Interactions : אינטראקציות

4.5   Interaction with other medicinal products and other forms of interaction

No interactions studies in paediatrics have been performed.

Glucocorticoids
Concomitant treatment with glucocorticoids may inhibit the growth-promoting effects of somatrogon.
Patients with adrenocorticotropic hormone (ACTH) deficiency should have their glucocorticoid replacement therapy carefully adjusted to avoid any inhibitory effect on growth. Therefore, patients treated with glucocorticoids should have their growth monitored carefully to assess the potential impact of glucocorticoid treatment on growth.

Growth hormone decreases the conversion of cortisone to cortisol and may unmask previously undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective (see section 4.4).

Insulin and hypoglycaemic medicinal products

In patients with diabetes mellitus requiring medicinal product therapy, the dose of insulin and/or oral/injectable hypoglycaemic medicinal products may require adjustment when somatrogon therapy is initiated (see section 4.4).

Thyroid medicinal products

Treatment with daily growth hormone may unmask previously undiagnosed or subclinical central hypothyroidism. Thyroxine replacement therapy may need to be initiated or adjusted (see section 4.4).

Oral oestrogen therapy

In female patients on oral oestrogen-containing therapy, a higher dose of somatrogon may be required to achieve the treatment goal (see section 4.4).

Cytochrome P450 metabolised products

Drug-drug interaction studies have not been performed with somatrogon. Somatrogon has been shown to induce CYP3A4 mRNA expression in vitro. The clinical significance of this is unknown. Studies with other human growth hormone (hGH) receptor agonists performed in growth hormone deficient children and adults, and healthy elderly men, suggest that administration may increase the clearance of compounds known to be metabolised by cytochrome P450 isoenzymes, especially CYP3A. The clearance of compounds metabolised by CYP3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and ciclosporin) may be increased and could result in lower exposure of these compounds.