Denosumab is a fully human monoclonal antibody (IgG2) that binds with high affinity and specificity to RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand), a key mediator of osteoclast formation, function, and survival. By inhibiting RANKL, denosumab prevents osteoclast-mediated bone resorption, leading to increased bone mineral density (BMD) and reduced fracture risk. The 60mg dose is specifically indicated for the treatment of postmenopausal osteoporosis in women at high risk for fracture.
Adult: 60 mg administered as a single subcutaneous injection once every 6 months.
Note: Administer by subcutaneous injection in the upper arm, upper thigh, or abdomen. Allow the prefilled syringe to reach room temperature (15-25°C) for 15-30 minutes prior to injection. Do not shake. Inspect for particulate matter and discoloration. Inject slowly. Proper aseptic technique is mandatory. Must be administered by a healthcare professional. Patient must receive adequate calcium and vitamin D supplementation.
Denosumab is a human monoclonal antibody that mimics the action of endogenous osteoprotegerin (OPG). It binds with high affinity to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts. By binding RANKL, denosumab prevents its interaction with the RANK receptor on osteoclast precursors and mature osteoclasts. This inhibition disrupts osteoclastogenesis, decreases osteoclast activity, and reduces osteoclast survival, leading to a profound decrease in bone resorption.
Pregnancy: Category X. Denosumab may cause fetal harm based on mechanism of action and animal data showing increased fetal ossification defects and postnatal mortality. Contraindicated in pregnancy. Exclude pregnancy before starting. Advise women of childbearing potential to use effective contraception during and for at least 5 months after the last dose.
Driving: Denosumab is not expected to affect the ability to drive or use machines. However, dizziness or symptomatic hypocalcemia (if it occurs) could impair these abilities.
| Calcium/Vitamin D Supplements | Concomitant use is REQUIRED to prevent hypocalcemia. Not an adverse interaction. | Essential Coadministration |
| Loop Diuretics (e.g., Furosemide) | May exacerbate urinary calcium excretion, increasing risk of hypocalcemia. Monitor serum calcium closely. | Major |
| Aminoglycosides | May potentiate hypocalcemic effect. Use with caution and monitor calcium. | Moderate |
| Bisphosphonates (e.g., Alendronate, Zoledronic acid) | Concurrent use not recommended. No additive benefit and may increase risk of ONJ and atypical fractures. | Major |
| Immunosuppressants (e.g., TNF inhibitors, corticosteroids) | May increase risk of serious infections. Clinical monitoring advised. | Moderate |
Same composition (Denosumab (60mg)), different brands: