Thyrogen 0.9 mg Powder for Solution for Injection

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Thyrotropin alfa

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

H01AB01

Dosage:

1.1 mg

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

Thyrotropin alfa 1.1 mg

Administration route:

INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Genzyme Corporation

Authorization status:

ACTIVE

Authorization date:

2005-12-27

Patient Information leaflet

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DESCRIPTION
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 tech nology. 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 thyroid-
stimulating hormone.
Both thyrotropin alfa and naturally occurring human pituitary thyroid-stimulating hormone
are synthesized as a mixture of glycosylation variants. Unlike pituitary TSH, which is
of the study, which was the success of ablation, was assessed 8 months later by a
Thyrogen-stimulated radioiodine scan. Patients were considered successfully ablated if
there was no visible thyroid bed uptake on the scan, or if visible, uptake was < 0.1%.
Success of ablation was also measured using two additional criteria: a Thyrogen-stimulated
serum Tg of < 2 ng/mL (in patients with no or only low levels of anti-Tg antibodies) and no
visible thyroid bed uptake on the radioiodine scan.  
The following table summarizes the results of this evaluation:
1
60 per protocol patients with interpretable scan data.
2 
Analysis limited to patients without anti-Tg antibodies at screening. 
3
95% CI for difference in ablation rates, rhTSH minus THW, = -6.9% to 27.1%. 
4
Interpretation by 2 of 3 reviewers. 
5
95% CI for difference in ablation rates, rhTSH minus THW, = -30.5% to 9.1%.
Abbreviations: Fol = Follicular, Pap = Pa

Summary of Product characteristics

SG/THY/0721/CCDSv1
Thyrogen
®
Thyrotropin Alpha for Injection
INDICATIONS AND USAGE

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.
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 Wa