Denosumab
Pronunciation: (eks-JEE-vuh).
- Generic name
- denosumab
- Brand names
- Denomac, Xgeva, Prolia, Denub
- Drug class
- Monoclonal antibody; RANK ligand (RANKL) inhibitor; Bone-modifying agent
Availability and supply rules vary by country
Trade names by country: United States · Canada
Australia: · Full directory
What denosumab is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how denosumab works
Denosumab, the active ingredient in Xgeva, is a fully human monoclonal antibody that binds to and inhibits RANK ligand (RANKL), a key mediator of osteoclast formation, function, and survival. By blocking RANKL, denosumab prevents osteoclast-mediated bone resorption, thereby reducing bone destruction and skeletal-related events in patients with bone metastases. (1)
What denosumab is used for
Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors
Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors (1)
Treatment of giant cell tumor of bone in adults and adolescents with mature skeletons
Treatment of giant cell tumor of bone in adults and adolescents with mature skeletons (1)
Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy
Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy (1)
Before taking denosumab
Do not take / not appropriate for
- pre-existing hypocalcemia and known hypersensitivity to denosumab. (Contraindication) (1)
Tell your clinician about
(1)How to take denosumab
- General Instructions: Xgeva is administered as a subcutaneous injection by a healthcare professional, usually every 4 weeks.. Adult Dosing: The recommended dose is 120 mg injected under the skin every 4 weeks. For giant cell tumor of bone, additional doses may be given on days 8 and 15 of the first month.. Pediatric Dosing: Safety and effectiveness in children and adolescents have not been established, except for certain cases of giant cell tumor of bone in skeletally mature adolescents.. Administration: Xgeva is injected under the skin of the upper arm, upper thigh, or abdomen. Do not inject into muscle or vein.. When To Stop: Do not stop Xgeva without consulting your doctor. Stopping may increase the risk of bone complications.. Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Allow to reach room temperature before injection.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
If you miss a dose, contact your healthcare provider as soon as possible to reschedule. Do not double up or self-administer extra doses.
Overdose
There is limited information on Xgeva overdose. If overdose is suspected, seek immediate medical attention. Supportive care and monitoring of calcium levels are recommended. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Hypocalcemia
Incidence: Reported in the clinician-authored database; frequency not established
Osteonecrosis of the jaw (ONJ)
Incidence: Reported in the clinician-authored database; frequency not established
Atypical femoral fracture
Incidence: Reported in the clinician-authored database; frequency not established
Serious infections
Incidence: Reported in the clinician-authored database; frequency not established
Back pain
Incidence: Reported in the clinician-authored database; frequency not established
Musculoskeletal pain
Incidence: Reported in the clinician-authored database; frequency not established
Dermatitis
Incidence: Reported in the clinician-authored database; frequency not established
Signs of low blood calcium: muscle spasms, twitching or cramps, numbness or tingling in fingers/toes/around the mouth, or an irregular heartbeat
(1)Jaw pain, swelling, numbness, or a feeling of heaviness in the jaw, or loose teeth (possible osteonecrosis of the jaw), especially after a dental procedure
(1)New or unusual thigh, hip, or groin pain (possible atypical femur fracture)
(1)Signs of a serious infection: fever, chills, warmth/redness/swelling of the skin, or severe abdominal or urinary symptoms
(1)Serious warnings
May cause severe low blood calcium, especially in people with kidney problems — serious
Symptoms: May cause severe low blood calcium, especially in people with kidney problems. Increases risk of osteonecrosis of the jaw, particularly after dental procedures. May cause atypical femur fractures. Risk of serious infections, including skin, abdominal, and urinary tract infections. Not recommended during pregnancy or breastfeeding.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindications include pre-existing hypocalcemia and known hypersensitivity to denosumab. Precautions: Use with caution in patients with renal impairment, history of hypoparathyroidism, or risk factors for osteonecrosis of the jaw. Dental examination and preventive dentistry are recommended prior to initiation.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Xgeva may interact with other medications that lower blood calcium, such as loop diuretics or certain anticonvulsants. Avoid concurrent use with other RANKL inhibitors or bisphosphonates unless directed by your doctor. Always inform your healthcare provider about all medicines and supplements you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
The FDA label advises females of reproductive potential to use effective contraception during Xgeva treatment and for at least 5 months after the last dose. Patients should contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment or within 5 months after the last dose, because animal data suggest denosumab could cause fetal harm. (1)
Breastfeeding
The FDA label states there is no information on the presence of denosumab (Xgeva) in human milk, its effects on the breastfed child, or its effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Xgeva and any potential adverse effects on the breastfed child — discuss this with your prescriber. (1)
Children
Frequency: Not applicable. Weight Based: Not recommended for pediatric use. Max Daily Dose: Not applicable. Max Single Dose: Not applicable. Age Restrictions: Safety not established in children (1)
Renal_impairment
FDA label: in clinical trials of patients with varying degrees of renal impairment (including those on dialysis), the degree of renal impairment did not affect denosumab's pharmacokinetics or pharmacodynamics, so no dose adjustment is defined based on renal function alone. However, a greater risk of hypocalcemia was observed with increasing renal impairment and with inadequate or no calcium supplementation, so calcium and vitamin D intake and monitoring are especially important in renal impairment. No clinical trials have evaluated the effect of hepatic impairment on denosumab pharmacokinetics; no hepatic dose-adjustment schedule exists. (1)
Hepatic_impairment
FDA label: in clinical trials of patients with varying degrees of renal impairment (including those on dialysis), the degree of renal impairment did not affect denosumab's pharmacokinetics or pharmacodynamics, so no dose adjustment is defined based on renal function alone. However, a greater risk of hypocalcemia was observed with increasing renal impairment and with inadequate or no calcium supplementation, so calcium and vitamin D intake and monitoring are especially important in renal impairment. No clinical trials have evaluated the effect of hepatic impairment on denosumab pharmacokinetics; no hepatic dose-adjustment schedule exists. (1)
Monitoring
(1)Storage
Store Xgeva refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Before use, it may be brought to room temperature (up to 25°C/77°F) in the original container, which generally takes 15-30 minutes; do not warm it any other way. Once removed from the refrigerator, it must not be exposed to temperatures above 25°C/77°F and must be used within 30 days or discarded.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors
Dose summary: 120 mg subcutaneously every 28 days.
Renal context: FDA label: renal impairment (including dialysis) does not affect denosumab pharmacokinetics/pharmacodynamics, so no dose adjustment is defined based on renal function. However, hypocalcemia risk increases with worsening renal impairment, particularly with inadequate calcium/vitamin D intake, so calcium levels should be monitored closely and adequate calcium/vitamin D supplementation ensured. (1)
Hepatic guidance
FDA label: no clinical trials have evaluated the effect of hepatic impairment on denosumab pharmacokinetics; no hepatic dose-adjustment schedule has been established.
Frequently asked questions
What is Xgeva used for?
Xgeva is used to prevent bone complications in people with bone metastases from solid tumors and to treat certain cases of giant cell tumor of bone.
How is Xgeva administered?
Xgeva is given as a subcutaneous injection (under the skin) by a healthcare professional, usually every 4 weeks.
What should I do if I miss a dose?
Contact your healthcare provider as soon as possible to reschedule your missed dose. Do not take extra doses on your own.
Can I take Xgeva if I have kidney problems?
People with kidney problems may be at higher risk for low calcium levels while taking Xgeva. Your doctor will monitor your calcium closely and may adjust your supplements.
What are the most serious side effects of Xgeva?
Serious side effects include low blood calcium, osteonecrosis of the jaw, atypical femur fractures, and severe infections. Seek medical attention if you experience symptoms such as jaw pain, muscle cramps, or signs of infection.
Can I have dental work while on Xgeva?
Inform your dentist that you are receiving Xgeva before any dental procedures. Preventive dental care is recommended before starting treatment.
Is Xgeva safe during pregnancy or breastfeeding?
Xgeva is not recommended during pregnancy or breastfeeding due to potential risks to the baby. Discuss with your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
What happens if I take too much Xgeva?
Taking too much Xgeva (denosumab) may lead to severe hypocalcemia, characterized by muscle spasms, numbness, or tingling. While specific overdose symptoms are not well-defined, any suspected overdose should be treated as a medical emergency. Immediately seek emergency medical attention or contact a poison control center if you believe an overdose has occurred.
Can I drink alcohol while taking Xgeva?
There are no known direct interactions between Xgeva (denosumab) and alcohol. However, excessive alcohol consumption can negatively impact bone health and liver function, which might indirectly affect the overall treatment efficacy or exacerbate certain side effects. It is always advisable to discuss alcohol consumption with your healthcare provider to ensure it aligns with your treatment plan and personal health.
Is Xgeva safe during pregnancy?
Xgeva (denosumab) is not recommended during pregnancy due to potential harm to the fetus, as indicated by its pregnancy category. Animal studies have shown adverse effects on fetal development. Women of childbearing potential should use effective contraception during treatment and for at least 5 months after the last dose. Always consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding before using Xgeva.
What is the mechanism of action of denosumab?
Denosumab, the active ingredient in Xgeva, is a fully human monoclonal antibody that binds to and inhibits RANK ligand (RANKL), a key mediator of osteoclast formation, function, and survival. By blocking RANKL, denosumab prevents osteoclast-mediated bone resorption, thereby reducing bone destruction and skeletal-related events in patients with bone metastases. (1)
What is the generic name of Denosumab?
The generic name is denosumab. It is sold under brand names including Denomac, Xgeva, Prolia, Denub.
What class of drug is denosumab?
Denosumab is classed as: Monoclonal antibody; RANK ligand (RANKL) inhibitor; Bone-modifying agent.
References
- Xgeva — Prescribing InformationU.S. Food and Drug Administration / DailyMed · United States · dated 2026-08-03 · accessed 2026-08-07 · source 1
- BOSAYA (DENOSUMAB-KYQQ) INJECTION [BIOCON BIOLOGICS INC.] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 2
- Denosumab Injection — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
- Stoboclo — FDA approval record (Drugs@FDA BLA761404)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- denosumab — RxNorm normalized drug concept (RXCUI 993449)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient denosumab names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- BOMYNTRA70 mg/mL · fresenius kabi usa, llc
- Denosumab-BMWO60 mg/mL, 120 mg.7mL · celltrion usa, inc.
- BOSAYA60 mg/mL · biocon biologics inc.
- Boncresa60 mg/mL · amneal pharmaceuticals llc
- Prolia60 mg/mL · amgen, inc
- WYOST120 mg.7mL · sandoz inc
- OSPOMYV60 mg/mL · cordavis limited
- OSVYRTI60 mg/mL · accord biopharma inc.
- XGEVA120 mg.7mL · amgen, inc
- JUBEREQ70 mg/mL · accord biopharma inc.
Canada
- PROLIA
- XGEVA