Somapacitan

What it is used for

SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with:

• Growth failure due to inadequate secretion of endogenous growth hormone (GH).
• Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age.
• Growth failure associated with Noonan syndrome (NS).
• Idiopathic Short Stature (ISS).

SOGROYA is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD).

Side effects, and when to stop

The following clinically significant adverse drug reactions are described elsewhere in the labeling:

• Increased mortality in patients with acute critical illness
• Severe hypersensitivity
• Increased risk of neoplasms
• Glucose intolerance and diabetes mellitus
• Intracranial hypertension
• Fluid retention
• Hypoadrenalism
• Hypothyroidism
• Slipped capital femoral epiphysis in pediatric patients
• Progression of preexisting scoliosis in pediatric patients
• Pancreatitis
• Lipohypertrophy/Lipoatrophy
• Sudden death in pediatric patients with Prader-Willi syndrome

Who should not take it

SOGROYA is contraindicated in patients with:

• Acute critical illness after open-heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure because of the risk of increased mortality with use of pharmacologic doses of SOGROYA.
• Hypersensitivity to SOGROYA or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with somatropin.
• Pediatric patients with closed epiphyses.
• Active malignancy.
• Active proliferative or severe non-proliferative diabetic retinopathy.
• Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to risk of sudden death.

Other medicines and interactions

Table 7 includes a list of drugs with clinically important drug interactions when administered concomitantly with SOGROYA and instructions for preventing or managing them.

Table 7. Clinically Important Drug Interactions with SOGROYA