somapacitan: clinical use

Prescribing considerations

• Confirm growth hormone deficiency and use specialist initiation and monitoring.
• Assess previous or current neoplasia, diabetes risk, adrenal reserve, thyroid function and oral-oestrogen use.
• Record product name and batch number for biological-medicine traceability.
• Use caution in severe hepatic impairment; clinical experience is limited in older adults and with prolonged adult treatment.
• Investigate persistent hip or knee pain or limping in growing patients and unexplained severe abdominal pain.

Contraindications and cautions

• Hypersensitivity to somapacitan or an excipient.
• Any evidence of active tumour; intracranial tumours must be inactive and antitumour treatment complete.
• Promotion of longitudinal growth after epiphyseal closure.
• Acute critical illness associated with major surgery, multiple trauma, acute respiratory failure or similar complications.

Monitoring

• IGF-I alongside clinical response and adverse effects.
• Growth, pubertal status and relevant auxology in children and adolescents.
• Glucose, lipid profile, thyroid function and adrenal status.
• Body composition and body mass index in adults where clinically appropriate.
• Tumour recurrence in patients with relevant history; symptoms of intracranial hypertension.
• Injection sites and adherence; consider anti-somapacitan antibody testing if response is unexpectedly poor.

Clinical pharmacology

Somapacitan is a 191-amino-acid recombinant human growth hormone derivative with an albumin-binding side chain. Reversible albumin binding delays elimination; effects are mediated through growth hormone receptors and tissue IGF-I production.

Formulation and product differences

• The selected presentation is a clear to slightly opalescent, colourless to slightly yellow solution in a multidose disposable pre-filled pen.
• The selected pen has a rubine-red dose button and requires separately supplied compatible disposable needles.
• The pen must not be refilled, shared or stored with a needle attached.

Injection

Route: Parenteral

Strengths: 10 mg/1.5 mL, 15 mg/1.5 mL