- Approval Id
- 92e74ba32304e41f
- Drug Name
- THYROGEN 0.9 MG POWDER FOR SOLUTION FOR INJECTION
- Product Name
- THYROGEN 0.9 MG POWDER FOR SOLUTION FOR INJECTION
- Approval Number
- SIN13164P
- Approval Date
- 2005-12-27
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION<br>
Recommended Dosage</strong><br>
THYROGEN should be used by physicians knowledgeable in the management of patients with thyroid cancer.</p>
<p>THYROGEN is indicated as a two-injection regimen. The recommended dosage of THYROGEN is a 0.9mg intramuscular injection to the buttock followed by a second 0.9 mg intramuscular injection to the buttock 24 hours later.</p>
<p>THYROGEN should be administered intramuscularly only. THYROGEN should not be administered intravenously.</p>
<p>Pretreatment with glucocorticoids should be considered for patients in whom tumor expansion may compromise vital anatomic structures [see <em>Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>
<p>Routine measurement of serum TSH levels is not recommended after THYROGEN use.</p>
<p><strong>Reconstitution, Preparation, and Administration of THYROGEN</strong><br>
The supplied lyophilized powder must be reconstituted with Sterile Water for Injection. THYROGEN should be prepared, and administered in the following manner:</p>
<ul>
<li>Reconstitute each 0.9 mg vial of THYROGEN with 1.2 mL of Sterile Water for Injection to yield a single-dose solution containing the 0.9 mg/mL of thyrotropin alfa that delivers 1 mL (0.9 mg).</li>
<li>Gently swirl the contents of the vial until all the material is dissolved. Do not shake the solution.</li>
<li>Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration.<br>
The reconstituted THYROGEN solution should be clear and colorless. Do not use if the solution has particulate matter or is cloudy or discolored.</li>
<li>Withdraw 1 mL of the reconstituted THYROGEN solution (0.9 mg of thyrotropin alfa) and inject intramuscularly in the buttocks. Discard any unused portions.</li>
<li>The reconstituted THYROGEN solution must be injected within 3 hours unless refrigerated;
<li>If necessary, the reconstituted solution can be stored refrigerated at a temperature between 2°C and 8°C (36°F to 46°F) for up to 24 hours while avoiding microbial contamination.</li>
<li>Do not mix with other substances.</li>
</ul>
<p><strong>Timing of Serum Thyroglobulin Testing Following THYROGEN Administration</strong><br>
For serum thyroglobulin testing, the serum sample should be obtained 72 hours after the final injection of THYROGEN [see <em>Clinical Studies</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>
<p><strong>Timing for Remnant Ablation and Diagnostic Scanning Following THYROGEN Administration</strong><br>
Oral radioiodine should be given 24 hours after the second injection of THYROGEN in both remnant ablation and diagnostic scanning. The activity of <sup>131</sup>I is carefully selected at the discretion of the nuclear medicine physician.<br>
Diagnostic scanning should be performed 48 hours after the radioiodine administration.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>INDICATIONS AND USAGE</strong><br>
<ul class="square">
<li><p><strong>Adjunctive Diagnostic Tool for Serum Thyroglobulin Testing in Well Differentiated Thyroid Cancer</strong></p>
<p>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.<p>
<p><u>Limitations of Use:</u></p>
<ul class="bullet">
<li>THYROGEN-stimulated Tg levels are generally lower than, and do not correlate with, Tg levels after thyroid hormone withdrawal [see <em>Clinical Studies</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</li>
<li>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.</li>
<li>Anti-Tg antibodies may confound the Tg assay and render Tg levels uninterpretable [see <em>Clinical Studies</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>]. Therefore, in such cases, even with a negative or low-stage THYROGEN radioiodine scan, consideration should be given to further evaluating patients.</li>
</ul>
</li>
<li><p><strong>Adjunct to Treatment for Ablation in Well Differentiated Thyroid Cancer</strong><br>
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.</li>
</ul>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
If THYROGEN is administered with radioiodine, the contraindications to radioiodine also apply to this combination regimen. Refer to the radioiodine prescribing information for a list of contraindications for radioiodine.</p>
- Atc Code
- H01AB01
- Atc Item Name
- thyrotropin alfa
- Pharma Manufacturer Name
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/sanofi-aventis-singapore-pte-ltd
