What is Thyrogen?

What is  Thyrogen?1

Thyrogen (thyrotropin alfa for injection), is a protein designed to be identical to natural human thyroid-stimulating hormone (TSH).  Thyrogen is a prescription medication given in two injections by a healthcare provider prior to radioactive iodine ablation or diagnostic testing in patients with well-differentiated thyroid cancer. Thyrogen is not approved for patients who have signs of thyroid cancer that has spread to other parts of the body (distant metastases).

Thyrogen and TSH
Thyrogen is produced using biotechnology, and designed to be identical to thyroid stimulating hormone found naturally in the body1

Thyrogen helps you avoid some of the signs and symptoms of hypothyroidism while still allowing your physician to perform a procedure to remove leftover thyroid tissue after surgery as well as to perform certain diagnostic tests to monitor for the recurrence of thyroid cancer.1

Thyrogen allows you to stay on your thyroid hormone replacement therapy in preparation for remnant ablation or diagnostic follow-up.1

In 1998, Thyrogen was approved by the United States Food and Drug Administration (FDA) for use in diagnostic follow-up. In 2007, Thyrogen was approved for use in preparation for treatment with radioiodine ablation of thyroid tissue remnants in patients with well-differentiated thyroid cancer that has not spread outside the neck, and who have undergone a total thyroidectomy.1

Use of Thyrogen in radioiodine remnant ablation

Thyrogen is administered by your healthcare provider as an injection two days in a row before the thyroid remnant ablation procedure or diagnostic follow-up testing.1

Thyrogen Helps Maintain Quality of Life for Patients Undergoing Remnant Ablation or Diagnostic Follow-up1,2

Two clinical studies evaluated quality of life for patients undergoing ablation2 or diagnostic follow-up1 with Thyrogen or thyroid hormone withdrawal. Patients used the SF-36 Health Survey to rate their mental and physical functioning in 8 different areas.

Over 4 weeks, patients who received Thyrogen during diagnostic follow-up rated their quality of life higher than patients who underwent thyroid hormone withdrawal in all of the 8 areas. Patients who received Thyrogen for ablation rated their quality of life higher than patients who underwent thyroid hormone withdrawal in 5 of the 8 areas (physical functioning, role physical, vitality, social functioning, and mental health).

Descriptions of the areas evaluated are provided below.

      • 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)

Thyrogen Administration Schedule1

Thyrogen is given as an injection into the muscle of the buttock for two days in a row.  These injections are given by a health care provider.  If you are receiving Thyrogen for ablation or diagnostic testing the following schedule may be used:

Ablation Schedule

Day 1

Day 2

Day 3

First Thyrogen Injection*

Second Thyrogen Injection*

Radioactive iodine dose

A post-ablation scan is performed 3 -7 days after the administration of radioiodine


Diagnostic Testing Schedule

Day 1

Day 2

Day 3

Day 4

Day 5

First Thyrogen Injection*

Second Thyrogen Injection*

Radioactive iodine dose (for whole body scan)

Serum thyroglobulin with or without whole-body scan

* 0.9 mg intramuscular injection to the buttock

  • Tg testing schedule is identical for both Tg testing alone and when combined with whole body scan.
  • Be sure that you understand and plan your schedule according to your doctor’s instructions.
  • Thyrogen is available by prescription only.

References

  1. Thyrogen (thyrotropin alfa for injection) Package Insert. Cambridge, MA. Genzyme Corp. 2014.
  2. 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.

INDICATIONS AND USAGE
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.

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.

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

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.

INDICATIONS AND USAGE

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.

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.

See full Prescribing Information for more details.

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.