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Role of Thyrogen

As discussed in the Thyroid Cancer Management section, it is important to maintain a regular schedule of follow-up visits with your doctor to make sure your cancer has not come back. At these visits, you will most likely undergo thyroglobulin (Tg) testing and/or a whole body scan (WBS).

Both of these tests usually require that you have elevated levels of thyroid stimulating hormone (TSH) in your bloodstream to stimulate any remaining or recurring thyroid cells. There are two different ways to make this happen: stop taking your thyroid hormones, which induces a condition called hypothyroidism, or use Thyrogen®. Thyrogen is recombinant human thyroid stimulating hormone (rhTSH) that can help you avoid the symptoms of hypothyroidism. For more information, please read the full product information (PDF) and the important safety information below.

Hypothyroidism

If you need to stop taking your thyroid hormone therapy (T3 and/or T4), you will become hypothyroid. Since thyroid hormones affect many of your body’s functions, particularly metabolism, hypothyroidism can be a big change to your body’s systems.

Some people experience only minor noticeable changes. Most, however, experience more intrusive, even debilitating symptoms of hypothyroidism. These can include:

  • Fatigue
  • Weight gain
  • Facial puffiness
  • Forgetfulness
  • Depression
  • Dry skin and hair
  • Constipation
  • Menstrual disturbances like heavy menstrual periods and/or lack of ovulation
  • Difficulty concentrating
  • Inability to tolerate cold

In some people, the effects of hypothyroidism can become so overwhelming that they cannot work, and may feel that their home and family lives are severely affected. These symptoms can persist for some time even after testing is completed. These changes can generally be reversed with thyroid hormone replacement, but readjustment can take as long as 1 to 3 months.

Thyrogen

With Thyrogen, some people with well-differentiated thyroid cancer may not have to deal with hypothyroidism when undergoing routine tests. If your doctor decides that Thyrogen is right for you, you will be able to stay on your thyroid hormones throughout testing.

Thyrogen is recombinant human thyroid stimulating hormone (rhTSH) that is given prior to testing. Thyrogen should activate any thyroid or thyroid cancer cells in your body. Once they are activated, the cells produce thyroglobulin (Tg), which will show up in a Tg blood test. Any activated cells should also show up in a whole body scan (WBS) with radioiodine. If either of these things happens, it is likely that you have thyroid cells in your body. These cells may be cancerous. For more, please see important safety information below.

If Thyrogen is prescribed by your doctor, instead of going off your hormone therapy for weeks before your tests, you will have two injections. These are the procedures you would undergo with Thyrogen:

• Day 1: A first injection of Thyrogen is given by a health care professional

• Day 2: A second injection is given 24 hours later

• Day 3: If a WBS is to be performed, the radioiodine is administered 24 hours after the second Thyrogen injection

• Day 4: Tests are not required on this day

• Day 5: Serum Tg testing and WBS (if indicated) are performed 72 hours after the second Thyrogen injection

Your doctor will help explain that it is important to follow this schedule. To help you with planning, you can download a testing schedule (PDF) that you and your doctor can fill out. For more, please see important safety information below.

Is Thyrogen right for you?

There are four main reasons that your doctor may decide to prescribe Thyrogen:

1. If your doctor believes that use of Thyrogen is appropriate and you prefer to continue taking your thyroid hormone therapy.

2. If, when you stop taking your thyroid hormone therapy, your body doesn’t produce enough thyroid stimulating hormone (TSH) on its own.

3. If you have certain medical conditions that prevent you from stopping your thyroid hormone therapy.

4. If a previous Tg blood test performed while on thyroid hormone therapy didn’t detect any cancer cells, and your doctor wants to confirm this result with a more accurate, Thyrogen-stimulated Tg blood test.

Please see important safety information below.

Important safety information about Thyrogen

In studies, the most common side effects experienced by people taking Thyrogen were nausea, headache, weakness, or vomiting after their injection. Cases of hives, rash, itching, or flushing were also reported.

Four patients out of 55 (7.3%) with CNS metastases who were followed in a special treatment protocol experienced acute hemiplegia, hemiparesis or pain one to three days after Thyrogen administration. The symptoms were attributed to local edema and/or focal hemorrhage at the site of the cerebral or spinal cord metastases. In addition, one case each of acute visual loss and of laryngeal edema with respiratory distress, requiring tracheotomy, with onset of symptoms within 24 hours after Thyrogen administration, have been reported in patients with metastases to the optic nerve and paratracheal areas, respectively. In addition, sudden, rapid and painful enlargement of locally recurring papillary carcinoma has been reported within 12-48 hours of Thyrogen administration. The enlargement was accompanied by dyspnea, stridor or dysphonia. Rapid clinical improvement occurred following glucocorticoid therapy. It is recommended that pretreatment with glucocorticoids be considered for patients in whom local tumor expansion may compromise vital anatomic structures.

A 77 year-old non-thyroidectomized patient with a history of heart disease and spinal metastases who received 4 Thyrogen injections over 6 days in a special treatment protocol experienced a fatal MI 24 hours after he received the last Thyrogen injection. The event was likely related to Thyrogen-induced hyperthyroidism.

For more information, please see the Adverse Reactions section of the full product information. If you experience any side effects or have any questions, contact your doctor.

To learn more about Thyrogen, download a PDF version of the booklet Understanding Thyrogen: Your Guide to Thyrogen and Its Role in the Monitoring of Well-Differentiated Thyroid Cancer (PDF).

More detail is also available in the full product information (PDF).


Safety Information
Thyrogen® (thyrotropin alfa for injection) is used in combination with other tests to detect recurring or leftover thyroid cancer cells in patients with a history of certain types of thyroid cancer. Thyrogen is injected in a muscle, and is available only by prescription. The most common side effects reported in clinical studies were nausea, headache, weakness & vomiting. When using Thyrogen, there is a risk that thyroid cancer cells may not be detected and diagnosis of recurring cancer may be missed. If you think that Thyrogen may be right for you, or if you have any problems with the use of Thyrogen, please contact your doctor. To learn more, please see full product information (PDF), contact Genzyme toll free at 1-88-THYROGEN (1-888-497-6436).
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If you or someone you know has Thyroid Cancer, the more you know about this disease and its management the better. Here are some additional resources for patients.

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