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Denosumab
Generic name: denosumab
Brand names: Prolia, Xgeva, Aukelso, Bomyntra, Boncresa, Bosaya, Conexxence, Degevma, Enoby, Jubbonti, Jubereq, Osenvelt, Ospomyv, Osvyrti, Oziltus, Stoboclo, Wyost, Xbryk, Xtrenbo
What is denosumab?
Denosumab is a human monoclonal antibody that works by inhibiting RANKL (receptor activator of nuclear factor kappa-B ligand), a protein essential for osteoclasts' formation, function, and survival.
- By inhibiting RANKL, denosumab decreases bone resorption and increases bone mass and strength.
In the United States, denosumab is marketed under the following brand names and biosimilars:
- Prolia (biosimilars Bildyos, Boncresa, Bosaya, Conexxence, Enoby, Jubbonti, Ospomyv, Osvyrti, Stoboclo, and Ponlimsi) for osteoporosis-related conditions
- Xgeva (biosimilars Aukelso, Bilprevda, Bomyntra, Degevma, Jubereq, Osenvelt, Oziltus, Wyost, Xbryk, and Xtrenbo) for the prevention of skeletal-related events due to certain cancers, or as a second-line treatment for hypercalcemia of malignancy.
There are currently 10 biosimilars to Prolia:
- Jubbonti (denosumab-bbdz), an interchangeable biosimilar manufactured by Sandoz Inc. (FDA approval March 5, 2024).
- Ospomyv (denosumab-dssb), an interchangeable biosimilar manufactured by Samsung Bioepis (FDA approval February 16, 2025)
- Stoboclo (denosumab-bmwo), an interchangeable biosimilar manufactured by Celltrion (FDA approval February 28, 2025)
- Conexxence (denosumab-bnht), an interchangeable biosimilar manufactured by Fresenius Kabi (FDA approval March 25, 2025)
- Bildyos (denosumab-nxxp), an interchangeable biosimilar manufactured by Shanghai Henlius Biotech, Inc., for Organon LLC (FDA approval August 29, 2025)
- Bosaya (denosumab-kyqq), an interchangeable biosimilar manufactured by Biocon Biologics Ltd. (FDA approval September 16, 2025)
- Enoby (denosumab-qbde), an interchangeable biosimilar manufactured by Hikma Pharmaceuticals USA Inc. (FDA approval September 26, 2025)
- Osvyrti (denosumab-desu), an interchangeable biosimilar manufactured by Accord BioPharma (FDA approval November 20, 2025)
- Boncresa (denosumab-mobz), a biosimilar manufactured by Amneal Pharmaceuticals LLC (FDA approval December 19, 2025).
- Ponlimsi (denosumab-adet), a biosimilar manufactured by Teva Pharmaceuticals Inc (FDA approved March 30, 2026).
FDA-Approved Indications for Prolia and its biosimilars
- Postmenopausal Osteoporosis: Treatment of postmenopausal women with osteoporosis at high risk for fracture
- Male Osteoporosis: Treatment of men with osteoporosis at high risk for fracture
- Glucocorticoid-Induced Osteoporosis: Treatment of men and women at high risk of fracture who are receiving systemic glucocorticoids
- Bone Loss in Hormone Ablation Therapy: Treatment of men receiving androgen deprivation therapy for nonmetastatic prostate cancer Treatment of women receiving adjuvant aromatase inhibitor therapy for breast cancer.
Dosage for Prolia
Standard Dosage: 60 mg administered as a subcutaneous injection once every 6 months.
Administration: Given by a healthcare professional in the upper arm, upper thigh, or abdomen.
Common Side Effects of Prolia
- Back pain
- Pain in extremities
- Musculoskeletal pain
- Hypercholesterolemia
- Cystitis.
Serious Side Effects of Prolia
- Hypocalcemia (low blood calcium)
- Serious infections
- Dermatologic reactions (dermatitis, rashes, eczema)
- Osteonecrosis of the jaw (ONJ)
- Atypical femoral fractures
- Multiple vertebral fractures following discontinuation
- Suppression of bone turnover
- Serious allergic reactions.
There are currently 10 biosimilars to Xgeva:
- Wyost (denosumab-bbdz), an interchangeable biosimilar manufactured by Sandoz Inc. (FDA approval March 5, 2024)
- Xbryk (denosumab-dssb), an interchangeable biosimilar manufactured by Samsung Bioepis (FDA approval February 16, 2025)
- Osenvelt (denosumab-bmwo), an interchangeable biosimilar manufactured by Celltrion (FDA approval February 28, 2025)
- Bomyntra (denosumab-bnht), an interchangeable biosimilar manufactured by Fresenius Kabi (FDA approval March 25, 2025)
- Bilprevda (denosumab-nxxp), an interchangeable biosimilar manufactured by Shanghai Henlius Biotech, Inc., for Organon LLC (FDA approval August 29, 2025)
- Aukelso (denosumab-kyqq), and an interchangeable biosimilar manufactured by Biocon Biologics Ltd. (FDA approval September 16, 2025)
- Xtrenbo (denosumab-qbde), an interchangeable biosimilar manufactured by Hikma Pharmaceuticals USA Inc. (FDA approval September 26, 2025)
- Jubereq (denosumab-desu), an interchangeable biosimilar manufactured by Accord BioPharma (FDA approval November 20, 2025)
- Oziltus (denosumab-mobz), a biosimilar manufactured by Amneal Pharmaceuticals LLC (FDA approval December 19, 2025)
- Degevma (denosumab-adet), manufactured by Teva Pharmaceuticals, Inc. (FDA approval September 25, 2026).
FDA-Approved Indications for Xgeva and its biosimilars
- Prevention of Skeletal-Related Events: In patients with multiple myeloma and in patients with bone metastases from solid tumors
- Giant Cell Tumor of Bone: Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity
- Hypercalcemia of Malignancy: Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Dosage for Xgeva and its biosimilars
For Prevention of Skeletal-Related Events: 120 mg administered as a subcutaneous injection every 4 weeks for patients with multiple myeloma or bone metastases from solid tumors
For Giant Cell Tumor of Bone: 120 mg administered as a subcutaneous injection every 4 weeks, with additional 120 mg doses on days 8 and 15 of the first month of therapy
For Hypercalcemia of Malignancy: 120 mg administered as a subcutaneous injection every 4 weeks, with additional 120 mg doses on days 8 and 15 of the first month of therapy.
Common Side Effects of Xgeva
- Fatigue/lack of energy
- Low phosphate levels
- Nausea
- Joint pain
- Headache.
Serious Side Effects of Xgeva
- Low calcium levels (more common and potentially more severe than with Prolia)
- Osteonecrosis of the jaw (more frequent than with Prolia)
- Stress fractures in the femur bone
- Harm to an unborn baby
- Increased risk of a new cancer(in patients with multiple myeloma).
- Increased risk of broken bones in the spine (multiple vertebral fractures) after stopping treatment
- High calcium levels (hypercalcemia) after stopping treatment in patients with giant cell tumor of bone or growing skeletons
- Serious allergic reactions
Warnings for denosumab
Prolia, Xgeva, and their biosimilars carry a boxed warning for life-threatening severe hypocalcemia (very low calcium levels) in patients with advanced chronic kidney disease (CKD), particularly those on dialysis. Xgeva and its biosimilars also carry a warning for this risk.
- The risk is even greater in those patients with CKD who also have a condition known as mineral and bone disorder (CKD-MBD).
- Your healthcare provider will evaluate you for CKD-MBD before starting treatment, and monitor you throughout.
Pre-Treatment Assessments
- Calcium Levels: Hypocalcemia must be corrected before initiating therapy
- Renal Function: Patients with severe renal impairment or receiving dialysis are at greater risk for hypocalcemia
- Dental Examination: A comprehensive dental exam is recommended before starting therapy, especially for patients with risk factors for ONJ
- Vitamin D Status: Assessment and correction of vitamin D deficiency
- Pregnancy Testing: For women of childbearing potential.
Calcium: All patients should take calcium supplements
- Prolia and biosimilar patients: 1000 mg of calcium daily
- Xgeva and biosimilar patients: 500 mg of calcium daily (or as directed by healthcare provider).
Vitamin D: All patients should take vitamin D supplements
- Recommended daily intake: 400-800 IU for most patients
- Higher doses may be needed for patients with a deficiency.
- Low calcium levels (hypocalcemia): Denosumab is contraindicated in patients with pre-existing hypocalcemia
- Pregnancy: Prolia and its biosimilars are contraindicated during pregnancy
- Hypersensitivity: Known hypersensitivity to denosumab or any of its excipients.
Pediatric Patients:
- Prolia and its biosimilars are not approved for pediatric patients. Serious high calcium levels (hypercalcemia) have been reported in children with osteogenesis imperfecta treated with denosumab.
- Xgeva and its biosimilars are only approved for skeletally mature adolescents with giant cell tumor of bone.
Elderly Patients:
- No dosage adjustment required based on age
- Higher incidence of certain adverse reactions may occur.
Renal Impairment:
- No dosage adjustment necessary
- Greater risk for hypocalcemia; monitoring required.
Hepatic Impairment:
- No studies conducted
- Unlikely to require dose adjustment as denosumab is a monoclonal antibody not cleared by hepatic mechanisms.
Calcium Levels:
- For Prolia and biosimilars: Monitor calcium before each dose and within 2 weeks after the initial dose in patients at risk for hypocalcemia
- For Xgeva and biosimilars: Monitor calcium prior to initial dose, within the first week, and for hypocalcemia symptoms throughout therapy.
Dental Health:
- Regular dental checkups
- Maintain good oral hygiene
- Report any dental symptoms promptly.
Bone Turnover Markers:
- May be monitored in some patients to assess treatment response.
Adverse Reactions:
Monitor for signs of infection, dermatological reactions, and musculoskeletal pain.
Prolia and Biosimilars:
- Increased risk of vertebral fractures, often multiple, following discontinuation
- Consider alternative therapy if Prolia is discontinued
- No established recommendations for a drug holiday (unlike bisphosphonates).
Transition Between Therapies:
Specific protocols may be needed when transitioning from or to other osteoporosis medications.
Drug Interactions
- Limited drug interactions due to the monoclonal antibody nature of denosumab
- No formal drug interaction studies have been conducted
- Caution with immunosuppressants due to the potential increased risk of infection
- Patients receiving one denosumab product should not receive other denosumab products at the same time
- Taking calcimimetic drugs at the same time can worsen the risk of low calcium levels.
Hypocalcemia Risk:
- Importance of calcium and vitamin D supplementation
- Symptoms to watch for (muscle spasms, twitches, cramps, numbness or tingling).
Osteonecrosis of the Jaw Prevention:
- Maintain good oral hygiene
- Schedule routine dental exams
- Inform your dentist about denosumab treatment
- Avoid invasive dental procedures if possible.
Atypical Fracture Awareness:
- Report new or unusual thigh, hip, or groin pain.
Infection Risk:
Seek prompt medical attention for signs of infection (fever, chills, severe abdominal pain, skin issues).
Pregnancy Considerations:
- Avoid pregnancy during treatment
- Use effective birth control while using denosumab and for 5 months after your last dose
- Report suspected pregnancy immediately.
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for denosumab.
Prolia (denosumab) - Amgen Inc.
| Formulation type | Strength |
|---|---|
| Pre-Filled Syringe | 60 mg/mL |
| Single-Dose Vial | 60 mg/mL Discontinued |
View Prolia information in detail.
Xgeva (denosumab) - Amgen Inc.
| Formulation type | Strength |
|---|---|
| Single-Dose Vial | 120 mg/1.7 mL (70 mg/mL) |
View Xgeva information in detail.
Prolia, Xgeva interchangeable products
Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.
Pharmacy laws for biosimilar prescribing may vary by state.
Aukelso (denosumab-kyqq) - Biocon Biologics Inc.
| Formulation type | Strength |
|---|---|
| Single-Dose Vial | 120 mg/1.7 mL (70 mg/mL) |
View Aukelso information in detail.
Bildyos (denosumab-nxxp) - Shanghai Henlius Biotech, Inc.
| Formulation type | Strength |
|---|---|
| Pre-Filled Syringe | 60 mg/mL |
| Single-Dose Vial | 60 mg/mL |
View Bildyos information in detail.
Bilprevda (denosumab-nxxp) - Shanghai Henlius Biotech, Inc.
| Formulation type | Strength |
|---|---|
| Single-Dose Vial | 120 mg/1.7 mL (70 mg/mL) |
View Bilprevda information in detail.
Bomyntra (denosumab-bnht) - Fresenius Kabi USA, LLC
| Formulation type | Strength |
|---|---|
| Pre-Filled Syringe | 120 mg/1.7 mL (70 mg/mL) |
| Single-Dose Vial | 120 mg/1.7 mL (70 mg/mL) |
View Bomyntra information in detail.
Boncresa (denosumab-mobz) - Amneal Pharmaceuticals LLC
| Formulation type | Strength |
|---|---|
| Pre-Filled Syringe | 60 mg/mL |
View Boncresa information in detail.
Bosaya (denosumab-kyqq) - Biocon Biologics Inc.
| Formulation type | Strength |
|---|---|
| Pre-Filled Syringe | 60 mg/mL |
View Bosaya information in detail.
Conexxence (denosumab-bnht) - Fresenius Kabi USA, LLC
| Formulation type | Strength |
|---|---|
| Pre-Filled Syringe | 60 mg/mL |
View Conexxence information in detail.
Degevma (denosumab-adet) - Teva Pharmaceuticals, Inc.
| Formulation type | Strength |
|---|---|
| Single-Dose Vial | 120 mg/1.7 mL (70 mg/mL) |
Degevma
Enoby (denosumab-qbde) - Hikma Pharmaceuticals USA Inc.
| Formulation type | Strength |
|---|---|
| Pre-Filled Syringe | 60 mg/mL |
View Enoby information in detail.
Jubbonti (denosumab-bbdz) - Sandoz Inc.
| Formulation type | Strength |
|---|---|
| Pre-Filled Syringe | 60 mg/mL |
View Jubbonti information in detail.
Jubereq (denosumab-desu) - Accord BioPharma Inc.
| Formulation type | Strength |
|---|---|
| Single-Dose Vial | 120 mg/1.7 mL (70 mg/mL) |
View Jubereq information in detail.
Osenvelt (denosumab-bmwo) - CELLTRION, Inc.
| Formulation type | Strength |
|---|---|
| Single-Dose Vial | 120 mg/1.7 mL (70 mg/mL) |
View Osenvelt information in detail.
Ospomyv (denosumab-dssb) - Samsung Bioepis Co., Ltd.
| Formulation type | Strength |
|---|---|
| Pre-Filled Syringe | 60 mg/mL |
View Ospomyv information in detail.
Osvyrti (denosumab-desu) - Accord BioPharma Inc.
| Formulation type | Strength |
|---|---|
| Pre-Filled Syringe | 60 mg/mL |
View Osvyrti information in detail.
Oziltus (denosumab-mobz) - Amneal Pharmaceuticals LLC
| Formulation type | Strength |
|---|---|
| Single-Dose Vial | 120 mg/1.7 mL (70 mg/mL) |
View Oziltus information in detail.
Ponlimsi (denosumab-adet) - Teva Pharmaceuticals, Inc.
| Formulation type | Strength |
|---|---|
| Pre-Filled Syringe | 60 mg/mL |
Ponlimsi
Stoboclo (denosumab-bmwo) - CELLTRION, Inc.
| Formulation type | Strength |
|---|---|
| Pre-Filled Syringe | 60 mg/mL |
View Stoboclo information in detail.
Wyost (denosumab-bbdz) - Sandoz Inc.
| Formulation type | Strength |
|---|---|
| Single-Dose Vial | 120 mg/1.7 mL (70 mg/mL) |
View Wyost information in detail.
Xbryk (denosumab-dssb) - Samsung Bioepis Co., Ltd.
| Formulation type | Strength |
|---|---|
| Single-Dose Vial | 120 mg/1.7 mL (70 mg/mL) |
Xbryk
Xtrenbo (denosumab-qbde) - Hikma Pharmaceuticals USA Inc.
| Formulation type | Strength |
|---|---|
| Single-Dose Vial | 120 mg/1.7 mL (70 mg/mL) |
View Xtrenbo information in detail.
Common questions about denosumab
How long should you take Xgeva for?
Is Xgeva a chemotherapy drug?
Does Xgeva cause bone pain?
Does Xgeva cause low blood pressure?
Related medicines
Content is provided for education and is not medical advice. See our medical disclaimer. Source page medically reviewed by Carmen Pope, Senior Medical Editor, B. Pharm on September 30, 2026.