RANKL Inhibitor — Monoclonal Antibody Pregnancy: Not recommended for use in pregnant women and in women of child-bearing potential not using contraception. There are no or limited data from use in pregnant women; animal studies have shown reproductive toxicity. Women should be advised not to become pregnant during, and for at least 5 months after, treatment. Effects are likely to be greater during the second and third trimesters as monoclonal antibodies cross the placenta increasingly as pregnancy progresses. It is unknown whether denosumab is excreted in human milk; a decision on whether to abstain from breast-feeding or from therapy should take account of the benefit of each.

Denosumab (Rheumatology — Osteoporosis)

Brand names: Prolia, Xgeva

This is denosumab used in rheumatology for osteoporosis — a subcutaneous monoclonal antibody given twice yearly to reduce fracture risk in postmenopausal women and others at high risk.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 60 mg

Route: Subcutaneous injection into the thigh, abdomen or upper arm; administration should be performed by an individual who has been adequately trained in injection techniques

Frequency: A single injection once every 6 months

Fetched UK SPC: Acvybra 60 mg solution for injection in pre-filled syringe (eMC product 101736) — this is the 60 mg six-monthly osteoporosis presentation, not the 120 mg oncology presentation. Patients must be adequately supplemented with calcium and vitamin D. Patients should be given the package leaflet and the patient reminder card. The optimal total duration of antiresorptive treatment for osteoporosis (including both denosumab and bisphosphonates) has not been established; the need for continued treatment should be re-evaluated periodically on an individual patient basis, particularly after 5 or more years of use. No dose adjustment is required in elderly patients (aged 65 and over). Safety and efficacy have not been studied in patients with hepatic impairment. Paediatric (no per-kg dose is stated, so paedDose is null): the SPC states Acvybra should not be used in children aged under 18 years because of safety concerns of serious hypercalcaemia, and potential inhibition of bone growth and lack of tooth eruption; data for children aged 2 to 17 years are described in §5.1 and §5.2 but no paediatric posology is given. Verify any under-18 use against a children's formulary. Neither the fetched eMC bundle (§4.5 not retrieved) nor the fetched US label (Stoboclo, Celltrion USA, label date 2026-02-05) contains a drug interactions section, so no interactions are listed below.

Dose adjustments

Renal

No dose adjustment is required in patients with renal impairment (see §4.4 for recommendations relating to monitoring of calcium). No data are available in patients on long-term systemic glucocorticoid therapy with severe renal impairment (GFR less than 30 mL/min).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Hypocalcaemia

Side effects

Pain in extremity and musculoskeletal pain (very common)
Urinary tract infection and upper respiratory tract infection (common); cellulitis, diverticulitis and ear infection (uncommon)
Rash, eczema and alopecia (common); lichenoid drug eruptions (uncommon)
Constipation and abdominal discomfort (common); sciatica (common)
Hypocalcaemia, drug hypersensitivity and anaphylactic reaction (rare)
Osteonecrosis of the jaw and atypical femoral fractures (rare); osteonecrosis of the external auditory canal (not known)

Clinical monograph

How it works

It binds and neutralises RANK ligand, preventing osteoclast formation and activity and thereby reducing bone resorption and increasing bone mineral density.

Prescribing in practice

Stopping treatment causes rapid loss of bone density and a rebound risk of multiple vertebral fractures, so doses must be given on time and alternative therapy planned if it is discontinued.
Correct hypocalcaemia before each dose and ensure adequate calcium and vitamin D intake, with caution in significant renal impairment.
Counsel on osteonecrosis of the jaw and atypical femoral fracture; for the osteoporosis indication use the lower-strength product per the SPC.

Monitoring

Check calcium before each injection, particularly in renal impairment, and review dental health and adherence to the dosing schedule.

Counselling the patient

Do not delay or stop injections without discussing follow-on treatment.
Take calcium and vitamin D as advised and report jaw pain or thigh pain.
Maintain good dental hygiene and report mouth problems.

Evidence & guidelines

Fracture-risk reduction in postmenopausal osteoporosis is demonstrated by a large randomised controlled trial.

Reference: FREEDOM Trial (NEJM 2009); MHRA DSU 2020 (hypocalcaemia); NICE TA204; NOGG Osteoporosis Guidelines; SPC Prolia; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways