Abaloparatide: clinical use

Prescribing considerations

• Confirm increased fracture risk and that the patient is within the postmenopausal licensed population.
• Assess blood pressure, cardiac status and ECG before initiation; undertake an individual benefit–risk assessment in cardiovascular disease.
• Ensure the patient or caregiver receives pen training and initial supervision.
• Review calcium and vitamin D intake and address inadequate dietary intake.
• Consider subsequent osteoporosis therapy when abaloparatide is stopped to maintain skeletal benefit.
• Use caution with active or previous urolithiasis and medicines that can worsen orthostatic hypotension or digitalis toxicity.

Contraindications and cautions

• Hypersensitivity to abaloparatide or an excipient
• Pregnancy, breastfeeding or childbearing potential
• Pre-existing hypercalcaemia
• Severe renal impairment, including end-stage renal disease
• Unexplained elevation of serum alkaline phosphatase
• Known osteosarcoma risk, including previous external-beam or implant radiation involving the skeleton
• Skeletal malignancy or bone metastases

Monitoring

• Assess blood pressure, cardiovascular status and ECG before treatment; monitor established cardiac disease for deterioration.
• If serum calcium is measured, collect the sample approximately 24 hours after the most recent injection to avoid the transient peak.
• Routine calcium monitoring is unnecessary without additional hypercalcaemia risk factors.
• Consider urinary calcium measurement where hypercalciuria or active stone disease is suspected.
• Review severe orthostatic or cardiovascular symptoms promptly and discontinue where clinically required.

Clinical pharmacology

Abaloparatide is a synthetic 34-amino-acid PTHrP analogue and PTH1-receptor agonist. It is absorbed rapidly after subcutaneous administration, broken down proteolytically into smaller peptides and cleared renally. Clinically relevant CYP inhibition or induction is not expected.

Formulation and product differences

• Eladynos is a clear, colourless solution in a multi-dose pre-filled pen.
• Needles are not included; the pen is specified for use with 8 mm, 31-gauge needles.
• Store unopened pens refrigerated and do not freeze. Once removed from refrigeration or first used, keep below 25°C and discard 30 days after first use.
• Do not store the pen with a needle attached or use cloudy, coloured or particulate solution.