IMPORTANT SAFETY INFORMATION: WARNINGS AND PRECAUTIONS:
There have been reports of death in non-thyroidectomized patients and in patients with distant metastatic thyroid cancer in which events leading to death occurred within 24 hours after administration of Thyrogen. Caution should be exercised in patients who have substantial thyroid tissue still in situ… View More

HELP AVOID THE SIGNS & SYMPTOMS OF HYPOTHYROIDISM

The effective Radioactive iodine ablation of the post-surgical thyroid remnant tissue, as well as the effective detection long-term of remaining tumor using the stimulated Thyroglobulin or Whole Body Scan, depends on the thyroid cancer tissue being metabolically stimulated by TSH, which is achieved by one of two methods:

  1. raise blood levels of endogenous TSH by withdrawing thyroid hormone from patients, which makes them clinically hypothyroid, or
  2. raise blood levels of TSH by injecting thyrotropin alfa; a method that allows patients to remain on thyroid hormone and help remain clinically euthyroid.

Thyrogen Helps to Avoid the Signs and Symptoms of Hypothyroidism observed with THW

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 of all signs and symptoms were observed during the hypothyroid phase (P<.01).

Assessment of hypothyroid symptoms: Billewicz scale (Diagnostic indication: 0.9 mg Thyrogen q24 hours x 2 doses vs THW phase)

Billewicz scale | The assessment of hypothyroid symptoms

Featuring Douglas Van Nostrand, MD, FACP, FACNP

Medstar Washington Hospital Center, Washington, DC Presented in a Sanofi Genzyme–sponsored symposium at the 2015 International Thyroid Congress

Featuring Douglas Van Nostrand, MD, FACP, FACNP Medstar Washington Hospital Center, Washington, DC Presented in a Sanofi Genzyme–sponsored symposium at the 2015 International Thyroid Congress

Learn More

How to Get Thyrogen

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

INDICATIONS AND USAGE

Thyrogen is a thyroid stimulating hormone indicated for:

Diagnostic: Use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy.

Limitations of Use:

  • Thyrogen -stimulated Tg levels are generally lower than, and do not correlate with Tg levels after thyroid hormone withdrawal.
  • Even when Thyrogen -Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or underestimating the extent of the disease.
  • Anti-Tg Antibodies may confound the Tg assay and render Tg levels uninterpretable.

Ablation: Use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer.

Limitations of Use:

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

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

There have been reports of death in non-thyroidectomized patients and in patients with distant metastatic thyroid cancer in which events leading to death occurred within 24 hours after administration of Thyrogen.

Caution should be exercised in patients who have substantial thyroid tissue still in situ or functional thyroid cancer metastases, specifically in the elderly and those with a known history of heart disease.

Hospitalization for administration of Thyrogen and post-administration observation in patients at risk should be considered.

There are post marketing reports of stroke in young women with risk factors for stroke, and neurological findings suggestive of stroke (e.g., unilateral weakness) occurring within 72 hours of Thyrogen administration in patients without known central nervous system metastases.

Patients should be well-hydrated prior to treatment with Thyrogen.

Sudden, rapid and painful enlargement of residual thyroid tissue or distant metastases can occur following treatment with Thyrogen.

Pretreatment with glucocorticoids should be considered for patients in whom tumor expansion may compromise vital anatomic structures.

ADVERSE REACTIONS

The most common adverse reactions reported in clinical trials were nausea and headache.

USE IN SPECIFIC POPULATIONS

Pregnancy Category C: Animal reproduction studies have not been conducted with Thyrogen. It is also not known whether Thyrogen can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Thyrogen should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Thyrogen is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Results from controlled trials do not indicate a difference in the safety and efficacy of Thyrogen between adult patients less than 65 years and those over 65 years of age.

Renal Impairment: Elimination of Thyrogen is significantly slower in dialysis-dependent end stage renal disease patients, resulting in prolonged elevation of TSH levels.

Reference

  1. Thyrogen (thyrotropin alfa for injection) Prescribing Information. Genzyme Corporation.