Renal Dose Adjustment (Based on CrCl)
- <50 mL: Start with 200 mg PO per day
Hepatic Dose Adjustment
- Child-Pugh Class B or C: Use contraindicated
See Supplemental Patient Information
- Vandetanib can prolong QT interval. Torsades de pointes, ventricular tachycardia and sudden death have been reported with the drug [US Black Box Warning]
- Vandetanib is not recommended in patients whose QTcF interval is >450 ms. Not recommended in patients with Hx of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure
- Monitoring of ECG and levels of serum potassium, calcium, magnesium, and TSH should be obtained at baseline, at 2 to 4 wk, at 8 to 12 wk after starting treatment, and every 3 months thereafter [US Black Box Warning]
- Following any dose reduction for QT prolongation or any dose interruptions more than 2 wk, QT assessment should be conducted [US Black Box Warning]
- Cases of diarrhea have been observed with vandetanib. Frequent monitoring of electrolytes and ECGs is recommended. Discontinue drug if diarrhea occurs and resume therapy at lower dose upon improvement
- Hypothyroidism has been reported with this drug, hence monitor TSH as per above mentioned schedule and adjust thyroid replacement dosage accordingly
- Concomitant use of drugs known to prolong the QT interval should be avoided and if administered, more frequent ECG monitoring is advised [US Black Box Warning]
- In cases of QTcF >500 ms, discontinue therapy until QTcF returns to <450 ms and resume at a reduced dose
- Fatal cases of skin reactions including Stevens-Johnson syndrome have been reported with this drug. If CTCAE grade 3 or greater skin reactions occur, discontinue until condition improves. On improvement, restart therapy at lower dose or stop the drug
- Photosensitivity reactions are increased with vandetanib hence advise patient to wear sunscreen and protective clothing when exposed to sun and continue wearing protective clothing and applying sunscreen for 4 months after discontinuation of treatment due to longer half life of this drug
- Fatal cases of interstitial lung disease (ILD) or pneumonitis have been reported with vandetanib. In patients presenting with non-specific respiratory signs and symptoms such as hypoxia, pleural effusion, cough, or dyspnea, and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations do consider diagnosis of ILD. Advise patients to report promptly any new or worsening respiratory symptoms. In patients with radiological changes suggestive of ILD and few or no symptoms, vandetanib may be continued but close monitoring at the discretion of the treating physician is advised. Therapy may be interrupted until improvement occurs in cases of moderate symptoms; however, in cases of severe symptoms, discontinue therapy until clinical symptoms resolve and institute treatment with corticosteroids and antibiotics. Consider discontinuation of therapy even upon permanent resolution of severe ILD
- Ischemic cerebrovascular events with some fatal cases have been reported with vandetanib. Discontinue therapy in patients with severe ischemic cerebrovascular event
- Serious hemorrhagic events with some fatal cases have been reported with vandetanib and it is advised not to administer this drug in patients with recent Hx of hemoptysis of
1/2 teaspoon of red blood. Discontinue drug in cases of severe hemorrhage - Fatal cases of heart failure have been reported with vandetanib, discontinue therapy. Monitor for signs and symptoms of heart failure during treatment
- Hypertension, including hypertensive crisis has been observed with this drug. Monitoring and control with appropiate therapy advised. Dose reduction or interruption of vandetanib recommended and if no control of HT then do not restart therapy
- Reversible posterior leukoencephalopathy syndrome (RPLS) has been reported with vandetanib. Discontinue therapy in such syndrome. Diagnosis of RPLS should be considered in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function
- Concomitant administration with agents that are strong CYP3A4 inducers should be avoided
Cautions: Use cautiously in
- Moderate-severe renal impairment
- Moderate-severe hepatic impairment (Child-Pugh Class B or C)
- Congenital QT prolongation
- QTc >450 msec
- Hx of torsades de pointes
- Hx of bradyarrhythmia
- Hx of heart failure
- Avoid pregnancy
Supplemental Patient Information
- Advise women of childbearing potential to avoid pregnancy while taking this drug and for at least four months following the last dose
Pregnancy Category:D
Breastfeeding: As per manufacturer information it is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from vandetanib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
