Vandetanib
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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Black Box Warning
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WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH
See full prescribing information for complete Boxed Warning.
* 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.
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Overview
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
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.
Dosage
- 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.
- The 300-mg daily dose can be reduced to 200 mg (two 100-mg tablets) and then to 100 mg for CTCAE grade 3 or greater toxicities.
Elderly
- No adjustment in starting dose is required for patients over 65 years of age. There are limited data for patients over the age of 75.
Concomitant Strong CYP3A4 Inducers
- Avoid the concomitant use of strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital). Patients should also avoid taking St. John’s Wort.
Patients With Renal Impairment
- The starting dose should be reduced to 200 mg in patients with moderate (creatinine clearance ≥30 to <50 mL/min) and severe (creatinine clearance <30 mL/min) renal impairment.
Patients with Hepatic Impairment
- Single dose pharmacokinetic data from volunteers with hepatic impairment receiving 800 mg suggest that there were no differences in pharmacokinetics compared to patients with normal hepatic function. There are limited data in patients with liver impairment (serum bilirubin greater than 1.5 times the upper limit of normal). Vandetanib is not recommended for use in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment, as safety and efficacy have not been established.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Vandetanib in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Vandetanib in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Vandetanib FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Vandetanib in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Vandetanib in pediatric patients.
Contraindications
There is limited information regarding Vandetanib Contraindications in the drug label.
Warnings
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WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH
See full prescribing information for complete Boxed Warning.
* 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.
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There is limited information regarding Vandetanib Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Vandetanib Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Vandetanib Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Vandetanib Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Vandetanib in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Vandetanib in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Vandetanib during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Vandetanib in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Vandetanib in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Vandetanib in geriatric settings.
Gender
There is no FDA guidance on the use of Vandetanib with respect to specific gender populations.
Race
There is no FDA guidance on the use of Vandetanib with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Vandetanib in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Vandetanib in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Vandetanib in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Vandetanib in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Vandetanib Administration in the drug label.
Monitoring
There is limited information regarding Vandetanib Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Vandetanib and IV administrations.
Overdosage
There is limited information regarding Vandetanib overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Vandetanib Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Vandetanib Mechanism of Action in the drug label.
Structure
There is limited information regarding Vandetanib Structure in the drug label.
Pharmacodynamics
There is limited information regarding Vandetanib Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Vandetanib Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Vandetanib Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Vandetanib Clinical Studies in the drug label.
How Supplied
There is limited information regarding Vandetanib How Supplied in the drug label.
Storage
There is limited information regarding Vandetanib Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Vandetanib Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Vandetanib interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Vandetanib Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Vandetanib Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.