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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 THYROGEN in 481 thyroid cancer patients who participated in a total of 6 clinical trials of THYROGEN: 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 THYROGEN injection given 24 hours apart [see Clinical Studies].
The safety profile of patients who have undergone thyroidectomy and received THYROGEN as adjunctive treatment for radioiodine ablation of thyroid tissue remnants for well-differentiated thyroid cancer did not differ from that of patients who received THYROGEN 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 THYROGEN and thyroid hormone withdrawal [see Clinical Studies].
Table 1: Summary of Adverse Reactions by THYROGEN and
Thyroid Hormone Withdrawal in Pooled Clinical Trials ( ≥ 1% of Patients in
|Thyroid Hormone Withdrawal
|Nausea||53 (11)||2 ( < 1)|
|Fatigue||11 (2)||2 ( < 1)|
|Dizziness||9 (2)||0 (0.0)|
|Asthenia||5 (1)||1 ( < 1)|
The following adverse reactions have been identified during post-approval use of THYROGEN. 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.
Read the Thyrogen (thyrotropin alfa for injection) Side Effects Center for a complete guide to possible side effects
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Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.
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