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Thyrogen

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Thyrogen

Thyrogen

Thyrogen Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Thyrogen (thyrotropin alfa for injection) contains a form of human thyroid stimulating hormone (TSH) and is used as a diagnostic tool in patients who have had thyroid cancer and needed a thyroidectomy (thyroid surgery), to detect any possible remaining thyroid tissue. Common side effects include nausea and headache.

A two-injection dose regimen is recommended for Thyrogen administration. The two-injection regimen is Thyrogen 0.9 mg intramuscularly (IM), followed by a second 0.9 mg IM injection 24 hours later. Thyrogen may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Thyrogen should be used only if prescribed. It is unknown if this drug is passes into breast milk. Consult your doctor before breastfeeding.

Our Thyrogen (thyrotropin alfa for injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Thyrogen FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 any Phase)

Preferred Term  THYROGEN
(N=481)
n (%) 
Thyroid Hormone Withdrawal
(N=418)
n (%) 
Nausea  53 (11)  2 ( < 1) 
Headache  29 (6)  0
Fatigue  11 (2)  2 ( < 1) 
Vomiting  11 (2)  0
Dizziness  9 (2)  0 (0.0) 
Asthenia  5 (1)  1 ( < 1) 

Postmarketing Experience

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.

Read the entire FDA prescribing information for Thyrogen (Thyrotropin Alfa for Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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