Indications and clinical use:

Sogroya^® (somapacitan injection) is indicated for:

• the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency (GHD))
• the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (AGHD)

Pediatric:

The efficacy and safety of Sogroya^® in pediatric patients aged 2.5 years to 11 years with growth failure due to growth hormone deficiency have been established in clinical trials. The efficacy and safety of Sogroya^® have not been established in patients under 2.5 years of age. Data on the efficacy and safety of Sogroya^® in patients 12 to under 18 years of age are limited. Pediatric patients with a history or presence of malignancy, including intracranial tumours, were not studied in clinical trials.

Geriatric:

Elderly patients may be more sensitive to the action of somapacitan, and therefore may be at increased risk for adverse reactions. Initiate Sogroya^® with a dose of 1 mg once weekly and use smaller increments when increasing the dose.

Contraindications:

• Neoplastic activity 
• Children with closed epiphyses
• Adults with acute critical illness suffering from complications 
• Hypersensitivity 
• Pediatric patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment

Relevant warnings and precautions:

• Increased mortality in patients with acute critical illness
• Use in patients with Prader-Willi syndrome not studied
• Discontinue if evidence of active malignancy
• Risk of second neoplasm
• Risk of malignancy during treatment
• Fluid retention (edema) usually transient and dose-dependent
• Monitor for reduced serum cortisol levels and/or need for glucocorticoid dose increases in patients with hypoadrenalism
• Monitor for impaired glucose tolerance and diabetes mellitus
• Monitoring for hypothyroidism
• Consider pancreatitis in patients who develop persistent severe abdominal pain
• Injection site should be rotated to reduce risk of lipohypertrophy
• Risk of serious systemic hypersensitivity
• Risk of epiphyseal disorders
• Risk of scoliosis progression
• Monitor for benign intracranial hypertension
• Use in pregnant and breast-feeding women not studied
• Lower doses may be necessary in older patients due to potential increased risk of adverse reactions

For more information:

Please consult the Product Monograph here for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece.