RANK Ligand Inhibitor (Anti-resorptive) Pregnancy: Not recommended for use in pregnant women or in women of child-bearing potential not using contraception; women should be advised not to become pregnant during and for at least 5 months after treatment. It is unknown whether denosumab is excreted in human milk - a decision on whether to abstain from breast-feeding or from therapy should weigh the benefit of breast-feeding against the benefit of therapy. No human fertility data. US labelling: contraindicated in pregnancy; pregnancy testing should be performed in females of reproductive potential prior to initiation.

Denosumab

Brand names: Prolia (osteoporosis 60mg), Xgeva (oncology 120mg)

Used in: Osteoporosis

Denosumab is a monoclonal antibody given by subcutaneous injection (typically every 6 months) to treat osteoporosis and reduce fracture risk; higher-dose regimens are used in cancer-related bone disease.

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 denosumab as a single subcutaneous injection

Route: Subcutaneous injection into the thigh, abdomen or upper arm

Frequency: Once every 6 months

UK SPC source is Prolia 60 mg solution for injection in pre-filled syringe (osteoporosis indication) §4.2 - other denosumab products/indications were not fetched and may carry a different posology; confirm the product before publishing. Patients must be adequately supplemented with calcium and vitamin D (§4.4). 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. Elderly (age >= 65): no dose adjustment required. Hepatic impairment: safety and efficacy have not been studied. Administration should be performed by an individual adequately trained in injection techniques. PAEDIATRIC: Prolia should not be used in children aged < 18 years because of safety concerns of serious hypercalcaemia and potential inhibition of bone growth and lack of tooth eruption; no paediatric dose is given. US labelling cross-check (Stoboclo, CELLTRION, DailyMed 2026-02-05) gives the same 60 mg subcutaneously once every 6 months in the upper arm, upper thigh or abdomen, and adds: pregnancy must be ruled out prior to administration; all patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily; in advanced chronic kidney disease (eGFR < 30 mL/min/1.73 m2, including dialysis) evaluate for chronic kidney disease mineral and bone disorder before treatment decisions; if a dose is missed, administer as soon as the patient is available and then schedule injections every 6 months from the date of the last injection.

Dose adjustments

Renal

No dose adjustment is required in patients with renal impairment (§4.2), but see §4.4 for calcium monitoring. No data are available in patients on long-term systemic glucocorticoid therapy with severe renal impairment (GFR < 30 mL/min). §4.4: patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia, with severe and fatal cases reported; adequate calcium and vitamin D intake and regular calcium monitoring are especially important.

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.

US labelling (FDA)

Reference — US labelling, may differ from UK

Pregnancy must be ruled out prior to administration of Stoboclo. ( 2.1 ) Before initiating Stoboclo in patients with advanced chronic kidney disease, including dialysis patients, evaluate for the presence of chronic kidney disease mineral and bone disorder with intact parathyroid hormone, serum calcium, 25(OH) vitamin D, and 1,25(OH) 2 vitamin D. ( 2.2 , 5.1 , 8.6 ) Stoboclo should be administered by a healthcare provider. ( 2.3 ) Administer 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen. ( 2.3 ) Instruct patients to take calcium 1000 mg daily and at least 400 IU vitamin D daily. ( 2.3 ) 2.1 Pregnancy Testing Prior to Initiation of Stoboclo …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2026-02-05. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Hypocalcaemia
US labelling additionally contraindicates use in pregnant women (denosumab products may cause fetal harm) and in patients with a history of systemic hypersensitivity to any component

Side effects

Musculoskeletal pain and pain in extremity (very common)
Urinary tract infection and upper respiratory tract infection (common); cellulitis, diverticulitis and ear infection (uncommon)
Constipation and abdominal discomfort (common); sciatica (common)
Rash, eczema and alopecia (common); lichenoid drug eruptions (uncommon); hypersensitivity vasculitis (very rare)
Hypocalcaemia, drug hypersensitivity and anaphylactic reaction (rare) - severe symptomatic hypocalcaemia including life-threatening and fatal cases reported post-marketing
Osteonecrosis of the jaw and atypical femoral fractures (rare); osteonecrosis of the external auditory canal (not known)
Injection site reactions including injection site pain (uncommon)

Clinical monograph

How it works

It binds RANK ligand, inhibiting osteoclast formation and activity and so reducing bone resorption.

Prescribing in practice

Correct hypocalcaemia and ensure adequate calcium and vitamin D before and during treatment — check calcium before each dose, especially in renal impairment.
Stopping or delaying doses without follow-on bone therapy risks a rebound in bone turnover and multiple vertebral fractures — doses must be given on time and not simply stopped.
Osteonecrosis of the jaw and atypical femoral fractures can occur; a dental check before starting is advised.

Monitoring

Check calcium (and vitamin D) before each dose; plan continuation/transition therapy if it is to be stopped; review dental health.

Counselling the patient

It is an injection roughly every six months — keep to the schedule and do not stop without a plan.
Take your calcium and vitamin D as advised.
Report new thigh/groin pain or dental problems, or symptoms of low calcium (tingling, muscle cramps).

Evidence & guidelines

Recommended for osteoporosis fracture prevention (NICE TA204), with important cautions on hypocalcaemia and rebound fractures if stopped.

Reference: NICE TA204; FREEDOM Trial (NEJM 2009); 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