A new treatment option is available to facilitate prevent bone loss and fractures in at-risk individuals, with healthcare providers advised to monitor calcium levels and dental health in patients receiving the therapy.
Indications
Jubbonti is indicated for the treatment of osteoporosis in women after menopause and in men with a high risk of fractures. In postmenopausal women, it significantly reduces the likelihood of vertebral, non-vertebral, and hip fractures.
The treatment is also approved for addressing bone loss linked to hormone-blocking therapy in men with prostate cancer who are at increased fracture risk, significantly lowering the risk of vertebral fractures in this population. Jubbonti is indicated for bone loss associated with long-term systemic glucocorticoid treatment in adults at high risk of fractures.
How it Works
Denosumab, the active ingredient in Jubbonti, is a human monoclonal antibody of the IgG2 type. It targets the receptor activator of nuclear factor-κB ligand (RANKL), a transmembrane protein. By specifically and strongly binding to RANKL, it inhibits the formation, function, and survival of osteoclasts, thereby reducing bone resorption in cortical and trabecular bone.
Dosage
The recommended dosage is 60 mg administered as a single dose every six months via subcutaneous injection in the thigh, abdomen, or upper arm.
Contraindications
- Hypersensitivity to the active substance or any of the excipients.
- Hypocalcemia.
Pregnancy and Breastfeeding
Jubbonti is not recommended during pregnancy or in women of childbearing potential not using contraception. Women should be advised not to become pregnant during treatment and for at least five months afterward. If breastfeeding, the decision to continue or discontinue treatment should be based on an assessment of the benefit/risk ratio for the mother, and child.
Side Effects
The most common side effects include urinary tract infections and upper respiratory tract infections, sciatica, constipation, abdominal discomfort, rash, eczema, alopecia, and musculoskeletal and limb pain.
Drug Interactions
Denosumab is not expected to alter the pharmacokinetics of drugs metabolized by cytochrome P450 (CYP) 3A4. The likelihood of a pharmacodynamic interaction when co-administered with hormone replacement therapy (estrogens) is considered low.
Special Monitoring
Any hypocalcemia should be corrected with appropriate calcium and vitamin D supplementation before starting treatment. Clinical monitoring of calcium levels is recommended before each administration and, in patients predisposed to hypocalcemia, during the two weeks following the initial dose.
A dental examination, including preventive care and an individual benefit/risk assessment, is recommended before initiating denosumab treatment in patients with risk factors for developing osteonecrosis of the jaw.
The possibility of osteonecrosis of the external auditory canal should be considered in individuals presenting with auditory symptoms, including chronic ear infections.
Storage
Store in a refrigerator between 32°F and 46°F (2°C and 8°C). Do not freeze. Keep the container in the outer packaging protected from light.
Inform the Patient
- Patients should have adequate calcium and vitamin D intake.
- Inform them of the need to promptly consult a doctor if signs or symptoms of skin infections (primarily cellulitis) appear.
- Encourage them to maintain good oral hygiene, undergo regular check-ups, and immediately report any oral symptoms such as tooth mobility, pain or swelling, non-healing ulcers, or discharge during treatment.
- During treatment, patients should be informed that any new or unusual pain in the thigh, hip, or groin should be reported due to the risk of atypical femoral fracture.
HAS Opinion
The level of medical service benefit (SMR) of Prolia is applicable to Jubbonti.
Dispensing
Schedule I controlled substance.
Technical Sheet
Jubbonti 60 mg (denosumab), injectable solution, 1 ml (60 mg/ml) in a pre-filled syringe, $103.48, CIP: 34009 303 058 6 7.
Schedule I, SS reimbursement at 65%.
Prices are listed excluding dispensing fees.
Sandoz: +1 49 64 48 00
