mecasermin: clinical use

Prescribing considerations

• Confirm severe primary IGF-1 deficiency and exclude secondary causes before treatment.
• Use only under an experienced paediatric growth-disorder specialist.
• It is not a substitute for growth hormone and is unsuitable when epiphyses are closed.
• Pay particular attention to previous hypoglycaemia, inconsistent food intake, or limited renal or hepatic data.
• Record product name and batch number for biological-medicine traceability.

Contraindications and cautions

• Hypersensitivity to mecasermin or an excipient
• Active or suspected neoplasia
• Any condition or history that increases benign or malignant neoplasia risk
• Premature babies and neonates, because the formulation contains benzyl alcohol

Monitoring

• Blood glucose when treatment starts and when hypoglycaemic symptoms occur
• Growth response and IGF-1 as clinically indicated
• Fundoscopy at baseline, periodically, and if symptoms suggest intracranial hypertension
• Echocardiography before treatment, with further assessment for abnormal findings or cardiovascular symptoms
• Tonsillar or adenoidal enlargement, snoring, sleep apnoea and middle-ear complications
• Limp, hip or knee pain, scoliosis progression and other consequences of rapid growth
• Symptoms or signs of benign or malignant neoplasia

Clinical pharmacology

Mecasermin is recombinant human IGF-1. Activation of the type-1 IGF-1 receptor promotes signalling involved in linear growth, cell proliferation and tissue growth; insulin-like metabolic activity can suppress hepatic glucose production and increase peripheral glucose use.

Formulation and product differences

• The selected product is a multidose solution for subcutaneous injection.
• It contains benzyl alcohol as a preservative and is essentially sodium-free.
• It requires refrigerated storage, must not be frozen, and should be protected from light.
• It must not be mixed with other medicinal products.

Injection

Route: Parenteral

Strengths: 10 mg/mL