About Thyrogen

Thyrogen^® is a highly purified recombinant source of human thyroid stimulating hormone (rhTSH) developed for use in well-differentiated thyroid cancer patients who have had near-total or total thyroidectomy, and who must therefore take thyroid hormones and undergo periodic testing for recurrent or persistent cancer. Thyrogen raises serum TSH levels, stimulating I-131 uptake and thyroglobulin (Tg) production and release by cells of thyroid origin.[1]

Thyrogen is indicated for use as an adjunctive diagnostic tool for serum Tg testing with or without radioiodine whole body scans (WBS) in the follow-up of patients with well-differentiated thyroid cancer. Potential clinical uses include:^[1]

Patients with undetectable on-suppression Tg

Patients who are unwilling to undergo withdrawal and whose physicians believe that use of a less sensitive test is justified

Patients with an inadequate endogenous TSH response

Patients in whom withdrawal is contraindicated

For more information, please see the full product information (PDF) and the safety information below.

Genzyme and Thyrogen

Genzyme has been committed to helping patients with well-differentiated thyroid cancer since the 1980s, when they were among the first to research rhTSH. Further important milestones in Thyrogen’s development include:

1987: Research on recombinant human thyroid stimulating hormone (rhTSH) leads researchers to begin development of thyrotropin alfa for injection

1991: Clinical trials begin

1997: NDA filed

1998: FDA approval granted

To date, an estimated 50,000 patients worldwide have received Thyrogen, [2] and Genzyme continues its commitment to thyroid cancer and other endocrine research.

Thyrogen provides an alternative to hormone withdrawal prior to follow-up testing. In the past, Tg tests and WBS required patients to stop taking their hormone supplements for 2 to 6 weeks prior to, during, and sometimes after testing, to raise the level of TSH in the bloodstream to check for metastases or other recurrences.[3] For more information, please see the important safety information below.

Hormone withdrawal results in hypothyroidism, the symptoms of which can include the following:^[1,4]

Facial puffiness

Cold intolerance

Cold and/or dry skin

Slow movements

Weight gain

Hoarseness

Constipation

Slowing of reflexes

Decreased pulse

Paresthesia

Diminished sweating

Deafness

Anovulation and menstrual abnormalities

In some patients, hypothyroidism causes little discomfort. In others, however, the effects can be debilitating. Thyrogen can allow patients to stay on their thyroid hormone supplement throughout the course of the periodic testing.

With Thyrogen, quality of life (QOL) was unchanged from baseline as measured using a validated QOL tool. Conversely, during withdrawal, significant decline from baseline was observed in 4 of 8 parameters. Thyrogen administration was not associated with the signs and symptoms of hypothyroidism that accompanied thyroid hormone withdrawal as measured by the Billewicz scale. Statistically significant worsening in all signs and symptoms were observed during the hypothyroid phase (p<0.01).^[1] For more information, please see the important safety information below.

Thyrogen is used in the detection of well-differentiated thyroid cancer. In one clinical study, Tg levels were >/= 2.5 ng/mL in 69% (40/58) of patients after 2 doses of Thyrogen versus 45% who did not receive Thyrogen but who underwent thyroid hormone suppression therapy. In these same patients, adding WBS increased the detection rate of thyroid remnant or cancer to 84% (49/58) in patients treated with 2 doses of Thyrogen. In 35 patients with confirmed metastatic disease, Thyrogen-stimulated Tg was >/= 2.5 ng/mL in 100% of patients; this was only true for 79% of patients on THST who did not receive Thyrogen.^[1] For more information, please see the important safety information below.

In this section of the site you can:

Get an overview of Thyrogen’s use and administration

Access the Thyrogen monograph and learn more about its pharmacology, clinical development, and approved use

Download key articles and view a comprehensive bibliography

Learn about ongoing clinical trials with Thyrogen

Take an in-depth look at Thyrogen’s role in ongoing patient management

Read a peer’s suggestions about how to discuss Thyrogen with your patients

For more information, please see the full product information (PDF) and the safety information below.

References

1. Thyrogen (see full prescribing information). Cambridge, MA: Genzyme Corporation; 2001. Genzyme Corporation. Data on file.

2. American Association of Clinical Endocrinologists. AACE/AAES medical/surgical guidelines for clinical practice: management of thyroid carcinoma. Endocr Pract. 2001;7:202-220.

3. Mazzaferri EL. Evaluation and management of common thyroid disorders in women. Am J Obstet Gynecol. 1997;176:507-514.

4. 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.