PROLIA 60 mg
DENOSUMAB
What it does
Denosumab is a medication that helps strengthen bones and reduce the risk of fractures.
Commonly used for: osteoporosis (weak bones), bone loss due to cancer treatments, bone metastases (cancer spread to bones)
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Sourcing - Kenya onlyRegistration & product details
Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:13:33 · updated 2026-10-28 04:11:08
About this medicine
Denosumab is a medication that helps strengthen bones and reduce the risk of fractures.
What it treats
- osteoporosis (weak bones)
- bone loss due to cancer treatments
- bone metastases (cancer spread to bones)
How it works
Denosumab works by blocking a protein that causes bone loss, helping to keep bones strong and healthy.
Who it's for
This medication is for adults at risk of bone fractures due to osteoporosis or cancer-related bone issues.
AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.
Clinical monograph: Denosumab
BNF-referencedDenosumab is a human monoclonal antibody that targets and inhibits osteoclast formation, function, and survival, leading to decreased bone resorption. It is utilized in the management of bone metabolism disorders such as osteoporosis and certain cancers that result in bone metastases. Denosumab is administered via subcutaneous injection and has specific dosing regimens depending on the indication.
Indications
- Osteoporosis in postmenopausal women
- Osteoporosis in men at increased risk of fractures
- Bone loss associated with hormone ablation in men with prostate cancer
- Bone loss associated with long-term systemic glucocorticoid therapy
- Prevention of skeletal-related events in patients with bone metastases
- Giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity
Dosage
Children: Refer to the BNF for Children for specific dosing information.
Adults: Denosumab 60 mg every 6 months for osteoporosis, and 120 mg every 4 weeks for cancer indications, with calcium and vitamin D supplementation recommended.
Mechanism of action
Denosumab works by binding to RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand), a key factor in the formation, function, and survival of osteoclasts. By inhibiting RANKL, denosumab effectively reduces the number of osteoclasts, leading to decreased bone resorption and an overall increase in bone density.
Pharmacodynamics
Denosumab leads to an increased bone mineral density and reduced incidence of fractures in at-risk populations, particularly postmenopausal women and men undergoing hormone ablation for prostate cancer. The drug has shown efficacy in preventing skeletal-related events in patients with bone metastases.
Pharmacokinetics
Denosumab has a half-life of approximately 26 days, allowing for less frequent dosing. It is primarily eliminated through the reticuloendothelial system. The pharmacokinetic profile may be affected by factors such as renal function, with caution advised in patients with severe renal impairment.
Contra-indications
- Hypocalcaemia
- Unhealed dental or oral surgery lesions
- Dental or jaw conditions requiring surgery
Adverse effects
- Hypocalcaemia
- Osteonecrosis of the jaw (ONJ)
- Atypical femoral fractures
- Musculoskeletal pain
- Nausea
- Secondary malignancy
- Bronchospasm
- Throat swelling
Interactions
- Calcitonin (salmon)
- Other drugs affecting bone metabolism
Precautions
- Dental examination before treatment
- Maintain good oral hygiene
- Regular dental check-ups during treatment
- Monitor plasma-calcium levels, especially in patients with renal impairment
- Use the lowest effective dose for the shortest possible time
Pregnancy
Denosumab is not recommended during pregnancy due to potential adverse effects on fetal bone development.
Breast-feeding
There is insufficient data on the excretion of denosumab in human milk; caution is advised.
Storage
Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light.
Formulations
- 60 mg solution for injection in pre-filled syringe (Prolia)
- 120 mg solution for injection in pre-filled syringe (Xgeva)
AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.
This drug in other countries
The same active ingredient registered across other registries we cover - including different brands.