Thyrogen Kit 0.9mg Injection

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: Thyrotropin Alfa-stimulated Tg levels are generally lower than, and do not correlate with Tg levels after thyroid hormone withdrawal. Even when Thyrotropin Alfa-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. 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 Thyrotropin Alfa on thyroid cancer recurrence greater than 5 years post-remnant ablation has not been evaluated. Adjunctive Diagnostic Tool for Well-Differentiated Thyroid Cancer Thyrotropin Alfa ® is indicated for 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. Even when Thyrotropin Alfa-stimulated Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or of underestimating the extent of disease. Therefore, in such cases, even with a negative or low-stage Thyrotropin Alfa radioiodine scan, consideration should be given to further evaluating patients. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Thyrotropin Alfa-induced hyperthyroidism: Hospitalization for administration of Thyrotropin Alfa and postadministrative observation should be considered for patients at risk. Stroke: Stroke in female patients as well as other neurologic events in patients with central nervous system metastases. Sudden rapid tumor enlargement: Sudden, rapid and painful enlargement in distant metastatic thyroid cancer. Risks associated with radioiodine (RAI) combination treatment: If Thyrotropin Alfa is administered with RAI, the warnings and precautions for RAI also apply to this combination regimen. Thyrotropin Alfa-Induced Hyperthyroidism When given to patients who have substantial thyroid tissue still in situ or functional thyroid cancer metastases, Thyrotropin Alfa is known to cause a transient (over 7 to 14 days) but significant rise in serum thyroid hormone concentration. 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 Thyrotropin Alfa. Patients with residual thyroid tissue at risk for Thyrotropin Alfa-induced hyperthyroidism include the elderly and those with a known history of heart disease. Hospitalization for administration of Thyrotropin Alfa and postadministration observation in patients at risk should be considered. Stroke There are postmarketing reports of radiologically-confirmed stroke and neurological findings suggestive of stroke unconfirmed radiologically (e.g., unilateral weakness) occurring within 72 hours (range 20 minutes to three days) of Thyrotropin Alfa administration in patients without known central nervous system metastases. The majority of such patients were young women taking oral contraceptives at the time of their event or had other risk factors for stroke, such as smoking or a history of migraine headaches. The relationship between Thyrotropin Alfa administration and stroke is unknown. Patients should be well-hydrated prior to treatment with Thyrotropin Alfa. Sudden Rapid Tumor Enlargement Sudden, rapid and painful enlargement of residual thyroid tissue or distant metastases can occur following treatment with Thyrotropin Alfa. This may lead to acute symptoms, which depend on the anatomical location of the tissue. Such symptoms include acute hemiplegia, hemiparesis, and loss of vision one to three days after Thyrotropin Alfa administration. Laryngeal edema, pain at the site of distant metastasis, and respiratory distress requiring tracheotomy have also been reported after Thyrotropin Alfa administration. Pretreatment with glucocorticoids should be considered for patients in whom tumor expansion may compromise vital anatomic structures. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The most common adverse reactions (>5%) reported in clinical trials were nausea and headache. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to Thyrotropin Alfa in 481 thyroid cancer patients who participated in a total of 6 clinical trials of Thyrotropin Alfa: 4 trials for diagnostic use and 2 trials for ablation. In clinical trials, patients had undergone near-total thyroidectomy and had a mean age of 46.1 years. Thyroid cancer diagnosis was as follows: papillary (69.2%), follicular (12.9%), Hurthle cell (2.3%) and papillary/follicular (15.6%). Most patients received 2 intramuscular injections of 0.9 mg of Thyrotropin Alfa injection gin 24 hours apart. The safety profile of patients who have undergone thyroidectomy and received Thyrotropin Alfa as adjunctive treatment for radioiodine ablation of thyroid tissue remnants for well-differentiated thyroid cancer did not differ from that of patients who received Thyrotropin Alfa for diagnostic purposes. Reactions reported in ≥1% of patients in the combined trials are summarized in Table 1. In some studies, an individual patient may have participated in both Thyrotropin Alfa and thyroid hormone withdrawal. Table 1: Summary of Adverse Reactions by Thyrotropin Alfa and Thyroid Hormone Withdrawal in Pooled Clinical Trials (≥1% of Patients in any Phase) Thyrotropin Alfa Thyroid Hormone Withdrawal (N=481) (N=418) Preferred Term n (%) n (%) Nausea 53 2 (<1) Headache 29 0 Fatigue 11 2 (<1) Vomiting 11 0 Dizziness 9 0 Asthenia 5 1 (<1) Postmarketing Experience The following adverse reactions have been identified during postapproval use of Thyrotropin Alfa. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Transient (<48 hours) influenza-like symptoms, including fever (>100°F/38°C), chills/shivering, myalgia/arthralgia, fatigue/asthenia/malaise, headache, and chills. Hypersensitivity including urticaria, rash, pruritus, flushing, and respiratory signs and symptoms. Injection site reactions, including pain, erythema, bruising, and pruritus.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.