 and 6 100 mg every other day
        1.2 – < 1.6 m² 7-day pattern: 100 mg/day on days 1, 3, 5 and 7; 200 mg/day on days 2, 4 and 6 200 mg/day 100 mg/day
        > 1.6 m² 200 mg/day 300 mg/day 7-day pattern: 100 mg/day on days 1, 3, 5 and 7; 200 mg/day on days 2, 4 and 6

         

      • The treatment should be discontinued if grade 3 toxicity or higher occurs or if there is extension of the QTc interval; restart at a reduced dose after recovery or improvement to grade 1; in children who are receiving the increased dose, this means restarting at the initial dose, and in children receiving the initial dose, this means restarting at the reduced dose
        The treatment can be continued until the disease progresses or until the toxicity is unacceptable.

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Renal impaiment in children > 3 months

Changing the initial dose is not recommended in paediatric patients with mild renal insufficiency. The reduced dose as described in the dosage table can be used in paediatric patients with moderate renal insufficiency. Patients should be checked individually by the doctor, particularly paediatric patients with a low BSA. Vandetanib is not recommended for use in paediatric patients with severe renal insufficiency.

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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

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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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Anthracyclines and related substances
L01DB02
L01DB01
L01DB06
L01DB07
Other cytotoxic antibiotics
L01DC01
OTHER MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
L01FX06

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Reference

  1. Genzyme Europe BV, SmPC Caprelsa (EU/1/11/749/001-002) 09-02-2017, www.geneesmiddeleninformatiebank.nl

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Changes

Changes