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Vandesa (Vandetanib)

Vandesa (Vandetanib)

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100 mg and 300 mg tablets

 

In vitro studies have shown that vandetanib inhibits the tyrosine kinase activity of the EGFR and VEGFR families, RET, BRK, TIE2, and members of the EPH receptor and Src kinase families. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment. In addition, the N-desmethyl metabolite of the drug, representing 7 to 17.1% of vandetanib exposure, has similar inhibitory activity to the parent compound for VEGF receptors (KDR and Flt-1) and EGFR. In vitro, vandetanib inhibited epidermal growth factor (EGF)-stimulated receptor tyrosine kinase phosphorylation in tumor cells and endothelial cells and VEGF-stimulated tyrosine kinase phosphorylation in endothelial cells. In vivo, vandetanib administration reduced tumor cell-induced angiogenesis, tumor vessel permeability, and inhibited tumor growth and metastasis in mouse models of cancer.




INDICATIONS

VANDESA® is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

Use VANDESA® in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of VANDESA®.

DOSAGE AND ADMINISTRATION
  • 300 mg once daily.
  • VANDESA® may be taken with or without food.
  • Dosage reduction may be necessary in the event of severe toxicities or QTc interval prolongation.
  • The starting dose is 200 mg in patients with moderate renal impairment.

 

- Do not use in patients with congenital long QT syndrome.

WARNINGS AND PRECAUTIONS

Vandetanib may cause serious side effects including:

 

  • Prolonged QT interval, torsades de pointes, and sudden death: Monitor electrocardiograms and levels of serum potassium, calcium, magnesium and TSH. Reduce VANDESA® dose as appropriate.
  • Severe skin reactions, including toxic epidermal necrolysis and Stevens Johnson syndrome, some fatal. Discontinue VANDESA® for severe skin reactions.
  • Interstitial lung disease (ILD), including fatalities: investigate unexplained non-specific respiratory signs and symptoms. Discontinue VANDESA® for confirmed ILD.
  • Ischemic cerebrovascular events, hemorrhage, heart failure, diarrhea, hypertension, and reversible posterior leukoencephalopathy syndrome: Discontinue or interrupt VANDESA®.
  • Impaired wound healing: Withhold for at least 1 month prior to elective surgery. Do not administer VANDESA® for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of treatment with VANDESA® after resolution of wound healing complications has not been established.
  • Embryo-fetal toxicity: Can cause fetal harm. Advise women of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with VANDESA® and for 4 months following the last dose.

 

DRUG INTERACTIONS

 

  • Rifampicin, a strong CYP3A4 inducer, decreased VANDESA® plasma concentrations. Avoid concomitant use of known strong CYP3A4 inducers during VANDESA® therapy. Avoid concomitant use of St. John’s wort because it can decrease VANDESA® exposure unpredictably.
  • VANDESA® increased plasma concentrations of metformin. Use caution and closely monitor for toxicities.
  • VANDESA® increased plasma concentrations of digoxin. Use caution and closely monitor for toxicities.
  • Avoid concomitant use of VANDESA® with agents that may prolong the QT interval (including but not limited to chloroquine, clarithromycin, dolasetron, granisetron, haloperidol, methadone, moxifloxacin, and pimozide). If such drugs are given to patients already receiving VANDESA® and no alternative therapy exists, perform ECG monitoring of the QT interval more frequently.
  • Avoid administration of VANDESA® with anti-arrhythmic drugs (including but not limited to amiodarone, disopyramide, procainamide, sotalol, dofetilide).
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