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This document describes the Risk Evaluation and Mitigation Strategy (REMS) for vandetanib, a kinase inhibitor used in the treatment of medullary thyroid cancer. It outlines the goals of the REMS program,
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How to fill out vandetanib rems program
How to fill out Vandetanib REMS Program
01
Step 1: Obtain the Vandetanib REMS Program enrollment form from the official website or your healthcare provider.
02
Step 2: Fill out the patient information section accurately with your personal details.
03
Step 3: Provide your healthcare provider's information, including their name, contact number, and address.
04
Step 4: Indicate the reason for enrollment, specifying that you are prescribed Vandetanib.
05
Step 5: Read and acknowledge the risks associated with Vandetanib treatment by signing the provided consent section.
06
Step 6: Submit the completed form to the REMS Program via the method specified on the form (fax, mail, or online submission).
07
Step 7: Confirm your enrollment status by contacting the REMS Program support line.
Who needs Vandetanib REMS Program?
01
Patients who have been prescribed Vandetanib for the treatment of medullary thyroid cancer or non-small cell lung cancer.
02
Healthcare providers who prescribe Vandetanib must ensure that patients are enrolled in the REMS Program.
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People Also Ask about
What is the use of vandetanib?
Vandetanib is an antineoplastic kinase inhibitor used to treat symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.
What is the life expectancy of someone with thyroid cancer?
HOW IS MTC TREATED? The primary treatment for MTC is surgery, and the currently accepted approach is to remove the entire thyroid gland (total thyroidectomy) (See thyroid surgery brochure). Often patients with MTC will have thyroid cancer present in the lymph nodes of the neck or upper chest.
When was vandetanib approved?
On April 6, 2011, the U.S. Food and Drug Administration approved vandetanib (Caprelsa tablets; AstraZeneca Pharmaceuticals LP) for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable, locally advanced, or metastatic disease.
What is the half life of vandetanib?
Vandetanib has a median plasma half-life of 19 days with steady state achieved at approximately 3 months.
Why does caprelsa have a rems program?
The goals of the CAPRELSA REMS Program are to mitigate the serious risks of QT prolongation, Torsdes de pointes, and sudden death associated with use of CAPRELSA by: Educating prescribers on the following: Serious risks of QT prolongation,Torsades de pointes, and sudden death associated with use of CAPRELSA.
What is the new drug for thyroid cancer?
On September 27, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who
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What is Vandetanib REMS Program?
The Vandetanib REMS Program is a Risk Evaluation and Mitigation Strategy designed to ensure that the benefits of Vandetanib treatment outweigh its risks, particularly concerning the potential for serious adverse effects.
Who is required to file Vandetanib REMS Program?
Healthcare providers who prescribe Vandetanib, as well as pharmacies that dispense it, are required to enroll in and comply with the Vandetanib REMS Program.
How to fill out Vandetanib REMS Program?
The Vandetanib REMS Program includes specific forms that must be completed by healthcare providers when prescribing the medication, which includes patient information and consent for treatment.
What is the purpose of Vandetanib REMS Program?
The purpose of the Vandetanib REMS Program is to mitigate the risks of serious side effects, including QT prolongation and thyroid dysfunction, associated with the use of the drug.
What information must be reported on Vandetanib REMS Program?
The information that must be reported includes patient demographics, treatment plan, monitoring results, and any adverse effects experienced by the patient while on Vandetanib.
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