Sogroya

HOS-099091 · has-adverse-reaction-information · PDF-Seite 9

Summary of safety profile The commonly most frequently reported adverse drug reactions (ADRs) are (in decreasing order [paediatric GHD, adult GHD]) headache (12%, 12%), pain in extremity (9%, NA), hypothyroidism (5%, 2%), injection site reactions (5%, 1%), peripheral oedema (3%, 4%), arthralgia (2%, 7%), hyperglycaemia (2%, 1%), fatigue (2%, 6%) and adrenocortical insufficiency (1.5%, 3%). Tabulated list of adverse reactions The ADRs listed in Table 2 are based on the safety data from one ongoing pivotal phase 3 trial (52 weeks) in paediatric patients with GHD (baseline age: 2.5 to 11 years) and adverse reactions from somapacitan treatment. The frequencies of the ADRs have been calculated based on the frequencies in the pivotal phase 3 trial. The adverse reactions listed in Table 3 are based on the compiled safety data from three completed phase 3 trials in adult patients with GHD (baseline age: 19 to 77 years). The ADRs are listed by MedDRA system organ class and frequency category defined 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). 9 Table 2: Adverse reactions from phase 3 clinical trial in paediatric GHD MedDRA system organ class Very common Common Endocrine disorders Hypothyroidism* Adrenocortical insufficiency Metabolism and nutrition Hyperglycaemia disorders Nervous system disorders Headache* Musculo-skeletal and connective Arthralgia tissue disorders Pain in extremity** General disorders and Peripheral oedema* administration site conditions Injection site reactions*# Fatigue *In general, these adverse reactions were non-serious, of mild severity and transient # The injection site reactions included injection site bruising (1.5%), injection site pain (1.5%), injection site haematoma (1.5%), and injection site swelling (0.8%). **Primarily mild leg pain Table 3: Adverse reactions from th

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HOS-099087 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Somapacitan must not be used when there is any evidence of activity of a tumour. Intracranial tumours must be inactive and antitumour therapy must be completed prior to starting somapacitan therapy. Treatment should be discontinued if there is evidence of tumour growth, see section 4.4. Somapacitan must not be used for longitudinal growth promotion in children with closed epiphyses, see section 4.2. 5 Patients with acute critical illness suffering from complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions must not be treated with somapacitan (regarding patients undergoing substitution therapy, see section 4.4).

HOS-099086 · has-indication-information · PDF-Seite 2

Sogroya is indicated for the replacement of endogenous growth hormone (GH) in children aged 3 years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric GHD), and in adults with growth hormone deficiency (adult GHD).

HOS-099089 · has-interaction-information · PDF-Seite 8

Cytochrome P450 metabolised drugs Data from an interaction study performed in growth hormone deficient adults suggests that growth hormone administration may increase the clearance of compounds known to be metabolised by cytochrome P450 isoenzymes. The clearance of compounds metabolised by cytochrome P450 (e.g. sex steroids, corticosteroids, anticonvulsants and cyclosporine) may be especially increased resulting in lower plasma levels of these compounds. The clinical significance of this is unknown. Glucocorticoids 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. Oral oestrogens In females on oral oestrogen therapy, a higher dose of somapacitan may be required to achieve the treatment goal, see sections 4.2 and 4.4. Antihyperglycaemic products Antihyperglycaemic treatment including insulin may require dose adjustment in case of somapacitan co-administration since somapacitan may decrease insulin sensitivity, see sections 4.4 and 4.8. Other The metabolic effects of somapacitan can also be influenced by concomitant therapy with other hormones, e.g. testosterone and thyroid hormones, see section 4.4.

HOS-099090 · has-pregnancy-information · PDF-Seite 8

Pregnancy There are no data from the use of somapacitan in pregnant women. Studies in animal have shown reproductive toxicity, see section 5.3. Sogroya is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding It is unknown whether somapacitan/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of somapacitan in milk, see section 5.3. A risk to the breastfed newborns/infants cannot be excluded. 8 A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Sogroya therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility There is no clinical experience with somapacitan use and its potential effect on fertility. No adverse effects were observed on male and female fertility in rats,see section 5.3.

HOS-099088 · has-warning-information · PDF-Seite 6

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. Adrenocortical insufficiency Introduction of growth hormone treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. In patients treated with growth hormone, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of growth hormone treatment. It is necessary to monitor patients with known hypoadrenalism for reduced serum cortisol levels and/or for the need of increased doses of glucocorticoid, see section 4.5. Glucose metabolism impairment Treatment with growth hormone may decrease insulin sensitivity, particularly at higher doses in susceptible patients and consequently hyperglycaemia may occur in subjects with inadequate insulin secretory capacity. As a result, previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked during growth hormone treatment. Therefore, glucose levels should be monitored periodically in all patients treated with growth hormone, especially in those with risk factors for diabetes mellitus, such as obesity, or a family history of diabetes mellitus. Patients with pre-existing type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely during growth hormone therapy. The doses of antihyperglycaemic medicinal products may require adjustment when growth hormone therapy is instituted in these patients. Neoplasms There is no evidence for increased risk of new primary cancers in patients treated with growth hormone. In patients in complete remission from malignant diseases or who have been treated for benign tumours, growth hormone therapy has not been associated with an increased relapse rate. Patients who have achieved complete remission of malignant diseases or who have been treated for benign tumours should be followed closely for relapse after commencement of growth hormone therapy. Growth hormone treatment should be interrupted in case of any development or reoccurrence of malignant or benign tumour. An overall slight increase in second neoplasms has been observed in childhood cancer survivors treated with growth h

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