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Thyrogen is a brand name for Thyrotropin Alfa. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy (THST). Low risk patients with well-differentiated thyroid…
Verbatim from this product's EMA label. Tap a section to expand.
Therapy should be supervised by physicians with expertise in thyroid cancer. 9 mg thyrotropin alfa administered at a 24-hour interval by intramuscular injection only. Paediatric population Due to a lack of data on the use of Thyrogen in children, Thyrogen should be given to children only in exceptional circumstances.
Elderly Results from controlled trials indicate no difference in the safety and efficacy of Thyrogen between adult patients less than 65 years and those greater than 65 years of age, when Thyrogen is used for diagnostic purposes. 4).
3 Patients with renal/hepatic impairment Information from post marketing surveillance, as well as published information, suggests that elimination of Thyrogen is significantly slower in dialysis-dependent end stage renal disease (ESRD) patients, resulting in prolonged elevation of thyroid stimulating hormone (TSH) levels for several days after treatment.
This may lead to increased risk of headache and nausea. There are no studies of alternative dose schedules of Thyrogen in patients with ESRD to guide dose reduction in this population. In patients with significant renal impairment the activity of radioiodine should be carefully selected by the nuclear medicine physician.
The use of Thyrogen in patients with reduced liver function does not warrant special considerations. 9 mg thyrotropin alfa) is administered by intramuscular injection to the buttock. 6. For radioiodine imaging or ablation, radioiodine administration should be given 24 hours following the final Thyrogen injection.
Diagnostic scintigraphy should be performed 48 to 72 hours following radioiodine administration, whereas post-ablation scintigraphy may be delayed additional days to allow background activity to decline. For diagnostic follow-up serum thyroglobulin (Tg) testing, the serum sample should be obtained 72 hours after the final injection of Thyrogen.
Use of Thyrogen with Tg testing in follow up of post-thyroidectomy well differentiated thyroid cancer patients should be in accordance with official guidelines.
Summary of the safety profile The most commonly reported adverse reactions are nausea and headache, occurring in approximately 11%, and 6% of patients, respectively. Tabulated list of adverse reactions The adverse reactions mentioned in the table, combine adverse reactions in the six prospective clinical trials (N=481) and undesirable effects that have been reported to Sanofi after licensure of Thyrogen.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
MedDRA System Organ Class Very Common Common Uncommon Not known Infections and infestations influenza Neoplasm benign, malignant and unspecified (incl. 9 mg has been administered in patients with presence of either partial or entire thyroid gland.
Manifestations of hypersensitivity have been reported uncommonly in both clinical and post-marketing settings. These reactions consisted of urticaria, rash, pruritus, flushing and respiratory signs and symptoms. In clinical trials involving 481 patients, no patients have developed antibodies to thyrotropin alfa either after single or repeated limited (27 patients) use of the product.
It is not recommended to perform TSH assays after Thyrogen administration. The occurrence of antibodies which could interfere with endogenous TSH assays performed during regular follow-ups cannot be excluded. Enlargement of residual thyroid tissue or metastases can occur following treatment with Thyrogen.
This may lead to acute symptoms, which depend on the anatomical location of the tissue. For example, hemiplegia, hemiparesis or loss of vision have occurred in patients with CNS metastases. Laryngeal oedema, respiratory distress requiring tracheotomy, and pain at the site of metastasis have also been reported after Thyrogen administration.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Thyrogen should not be administered intravenously. When used as an alternative to thyroid hormone withdrawal, the combination of the whole-body scintigraphy (WBS) and Tg testing after Thyrogen administration assures the highest sensitivity for detection of thyroid remnants or cancer.
False negative results may occur with Thyrogen. If a high index of suspicion for metastatic disease persists, a confirmatory withdrawal WBS and Tg testing should be considered. The presence of Tg autoantibodies can be expected in 18-40% of patients with differentiated thyroid cancer and may cause false negative serum Tg measurements.
Therefore, both TgAb and Tg assays are needed. g. valvular heart disease, cardiomyopathy, coronary artery disease, and prior or current tachyarrhythmia including atrial fibrillation) and have not undergone thyroidectomy. Thyrogen is known to cause a transient but significant rise in serum thyroid hormone concentration when given to patients who have substantial thyroid tissue still in situ.
Therefore, careful evaluation of individual risk-benefit is necessary for patients with significant residual thyroid tissue. Effect on tumour growth and/or size In patients with thyroid cancer, several cases of stimulated tumour growth have been reported during withdrawal of thyroid hormones for diagnostic procedures which have been attributed to the associated prolonged elevation of TSH levels.
There is a theoretical possibility that Thyrogen, like thyroid hormone withdrawal, may lead to stimulated tumour growth. In clinical trials with thyrotropin alfa, which produces a short-term increase in serum TSH levels, no case of tumour growth has been reported.
Due to elevation of TSH levels after Thyrogen administration patients with metastatic thyroid cancer particularly in confined spaces such as the brain, spinal cord and orbit or disease infiltrating the neck, may experience local oedema or focal haemorrhage at the site of these metastases resulting in increased tumour size.
1. 6).
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It is recommended that pre-treatment with corticosteroids be considered for patients in whom local tumour expansion may compromise vital anatomic structures. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
g. hemiplegia, hemiparesis, loss of vision have occurred in patients with CNS metastases. Laryngeal oedema, respiratory distress requiring tracheotomy, and pain at the site of metastasis have also been reported after Thyrogen administration.
It is recommended that pre-treatment with corticosteroids be considered for patients in whom local tumour expansion may compromise vital anatomic structures. e. essentially ‘sodium- free’.