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:
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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).
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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.
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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.
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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.
Clinical Trials Related to Thyrogen (Thyrotropin)
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.
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 Retrospective Observational Study Comparing Two Different Treatment Options in Thyroid Cancer Patients With T4 Tumours [Completed]
The study is to demonstrate non-inferior thyroid remnant first ablation success of Thyrogen
and 131I compared to thyroid hormone withdrawal (THW) and 131I in patients with T4 tumour
based on historical diagnostic whole body scan (DxWBS) records.
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.
Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer [Completed]
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.
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 >>
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Page last updated: 2011-12-09
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