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Thyrogen (Thyrotropin Alfa Recombinant) - Summary

 
 



THYROGEN SUMMARY

Thyrogen® (thyrotropin alfa for injection) contains a highly purified recombinant form of human thyroid stimulating hormone (TSH), a glycoprotein which is produced by recombinant DNA technology. Thyrotropin alfa is synthesized in a genetically modified Chinese hamster ovary cell line.

Thyrogen (thyrotropin alfa for injection) 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.

POTENTIAL CLINICAL USES:

  1. Thyrogen Tg testing may be used in patients with an undetectable Tg on thyroid hormone suppressive therapy to exclude the diagnosis of residual or recurrent thyroid cancer (see CLINICAL PHARMACOLOGY, Clinical Trials, Thyroglobulin (Tg) Results).
  2. Thyrogen testing may be used in patients requiring serum Tg testing and radioiodine imaging who are unwilling to undergo thyroid hormone withdrawal testing and whose treating physician believes that use of a less sensitive test is justified.
  3. Thyrogen testing may be used in patients who are either unable to mount an adequate endogenous TSH response to thyroid hormone withdrawal or in whom withdrawal is medically contraindicated.

See all Thyrogen indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Thyrogen (Thyrotropin)

Effect of postoperative thyrotropin suppressive therapy on bone mineral density in patients with papillary thyroid carcinoma: A prospective controlled study. [2011.12]
BACKGROUND: The influence of thyrotropin (thyroid-stimulating hormone [TSH]) suppressive therapy on bone mineral density (BMD) remains contentious. We have conducted a randomized controlled trial evaluating the effects of postoperative TSH suppressive therapy on disease-free survival for papillary thyroid carcinoma (PTC) since 1996, while prospectively verifying the effects of TSH suppression on BMD... CONCLUSION: This prospective controlled trial suggests that TSH suppression after surgery for PTC has adverse effects on BMD in women >/=50 years of age. Copyright (c) 2011 Mosby, Inc. All rights reserved.

Effects of physical activity on body composition and fatigue perception in patients on thyrotropin-suppressive therapy for differentiated thyroid carcinoma. [2011.07]
BACKGROUND: Subclinical thyrotoxicosis (scTox) may be associated with alterations in body composition and fatigue that can be possibly reversed with physical activity. The aim of the present study was to evaluate whether the systematic practice of physical activity improves lower extremity muscle mass and fatigue perception in patients with scTox... CONCLUSIONS: scTox is associated with lower muscle mass and mid-thigh girth and more fatigue. Physical activity training can partially ameliorate these characteristics. More studies are needed to determine what training program would be optimum, both in terms of beneficial effects and for avoiding potential adverse responses.

Low-normal or high-normal thyrotropin target levels during treatment of hypothyroidism: a prospective, comparative study. [2011.04]
BACKGROUND: Recent literature advocates the decrease of the upper limit of the normal thyrotropin (TSH) reference range. The objective of this study was to determine whether treated hypothyroid patients maintained within a low-normal TSH range (0.4-2.0 mIU/L) have better clinical outcomes than those maintained within a high-normal TSH range (2.0-4.0 mIU/L)... CONCLUSIONS: Despite recent trends toward lowering the upper limit of normal TSH range, the results of this 12-month study provided no substantial clinical evidence to corroborate that treatment of primary hypothyroidism should aim at maintaining TSH levels in a low-normal range

Does postoperative thyrotropin suppression therapy truly decrease recurrence in papillary thyroid carcinoma? A randomized controlled trial. [2010.10]
CONTEXT: TSH suppression therapy has been used to decrease thyroid cancer recurrence. However, validation of effects through studies providing a high level of evidence has been lacking. OBJECTIVE: This single-center, open-label, randomized controlled trial tested the hypothesis that disease-free survival (DFS) for papillary thyroid carcinoma (PTC) in patients without TSH suppression is not inferior to that in patients with TSH suppression... CONCLUSIONS: DFS for patients without TSH suppression was not inferior by more than 10% to DFS for patients with TSH suppression. Thyroid-conserving surgery without TSH suppression should be considered for patients with low-risk PTC to avoid potential adverse effects of TSH suppression.

Recombinant human thyrotropin-stimulated radioiodine therapy of nodular goiter allows major reduction of the radiation burden with retained efficacy. [2010.08]
CONTEXT AND OBJECTIVE: Stimulation with recombinant human TSH (rhTSH) before radioiodine (131I) therapy augments goiter volume reduction (GVR). Observations indicate that rhTSH has a preconditioning effect beyond increasing thyroid (131)I uptake. We test the hypothesis that an equivalent GVR might be obtained by an absorbed thyroid dose well below what has been used previously... CONCLUSIONS: This is the first study to demonstrate that rhTSH not only increases the thyroid 131I uptake, but per se potentiates the effect of 131I-therapy, allowing a major reduction of the 131I-activity without compromising efficacy. This approach is attractive in terms of minimizing posttherapeutic restrictions and in reducing the potential risk of radiation-induced malignancy.

more studies >>

Clinical Trials Related to Thyrogen (Thyrotropin)

Comparison of the Safety and Successful Ablation of Thyroid Remnant in Post-Thyroidectomized Euthyroid Patients (i.e. Patients Administered Thyrogen) Versus Hypothyroid Patients (no Thyrogen) Following 131I Administration [Completed]
This study was conducted in patients with differentiated thyroid cancer who had undergone near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation (use of radioiodine to remove any remaining thyroid tissue). One group of patients who took thyroid hormone medicine and were euthyroid [i. e. their thyroid stimulating hormone (TSH) levels are normal], and received injections of Thyrogen (0. 9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i. e. their TSH levels were high), and were given oral radioiodine. All patients received the same amount of radioactive iodine (100 mCi or 3. 7 GBq of 131I). Approximately 8 months later, whole body scans were performed on all patients to learn whether the thyroid remnants had been successfully ablated. The safety profile of Thyrogen when used for radioiodine remnant ablation also was assessed. The Quality of Life, the radioiodine uptake and retention into the thyroid bed, as well as radiation exposure to the remainder of the body also were assessed in both groups of patients.

A New Study to Follow-up Thyroid Cancer Patients Who Participated in a Previous Study, Which Compared the Success of Destruction of the Thyroid Remnant Using Standard Treatment or Thyrogen. [Completed]
Patients diagnosed with thyroid cancer are commonly treated with surgery to remove their thyroid gland followed by radioiodine ablation to destroy any remaining parts of the thyroid gland that may have been missed during surgery. It is thought that ablation with radioiodine destroys normal remaining thyroid tissue as well as cancerous cells either in the thyroid area or at other sites.

Following successful treatment, patients are then monitored by their physicians at regular intervals with testing to detect any recurrence of thyroid cancer throughout the body. If thyroid cells are detected by these follow up tests, the physician will decide the best method to re-treat the patient.

In 2001-2003 Genzyme conducted a clinical study to test if Thyrogen® can be used to accomplish radioiodine ablation treatment. This study aimed to determine that the success rates of radioiodine ablation were comparable when patients were prepared for ablation with Thyrogen® while being maintained on their normal thyroid hormone therapy, or, alternatively, by thyroid hormone withdrawal. Thyroid hormone withdrawal commonly causes uncomfortable side effects for patients, and these might be avoided by the use of Thyrogen.

Eight months after the initial Thyrogen plus radioiodine treatment to achieve ablation, all patients in both groups were given Thyrogen® to test for any remaining thyroid tissue. The results of this testing showed that all patients (in both groups) had successfully achieved remnant ablation and had no detectable thyroid tissue remaining.

In order to confirm these remnant ablation results we will conduct follow up testing in this study for all patients that were enrolled in the previous study and we also will determine if their thyroid cancer has recurred. Only patients who completed this previous Thyrogen ablation study are eligible for entry into this study.

Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer [Recruiting]
To evaluate quality of life in patients after 10 days pause of thyroid medication (Liothyronine) compared to treatment with recombinant TSH (Thyrogen) before radioiodine uptake and treatment in a double-blinded, randomised cross-over design.

Study of Radioiodine (131-I) Uptake Following Administration of Thyrogen and Hypothyroid States During Thyroid Hormone Withdrawal. [Completed]
Thyroid cancer is typically treated with surgery, radiation or a combination of both. Following surgical removal of thyroid tissue patients receive thyroid hormone replacement medication. In addition patients undergo tests to determine the status of the disease. One of the tests conducted is a whole body scan using radioactive iodine to detect and locate any remaining cancerous thyroid tissue.

Thyroid tissue uses iodine to make thyroid hormones (T3 and T4). In order for a radioiodine scan to work, cancerous thyroid tissue must be "hungry" for iodine. Thyroid stimulating hormone (TSH) produced in the pituitary gland is responsible for making thyroid tissue "hungry" for iodine. Once thyroid tissue absorbs the radioactive iodine it will be clearly visible on the scan and can be located for removal. However, thyroid hormone replacement medication tends to lower the activity of the pituitary gland and the amount of naturally produced TSH. So it is necessary to stop thyroid hormone replacement to increase TSH. A problem arises when there is a lack of thyroid hormone replacement causing patients to experience hypothyroidism. This condition is associated with unpleasant physical and emotional symptoms.

TSH has been created in a laboratory and called Thyrogen. It is basically the same as the TSH produced in the human pituitary gland. However, Thyrogen increases the level of TSH in the body without having to stop thyroid replacement medication. Therefore patients will not experience hypothyroidism while preparing for a radioactive iodine scan.

The objective of this study is to compare the activity of radioiodine (131I) in patients taking Thyrogen with normal thyroid activity versus patients with hypothyroid activity after thyroid replacement medication is withdrawn. In addition the study will provide information on how radioactive iodine is eliminated from the body. The study will help researchers understand how to give Thyrogen and radioiodine for purposes of scanning and therapeutic ablation (the destruction of function) of cancerous thyroid tissue.

The study will accept patients with non-medullary thyroid cancer who are preparing for ablation therapy. The patients will be placed in one of two groups. Group one will receive Thyrogen in 2 doses 24 hours apart. Group two will receive Thyrogen in 3 doses 72 hours apart. The patients will undergo two 131I whole body scans: one after Thyrogen while taking thyroid hormone suppressive and the second after withdrawal from thyroid hormone. 131I ablative therapy will be given under hypothyroid conditions at the completion of the study.

Study Comparing Thyrogen Versus a Modified Release of Recombinant Human Thyroid Stimulating Hormone [Completed]
Forty-six (46) eligible, healthy subjects who provide written informed consent will be enrolled to participate in a 2 arm parallel group study to assess and compare the pharmacokinetics and safety profile of Thyrogen dosed at 0. 1 mg versus a modified release formulation of recombinant human thyroid stimulating hormone (rhTSH) dosed at 0. 1 mg. Ten (10) of these subjects will have the thyroid uptake of radioiodine (123I) measured at baseline and following their single dose of study medication. All doses will be administered via intramuscular (IM) injection.

Following confirmation of study eligibility, subjects will be randomized in a 1: 1 ratio to receive either a single administration of 0. 1 mg of Thyrogen (THYR) or 0. 1 mg of the modified release.

Randomization will be stratified by whether or not patients will have the thyroid uptake of radioiodine (123I) measured following their single dose of study medication. Five (5) patients in each treatment arm will have uptake measured, while 18 in each arm will not.

Each subject will have blood samples taken to determine the pharmacokinetics of serum TSH at

- 12 hours and just prior to dosing and at various hours up to 14 days following the

administration of Thyrogen or the modified release formulation. In addition, for the evaluation of pharmacodynamics, each subject will have samples of blood taken to determine

serum free T4, total T4, free T3, and total T3 at - 12 hours and just prior to dosing and at

various hours up to 14 days following the administration of study treatments.

All subjects will undergo a 12-lead electrocardiogram (ECG) just prior to dose administration and 1, 2, 3, 4, 5, 7, 10 and 14 days following study treatment administration. In addition, subjects will undergo 24 hours of Holter monitoring at baseline and four (4) consecutive 24-hour Holter monitoring sessions post treatment to yield a total of 96 hours of continuous monitoring of cardiac function following treatment administration. All subjects will undergo ultrasound evaluations to determine thyroid volume at baseline and 48 hours following treatment administration.

Twenty-four hours following the administration of Thyrogen or the modified release formulation, a subset of five (5) subjects in each treatment arm will receive a dose of 123I prepared to be 400µCi on the day of radioiodine administration based on the utilized nuclear pharmacy’s calibration schedule. Thyroid gland uptake will be measured via a probe in these 10 subjects at 6, 24 and 48 hours following radioiodine administration.

Blood chemistry, complete blood count (CBC), urinalysis and a physical exam will be conducted 14 days after treatment administration, or at the time of early termination, as a final safety assessment.

Each subject’s duration of study participation will be approximately 4 weeks.

more trials >>

Reports of Suspected Thyrogen (Thyrotropin) Side Effects

Nausea (16)Myalgia (8)Malaise (7)Vomiting (7)Asthenia (6)Hypersensitivity (3)Pain (3)Influenza Like Illness (3)Fatigue (3)RED Blood Cell Sedimentation Rate Increased (3)more >>


Page last updated: 2011-12-09

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