Classes
DEA Class; Rx
Common Brand Names; Miacalcin
- Calcium Metabolism Modifiers
Description
Subcutaneously administered monoclonal antibody against human RANKL
Prolia is used for treatment of osteoporosis in men and postmenopausal women, and for osteoporosis prophylaxis in women with breast cancer and men with nonmetastatic prostate cancer
Xgeva is used for prevention of skeletal-related events due to bone metastases from solid tumors or multiple myeloma, for the treatment of refractory hypercalcemia of malignancy, and for adults and skeletally mature adolescents with giant cell tumor of bone
Severe hypocalcemia may occur in patients with severe renal impairment or with renal failure receiving dialysis
Indications
Prolia only
Indicated for postmenopausal women with osteoporosis at high risk for fracture (defined as history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy)
Indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture
Indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
Indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
Indicated for glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids equivalent to ≥7.5 mg/day of prednisone and are expected to remain on glucocorticoids for at least 6 months
Prevention of skeletal-related events (SREs; eg, bone fractures and pain) in patients with multiple myeloma and in patients with bone metastases from solid tumors
Treatment of adults and skeletally mature adolescents with giant cell tumor of bone in whom surgical resection is impossible or is likely to result in severe morbidity
Indicated for treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy
Contraindications
Hypersensitivity
Hypocalcemia
Pregnancy (Prolia only)
Adverse Effects
- Back pain (34.7%)
- Extremity pain (11.7%)
- Fatigue/asthenia (45%)
- Hypophosphatemia (32%)
- Nausea (31%)
- Dyspnea (21%)
- Diarrhea (20%)
- Hypocalcemia (18%)
- Cough (15%)
- Headache (13%)
- Musculoskeletal pain (7.6%)
- Cystitis (5.9%)
- Vertigo (5%)
- Upper respiratory tract infection (4.9%)
- Peripheral edema (4.9%)
- Sciatica (4.6%)
- Pneumonia (3.9%)
- Bone pain (3.7%)
- Upper abdominal pain (3.3%)
- Anemia (3.3%)
- Insomnia (3.2%)
- Myalgia (2.9%)
- Angina pectoris (2.6%)
- Rash (2.5%)
- Pharyngitis (2.3%)
- Asthenia (2.3%)
- Flatulence (2.2%)
- Pruritus (2.2%)
- Spinal osteoarthritis (2.1%)
- Gastroesophageal reflux disease (2.1%)
- Atrial fibrillation (2%)
- Herpes zoster (2%)
Warnings
Denosumab is available as 2 distinct brands (Prolia and Xgeva) that have different dosage strengths for their respective indications; do not use concurrently
Serious infections (including cellulitis) and dermatologic reactions (eg, dermatitis, rashes, eczema) have been reported; advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis; consider discontinuing therapy if severe symptoms develop
Hypersensitivity (including anaphylaxis) has been reported; symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus, and urticaria
Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported; discontinue use if severe symptoms develop
Atypical femoral fracture reported; risk increased with longer duration of treatment; events have occurred during and after treatment discontinued; evaluate patients with thigh or groin pain to rule out a femoral fracture
Following discontinuation of denosumab, fracture risk increases, including risk of multiple vertebral fractures
Thearpy results in significant suppression of bone turnover; cessation of therapy results in increased bone turnover above pretreatment values 9 months after last dose; bone turnover then returns to pretreatment values 24 months after last dose
Significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry; long-term consequences of the degree of suppression of bone remodeling observed may contribute to adverse outcomes such as osteonecrosis of the jaw, atypical fractures, and delayed fracture healing
Pregnancy and Lactation
Prolia: Contraindicated
There is no information regarding presence of denosumab in human milk, effects on breastfed infant, or effects on milk production
Maximum Dosage
Treatment and prevention of osteoporosis (Prolia): 60 mg/dose subcutaneously.
Prevention of skeletal-related events in patients with bone metastases from solid tumors (Xgeva): 120 mg/dose subcutaneously.
Treatment of unresectable giant cell tumor of the bone (Xgeva): 120 mg/dose subcutaneously.
Treatment and prevention of osteoporosis (Prolia): 60 mg/dose subcutaneously.
Prevention of skeletal-related events in patients with bone metastases from solid tumors (Xgeva): 120 mg/dose subcutaneously.
Treatment of unresectable giant cell tumor of the bone (Xgeva): 120 mg/dose subcutaneously.
Treatment and prevention of osteoporosis (Prolia): safety and efficacy have not been established.
Prevention of skeletal-related events in patients with bone metastases from solid tumors (Xgeva): safety and efficacy have not been established.
Treatment of unresectable giant cell tumor of the bone (Xgeva): 120 mg/dose subcutaneously (in skeletally mature adolescents only).
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Denosumab
injectable solution
- Prolia: 60mg/mL (1mL prefilled syringe or vial)
- Xgeva: 70mg/mL (120mg/1.7mL vial)
