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Thyrogen

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Thyrogen

INDICATIONS

Adjunctive Diagnostic Tool For Serum Thyroglobulin Testing In Well Differentiated Thyroid Cancer

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].
  • 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]. Therefore, in such cases, even with a negative or low-stage THYROGEN radioiodine scan, consideration should be given to further evaluating patients.

Adjunct To Treatment For Ablation In Well Differentiated Thyroid Cancer

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.

DOSAGE AND ADMINISTRATION

Recommended Dosage

THYROGEN 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].

Routine measurement of serum TSH levels is not recommended after THYROGEN use.

Reconstitution, Preparation, and Administration of THYROGEN

The 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.

Timing Of Serum Thyroglobulin Testing Following THYROGEN Administration

For serum thyroglobulin testing, the serum sample should be obtained 72 hours after the final injection of THYROGEN [see Clinical Studies].

Timing For Remnant Ablation And Diagnostic Scanning Following THYROGEN Administration

Oral 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.

HOW SUPPLIED

Dosage Forms And Strengths

THYROGEN is a lyophilized powder containing 1.1 mg of thyrotropin alfa for single use after reconstitution with Sterile Water for Injection.

Supplied as:

  • Two vial kit (two vials of lyophilized thyrotropin alfa)
  • Four vial kit (two vials of lyophilized thyrotropin alfa) and two vials of 10 mL vials of Sterile Water for Injection).

Storage And Handling

THYROGEN (thyrotropin alfa for injection) is supplied as a sterile, nonpyrogenic, lyophilized product. It is available either in a two-vial kit or a four-vial kit. The two-vial kit contains two 1.1 mg vials of THYROGEN. The four-vial kit contains two 1.1 mg vials of THYROGEN, as well as two 10 mL vials of Sterile Water for Injection, USP.

NDC 58468-1849-4 (4-vial kit)
NDC 58468-0030-2 (2-vial kit)

THYROGEN is for intramuscular injection to the buttock. The lyophilized powder should be reconstituted immediately prior to use with 1.2 mL of Sterile Water for Injection, USP [see DOSAGE AND ADMINISTRATION]. Each vial of THYROGEN and each vial of diluent, if provided, is intended for single use.

THYROGEN should be stored at 2-8°C (36-46°F).

If necessary, the reconstituted solution can be stored for up to 24 hours at a temperature between 2°C and 8°C, while avoiding microbial contamination.

Protect from light.

Manufactured and distributed by: Genzyme Corporation 500 Kendall Street Cambridge, MA 02142. Revised: March 2014

Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.

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