Xgeva
Pronunciation: x-gee-va
Generic name: denosumab
Dosage form: single-dose vial (120 mg/1.7 mL)
Drug class: Miscellaneous bone resorption inhibitors
What is Xgeva?
Xgeva is used to prevent bone fractures and other skeletal conditions in people with multiple myeloma, and in people with solid tumors that have metastasized (spread) to the bone.
Xgeva is also used to treat giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, in adults and teenagers with a fully matured bone structure.
In hypercalcemia of malignancy that has not responded to bisphosphonates such as pamidronate or zoledronic acid, Xgeva is used to treat high blood levels of calcium caused by cancer.
Xgeva is not approved for children. It may be used in teenagers with giant cell tumor of bone that have a fully matured bone structure.
Xgeva was FDA-approved on June 1, 2010. There are currently 4 biosimilars to Xgeva:
- Wyost (denosumab-bbdz) made by Sandoz Inc. (FDA approval March 5, 2024)
- Xbryk (denosumab-dssb) made by Samsung Bioepis (FDA approval February 16, 2025)
- Osenvelt (denosumab-bmwo) made by Celltrion (FDA approval February 28, 2025)
- Bomyntra (denosumab-bnht) made by Fresenius Kabi (FDA approval March 25, 2025).
Prolia Vs Xgeva
Prolia is another brand of denosumab used to treat osteoporosis and increase bone mass.
- Xgeva and Prolia have different dosages and uses and are not interchangeable (see Xgeva vs Prolia. How do they compare? for more information).
Side effects
The most common side effects of Xgeva are:
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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
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pain or swelling in your arms or legs
- laboratory changes (such as low phosphate levels, low calcium levels, and low platelets).
Serious side effects and warnings
Xgeva carries a Boxed warning for severe hypocalcemia in patients with advanced kidney disease.
Xgeva can cause the following serious side effects.
- Hypersensitivity reactions, including anaphylaxis, may occur. Do not receive Xgeva if you are allergic to denosumab, Xgeva, Prolia, or any inactive ingredients in the injection. Get emergency medical help if you have any signs of an allergic reaction to Xgeva: itching, rash, hives; difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.
- Hypocalcemia (low calcium levels). Xgeva can cause severe symptomatic low calcium levels, and deaths have been reported. Your healthcare provider will monitor calcium levels during therapy, especially in the first weeks of starting treatment, and give you calcium and vitamin D supplements if needed.
- Osteonecrosis of the jaw. 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. Avoid invasive dental work while you are receiving Xgeva.
- Atypical femoral fracture. Tell your healthcare provider if you develop thigh or groin pain to rule out a fracture of the thigh bone.
- High calcium levels following discontinuation in people with Giant Cell Tumor of Bone and in patients with growing skeletons. Your healthcare provider will monitor you for high blood calcium levels and treat if appropriate.
- Multiple vertebral fractures following treatment discontinuation. People at higher risk include those with risk factors for or a history of osteoporosis or prior fractures. Talk to your healthcare provider about this risk.
Xgeva may cause harm to an unborn baby. Do not take this medicine while you are pregnant. Females of childbearing potential should use effective contraception while taking Xgeva and for 5 months following the last dose.
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.
Xgeva contains the same active ingredient as Prolia, called denosumab. Do not take both Xgeva and Prolia.
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 the FDA at 1-800-FDA-1088.
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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).
Before you receive this medicine, tell your healthcare provider about all your medical conditions, including if you
- have kidney disease, or if you are on dialysis
- are taking other forms of denosumab, such as Prolia
- have any dental problems
- are pregnant or intending to become pregnant
- are breastfeeding or intend to breastfeed.
Pregnancy
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.
Breastfeeding
You should not breast-feed while using Xgeva.
How is Xgeva given?
Xgeva is injected subcutaneously (under the skin) in your stomach, upper thigh, or upper arm. A healthcare provider will give you this injection.
Xgeva is usually given once every 4 weeks.
- For Giant Cell Tumor of Bone and hypercalcemia of malignancy, additional doses are given on day 8 and day 15 of the first month of therapy.
Your doctor may tell you to 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.
Dosing information
Multiple Myeloma and Bone Metastasis from Solid Tumors:
- 120 mg every 4 weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen.
Giant Cell Tumor of Bone:
- 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy.
Administer subcutaneously in the upper arm, upper thigh, or abdomen.
Hypercalcemia of Malignancy:
- 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy.
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.
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.
Ingredients
Active: denosumab
Inactive ingredients: acetate, polysorbate 20, sorbitol, Water for Injection (USP), and sodium hydroxide to adjust the pH to 5.2.
Each single-dose vial of Xgeva contains 120 mg denosumab in 1.7 mL.
Manufacturer
Xgeva is manufactured by Amgen Inc., a biotechnology company headquartered in Thousand Oaks, California, USA.
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 Discontinued |
View Jubbonti information in detail.
Wyost (denosumab-bbdz) - Sandoz Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 120 mg/1.7 mL (70 mg/mL) Discontinued |
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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