n attributed to the associated prolonged elevation of thyroid stimulating hormone (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, 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 pretreatment with corticosteroids be considered for patients in whom local tumour expansion may compromise vital anatomic structures.
Important information about some of the ingredients of Thyrogen
This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially 'sodium- free'.
4.5 Interaction with other medicinal products and other forms of interaction
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.
4.6 Fertility, pregnancy and lactation
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.
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.
4.7 Effects on ability to drive and use machinesNo studies on the effects on the ability to drive and use machines have been performed.
Thyrogen may reduce the ability to drive or use machines, since dizziness and headaches have been reported.
4.8 Undesirable effects
Tabulated list of adverse reactions
The most commonly reported adverse reactions are nausea and headache, occurring in approximately 12%, and 7% of patients, respectively.
The adverse reactions mentioned in the table, comb |
