THYROGEN- thyrotropin alfa injection, powder, lyophilized, for solution THYROGEN- thyrotropin alfa kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

THYROTROPIN ALFA (UNII: AVX3D5A4LM) (THYROTROPIN ALFA - UNII:AVX3D5A4LM)

Available from:

Genzyme Corporation

INN (International Name):

THYROTROPIN ALFA

Composition:

THYROTROPIN ALFA 0.9 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 w

Product summary:

THYROGEN (thyrotropin alfa) for injection is as a sterile white to off-white lyophilized powder in a single-dose vial. Each carton (NDC 58468-0030-2) contains two 0.9 mg single-dose vials of THYROGEN (NDC 58468-0030-1). Store THYROGEN refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

THYROGEN- THYROTROPIN ALFA INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
THYROGEN- THYROTROPIN ALFA
GENZYME CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
THYROGEN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR THYROGEN.
THYROGEN (THYROTROPIN ALFA) FOR INJECTION, FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
THYROGEN is a thyroid stimulating hormone indicated for:
ADJUNCTIVE DIAGNOSTIC TOOL FOR WELL-DIFFERENTIATED THYROID CANCER:
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. (1.1)
Limitations of Use:
THYROGEN-stimulated Tg levels are generally lower than, and do not
correlate with Tg levels after
thyroid hormone withdrawal.
Even when THYROGEN-Tg testing is performed in combination with
radioiodine imaging, there
remains a risk of missing a diagnosis of thyroid cancer or
underestimating the extent of the disease.
Anti-Tg Antibodies may confound the Tg assay and render Tg levels
uninterpretable.
ADJUNCT FOR THYROID REMNANT ABLATION IN WELL-DIFFERENTIATED THYROID
CANCER: 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. (1.2)
Limitations of Use:
The effect of THYROGEN on thyroid cancer recurrence greater than 5
years post-remnant ablation
has not been evaluated.
DOSAGE AND ADMINISTRATION
THYROGEN should be used by physicians knowledgeable in the management
of patients with thyroid
cancer. (2.1)
A two-injection regimen is recommended: THYROGEN 0.9 mg is
administered intramuscularly, followed
by a second 0.9 mg intramuscular injection 24 hours later. (2.1)
DOSAGE FORMS AND STRENGTHS
For injection: 0.9 mg of thyrotropin alfa