Thyroid-cancer.gif  

Dear Healthcare Provider:zactima.jpg  

AstraZeneca Pharmaceuticals LP would like to inform you of the approval of vandetanib, a

new kinase inhibitor that has been approved by the Food and Drug Administration (FDA) 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.

Vandetanib can prolong the QT interval and cases of Torsades de pointes and sudden

death were reported in clinical trials. Because of these risks, vandetanib is available only

through a restricted distribution program called Vandetanib REMS Program. Under the

Vandetanib REMS Program, only prescribers and pharmacies enrolled in the program

can prescribe and dispense vandetanib.

In order to prescribe vandetanib, you must:

Read this Healthcare Provider (HCP) Letter; review HCP Education Pamphlet or HCP

REMS Education Slide Set; and the vandetanib full Prescribing Information

Complete the Prescriber Training Program (online or by phone)

Complete the Prescriber Enrollment Form

To ENROLL, visit www.vandetanibrems.com or call 1-800-236-9933.

Please see the enclosed HCP Education Pamphlet that outlines the risk of QT prolongation,

Torsades de pointes and sudden death associated with vandetanib.


arrow
arrow
    全站熱搜

    快樂小藥師 發表在 痞客邦 留言(0) 人氣()