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Vandetanib (Vandetanib) - Indications and Dosage

 
 



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.

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)].

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. [see Dosage and Administration]

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. [see Warnings and Precautions and Drug Interactions]

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. [see Warnings and Precautions and Use in Specific Populations]

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.

DOSAGE FORMS & STRENGTHS

Vandetanib 100-mg tablets are white, round, biconvex, film-coated, and intagliated with ‘Z 100‘ on one side and plain on the reverse side.

Vandetanib 300-mg tablets are white, oval, biconvex, film-coated, and intagliated with ‘Z 300’ on one side and plain on the reverse side.

HOW SUPPLIED/STORAGE AND HANDLING

100 mg Tablets Available in bottles containing 30 tablets (NDC 0310–7810–30).

300 mg Tablets Available in bottles containing 30 tablets (NDC 0310–7830–30).

Storage and Handling

Vandetanib tablets should be stored at 25°C (77°F); excursions permitted to 15oC – 30oC (59oF – 86oF) [See USP controlled room temperature].

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published1-4. Vandetanib tablets should not be crushed. Direct contact of crushed tablets with the skin or mucous membranes should be avoided. If such contact occurs, wash thoroughly as outlined in the references. Personnel should avoid exposure to crushed tablets.

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