Dosage

Jubbonti® is given as a single 60mg subcutaneous injection once every 6 months. Discontinuation requires transitioning to an alternative antiresorptive therapy.

Required Supplementation

Patients should take 1,000 mg of calcium daily and at least 400 IU of vitamin D throughout treatment to reduce the risk of hypocalcemia (low blood calcium).

Warnings

• Hypocalcemia (low blood calcium): risk is elevated in patients with kidney disease, including those on dialysis. A boxed warning applies to patients with advanced chronic kidney disease under the REMS program
• Osteonecrosis of the jaw (bone damage in the jaw, typically associated with dental procedures)
• Atypical femoral fractures: evaluate any new thigh or groin pain promptly
• Severe musculoskeletal (bone, muscle, and joint) pain: may require discontinuation if symptoms become severe
• Not approved for patients under 18 years of age
• Pregnancy testing is required before each administration in females of reproductive potential

• Treatment of postmenopausal women with osteoporosis at high risk for fracture
• Increasing bone mass in men with osteoporosis at high risk for fracture
• Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
• Increasing bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
• Increasing bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

Product Specifications

• Sterile, preservative-free, clear solution
• Colorless to slightly yellowish or slightly brownish in appearance
• pH approximately 5.2
• Single-use 1 mL pre-filled syringe
• Contains sorbitol; note additive exposure in patients using other sorbitol- or fructose-containing products

Contraindications

• Uncorrected hypocalcemia (low blood calcium that has not been treated)
• Known hypersensitivity to denosumab or any formulation ingredient
• Pregnancy: Jubbonti can cause fetal harm; pregnancy testing is required before administration

Special Populations

No dose adjustment is needed for elderly patients or those with kidney impairment, though calcium levels should be monitored closely. Jubbonti is not approved for patients under 18.

1. Perform blood tests before the first injection and periodically during treatment to monitor calcium levels
2. Administer one 60mg dose every 6 months via subcutaneous injection (under the skin) into the upper arm, upper thigh, or abdomen; provide the package leaflet and patient reminder card at each visit
3. Must be administered by a trained healthcare professional only
4. Permanently discontinue treatment if a hypersensitivity reaction occurs