Thyrogen · 4.3 Contraindications · 1

HOS-083798 · has-adverse-reaction-information · PDF-Seite 5

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 Very Common Uncommon Not known Organ Class Common Infections and influenza infestations Neoplasm benign, neoplasm swelling, malignant and metastatic pain unspecified (incl. cysts and polyps) Nervous system dizziness, headache ageusia, stroke, tremor disorders dysgeusia, paraesthesia Cardiac disorders palpitations Vascular disorders flushing Respiratory, dyspnoea thoracic and mediastinal disorder Gastrointestinal nausea vomiting diarrhoea disorders Skin and urticaria, rash pruritus, subcutaneous hyperhidrosis tissue disorders Musculoskeletal neck pain, back arthralgia, myalgia and connective pain tissue disorder 5  MedDRA System Very Common Uncommon Not known Organ Class Common General disorders fati

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HOS-083794 · has-contraindication-information · PDF-Seite 3

• Hypersensitivity to bovine or human thyroid stimulating hormone or to any of the excipients listed in section 6.1. • Pregnancy (see section 4.6).

HOS-083793 · has-indication-information · PDF-Seite 2

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 carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rhTSH-stimulated Tg levels. Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for 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 (see section 4.4).

HOS-083796 · has-interaction-information · PDF-Seite 4

Formal interaction studies between Thyrogen and other medicinal products have not been performed. In clinical trials, no interactions were observed between Thyrogen and the thyroid hormones triiodothyronine (T3) and thyroxine (T4) when administered concurrently. The use of Thyrogen allows for radioiodine imaging while patients are euthyroid on thyroid hormone suppression treatment. Data on radioiodine kinetics indicate that the clearance of radioiodine is approximately 50% greater while euthyroid than during the hypothyroid state when renal function is decreased, thus resulting in less radioiodine retention in the body at the time of imaging. This factor should be considered when selecting the activity of radioiodine for use in radioiodine imaging.

HOS-083797 · has-pregnancy-information · PDF-Seite 4

Pregnancy Animal reproduction studies have not been conducted with Thyrogen. It is not known whether Thyrogen can cause foetal harm when administered to a pregnant woman or whether Thyrogen can affect reproductive capacity. Thyrogen in combination with diagnostic radioiodine whole body scintigraphy is contra-indicated in pregnancy (see section 4.3), because of the consequent exposure of the foetus to a high dose of radioactive material. 4 Breast-feeding It is unknown whether thyrotropin alfa /metabolites are excreted in human milk. A risk to the suckling child cannot be excluded. Thyrogen should not be used during breast-feeding. Fertility It is not known whether Thyrogen can affect fertility in humans.

HOS-083795 · has-warning-information · PDF-Seite 3

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. 3 Careful evaluation of benefit-risk relationships should be assessed for Thyrogen administration in high- risk elderly patients who have heart disease (e.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. This may lead to acute symptoms, which depend on the anatomical location of the tissue e.g. hemiplegia, he

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