Vandetanib
Dosage Form: tablet
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 (5.15)].
1. INDICATIONS AND USAGE
. Medullary Thyroid Cancer (MTC)
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.
2. DOSAGE AND ADMINISTRATION
The recommended daily dose is 300 mg of Vandetanib taken orally. Vandetanib treatment should be continued until patients are no longer benefiting from treatment or an unacceptable toxicity occurs.
Vandetanib may be taken with or without food.
If a patient misses a dose, the missed dose should not be taken if it is less than 12 hours before the next dose.
For Patients who have Difficulty Swallowing Solids
Vandetanib tablets should not be crushed. If Vandetanib tablets cannot be taken whole, the tablets can be dispersed in a glass containing 2 ounces of non-carbonated water and stirred for approximately 10 minutes until the tablet is dispersed (will not completely dissolve). No other liquids should be used. The dispersion should be swallowed immediately. To ensure the full dose is received, any residues in the glass should be mixed again with an additional 4 ounces of non-carbonated water and swallowed.
The dispersion can also be administered through nasogastric or gastrostomy tubes.
Direct contact of crushed tablets with the skin or mucous membranes should be avoided. If such contact occurs, wash thoroughly. Avoid exposure to crushed tablets.
Dosage Adjustment
In the event of corrected QT interval, Fridericia (QTcF) greater than 500 ms, interrupt dosing until QTcF returns to less than 450 ms, then resume at a reduced dose.
For CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or greater toxicity, interrupt dosing until toxicity resolves or improves to CTCAE grade 1, and then resume at a reduced dose.
Because of the 19-day half-life, adverse reactions including a prolonged QT interval may not resolve quickly. Monitor appropriately [see Warnings and Precautions (5.1-5.7, 5.9)].