Thyrogen (thyrotropin alfa for injection) Product Monograph
Listed below are the contents of the Thyrogen® Monograph:
I. Introduction
II. Well-differentiated thyroid cancer
 | Incidence and prevalence
|
| Natural history affects management
|
| Treatment and management of thyroid cancer
|
| Monitoring for cancer recurrences or metastases |
III. Description and pharmacology of Thyrogen
| Description
|
| Clinical pharmacology |
IV. Overview of preclinical and clinical development of Thyrogen
| Preclinical studies
|
| Clinical studies |
V. Phase III clinical trials
| Overview
|
| Study designs
|
| Efficacy results of WBS in the first phase III study
|
| Refinements to the second Phase III study design based on the first phase III |
VI. Second Phase III clinical trial
| Study design
|
| Pharmacokinetic results
|
| Scan review
|
| Efficacy results of WBS alone
|
| Efficacy results of WBS in combination with Tg testing
|
| Efficacy results of Tg testing alone
|
| Results of hypothyroid symptom evaluation and quality-of-life assessment |
VII. Safety and tolerability profile
VIII. Reconstitution and administration
| Recommended dosing regimen |
IX. Guidelines for use
| Suggested WBS protocol |
X. Clinical management strategies
| Management strategies using Thyrogen
|
| Guidelines for Monitoring with Thyrogen |
XI. References
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Safety Information
Thyrogen® (thyrotropin alfa for injection) is indicated for use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine whole-body scan (WBS) in the follow-up of patients with well-differentiated thyroid cancer. It is a prescription product injected into the muscle. Thyrogen® may not be appropriate for all patients. The most commonly reported adverse events are headache, nausea, weakness and vomiting. Even with a Thyrogen®-stimulated Tg testing and WBS, a risk remains of missing a diagnosis of thyroid cancer or of underestimating the extent of disease. Adverse events should be reported promptly to Genzyme Medical Information at 1-800-745-4447. For more information on Thyrogen®, please see
full prescribing information (PDF), contact the Medical Information department or contact Genzyme
toll free at 1-88-THYROGEN (1-888-497-6436). |
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