Xgeva
Generic name: denosumab [ den-OH-sue-mab ]
Drug class: Miscellaneous bone resorption inhibitors
What is Xgeva?
Xgeva is a monoclonal antibody. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.
The Xgeva brand of denosumab is used to prevent bone fractures and other skeletal conditions in people with multiple myeloma, and in people with tumors that have spread to the bone.
Xgeva is also used to treat giant cell bone tumor in adults and teenagers with fully matured bone structure.
Xgeva is also used to treat high blood levels of calcium caused by cancer, when other medicines such as pamidronate or zoledronic acid (Zometa) have been used without success.
Xgeva was FDA-approved on June 1, 2010. Prolia is another brand of denosumab used to treat osteoporosis in postmenopausal women who have a high risk of bone fracture, and this was approved on the same date. Xgeva and Prolia have different dosages and uses and are not interchangeable (see Xgeva vs Prolia. How do they compare? for more information).
Wyost (denosumab-bbdz) is an interchangeable biosimilar to Xgeva that was FDA-approved on 5 March 2024. An interchangeable biosimilar is a biological product that can be substituted in the pharmacy for the reference biologic because there are no clinically meaningful differences in safety, purity, and potency.
Warnings
This medication guide provides information about the Xgeva brand of denosumab. Prolia is another brand of denosumab used to treat osteoporosis in postmenopausal women who have high risk of bone fracture.
Do not use denosumab if you are pregnant.
You should not receive Xgeva if you are allergic to denosumab, or if you have low levels of calcium in your blood (hypocalcemia).
Before you receive this medicine, tell your doctor if you have kidney disease or if you are on dialysis.
Some people using Xgeva have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving Xgeva. You may need to stop using the medicine for a short time.
Before receiving Xgeva
You should not receive Xgeva if you are allergic to denosumab or if you have low levels of calcium in your blood (hypocalcemia).
While you are receiving Xgeva, you should not use Prolia, another brand of denosumab.
To make sure you can safely use this medicine, tell your doctor if you have kidney disease (or if you are on dialysis).
Xgeva may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work.
Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
Denosumab can harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control while using this medicine, and for at least 5 months after your last dose.
You should not breast-feed while using Xgeva.
How is Xgeva given?
Xgeva is injected under the skin of your stomach, upper thigh, or upper arm. A healthcare provider will give you this injection.
Xgeva is usually given once every 4 weeks.
Your doctor may have you take extra calcium and vitamin D while you are being treated with denosumab. Take only the amount of calcium and vitamin D that your doctor has prescribed.
If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving Xgeva. You may need to stop using the medicine for a short time.
Pay special attention to your dental hygiene. Brush and floss your teeth regularly while receiving this medication. You may need to have a dental exam before you begin treatment with this medicine. Follow your doctor's instructions.
Related/similar drugs
prednisone, dexamethasone, Reclast, Decadron, denosumab, cinacalcet, Zometa, zoledronic acid, pamidronate, Aclasta
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Xgeva injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Xgeva side effects
Get emergency medical help if you have any signs of an allergic reaction to Xgeva: itching, rash, hives; difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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new or unusual pain in your thigh, hip, or groin;
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trouble breathing;
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low red blood cells (anemia)- pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
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low levels of calcium in your blood (hypocalcemia) - numbness or tingly feeling around your mouth or in your fingers or toes, muscle tightness or contraction, overactive reflexes.
After you stop using this medicine, tell your doctor if you have symptoms of high calcium levels (hypercalcemia) such as nausea, vomiting, headache, confusion, lack of energy, or tiredness.
Common Xgeva side effects may include:
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feeling weak or tired;
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nausea, vomiting, loss of appetite;
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diarrhea, constipation;
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headache, back pain; or
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pain or swelling in your arms or legs.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Xgeva?
Other drugs may interact with denosumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Xgeva Biosimilars
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 Xgeva.
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) |
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.
Jubbonti (denosumab-bbdz) - Sandoz Inc.
| Formulation type | Strength |
|---|---|
| Pre-Filled Syringe | 60 mg/mL |
View Jubbonti 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.
Popular FAQ
Xgeva vs Prolia. How do they compare?
Xgeva and Prolia are both brand names for the generic drug denosumab. Both are injectable preparations, both are made by Amgen, and both have similar side effects; but they differ in their indications, the way they are given, and their dosage. Continue reading
How long should you take Xgeva for?
Xgeva is meant to be taken long-term. However, Xgeva should be discontinued if you experience intolerable side effects or serious side effects such as osteonecrosis of the jaw or osteomyelitis, or if Xgeva appears to be ineffective for you. Continue reading
Is Xgeva a chemotherapy drug?
Xgeva is not a chemotherapy drug, it is a targeted treatment, called a monoclonal antibody that modifies bone. Although it is not a chemotherapy drug it is often given with chemotherapy medicines. Continue reading
Does Xgeva cause bone pain?
Xgeva may cause pain in the bones, muscles, and joints. Xgeva may also rarely cause osteonecrosis of the jaw, a bone condition with symptoms such as jaw pain or persistent mouth pain. Conversely, Xgeva is more effective than zoledronic acid at extended the bone pain-free interval. Always report new or unusual thigh, hip, groin, bone, joint, muscle, or jaw pain to your doctor. Continue reading
Does Xgeva cause low blood pressure?
Low blood pressure is not a common side effect of Xgeva; however, it may occur in people who are allergic to Xgeva alongside other allergy symptoms such as facial and throat swelling and tightness, shortness of breath, and a rash. Continue reading
More FAQ
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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Xgeva only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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