denosumab at a glance
Medicine class
Human monoclonal antibody and antiresorptive treatment
How it is given
Injection under the skin by a trained person; some formulations must be administered by a healthcare professional
Important safety checks
Calcium status, kidney-related hypocalcaemia risk and dental health need consideration
Stopping treatment
Osteoporosis treatment should not be stopped or delayed without clinical review because spinal-fracture risk can increase
What is denosumab used for?
Different formulations have distinct licensed uses:
Osteoporosis in postmenopausal women and men at increased fracture risk.
Bone loss in adults receiving long-term systemic glucocorticoids who are at increased fracture risk.
Bone loss associated with hormone-ablation treatment for prostate cancer in men at increased fracture risk.
Prevention of pathological fractures and other skeletal complications in adults with advanced malignancy involving bone.
Giant cell tumour of bone in adults and skeletally mature adolescents when it cannot be resected or surgery is likely to cause severe morbidity.
How does denosumab work?
Denosumab binds RANK ligand and prevents it from activating RANK on osteoclasts and their precursor cells. This reduces osteoclast formation, activity and survival, slowing bone breakdown.
denosumab preparations and strengths
Injection
Route: Parenteral
Strengths: 60 mg, 60 mg/mL, 120 mg
How to take denosumab
Denosumab is injected under the skin of the thigh, abdomen or upper arm. The vial must be administered by a healthcare professional; a trained patient or carer may administer the pre-filled syringe if the clinical team considers this suitable.
Follow the product-specific training and instructions supplied by the clinical team.
Do not shake the syringe or vial.
Do not use the solution if it is cloudy, discoloured or contains particles.
Take prescribed calcium and vitamin D unless advised otherwise; supplementation may be inappropriate if calcium is already high.
Maintain good oral hygiene, attend routine dental care and tell the dentist about denosumab treatment.
denosumab side effects
Common or expected effects
- Muscle, joint, bone or limb pain
- Constipation or abdominal discomfort
- Rash or eczema
- Upper respiratory or urinary tract infection with the osteoporosis formulation
- Diarrhoea or shortness of breath with the cancer and giant-cell-tumour formulation
- Low calcium or phosphate levels, particularly with the cancer and giant-cell-tumour formulation
Get urgent medical advice
- Severe hypocalcaemia: spasms, twitching, tingling, confusion, seizures or loss of consciousness
- Serious allergic reaction: wheezing, breathing difficulty, facial or throat swelling, widespread hives or collapse
- Osteonecrosis of the jaw: persistent jaw pain, swelling, loose teeth, discharge or a mouth sore that does not heal
- Atypical thigh-bone fracture: new or unusual thigh, hip or groin pain
- Cellulitis: a hot, swollen, tender red area of skin, sometimes with fever
- Possible ear-canal osteonecrosis: persistent ear pain, discharge or recurrent infection
denosumab in pregnancy
Denosumab is not recommended during pregnancy because human evidence is limited and animal studies found reproductive toxicity. People who could become pregnant should use effective contraception during treatment and for at least five months afterwards, and contact their specialist promptly if pregnancy occurs or is planned.
denosumab while breastfeeding
It is unknown whether denosumab enters human milk, and a risk to the infant cannot be excluded. The prescriber and patient should decide whether to avoid breastfeeding or denosumab after weighing breastfeeding against the clinical need for treatment.
denosumab interactions
Duplicate bone-resorption treatment and medicines that increase hypocalcaemia or jaw-necrosis risk require attention.
Other denosumab-containing products
Do not use concurrently because this duplicates the same active treatment.
Bisphosphonates
The cancer and giant-cell-tumour formulation should not be given concurrently with a bisphosphonate.
Systemic corticosteroids
They may add to hypocalcaemia and osteonecrosis-of-the-jaw risk, so stronger risk assessment and monitoring may be needed.
Common questions about denosumab
Answers are fully visible for fast scanning and source review.
Is denosumab a bisphosphonate?
No. It is a monoclonal antibody that blocks RANKL. Both treatments reduce bone breakdown but work differently.
Why are calcium and vitamin D important?
Denosumab can lower blood calcium. Adequate calcium and vitamin D reduce this risk, although supplementation must be reviewed if calcium is already high.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.