somatrogon: clinical use

Prescribing considerations

• Initiation and monitoring require a clinician experienced in paediatric growth hormone deficiency.
• Assess growth plates and exclude active malignancy before treatment.
• Review previous malignancy, intracranial disease, glucose intolerance, pituitary hormone deficiencies, scoliosis and symptoms suggesting intracranial hypertension or epiphyseal disorders.
• Record product name and batch number for biological-medicine traceability.

Contraindications and cautions

• Hypersensitivity to somatrogon or an excipient
• Evidence of active tumour; intracranial tumours must be inactive and antitumour treatment completed
• Use for growth promotion after epiphyseal closure
• Acute critical illness associated with major surgery, multiple trauma, acute respiratory failure or similar complications

Monitoring

• Growth and other auxological measures, body weight and pubertal status
• IGF-1 using the product-specified post-injection sampling point
• Thyroid function, glucose metabolism and other pituitary hormones as clinically indicated
• Cortisol status in patients with, or at risk of, hypoadrenalism
• Fundoscopy and symptoms of intracranial hypertension when indicated
• Tumour recurrence or progression, scoliosis, limp and hip or knee pain

Clinical pharmacology

A recombinant glycoprotein containing the human growth hormone amino-acid sequence and C-terminal peptide domains. It activates the growth hormone receptor–STAT5b pathway, raises IGF-1 and undergoes protein catabolism.

Formulation and product differences

• The 24 mg and 60 mg presentations are multi-dose disposable pre-filled pens with different concentrations, selectable increments and delivery ranges.
• The 24 mg pen has lilac components; the 60 mg pen has blue components. Sterile pen needles are required but are not supplied.

Injection

Route: Parenteral

Strengths: 24 mg, 60 mg