Osenvelt (Xgeva, Biosimilars of Xgeva) — Uses, Dosage, Side Effects & Warnings

What is denosumab?

This medication guide is specific to Xgeva and its Biosimilars.

Denosumab is used to prevent bone problems in people with multiple myeloma or tumors that have spread to the bone.

Denosumab is also used in adults and children who are at least 12 years old with a fully matured bone structure to treat giant cell tumor of bone that cannot be removed with surgery.

Denosumab is also used to treat high calcium levels in the blood caused by cancer when a certain type of medicine used to lower blood calcium levels has not worked.

Denosumab may also be used for purposes not listed in this medication guide.

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Warnings

You do not receive denosumab if you have low levels of calcium in your blood (hypocalcemia). Your low blood calcium must be treated before you receive denosumab.

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Before taking this medicine

You should not receive denosumab if you are allergic to it or if you have low levels of calcium in your blood (hypocalcemia). Your low blood calcium will need to be treated before you receive denosumab.

You should not use any other medicines that contain denosumab while you are receiving Osenvelt.

Tell your doctor if you have or have ever had:

low levels of calcium in your blood (hypocalcemia);
osteoporosis or broken bones;
if you are scheduled for a dental procedure;
if you cannot take daily calcium and vitamin D;
if you are taking medicine that lowers your blood calcium levels; or
kidney disease (or if you are on dialysis).

Denosumab may cause very low levels of calcium in your blood (hypocalcemia), which can lead to death. Talk with your doctor about this risk.

This medicine may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.

May harm an unborn baby. Do not use if you are pregnant. You may need a pregnancy test before starting this treatment. Use effective birth control while receiving denosumab and for at least 5 months after your last dose. Tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

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Denosumab side effects

Get emergency medical help if you notice signs of an allergic reaction: hives, trouble breathing, or swelling of your face, lips, tongue, or throat.

Osenvelt may lead to serious side effects. Contact your doctor right away if you experience:

new or unusual pain in your thigh, hip, or groin;
jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work; or
low blood calcium, which can cause muscle spasms or contractions, numbness, or a tingling sensation (around your mouth, or in your fingers and toes).

After stopping denosumab, inform your doctor if you have signs of high calcium levels (hypercalcemia) such as confusion, tiredness, nausea, vomiting, loss of appetite, constipation, or increased thirst or urination, or weight loss.

Common side effects of Osenvelt may include:

tiredness, lack of energy;
rash, shortness of breath;
abnormal blood tests;
nausea, vomiting, diarrhea, constipation, or loss of appetite;
headache, back or joint pain, or pain or swelling in your arms or legs; or
cold symptoms like a stuffy nose, sneezing, or sore throat.

This is not a complete list of side effects, and others may occur. Contact 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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How is denosumab given?

Denosumab is injected under the skin. A healthcare provider will give you this injection.

Denosumab is usually given once every 4 weeks. You may need to receive additional doses depending on the condition being treated. Follow your doctor's instructions.

Your blood will need to be tested often. 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 denosumab.

Pay special attention to your dental hygiene. Brush and floss your teeth regularly while receiving this medication. You may need to have an oral examination before you begin treatment with denosumab. Follow your doctor's instructions.

Your risk of bone fractures can increase when you stop using denosumab. Do not stop using this medicine without first talking to your doctor.

If you keep this medicine at home, store it in the original carton in a refrigerator. Protect from light and do not freeze. Do not shake the medicine.

After you have taken denosumab out of the refrigerator, you may keep it at room temperature for up to 14 to 63 days, depending on the brand form. Store in the original container away from heat and light.

What happens if I miss a dose?

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

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What happens if I overdose?

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.

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What other drugs will affect denosumab?

Other medicines may impact denosumab, including prescription and over-the-counter drugs, vitamins, and herbal products. Inform your doctor about all other medicines you are using.

Biosimilar and interchangeable products are biological products that are very similar to and have no significant differences from the original product.

Reference products

These are biological products that have already received FDA approval and are used to compare biosimilar products. There are 2 for Osenvelt.

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 provided by a pharmacist without needing approval from the prescriber of the original product.

Pharmacy laws regarding biosimilar prescriptions may differ 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)

View Degevma information in detail.

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)

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

View Ponlimsi information in detail.

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)

View Xbryk information in detail.

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.

This section was rewritten for readability and reviewed for meaning.

Common questions about Osenvelt

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

Related medicines

Before you take this medicine: the information on this page is general and may not cover your personal circumstances. Read the label supplied with your medicine and ask a pharmacist or doctor if you are unsure, especially if you are pregnant, breastfeeding, taking other medicines or managing a long-term condition.

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Content is provided for education and is not medical advice. See our medical disclaimer.