Active Ingredient: Vandetanib
Vandetanib is indicated for the treatment of aggressive and symptomatic Rearranged during Transfection (RET) mutant medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
Vandetanib is indicated in adults, children and adolescents aged 5 years and older.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 300 milligrams vandetanib, once daily.
Since the activity of vandetanib, based on available data, is considered insufficient in patients with no identified RET mutation, the presence of a RET mutation should be determined by a validated test prior to initiation of treatment with vandetanib. When establishing RET mutation status, tissue samples should be obtained if possible at the time of initiation of treatment rather than at the time of diagnosis.
The recommended dose is 300 mg once a day, taken with or without food at about the same time each day.
If a dose is missed, it should be taken as soon as the patient remembers. If it is less than 12 hours to the next dose, the patient should not take the missed dose. Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose.
QTc interval should be carefully assessed prior to initiation of treatment. In the event of common terminology criteria for adverse events (CTCAE) grade 3 or higher toxicity or prolongation of the ECG QTc interval, dosing with vandetanib should be at least temporarily stopped and resumed at a reduced dose when toxicity has resolved or improved to CTCAE grade 1. The 300 mg daily dose can be reduced to 200 mg, and then to 100 mg if necessary. The patient must be monitored appropriately. Due to the 19-day half-life, adverse reactions including a prolonged QTc interval may not resolve quickly.
Vandetanib may be administered until disease progression or until the benefits of treatment continuation do no longer outweigh its risk, thereby considering the severity of adverse events in relation to the degree of clinical stabilization of the tumour status.
No adjustment in starting dose is required for elderly patients. There is limited clinical data with vandetanib in patients with MTC aged over 75.
It should be taken with or without food at about the same time each day.
For:
Regimen A: In case that patient age in years is ≥ 5 and patient body surface area is ≥ 0.7 m² and patient body surface area is < 0.9 m², oral, 100 milligrams vandetanib, once every 2 days.
Regimen B: In case that patient age in years is ≥ 5 and patient body surface area is ≥ 0.9 m² and patient body surface area is < 1.2 m², oral, 100 milligrams vandetanib, once daily.
Regimen C: In case that patient age in years is ≥ 5 and patient body surface area is ≥ 1.2 m² and patient body surface area is < 1.6 m², oral, 100 milligrams vandetanib, one dose, over the duration of 1 day. Afterwards, in case that patient age in years is ≥ 5 and patient body surface area is ≥ 1.2 m² and patient body surface area is < 1.6 m², oral, 200 milligrams vandetanib, one dose, over the duration of 1 day. Afterwards, in case that patient age in years is ≥ 5 and patient body surface area is ≥ 1.2 m² and patient body surface area is < 1.6 m², oral, 100 milligrams vandetanib, one dose, over the duration of 1 day. Afterwards, in case that patient age in years is ≥ 5 and patient body surface area is ≥ 1.2 m² and patient body surface area is < 1.6 m², oral, 200 milligrams vandetanib, one dose, over the duration of 1 day. Afterwards, in case that patient age in years is ≥ 5 and patient body surface area is ≥ 1.2 m² and patient body surface area is < 1.6 m², oral, 100 milligrams vandetanib, one dose, over the duration of 1 day. Afterwards, in case that patient age in years is ≥ 5 and patient body surface area is ≥ 1.2 m² and patient body surface area is < 1.6 m², oral, 200 milligrams vandetanib, one dose, over the duration of 1 day. Afterwards, in case that patient age in years is ≥ 5 and patient body surface area is ≥ 1.2 m² and patient body surface area is < 1.6 m², oral, 100 milligrams vandetanib, once daily.
Regimen D: In case that patient age in years is ≥ 5 and patient body surface area is ≥ 1.6 m², oral, 200 milligrams vandetanib, once daily.
Since the activity of vandetanib, based on available data, is considered insufficient in patients with no identified RET mutation, the presence of a RET mutation should be determined by a validated test prior to initiation of treatment with vandetanib. When establishing RET mutation status, tissue samples should be obtained if possible at the time of initiation of treatment rather than at the time of diagnosis.
Dosing for paediatric patients should be on the basis of BSA in mg/m². Paediatric patients treated with vandetanib and patients' caregivers must be given the dosing guide and be informed on the correct dose to be taken with the initial prescription and each subsequent dose adjustment. Recommended dosing regimens and dose modifications are presented in Table 1.
Table 1. Dosing nomogram for paediatric patients with MTC:
| BSA (m²) | Start dose (mg)a | Dose increase (mg)b when tolerated well after 8 weeks at starting dose | Dose reduction (mg)c |
|---|---|---|---|
| 0.7 - <0.9 | 100 every other day | 100 daily | - |
| 0.9 - <1.2 | 100 daily | 7 day schedule: 100-200-100-200-100- 200-100 | 100 every other day |
| 1.2 - <1.6 | 7 day schedule: 100-200-100-200-100- 200-100 | 200 daily | 100 daily |
| ≥1.6 | 200 daily | 300 daily | 7 day schedule: 100-200-100-200-100- 200-100 |
a The starting dose is the dose at which treatment should be initiated.
b Higher vandetanib doses than 150 mg/m² have not been used in clinical studies in paediatric patients.
c Patients with an adverse reaction requiring a dose reduction should stop taking vandetanib for at least a week. Dosing can be resumed at a reduced dose thereafter when fully recovered from adverse reactions.
The patient must be monitored appropriately. Due to the 19-day half-life, adverse reactions including a prolonged QTc interval may not resolve quickly.
Vandetanib may be administered until disease progression or until the benefits of treatment continuation do no longer outweigh its risk, thereby considering the severity of adverse events in relation to the degree of clinical stabilization of the tumour status.
It should be taken with or without food at about the same time each day.
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