Thyrogen 0.9 mg powder for solution for injection
- Name:
Thyrogen 0.9 mg powder for solution for injection
- Company:
Sanofi Genzyme
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/02/21
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Sanofi Genzyme
Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 12 February 2021 PIL
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 2 December 2020 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 2 December 2020 PIL
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
Updated on 6 July 2020 PIL
Reasons for updating
- XPIL Removed
Updated on 25 March 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 10 March 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 11 October 2019 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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
Updated on 11 October 2019 PIL
Reasons for updating
- Joint PIL superseded by individual PILs
Updated on 4 July 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 4 July 2019 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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).
Updated on 14 January 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 7 January 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Updated on 7 January 2019 SPC
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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.
Updated on 17 July 2018 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 1 March 2018 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 1 March 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 5 February 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 30 June 2016 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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).
Updated on 30 June 2016 PIL
Reasons for updating
- Change to side-effects
- Addition of information on reporting a side effect.
Updated on 30 June 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 7 October 2014 PIL
Reasons for updating
- Change to further information section
Updated on 8 March 2013 PIL
Reasons for updating
- Change to date of revision
Updated on 7 March 2013 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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"
Updated on 29 May 2012 PIL
Reasons for updating
- Removal/change of distributor
Updated on 21 September 2011 PIL
Reasons for updating
- Change to date of revision
Updated on 20 September 2011 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Statement added:“Very rare cases of stroke have been reported from world-wide post marketing experience in female patients. The relationship to Thyrogen administration is unknown”.
Updated on 31 August 2010 PIL
Reasons for updating
- Change to further information section
Updated on 29 April 2010 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 28 April 2010 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)