Thyrogen
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Uses
THYROGEN® 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.
Limitations of Use:
- THYROGEN-stimulated Tg levels are generally lower than, and do not correlate with, Tg levels after thyroid hormone withdrawal [see Clinical Studies (14.1)].
- Even when THYROGEN-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.
- Anti-Tg antibodies may confound the Tg assay and render Tg levels uninterpretable [see Clinical Studies (14.1)]. Therefore, in such cases, even with a negative or low-stage THYROGEN radioiodine scan, consideration should be given to further evaluating patients.
THYROGEN is indicated for 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 THYROGEN on long-term thyroid cancer outcomes has not been determined. Due to the relatively small clinical experience with THYROGEN in remnant ablation, it is not possible to conclude whether long-term thyroid cancer outcomes would be equivalent after use of THYROGEN or use of thyroid hormone withholding for TSH elevation prior to remnant ablation.
THYROGEN® 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.
Limitations of Use:
- THYROGEN-stimulated Tg levels are generally lower than, and do not correlate with, Tg levels after thyroid hormone withdrawal [see Clinical Studies (14.1)].
- Even when THYROGEN-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.
- Anti-Tg antibodies may confound the Tg assay and render Tg levels uninterpretable [see Clinical Studies (14.1)]. Therefore, in such cases, even with a negative or low-stage THYROGEN radioiodine scan, consideration should be given to further evaluating patients.
THYROGEN is indicated for 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 THYROGEN on long-term thyroid cancer outcomes has not been determined. Due to the relatively small clinical experience with THYROGEN in remnant ablation, it is not possible to conclude whether long-term thyroid cancer outcomes would be equivalent after use of THYROGEN or use of thyroid hormone withholding for TSH elevation prior to remnant ablation.
History
There is currently no drug history available for this drug.
Other Information
Each vial of THYROGEN contains 1.1 mg thyrotropin alfa, 36 mg Mannitol, 5.1 mg Sodium Phosphate, and 2.4 mg Sodium Chloride.
THYROGEN (thyrotropin alfa for injection) contains recombinant human thyroid stimulating hormone (TSH). Thyrotropin alfa is synthesized in a genetically modified Chinese hamster ovary cell line.
Thyrotropin alfa is a heterodimeric glycoprotein comprised of two non-covalently linked subunits, an alpha subunit of 92 amino acid residues containing two N-linked glycosylation sites and a beta subunit of 118 residues containing one N-linked glycosylation site. The amino acid sequence of thyrotropin alfa is identical to that of human pituitary TSH.
Both thyrotropin alfa and naturally occurring human pituitary TSH are synthesized as a mixture of glycosylation variants. Unlike pituitary TSH, which is secreted as a mixture of sialylated and sulfated forms, thyrotropin alfa is sialylated but not sulfated. The biological activity of thyrotropin alfa is determined by a cell-based bioassay. In this assay, cells expressing a functional TSH receptor and a cAMP-responsive element coupled to a heterologous reporter gene, luciferase, enable the measurement of thyrotropin alfa activity by measuring the luciferase response. The specific activity of thyrotropin alfa is determined relative to an internal Genzyme reference standard that was calibrated against the World Health Organization (WHO) human TSH reference standard.
Sources
Thyrogen Manufacturers
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Genzyme Corporation
![Thyrogen (Thyrotropin Alfa) Injection, Powder, For Solution Thyrogen (Thyrotropin Alfa) Kit [Genzyme Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Thyrogen | Genzyme Corporation
2.1 Recommended DosageTHYROGEN should be used by physicians knowledgeable in the management of patients with thyroid cancer.
THYROGEN is indicated as a two-injection regimen. The recommended dosage of THYROGEN is a 0.9 mg intramuscular injection to the buttock followed by a second 0.9 mg intramuscular injection to the buttock 24 hours later.
THYROGEN should be administered intramuscularly only. THYROGEN should not be administered intravenously.
Pretreatment with glucocorticoids should be considered for patients in whom tumor expansion may compromise vital anatomic structures [see Warnings and Precautions (5.3)].
Routine measurement of serum TSH levels is not recommended after THYROGEN use.
2.2 Reconstitution, Preparation, and Administration of THYROGENThe supplied lyophilized powder must be reconstituted with Sterile Water for Injection. THYROGEN should be prepared, and administered in the following manner:
Add 1.2 mL of Sterile Water for Injection to the vial containing the THYROGEN lyophilized powder. Swirl the contents of the vial until all the material is dissolved. Do not shake the solution. The reconstituted THYROGEN solution has a concentration of 0.9 mg of thyrotropin alfa per mL. Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration. The reconstituted THYROGEN solution should be clear and colorless. Do not use if the solution has particulate matter or is cloudy or discolored. Withdraw 1 mL of the reconstituted THYROGEN solution (0.9 mg of thyrotropin alfa) and inject intramuscularly in the buttocks. The reconstituted THYROGEN solution must be injected within 3 hours unless refrigerated; if refrigerated, the reconstituted solution may be kept for up to 24 hours. Discard unused portions. Do not mix with other substances. 2.3 Timing of Serum Thyroglobulin Testing Following THYROGEN AdministrationFor serum thyroglobulin testing, the serum sample should be obtained 72 hours after the final injection of THYROGEN [see Clinical Studies (14.1)].
2.4 Timing for Remnant Ablation and Diagnostic Scanning Following THYROGEN AdministrationOral radioiodine should be given 24 hours after the second injection of THYROGEN in both remnant ablation and diagnostic scanning. The activity of 131I is carefully selected at the discretion of the nuclear medicine physician.
Diagnostic scanning should be performed 48 hours after the radioiodine administration.
2.1 Recommended DosageTHYROGEN should be used by physicians knowledgeable in the management of patients with thyroid cancer.
THYROGEN is indicated as a two-injection regimen. The recommended dosage of THYROGEN is a 0.9 mg intramuscular injection to the buttock followed by a second 0.9 mg intramuscular injection to the buttock 24 hours later.
THYROGEN should be administered intramuscularly only. THYROGEN should not be administered intravenously.
Pretreatment with glucocorticoids should be considered for patients in whom tumor expansion may compromise vital anatomic structures [see Warnings and Precautions (5.3)].
Routine measurement of serum TSH levels is not recommended after THYROGEN use.
2.2 Reconstitution, Preparation, and Administration of THYROGENThe supplied lyophilized powder must be reconstituted with Sterile Water for Injection. THYROGEN should be prepared, and administered in the following manner:
Add 1.2 mL of Sterile Water for Injection to the vial containing the THYROGEN lyophilized powder. Swirl the contents of the vial until all the material is dissolved. Do not shake the solution. The reconstituted THYROGEN solution has a concentration of 0.9 mg of thyrotropin alfa per mL. Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration. The reconstituted THYROGEN solution should be clear and colorless. Do not use if the solution has particulate matter or is cloudy or discolored. Withdraw 1 mL of the reconstituted THYROGEN solution (0.9 mg of thyrotropin alfa) and inject intramuscularly in the buttocks. The reconstituted THYROGEN solution must be injected within 3 hours unless refrigerated; if refrigerated, the reconstituted solution may be kept for up to 24 hours. Discard unused portions. Do not mix with other substances. 2.3 Timing of Serum Thyroglobulin Testing Following THYROGEN AdministrationFor serum thyroglobulin testing, the serum sample should be obtained 72 hours after the final injection of THYROGEN [see Clinical Studies (14.1)].
2.4 Timing for Remnant Ablation and Diagnostic Scanning Following THYROGEN AdministrationOral radioiodine should be given 24 hours after the second injection of THYROGEN in both remnant ablation and diagnostic scanning. The activity of 131I is carefully selected at the discretion of the nuclear medicine physician.
Diagnostic scanning should be performed 48 hours after the radioiodine administration.
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