Section 4.8

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. 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.

4.9     Overdose

Update of sections 4.4 and 5.1 of the SmPC with long term follow-up results from studies HiLo and ESTIMABL1. Additionally, the sodium content provision wording in the Package Leaflet is aligned to the Annex to the European Commission guideline on "Excipients in the labelling and package leaflet of medicinal products for human use" (SANTE-2017-11668).

4.9     Overdose

Data on exposure above the recommended dose is limited to clinical studies and a special treatment program.  Three patients in clinical trials and one patient in the special treatment program experienced symptoms after receiving Thyrogen doses higher than those recommended. Two patients had nausea after 2.7 mg IM dose, and in one of these patients nausea was also accompanied by weakness, dizziness and headache.  The third patient experienced nausea, vomiting and hot flushes after 3.6 mg IM dose.  In the special treatment program, a 77 year-old patient with metastatic thyroid cancer who had not been thyroidectomised received 4 doses of Thyrogen 0.9 mg over 6 days, developed atrial fibrillation, cardiac decompensation and terminal myocardial infarction 2 days later. 

One additional patient enrolled in a clinical trial experienced symptoms after receiving Thyrogen intravenously.  This patient received 0.3 mg of Thyrogen as a single intravenous (IV) bolus and, 15 minutes later experienced severe nausea, vomiting, diaphoresis, hypotension and tachycardia.

A suggested treatment in case of overdose would be the reestablishment of fluid balance and administration of an antiemetic may also be considered.

Section 4.8: To amend the frequencies of paraesthesia and diarrhoea (from common to uncommon adverse reactions) and to add influenza, ageusia, dysgeusia and neck pain as uncommon adverse reactions.

Section 4.2, 4.4, 4.7, 4.8, 5.1, 6.2, 6.4, 6.5 and 6.6: Minor editorial updates to reflect the preferred terms according to the most recent MedDRA version (SmPC template).

In section 4.1 - Therapeutic indications, the remnant ablation indication has been updated to include a range of 30-100 mCi radioiodine as opposed to the fixed dose of 100 mCi as follows: 

"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"