Formulary
Denosumab: Indications, Dosing, Side Effects and Interactions
Denosumab is a human monoclonal antibody that inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption.
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Denosumab: Indications, Dosing, Side Effects and Interactions
Denosumab is a human monoclonal antibody that inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption.
Drug action
Denosumab is a human monoclonal antibody that inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption.
Indications and dose
**Osteoporosis in postmenopausal women and in men at increased risk of fractures,Bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures,Bone loss associated with long-term systemic glucocorticoid therapy in patients at increased risk of fracture**
- **Adult** (By Subcutaneous Injection): 60 mg every 6 months, supplement with calcium and Vitamin D, to be administered into the thigh, abdomen or upper arm.
**Prevention of skeletal related events in patients with bone metastases**
- **Adult** (By Subcutaneous Injection): 120 mg every 4 weeks, supplementation of at least calcium 500 mg and Vitamin D 400 units daily should also be taken unless hypercalcaemia is present, to be administered into the thigh, abdomen or upper arm.
**Giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity**
- **Adult** (By Subcutaneous Injection): 120 mg every 4 weeks, give additional dose on days 8 and 15 of the first month of treatment only, supplementation of at least calcium 500 mg and Vitamin D 400 units daily should also be taken unless hypercalcaemia is present, to be administered into the thigh, abdomen or upper arm.
**Giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity in skeletally mature adolescents for XGEVA**
- **Child** (By subcutaneous injection): 120 mg every 4 weeks, give additional dose on days 8 and 15 of the first month of treatment only, supplementation of at least calcium 500 mg and Vitamin D 400 units daily should also be taken unless hypercalcaemia is present, to be administered into the thigh, abdomen or upper arm.
Cautions
Risk factors for osteonecrosis of the external auditory canal; risk factors for osteonecrosis of the jaw-consider temporary interruption of denosumab if occurs during treatment Cautions For Prolia When used for Osteoporosis in postmenopausal women Rebound increase in bone turnover on discontinuation (increased risk of fracture) Cautions, further information Rebound increase in bone turnover on discontinuation When used for Osteoporosis in postmenopausal women: Following discontinuation, transition to an alternative antiresorptive therapy should be considered to prevent rebound increase in bone turnover, bone loss and increased fracture risk. A
Contraindications
Contra-indications For XGEVA Unhealed lesions from dental or oral surgery
Side effects
Common or very common Abdominal discomfort; alopecia; constipation; diarrhoea; dyspnoea; hyperhidrosis; hypocalcaemia (including fatal cases); hypophosphataemia; increased risk of infection; osteonecrosis; pain; sciatica; second primary malignancy; skin reactions Uncommon Atypical femur fracture; cellulitis (seek prompt medical attention); hypercalcaemia (on discontinuation) Rare or very rare Hypersensitivity; hypersensitivity vasculitis Frequency not known Facial swelling
Interactions
**Other interactions (4):**
- In an interaction study, denosumab did not affect the pharmacokinetics of midazolam, which is metabolised by cytochrome P450 3A4 (CYP3A4).
- This indicates that denosumab should not alter the pharmacokinetics of medicinal products metabolised by CYP3A4.
- There are no clinical data on the co-administration of denosumab and hormone replacement therapy (oestrogen), however the potential for a pharmacodynamic interaction is considered to be low.
- In postmenopausal women with osteoporosis the pharmacokinetics and pharmacodynamics of denosumab were not altered by previous alendronate therapy, based on data from a transition study (alendronate...
Pregnancy
Manufacturer advises avoid-toxicity in animal studies; risk of toxicity increases with each trimester.
Breast feeding
Manufacturer advises avoid.
Renal impairment
Increased risk of hypocalcaemia if creatinine clearance less than 30 mL/minute, see Prescribing in renal impairment .
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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