BENEFITS OF THYROGEN

How was Thyrogen shown to help?

Clinical study results have shown that preparation with Thyrogen is as effective as thyroid hormone withdrawal for remnant ablation and diagnostic testing while allowing you to stay on your thyroid medication during these procedures.

Remnant ablation

In clinical studies of patients with differentiated thyroid cancer, preparation with Thyrogen resulted in similar successful ablation rates when compared to preparation with thyroid hormone withdrawal:

Results from 2 large clinical studies

Successful remnant ablation rates (study B)
(684 evaluable patients)

results from successful remnant ablation rate clinical studies

Successful remnant ablation rates (study A)
(421 evaluable patients)

Successful remnant ablation rates in 421 evaluable patients

  • Thyrogen was compared with thyroid hormone withdrawal (THW) using 2 different doses of radioiodine (RAI) in patients with well-differentiated thyroid cancer who had undergone thyroidectomy
  • In both studies, patients were randomized to 1 of 4 treatment groups: Thyrogen + low dose RAI, Thyrogen + high dose RAI, THW +low dose RAI, THW + high dose RAI.
  • Ablation success rates were assessed at approximately 8 months post ablation.

Diagnostic Testing

Thyrogen was also studied in 229 patients with well-differentiated thyroid cancer to compare radioactive iodine whole body scans (WBS) obtained after THYROGEN injections to radioactive iodine whole body scans after thyroid hormone withdrawal. This study also compared the combination of thyroglobulin (Tg) levels in the blood and WBS obtained after THYROGEN injections and after thyroid hormone withdrawal.

WBS alone

Each patient was scanned first after receiving THYROGEN, then scanned after undergoing thyroid hormone withdrawal. Scans were compared by blinded readers.

Disease detection rates were found to be similar between the scans after Thyrogen and scans after thyroid hormone withdrawal

WBS + Tg

The combination of whole body scans and Tg testing after Thyrogen injections showed comparable accuracy for detecting metastatic disease when compared to whole body scans and Tg testing after thyroid hormone withdrawal.

Stimulated Tg testing

In certain situations, stimulated Tg testing with THYROGEN will help your doctor determine future treatment recommendations

Thyrogen has been shown to help avoid some of the signs and symptoms of hypothyroidism

In two clinical trials, Thyrogen was compared with thyroid hormone withdrawal in preparing patients for a whole-body scan.

  • One group of patients received Thyrogen
  • One group underwent thyroid hormone withdrawal

The trials measured the signs and symptoms of hypothyroidism in each group.1

What signs and symptoms did the study measure?

The study measured the following symptoms1:

signs and symptoms measured for hypothyroidism

How were the signs and symptoms measured?

The signs and symptoms were measured by using a Billewicz scale.1 A Billewicz scale is an observer-rated set of clinical findings that has been widely used in assessing hypothyroidism. Higher scores are associated with a decrease in signs and symptoms of hypothyroidism.

How did Thyrogen compare with thyroid hormone withdrawal in these studies?

There were three sets of scores taken1:

  • For all patients during the pre-treatment phase when they were on thyroid hormone treatment.
  • For the patients who took Thyrogen
  • For the patients who were withdrawn from thyroid hormone replacement treatment

The chart below shows that patients who took Thyrogen did not experience the symptoms of hypothyroidism that were measured. However, the patients who went through thyroid hormone withdrawal experienced significantly worse signs and symptoms in all the parameters measured in the study.1

hypothyroid symptom assessment using the billewicz scale on Thyrogen vs hormone withdrawal 

Thyrogen has been proven to help maintain your quality of life1,3

Two clinical studies compared the quality of life of patients receiving Thyrogen with patients undergoing thyroid hormone withdrawal. In the first trial, patients were preparing for diagnostic follow-up while in the second they were undergoing radioactive iodine ablation. In both trials, one group of patients received Thyrogen while the other underwent thyroid hormone withdrawal.1,3

Researchers evaluated quality of life across eight areas:

Physical functioning (e.g., walking or lifting groceries)

Role physical (e.g., working and daily activities)

Bodily pain (e.g., no limitations due to pain)

General health (e.g., view of personal health)

Vitality (e.g., feeling full of pep and energy)

Social functioning (e.g., performing socially without problems)

Role emotional (e.g., performing work/daily activities without difficulty)

Mental health (e.g., feeling peaceful, happy and calm)

How was the quality of life of these patients measured?

In the two clinical studies, the quality of life of the patients was measured using The Short Form (36) Health Survey. The SF-36 is a 36-item, patient-reported survey of patient health, consisting of eight scaled scores. The lower the score the more disability. The higher the score the less disability.

How did Thyrogen compare with thyroid hormone withdrawal in these studies?

There were three sets of scores taken:

  • For all patients during the pre-treatment phase when they were on thyroid hormone treatment
  • For the patients who took Thyrogen
  • For the patients who were withdrawn from thyroid hormone replacement treatment

In the first trial, where patients were preparing for diagnostic follow up, those who received Thyrogen rated their quality of life higher in all of the eight areas than patients who underwent thyroid hormone withdrawal.1 In fact, the quality of life differences in all eight groups were considered statistically significant.


In the second trial, where patients were preparing for radioactive iodine ablation, those who received Thyrogen rated their quality of life higher than patients who underwent thyroid hormone withdrawal in all eight groups as well. In five of the eight areas (physical functioning, role physical, vitality, social functioning, and mental health), the difference in quality of life scores was considered statistically significant.


The chart below is from the diagnostic follow up study, where the quality of life differences between the Thyrogen group and thyroid hormone withdrawal group was statistically significant in all eight areas.

health survey results quality of life domains diagnostic indication 

Resources

Thyroid Cancer Glossary

My Doctor Discussion Guide

My Doctor Discussion Guide

Thyrogen Patient Kit

Thyrogen Patient Kit

More Resources

Thyrogen® (thyrotropin alfa for injection) 0.9 mg/mL after reconstitution

INDICATIONS AND USAGE

Diagnostic: Thyrogen is used to help identify thyroid disease by testing the blood for a hormone called thyroglobulin in the follow up of patients with a certain type of thyroid cancer known as well differentiated thyroid cancer. It is used with or without a radiology test using a form of iodine.

Limitations of Use:

The effect of Thyrogen on long term thyroid cancer outcomes has not been determined.

When Thyrogen is used to help detect thyroid cancer, there is still a chance all or parts of the cancer could be missed.

Ablation: Thyrogen is also used to help patients prepare for treatment with a form of iodine to remove leftover thyroid tissue in patients who have had surgery to take out the entire thyroid gland for patients with well differentiated thyroid cancer who do not have signs of thyroid cancer which has spread to other parts of the body.

Limitations of Use:

In a study of people being prepared for treatment with a form of iodine after thyroid surgery, results were similar between those who received Thyrogen and those who stopped taking their thyroid hormone. Researchers do not know if results would be similar over a longer period of time.

IMPORTANT SAFETY INFORMATION

There have been reports of events that led to death in patients who not had surgery to have their thyroid gland removed, and in patients with thyroid cancer cells that have spread to other parts of the body.

Patients over 65 years old with large amounts of leftover thyroid tissue after surgery, or with a history of heart disease, should discuss with their physicians the risks and benefits of Thyrogen.

Thyrogen can be administered in the hospital for patients at risk for complications from Thyrogen administration.

Since Thyrogen was first approved for use, there have been reports of central nervous system problems such as stroke in young women who have a higher chance of having a stroke, and weakness on one side of the body.

Patients should remain hydrated prior to treatment with Thyrogen.

Leftover thyroid tissue after surgery and cancer cells that have spread to other parts of the body can quickly grow and become painful after Thyrogen administration.

Patients with cancer cells near their windpipe, in their central nervous system, or in their lungs may need treatment with a glucocorticoid (a medication to help prevent an increase in the size of the cancer cells before using Thyrogen.)

ADVERSE REACTIONS

In clinical studies, the most common side effects reported were nausea and headache.

USE IN SPECIFIC PATIENT POPULATIONS

Pregnant patients: Thyrogen should be given to a pregnant woman only if the doctor thinks there is a clear need for it.

Breastfeeding patients: It is not known whether Thyrogen can appear in human milk. Breastfeeding women should discuss the benefits and risks of Thyrogen with their physician.

Children: Safety and effectiveness in young patients (under the age of 18) have not been established.

Elderly: Studies do not show a difference in the safety and effectiveness of Thyrogen between adult patients less than 65 years and those over 65 years of age.

Patients with kidney disease: Thyrogen exits the body much slower in dialysis patients and can lead to longer high TSH levels.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

References

  1. Thyrogen (thyrotropin alfa for injection) Package Insert. Cambridge, MA. Genzyme Corporation.
  2. Haugen BR, Pacini F, Reiners C, et al. A Comparison of Recombinant Human Thyrotropin and Thyroid Hormone Withdrawal for the Detection of Thyroid Remnant or Cancer. J Clin Endocrinol Metab. 1999;84:3877-3885.
  3. Pacini F, Landenson PW, Schlumberger M, et al. Radioiodine ablation of thyroid remnants after preparation with recombinant human thyrotropin in differentiated thyroid carcinoma: results of an international, randomized, controlled study. J Clin Endocrinol Metab. 2006;91:926-932.