Index of drugs

It is indicated for use in the determination of thyroglobulin (Tg) in blood serum with or without imaging after radioiodine to detect residual thyroid tissue and highly differentiated thyroid cancer in patients with thyroidectomies undergoing hormonal suppression (THST). Low-risk patients with highly differentiated thyroid cancer with undetectable thyroglobulin concentrations (Tg) in serum after using THST as well as no stimulated by rh TSH increase in Tg concentration can be controlled by determination of thyroglobulin concentration (Tg) stimulated by rh TSH. The product is indicated in combination with 100 mCi (3.7 GBq) of radioiodine in stimulation before treatment to destroy residual thyroid tissue in patients who have undergone almost total or complete thyroidectomy due to well-differentiated thyroid cancer without evidence of distant metastatic thyroid cancer .

1 vial contains 0.9 mg of thyrotropin alfa.

Thyrotropin alfa (recombinant human thyrotropin hormone) is a heterodimeric glycoprotein consisting of two non-covalently linked subunits. Biochemical properties are comparable to the human thyrotropin hormone (TSH). The binding of thyrotropin alfa to the TSH receptors on thyroid epithelial cells stimulates Iodine uptake, its conversion and the synthesis and release of thyroglobulin, triiodothyronine (T₃) and thyroxine (T.₄). In patients with highly differentiated thyroid cancer, almost complete or complete thyroidectomy is performed. In order to stimulate radioiodine uptake and / or thyroglobulin release for optimal recognition of thyroid or cancer residues by imaging with radioiodine or thyroglobulin and for radioiodine adjuvant therapy, high levels of TSH in serum are required. The standard procedure leading to increased levels of TSH consists in discontinuing suppression of thyroid hormones (THST) in patients, which usually leads to the appearance of signs and symptoms of hypothyroidism. Using the preparation, the TSH stimulation necessary for the radioiodine uptake and thyroglobulin release in the euthyreosis state is achieved while maintaining THST, which avoids adverse effects resulting from hypothyroidism. T_0,5 elimination of the drug is 22 ± 9 hours. The route of elimination of thyrotropin alfa from the body are mainly kidneys and to a lesser extent the liver.

Hypersensitivity to bovine or human thyrotropin hormone or to any of the excipients. Pregnancy and breastfeeding.

The combination of whole body scintigraphy and Tg determination after administration of the preparation used as an alternative to thyroid hormone withdrawal provides the highest sensitivity in tissue detection and thyroid cancer. False negative results can be obtained after using the preparation. In the case of a high probability of metastases, confirmation of whole body scintigraphy (WBS) and determination of Tg after discontinuation should be considered. In 18-40% of patients with differentiated thyroid cancer, autoantibodies against Tg may be formed, which may result in false negative Tg serum results. Therefore, the concentration of anti-Tg antibodies (TgAb) and thyroglobulin (Tg) should be determined at the same time. A thorough assessment of the benefit and risk of the medicine should be performed in elderly patients at risk of heart disease (eg valvular disease, cardiomyopathy, coronary heart disease and current or present tachyarrhythmia, including atrial fibrillation) who have not had thyroidectomy. The drug causes a transient but significant increase in serum thyroid hormone after administration to patients who still have a significant proportion of thyroid tissuein situtherefore care should be taken in patients with significant residual thyroid tissue. The efficacy of rhTSH in the ablative treatment of residual thyroid tissue in combination with low doses of radioiodine has not been proven. Theoretically, the preparation may lead to tumor growth.In patients with local tumor growth that may affect life-important organs, it is recommended to consider premedication with corticosteroids. In patients with end-stage renal failure requiring dialysis, the elimination of the preparation is significantly slowed down, resulting in prolonged elevated TSH levels for several days after discontinuation of treatment, which may lead to an increased risk of headache and nausea (no alternative dosing regimens). The preparation contains less than 1 mmol (23 mg) of sodium per injection, thus it is considered to be "sodium-free".

The preparation is contraindicated during pregnancy. The preparation should not be used during breastfeeding.

Very often: nausea. Common: dizziness, headache, paresthesia; vomiting, diarrhea, fatigue, weakness. Uncommon: hot feeling; urticaria, rash; flu-like symptoms, fever, chills, back pain. Not known: tumor edema, metastatic pain; trembling; palpitations; sudden redness especially of the face; dyspnoea; pruritus, excessive sweating; painful joints, muscle pain; discomfort, pain, pruritus, rash and urticaria at the site of intramuscular injection; reduction of TSH. After treatment with the preparation, the remaining thyroid tissue or metastases may be enlarged. In addition, laryngeal edema and respiratory failure requiring tracheotomy were observed. In patients with some or all of the thyroid gland, very rare cases of hyperthyroidism or atrial fibrillation were observed.

Treatment should be supervised by doctors with expertise in the treatment of thyroid cancer.
The recommended dosage schedule includes two doses of thyritropin alfa 0.9 mg given in 24-hour intervals only as intramuscular injections (the preparation must not be administered intravenously). After dissolving the medicinal product in water for injection, 1.0 ml of the solution (0.9 mg thyrotropin alfa) is injected by intramuscular injection into the buttock. For radioiodine imaging or ablation, the radioiodine should be administered 24 h after the last injection of the preparation. Diagnostic scintigraphy should be performed from 48 to 72 h after administration of radio Iodine, whereas scintigraphy after ablation can be postponed for a few days so that the background activity decreases. In order to check the diagnostic determination of thyroglobulin concentration (Tg) in blood serum, a blood sample should be taken 72 h after the last injection of the preparation. No dose adjustment is required in elderly patients. In patients with significant renal impairment, radioiodine activity should be carefully selected by a specialist in nuclear medicine.
The use of the preparation in the control of thyroglobulin (Tg) after thyroidectomy in patients with highly differentiated thyroid cancer should be carried out in accordance with official recommendations.