FDA approved Conexxence (denosumab) for Osteoporosis and Bone Loss IndicationsFDA approved Conexxence, a Twice-Yearly Shot for Weak Bones

Conexxence is a RANK ligand (RANKL) inhibitor. Denosumab binds to RANKL, preventing interaction with RANK on osteoclasts, thereby inhibiting osteoclast formation, function, and survival, which reduces bone resorption and increases bone mass.

Conexxence is indicated for: - Treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or failure/intolerance to other osteoporosis therapies. - Treatment to increase bone mass in men with osteoporosis at high risk for fracture. - Treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are initiating or continuing systemic glucocorticoids at a daily dose equivalent to ≥7.5 mg prednisone and expected to remain on glucocorticoids for at least 6 months. - Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. - Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Pregnancy must be ruled out prior to administration. The recommended dose is 60 mg administered as a single subcutaneous injection every 6 months in the upper arm, upper thigh, or abdomen. Conexxence should be administered by a healthcare provider. All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily. If a dose is missed, administer as soon as possible, then schedule subsequent injections every 6 months from the date of the last injection. Prior to administration, the prefilled syringe may be brought to room temperature (up to 25°C/77°F) by standing in the original container for 15 to 30 minutes; do not warm in any other way. Do not shake. Inspect visually for particulate matter and discoloration; do not use if discolored, cloudy, or contains particles.

Trial data not available in label.

Contraindications: Not reported in label. Warnings and precautions: The label includes warnings regarding the risk of chronic kidney disease mineral and bone disorder (CKD-MBD) in patients with advanced chronic kidney disease (eGFR <30 mL/min/1.73 m2), including dialysis patients. Evaluate for CKD-MBD with intact parathyroid hormone, serum calcium, 25(OH) vitamin D, and 1,25(OH)2 vitamin D prior to initiating treatment. Consider assessing bone turnover status. Based on animal findings, denosumab products can cause fetal harm when administered to pregnant women; pregnancy must be ruled out prior to administration. Other warnings and precautions are not detailed in the provided label text.

Conexxence provides an additional denosumab product for the treatment of osteoporosis and bone loss in the specified high-risk populations. Denosumab is a RANKL inhibitor that reduces bone resorption and has been shown to reduce fracture incidence in postmenopausal women with osteoporosis and vertebral fractures in men receiving androgen deprivation therapy. The label does not provide clinical trial data for Conexxence; clinicians should refer to the full prescribing information for complete safety and efficacy information.