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 10 biosimilars to Xgeva:

• Wyost (denosumab-bbdz) manufactured by Sandoz Inc. (FDA approval March 5, 2024)
• Xbryk (denosumab-dssb) manufactured by Samsung Bioepis (FDA approval February 16, 2025)
• Osenvelt (denosumab-bmwo) manufactured by Celltrion (FDA approval February 28, 2025)
• Bomyntra (denosumab-bnht) manufactured by Fresenius Kabi (FDA approval March 25, 2025)
• Bilprevda (denosumab-nxxp) manufactured by Shanghai Henlius Biotech, Inc., for Organon LLC (FDA approval August 29, 2025)
• Aukelso (denosumab-kyqq) manufactured by Biocon Biologics Ltd. (FDA approval September 16, 2025)
• Xtrenbo (denosumab-qbde) manufactured by Hikma Pharmaceuticals USA Inc. (FDA approval September 26, 2025)
• Jubereq (denosumab-desu), manufactured by Accord BioPharma (FDA approval November 20, 2025)
• Oziltus (denosumab-mobz), manufactured by Amneal Pharmaceuticals LLC (FDA approval December 19, 2025)
• Degevma (denosumab-adet), manufactured by Teva Pharmaceuticals, Inc. (FDA approval September 25, 2026).

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).

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.

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

Talk to your healthcare provider if you are breastfeeding or plan to breastfeed. You and your doctor should consider the developmental and health benefits of breastfeeding along with your clinical need for Xgeva treatment.

The most common side effects of Xgeva are:

• feeling weak or tired
• nausea, vomiting, loss of appetite
• diarrhea, constipation
• headache, back pain
• 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 can cause severe hypocalcemia (Boxed Warning), especially 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:

• new or unusual pain in your thigh, hip, or groin;
• trouble breathing;
• low red blood cells (anemia)- pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• 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 Xgeva with Prolia, or Xgeva with any biosimilars to Prolia or Xgeva.

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.

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.

Call your doctor for instructions if you miss an appointment for your Xgeva injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.

Active: denosumabInactive 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.

Xgeva is manufactured by Amgen Inc., a biotechnology company headquartered in Thousand Oaks, California, USA.

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.

View Prolia information in detail.

Xgeva (denosumab) - Amgen Inc.

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.

View Aukelso information in detail.

Bildyos (denosumab-nxxp) - Shanghai Henlius Biotech, Inc.

View Bildyos information in detail.

Bilprevda (denosumab-nxxp) - Shanghai Henlius Biotech, Inc.

View Bilprevda information in detail.

Bomyntra (denosumab-bnht) - Fresenius Kabi USA, LLC

View Bomyntra information in detail.

Boncresa (denosumab-mobz) - Amneal Pharmaceuticals LLC

View Boncresa information in detail.

Bosaya (denosumab-kyqq) - Biocon Biologics Inc.

View Bosaya information in detail.

Conexxence (denosumab-bnht) - Fresenius Kabi USA, LLC

View Conexxence information in detail.

Degevma (denosumab-adet) - Teva Pharmaceuticals, Inc.

Degevma

Enoby (denosumab-qbde) - Hikma Pharmaceuticals USA Inc.

View Enoby information in detail.

Jubbonti (denosumab-bbdz) - Sandoz Inc.

View Jubbonti information in detail.

Jubereq (denosumab-desu) - Accord BioPharma Inc.

View Jubereq information in detail.

Osenvelt (denosumab-bmwo) - CELLTRION, Inc.

View Osenvelt information in detail.

Ospomyv (denosumab-dssb) - Samsung Bioepis Co., Ltd.

View Ospomyv information in detail.

Osvyrti (denosumab-desu) - Accord BioPharma Inc.

View Osvyrti information in detail.

Oziltus (denosumab-mobz) - Amneal Pharmaceuticals LLC

View Oziltus information in detail.

Ponlimsi (denosumab-adet) - Teva Pharmaceuticals, Inc.

Ponlimsi

Stoboclo (denosumab-bmwo) - CELLTRION, Inc.

View Stoboclo information in detail.

Wyost (denosumab-bbdz) - Sandoz Inc.

View Wyost information in detail.

Xbryk (denosumab-dssb) - Samsung Bioepis Co., Ltd.

Xbryk

Xtrenbo (denosumab-qbde) - Hikma Pharmaceuticals USA Inc.

View Xtrenbo information in detail.