BOXED WARNING SECTION
WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH
Vandetanib can prolong the QT interval. Torsades de pointes and sudden death have been reported in patients receiving vandetanib. Vandetanib should not be used in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Hypocalcemia, hypokalemia and/or hypomagnesemia must be corrected prior to vandetanib administration and should be periodically monitored. Drugs known to prolong the QT interval should be avoided. If a drug known to prolong the QT interval must be administered, more frequent ECG monitoring is recommended. Given the half-life of 19 days, ECGs should be obtained to monitor the QT at baseline, at 2-4 weeks and 8-12 weeks after starting treatment with vandetanib and every 3 months thereafter. Following any dose reduction for QT prolongation, or any dose interruptions greater than 2 weeks, QT assessment should be conducted as described above. Because of the 19-day half-life, adverse reactions including a prolonged QT interval may not resolve quickly. Monitor appropriately. Only prescribers and pharmacies certified through the vandetanib REMS education program are able to prescribe and dispense vandetanib [see Warnings and Precautions].
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VANDETANIB SUMMARY
Vandetanib tablets for daily oral administration are available in two dosage strengths, 100 mg and 300 mg, containing 100 mg and 300 mg of vandetanib, respectively.
Vandetanib is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.
Use of vandetanib in patients with indolent, asymptomatic or slowly progressing disease should be carefully considered because of the treatment related risks of vandetanib.
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NEWS HIGHLIGHTS
Published Studies Related to Vandetanib
Vandetanib for the treatment of medullary thyroid carcinoma. [2014] CONCLUSIONS: Vandetanib prolongs PFS but has not been shown to improve OS.
Vandetanib: a novel targeted therapy for the treatment of metastatic or locally
advanced medullary thyroid cancer. [2013] CONCLUSION: Vandetanib has been shown to be more effective than placebo in the
Vandetanib: in medullary thyroid cancer. [2012] Vandetanib, an orally active, small-molecule, multitargeted tyrosine kinase
inhibitor, demonstrates potent inhibitory activity against vascular endothelial
growth factor receptor (VEGFR)-2 and -3, epidermal growth factor receptor (EGFR)
and the rearranged during transfection (RET) tyrosine kinase receptor...
Vandetanib Versus placebo in patients with advanced non-small-cell lung cancer
after prior therapy with an epidermal growth factor receptor tyrosine kinase
inhibitor: a randomized, double-blind phase III trial (ZEPHYR). [2012] chemotherapy regimens... CONCLUSION: The study did not demonstrate an overall survival benefit for
Vandetanib in patients with locally advanced or metastatic medullary thyroid
cancer: a randomized, double-blind phase III trial. [2012] patients with advanced hereditary MTC... CONCLUSION: Vandetanib demonstrated therapeutic efficacy in a phase III trial of
Reports of Suspected Vandetanib Side Effects
Diarrhoea (49),
Rash (27),
Fatigue (25),
Nausea (23),
Acne (22),
Electrocardiogram QT Prolonged (20),
Blood Pressure Increased (18),
Dizziness (15),
Dyspnoea (13),
Oral Pain (13), more >>
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Page last updated: 2014-11-30
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