Important Safety Information and Indications
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
If Thyrogen is administered with radioiodine, the contraindications to radioiodine also apply to this combination
regimen. Refer to the radioiodine prescribing information for a list of contraindications for radioiodine.
WARNINGS AND PRECAUTIONS
Thyrogen-Induced Hyperthyroidism:
- 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.
Stroke:
- 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. The relationship between
Thyrogen administration and stroke is unknown. Patients should be well-hydrated prior to treatment with
Thyrogen.
Sudden Rapid Tumor Enlargement:
- 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.
Risks Associated with Radioiodine Treatment:
- If Thyrogen is administered with radioiodine (RAI), the warnings and precautions for RAI apply to this
combination regimen. Refer to the RAI prescribing
information for a full list of the warnings and precautions for RAI.
ADVERSE REACTIONS
The most common adverse reactions reported in clinical trials were nausea and headache.
USE IN SPECIFIC POPULATIONS
Pregnancy:
- If Thyrogen is administered with radioiodine, the combination regimen is contraindicated in pregnant women.
- Available data with Thyrogen use in pregnant women are insufficient to evaluate for a drug-associated risk
of major birth defects, miscarriage, or adverse
maternal or fetal outcomes.
Lactation:
- The concomitant use of Thyrogen and radioiodine (RAI) is contraindicated in lactating women. If Thyrogen is
administered with RAI for diagnostic use,
discontinue breastfeeding after RAI administration because of the potential for serious adverse reactions
from RAI in the breastfed infant.
- If Thyrogen is not administered with RAI, the developmental and health benefits of breastfeeding should be
considered along with the mother’s clinical
need for Thyrogen and any potential adverse effects on the breastfed child. There are no available data on
the presence of thyrotropin alfa in human milk,
the effects on the breastfed infant, or the effects on milk production.
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.
INDICATIONS AND USAGE
Thyrogen® (thyrotropin alfa) is a thyroid stimulating hormone indicated for:
Adjunctive Diagnostic Tool for Well-Differentiated Thyroid Cancer: 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. Thyrogen is also used to
help patients prepare for treatment with a
form of iodine, called radioiodine, 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.
Adjunct for Thyroid Remnant Ablation in Well-Differentiated Thyroid Cancer: 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 thyroid cancer recurrence greater than 5 years post-remnant ablation has not been
evaluated.
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MAT-US-2017945-v1.0-08/2020