romosozumab: clinical use

Prescribing considerations

• Initiate and supervise treatment through a clinician experienced in osteoporosis management.
• Balance near-term fracture risk against cardiovascular risk factors, including established cardiovascular disease, hypertension, hyperlipidaemia, diabetes, smoking, severe renal impairment and age.
• Correct hypocalcaemia before treatment and ensure adequate calcium and vitamin D intake.
• Assess osteonecrosis-of-the-jaw risk and encourage routine dental care and good oral hygiene.
• Provide the patient leaflet and alert card.

Contraindications and cautions

• Hypersensitivity to romosozumab or a listed excipient
• Hypocalcaemia
• Any history of myocardial infarction or stroke

Monitoring

• Check calcium before treatment and when symptoms suggest hypocalcaemia.
• Monitor calcium particularly closely in severe renal impairment or dialysis.
• Stop treatment if myocardial infarction or stroke occurs.
• Assess new thigh, hip or groin pain for possible atypical femoral fracture.
• Refer suspected osteonecrosis of the jaw for appropriate dental or oral-surgery assessment.

Clinical pharmacology

A humanised IgG2 monoclonal antibody that inhibits sclerostin, activating bone formation while reducing osteoclast-mediated bone resorption. It has nonlinear, target-mediated pharmacokinetics.

Formulation and product differences

• The selected product is a single-use pre-filled pen containing a clear to opalescent, colourless to light-yellow solution.
• The pen contains polysorbate 20, which can cause allergic reactions, and is essentially sodium-free.

Injection

Route: Parenteral

Strengths: 105 mg