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Caprelsa is a brand name for Vandetanib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Caprelsa 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. Caprelsa is indicated in adults, children and adolescents aged 5 years and older.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated and supervised by a physician experienced in treatment of MTC and in the use of anticancer medicinal products and experienced in the assessment of electrocardiogram (ECG). Rearranged during transfection (RET) status Since the activity of Caprelsa, 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 Caprelsa.
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. Posology for MTC in adult patients The recommended dose is 300 mg once a day, taken with or without food at about the same time each day.
3 © ESTEVE (2026) INTERNAL USE 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.
Dose adjustments in adult patients with MTC QTc interval should be carefully assessed prior to initiation of treatment. 4). The 300 mg daily dose can be reduced to 200 mg (two 100 mg tablets), and then to 100 mg if necessary. The patient must be monitored appropriately.
4). Posology in paediatric patients with MTC Dosing for paediatric patients should be on the basis of BSA in mg/m2. Paediatric patients treated with Caprelsa 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. 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 Dose adjustments in paediatric patients with MTC • In the event of 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.
Summary of the safety profile The most commonly reported adverse drug reactions have been diarrhoea, rash, nausea, hypertension, and headache. Tabulated list of adverse reactions The following adverse reactions have been identified in clinical studies with patients receiving vandetanib as treatment for MTC and in post-marketing setting.
Their frequency is presented in Table 2, adverse reactions using Council for International Organizations of Medical Sciences (CIOMS III), listed by MedDRA System Organ Class (SOC) and at the preferred term level and then by frequency classification.
Frequencies of occurrence of undesirable effects are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
0% placebo patients. 7%. Eight percent of patients had a dose reduction due to QTc prolongation. 4 Description of selected adverse reactions Events such as Torsades de pointes, interstitial lung disease (sometimes fatal) and PRES (RPLS) have occurred in patients treated with vandetanib monotherapy.
It is expected that these would be uncommon adverse reactions in patients receiving vandetanib for MTC. 12 © ESTEVE (2026) INTERNAL USE Ocular events such as blurred vision are common in patients who received vandetanib for MTC. Scheduled slit lamp examinations have revealed corneal opacities (vortex keratopathies) in treated patients; however, routine slit lamp examinations are not required for patients receiving vandetanib.
5 g/dl compared to baseline. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
e. with a symptomatic-aggressive course of the disease. Either symptomatic disease or progressive disease alone is not enough to prompt the need of treatment with vandetanib. Rate of change in biomarker levels such as of calcitonin (CTN) and/or carcinoembryonic antigen (CEA) as well as the rate of change of tumour volume during watchful waiting might help to identify not only patients in need for treatment but also the optimal moment to commence treatment with vandetanib.
QTc prolongation and Torsades de Pointes Vandetanib at a dose of 300 mg is associated with a substantial and concentration dependent prolongation in QTc (mean 28 msec, median 35 msec). First QTc prolongations occurred most often in the first 3 months of treatment, but continued to first occur after this time.
8). At a dose of 300 mg per day in MTC, ECG QTc prolongation to above 500 msec was observed in a phase III study in 11% of patients. ECG QTc prolongation appears to be dose-dependent. Torsades de pointes and ventricular tachycardia have been uncommonly reported in patients administered vandetanib 300 mg daily.
8). Vandetanib treatment must not be started in patients whose ECG QTc interval is greater than 480 msec. Vandetanib should not be given to patients who have a history of Torsades de pointes. Vandetanib has not been studied in patients with ventricular arrhythmias or recent myocardial infarction.
An ECG, and levels of serum potassium, calcium and magnesium and thyroid stimulating hormone (TSH) should be obtained at baseline, at 1, 3, 6 and 12 weeks after starting treatment and every 3 months for at least a year thereafter. This schedule should apply to the period after dose reduction due to QTc prolongation and after dose interruption for more than two weeks.
ECGs and blood tests should also be obtained as clinically indicated during this period and afterwards. Frequent ECG monitoring of the QTc interval should be continued. Serum potassium, serum magnesium and serum calcium should be kept within normal range to reduce the risk of ECG QTc prolongation.
1. • Congenital long QTc syndrome. • Patients with a QTc interval over 480 msec. 5). 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• Patients who are on the starting dose (a in Table 1), should be recommenced at the reduced dose (c in Table 1). • Patients who are on the increased dose (b in Table 1), should be recommenced at the starting dose (a in Table 1). If another event of common terminology criteria for adverse events (CTCAE) grade 3 or higher toxicity or prolongation of the ECG QTc interval occurs, dosing with Caprelsa should be at least temporarily stopped and resumed at a reduced dose (c in Table 1) when toxicity has resolved or improved to CTCAE grade 1.
• If a further event of CTCAE grade 3 or higher toxicity or prolongation of the ECG QTc interval occurs, dosing with vandetanib should be permanently stopped. The patient must be monitored appropriately. 4). 8) in relation to the degree of clinical stabilization of the tumour status.
Special patient populations Paediatric population Caprelsa should not be given to children below 5 years of age. The safety and efficacy of Caprelsa in children below 5 years of age have not been established. No data are available. 1).
Patients aged 5-18 years should be dosed according to the nomogram in Table 1. Vandetanib doses higher than 150 mg/m2 have not been used in clinical studies in paediatric patients. Elderly No adjustment in starting dose is required for elderly patients.
There is limited clinical data with vandetanib in patients with MTC aged over 75. 2). Clinical data suggest that no change in starting dose is required in patients with mild renal impairment. There is limited data with 300 mg in patients with moderate renal impairment: the dose needed to be lowered to 200 mg in 5 out of 6 patients due to an adverse reaction of QT prolongation.
The starting dose should be reduced to 200 mg in patients with moderate renal impairment; safety and efficacy have however not […]
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 1) obtained during drug development is limited to 16 patients aged 9 years to 17 years with hereditary medullary thyroid carcinoma (Study IRUSZACT0098).
Whilst the study size is small owing to the rarity of MTC in children, it is considered representative of the target population. The safety findings in this study are consistent with the safety profile of vandetanib in adult patients with MTC.
Long term safety data in paediatric patients are not available.
Additional monitoring of QTc, electrolytes and renal function are required especially in case of diarrhoea, increase in diarrhoea/dehydration, electrolyte imbalance and/or impaired renal function. If QTc increases markedly but stays below 500 msec, cardiologist advice should be sought.
5). 5) 6 © ESTEVE (2026) INTERNAL USE Patients who develop a single value of a QTc interval of ≥500 msec should stop taking vandetanib. Dosing can be resumed at a reduced dose after return of the QTc interval to pretreatment status has been confirmed and correction of possible electrolyte imbalance has been made.
Posterior reversible encephalopathy syndrome, PRES (Reversible posterior leukoencephalopathy syndrome-RPLS) PRES is a syndrome of subcortical vasogenic oedema diagnosed by a MRI of the brain, has been observed infrequently with vandetanib treatment in combination with chemotherapy.
PRES has also been observed in patients receiving vandetanib as monotherapy. This syndrome should be considered in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Brain MRI should be performed in any patient presenting with seizures, confusion or altered mental status.
Severe Cutaneous Adverse Reactions (SCARs) and other skin reactions SCARs, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, have been reported in association with vandetanib treatment.
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. For suspected SJS or TEN, vandetanib should be withheld and the patient should be referred to a specialised unit for assessment and treatment.
If SJS or TEN is confirmed, vandetanib should be permanently discontinued and an alternative treatment considered (as appropriate). Photosensitivity reactions have been observed in patients who have received vandetanib. Care should be taken with sun exposure by wearing protective clothing and/or sunscreen due to the potential risk of phototoxicity reactions associated with vandetanib treatment.
Mild to moderate skin reactions can be managed by symptomatic treatment, or by dose reduction or interruption. Diarrhoea Diarrhoea is a disease related symptom as well as a known undesirable effect of vandetanib. Routine anti-diarrhoeal agents are recommended for the treatment of diarrhoea.
QTc and serum electrolytes should be monitored more frequently. If severe diarrhoea (CTCAE grade 3-4) develops, vandetanib should be stopped until diarrhoea improves. 8). Haemorrhage Caution should be used when administering vandetanib to patients with brain metastases, as intracranial haemorrhage has been reported.
Heart failure Heart failure has been observed in patients who received vandetanib. Temporary or permanent discontinuation of therapy may be necessary in patients with heart failure. It may not be reversible on stopping vandetanib. Some cases have been fatal.
Hypertension Hypertension, including hypertensive crisis, has been observed in patients treated with vandetanib. Patients should be monitored for hypertension and controlled as appropriate. If high blood pressure cannot be controlled with medical management, […]