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Frequently Asked Questions

Here you can find answers to the most common questions about OSENVELT.

What is OSENVELT?

OSENVELT is a biosimilar of Xgeva® (denosumab). Like Xgeva, OSENVELT is used to strengthen and protect bones and prevent serious bone problems. However, OSENVELT may be more affordable than Xgeva.

What is a biosimilar?

OSENVELT is a prescription biosimilar.

OSENVELT is a biosimilar of Xgeva® (denosumab). Biosimilar means that:

  • The biologic product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product
  • There are no clinically meaningful differences in how it works or in how safe it is compared to the reference product

A biosimilar is typically more affordable than the reference product. Since OSENVELT is a biosimilar of Xgeva, it can be used instead of Xgeva.

How is OSENVELT similar to Xgeva® (denosumab)?

OSENVELT is highly similar to Xgeva in terms of safety, effectiveness, and how it works in the body. Both medicines are used to prevent serious bone issues in people with cancers like breast and prostate cancer. OSENVELT has been tested to ensure it works just as well as Xgeva.

How is OSENVELT administered?

OSENVELT is given as an injection under the skin (subcutaneous injection) by your healthcare provider.

What should I know about treatment with OSENVELT?

If you receive OSENVELT, you should not receive other denosumab products.

OSENVELT can cause serious side effects including:

  • Increased risk of severe low calcium levels in your blood (hypocalcemia). OSENVELT may lower the calcium levels in your blood. If you have low blood calcium before you start receiving OSENVELT, it may get worse during treatment. Your low blood calcium must be treated before you receive OSENVELT. Talk to your doctor before starting OSENVELT. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take OSENVELT. Take calcium and vitamin D as your doctor tells you to.

    If you have advanced chronic kidney disease (may or may not be on kidney dialysis), OSENVELT may increase your risk for severe low calcium levels in your blood, which could result in hospitalization, life-threatening events and death. A mineral and bone disorder associated with kidney disease called chronic kidney disease-mineral bone disorder (CKD-MBD) may increase your risk for severe low calcium levels in blood. Before you start OSENVELT and during treatment, your doctor may need to do certain blood tests to check for CKD-MBD.

    Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:
    • spasms, twitches, or cramps in your muscles
    • numbness or tingling in your fingers, toes, or around your mouth
  • Serious allergic reactions. Serious allergic reactions have happened in people who take denosumab products. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction. Symptoms of a serious allergic reaction may include:
    • low blood pressure (hypotension)
    • rash
    • trouble breathing
    • itching
    • throat tightness
    • swelling of your face, lips, or tongue
    • hives
  • Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take OSENVELT. Your doctor should examine your mouth before you start OSENVELT. Your doctor may tell you to see your dentist before you start OSENVELT. It is important for you to practice good mouth care during treatment with OSENVELT. Ask your doctor or dentist about good mouth care if you have any questions.
  • Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.
  • Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying OSENVELT. Talk with your doctor before starting OSENVELT treatment. After your treatment with OSENVELT is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop, skip or delay taking OSENVELT without first talking with your doctor. If your OSENVELT treatment is stopped, talk to your doctor about other medicine that you can take.
  • Increased risk of high calcium levels in your blood (hypercalcemia) after stopping treatment. OSENVELT may cause dangerously high calcium levels in some people after they stop taking it, especially if they have giant cell tumor of bone or are still growing. This can lead to serious health problems like kidney damage that may require hospitalization. Hypercalcemia may occur within the first year after stopping OSENVELT.
    • Symptoms of high calcium levels like:
      • Nausea or vomiting
      • Feeling confused or weak
      • Muscle weakness
      • Frequent urination
    • Monitor your calcium levels regularly after stopping OSENVELT and adjust your calcium and vitamin D supplements if needed
  • ​Risk of harming an unborn baby (embryo-fetal toxicity). OSENVELT can cause serious harm to an unborn baby if taken during pregnancy. In animal studies, taking OSENVELT during pregnancy caused pregnancy loss, stillbirth, and problems with bone development in newborns. You should check in with your doctor to see if you are pregnant. During treatment, use effective birth control while on OSENVELT and for at least 5 months after your last dose. If you’re pregnant or planning to be, tell your doctor immediately.

Call your doctor right away if you have any of these side effects.

What are the benefits of treatment with OSENVELT?

OSENVELT can be used to prevent serious bone problems in:

  • People with Multiple Myeloma
  • People with Bone Metastases from solid tumors
  • Adults and skeletally mature adolescents with Giant Cell Tumor of Bone that is unresectable or where surgical resection is likely to result in severe morbidity
  • People receiving treatment for Hypercalcemia of malignancy refractory to bisphosphonate therapy

Is OSENVELT safe?

Yes. OSENVELT has been approved by the FDA, which means it has passed rigorous testing to ensure it is safe and effective for patients. Like any medicine, it may have side effects, so it’s important to talk to your doctor about any concerns.

FDA, Food and Drug Administration.

What are the side effects of OSENVELT?

The most common side effects in people with bone metastases from solid tumors are:

  • Tiredness/weakness
  • Low phosphate levels in the blood
  • Nausea

The most common side effects in people with multiple myeloma are:

  • Diarrhea
  • Nausea
  • Low number of red blood cells
  • Low number of blood platelets
  • Back pain
  • Low calcium levels
  • Swelling of the lower legs or hands
  • Upper respiratory tract infection
  • Rash
  • Headache

The most common serious side effect was pneumonia.

The most common side effects in people with giant cell tumor of bone:

  • Joint pain
  • Headache
  • Nausea
  • Back pain
  • Fatigue
  • Pain in legs, arms, or hands

The most common side effects in people getting treatment for hypercalcemia of malignancy are:

  • Nausea
  • Difficulty breathing
  • Decreased appetite
  • Headache
  • Swelling in the lower legs or hands
  • Vomiting
  • Low number of red blood cells
  • Constipation
  • Diarrhea

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of OSENVELT.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

IMPORTANT SAFETY INFORMATION

If you receive OSENVELT, you should not receive other denosumab products at the same time.

OSENVELT can cause serious side effects including:

Serious allergic reactions. Serious allergic reactions have occurred with denosumab products. Call your doctor or seek emergency care immediately if you experience symptoms such as low blood pressure (hypotension), rash, difficulty breathing, itching, throat tightness, hives, or swelling of your face, lips, or tongue.

Low blood calcium (Hypocalcemia). OSENVELT can lower your blood calcium levels, which can become severe or even life-threatening. Your doctor will check your calcium levels before and during treatment, especially in the first few weeks. You may need to take calcium, magnesium, and vitamin D supplements as instructed by your doctor. Your risk may be higher if you have kidney problems or take other medicines that lower blood calcium. Call your doctor immediately if you experience symptoms of low blood calcium, such as muscle spasms or cramps, numbness or tingling in fingers, toes, or around your mouth, twitching or stiffness.

Severe jawbone problems (osteonecrosis). Severe jaw bone problems may happen when you take OSENVELT. Your doctor should examine your mouth before starting treatment and may advise seeing a dentist. Practice good oral care and consult your doctor or dentist if needed.

Unusual thigh bone fractures. Symptoms include new or unusual pain in your hip, groin, or thigh.

High Blood Calcium After Stopping Treatment. If you have giant cell tumor of bone or are still growing, stopping OSENVELT can lead to high calcium levels in your blood (hypercalcemia). This condition can become severe, require hospitalization, and affect your kidneys. Your doctor will monitor your calcium levels after stopping treatment. Call your doctor right away if you notice symptoms of high blood calcium, such as nausea or vomiting, increased thirst or urination, confusion or tiredness, muscle weakness or pain. Follow your doctor's instructions carefully, and keep all scheduled appointments for calcium monitoring.

Multiple Spine Fractures After Stopping OSENVELT. After stopping treatment with OSENVELT, some patients have experienced multiple spine fractures. Your risk is higher if you have osteoporosis, previous fractures, or other risk factors. Your doctor will assess your individual fracture risk when stopping OSENVELT.

Risk to Unborn Babies. OSENVELT may harm your unborn baby if you take it while pregnant or within 5 months before becoming pregnant. Animal studies have shown serious harm, including pregnancy loss, birth defects, abnormal bone growth, missing lymph nodes, and slow growth after birth. Your doctor will check if you are pregnant before starting OSENVELT. Tell your doctor immediately if you become pregnant or think you may be pregnant during treatment.

Do not take OSENVELT if you have low blood calcium, are pregnant or planning pregnancy, or if you're allergic to denosumab or any ingredients in OSENVELT.

Before taking OSENVELT, tell your doctor if you:

  • take other denosumab products
  • have low blood calcium
  • cannot take daily calcium and vitamin D supplements
  • take medicines that can lower blood calcium
  • plan dental surgery or tooth removal
  • are pregnant, planning pregnancy, or breastfeeding. OSENVELT may harm an unborn baby; a pregnancy test is required before treatment; use effective birth control during treatment and for 5 months after your last dose; inform your doctor immediately if pregnancy occurs. It is unknown if OSENVELT passes into breast milk; do not breastfeed during treatment.

Tell your doctor of all medicines, vitamins, and herbal supplements you take. Keep an updated list to share with healthcare providers.

The most common side effects of OSENVELT are:

For patients with Bone Metastasis from Solid Tumors: fatigue or weakness, low phosphate levels, and nausea.

For patients with Multiple Myeloma: diarrhea, low phosphate, nausea, fatigue, low calcium, shortness of breath, and anemia.

For patients with Giant Cell Tumor of Bone: joint pain, headache, nausea, back pain, fatigue, and pain in arms or legs.

For patients with Hypercalcemia of Malignancy: nausea, trouble breathing, decreased appetite, and headache.

Tell your doctor if side effects are bothersome or persistent. These are not all possible side effects. Call your doctor for advice on side effects or report them to the FDA at 1‑800‑FDA‑1088.

Please see full Prescribing Information and talk with your healthcare provider.

INDICATIONS

OSENVELT (denosumab-bmwo) is a prescription medicine used to:

  • Help prevent bone complications in patients with multiple myeloma and in patients whose cancer from solid tumors has spread to the bones.
  • Treat adults and adolescents (whose bones have stopped growing) with giant cell tumor of bone that cannot be removed with surgery, or when surgery could cause severe complications.
  • Treat high blood calcium caused by cancer (hypercalcemia of malignancy) that has not improved after treatment with bisphosphonates.

Please see full Prescribing Information and talk with your healthcare provider.

INDICATIONS

OSENVELT® (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for:

  • Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
  • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
  • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

IMPORTANT SAFETY INFORMATION

If you receive OSENVELT, you should not receive other denosumab products at the same time.

OSENVELT can cause serious side effects including:

Serious allergic reactions. Serious allergic reactions have occurred with denosumab products. Call your doctor or seek emergency care immediately if you experience symptoms such as low blood pressure (hypotension), rash, difficulty breathing, itching, throat tightness, hives, or swelling of your face, lips, or tongue.

Low blood calcium (Hypocalcemia). OSENVELT can lower your blood calcium levels, which can become severe or even life-threatening. Your doctor will check your calcium levels before and during treatment, especially in the first few weeks. You may need to take calcium, magnesium, and vitamin D supplements as instructed by your doctor. Your risk may be higher if you have kidney problems or take other medicines that lower blood calcium. Call your doctor immediately if you experience symptoms of low blood calcium, such as muscle spasms or cramps, numbness or tingling in fingers, toes, or around your mouth, twitching or stiffness.

Severe jawbone problems (osteonecrosis). Severe jaw bone problems may happen when you take OSENVELT. Your doctor should examine your mouth before starting treatment and may advise seeing a dentist. Practice good oral care and consult your doctor or dentist if needed.

Unusual thigh bone fractures. Symptoms include new or unusual pain in your hip, groin, or thigh.

High Blood Calcium After Stopping Treatment. If you have giant cell tumor of bone or are still growing, stopping OSENVELT can lead to high calcium levels in your blood (hypercalcemia). This condition can become severe, require hospitalization, and affect your kidneys. Your doctor will monitor your calcium levels after stopping treatment. Call your doctor right away if you notice symptoms of high blood calcium, such as nausea or vomiting, increased thirst or urination, confusion or tiredness, muscle weakness or pain. Follow your doctor's instructions carefully, and keep all scheduled appointments for calcium monitoring.

Multiple Spine Fractures After Stopping OSENVELT. After stopping treatment with OSENVELT, some patients have experienced multiple spine fractures. Your risk is higher if you have osteoporosis, previous fractures, or other risk factors. Your doctor will assess your individual fracture risk when stopping OSENVELT.

Risk to Unborn Babies. OSENVELT may harm your unborn baby if you take it while pregnant or within 5 months before becoming pregnant. Animal studies have shown serious harm, including pregnancy loss, birth defects, abnormal bone growth, missing lymph nodes, and slow growth after birth. Your doctor will check if you are pregnant before starting OSENVELT. Tell your doctor immediately if you become pregnant or think you may be pregnant during treatment.

Do not take OSENVELT if you have low blood calcium, are pregnant or planning pregnancy, or if you're allergic to denosumab or any ingredients in OSENVELT.

Before taking OSENVELT, tell your doctor if you:

  • take other denosumab products
  • have low blood calcium
  • cannot take daily calcium and vitamin D supplements
  • take medicines that can lower blood calcium
  • plan dental surgery or tooth removal
  • are pregnant, planning pregnancy, or breastfeeding. OSENVELT may harm an unborn baby; a pregnancy test is required before treatment; use effective birth control during treatment and for 5 months after your last dose; inform your doctor immediately if pregnancy occurs. It is unknown if OSENVELT passes into breast milk; do not breastfeed during treatment.

Tell your doctor of all medicines, vitamins, and herbal supplements you take. Keep an updated list to share with healthcare providers.

The most common side effects of OSENVELT are:

For patients with Bone Metastasis from Solid Tumors: fatigue or weakness, low phosphate levels, and nausea.

For patients with Multiple Myeloma: diarrhea, low phosphate, nausea, fatigue, low calcium, shortness of breath, and anemia.

For patients with Giant Cell Tumor of Bone: joint pain, headache, nausea, back pain, fatigue, and pain in arms or legs.

For patients with Hypercalcemia of Malignancy: nausea, trouble breathing, decreased appetite, and headache.

Tell your doctor if side effects are bothersome or persistent. These are not all possible side effects. Call your doctor for advice on side effects or report them to the FDA at 1‑800‑FDA‑1088.

Please see full Prescribing Information and talk with your healthcare provider.

INDICATIONS

OSENVELT (denosumab-bmwo) is a prescription medicine used to:

  • Help prevent bone complications in patients with multiple myeloma and in patients whose cancer from solid tumors has spread to the bones.
  • Treat adults and adolescents (whose bones have stopped growing) with giant cell tumor of bone that cannot be removed with surgery, or when surgery could cause severe complications.
  • Treat high blood calcium caused by cancer (hypercalcemia of malignancy) that has not improved after treatment with bisphosphonates.

Please see full Prescribing Information and talk with your healthcare provider.