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What to expect during OSENVELT treatment

OSENVELT is given as a shot under the skin by your healthcare provider. It does not require an infusion.

Your doctor will inject OSENVELT in one of these 3 locations:

  • Upper arm
  • Upper thigh
  • Stomach area

Your doctor may test your blood calcium before you start OSENVELT and while you are taking OSENVELT.

Kidney function

You can take OSENVELT even with lower kidney function. If your kidney function is lower than normal, you ARE at increased risk for low blood calcium levels. Consult your doctor on how to manage your individual risk.

OSENVELT dosing


Before you start OSENVELT

Speak to your doctor about your medical history, especially if you are or may become pregnant, or if you have a history of kidney problems.

Your doctor may want to give you some tests to make sure OSENVELT is right for you. These tests include:

Calcium level test

Your doctor will give you a test to measure the amount of calcium in your blood. If the level is too low, you will probably need to take medicine to bring your calcium up to normal.

Pregnancy test

If you could become pregnant, your doctor will test to make sure you are not pregnant before starting OSENVELT. Women should use birth control the entire time they are taking OSENVELT and for 5 months after their last dose of OSENVELT.

Make sure you tell your doctor if you are pregnant, are planning to get pregnant, think you may be pregnant, or are breastfeeding.

Dental evaluation

Your doctor will likely want you to have a dental exam before starting OSENVELT.

Tell your doctor of any tooth pain or dental work you have had or are planning to have. In clinical studies, some patients taking denosumab experienced jawbone deterioration, a condition called osteonecrosis of the jaw.

Let your dentist know that you are taking OSENVELT. Make sure you visit your dentist as your doctor recommends.

Getting the most out of OSENVELT

At your appointment

  • Wear loose, comfortable clothing
  • Schedule your next appointments in advance as instructed by your doctor

Things to do every day

  • Maintain good oral hygiene
    • Brush twice daily
    • Use a fluoride toothpaste
    • Brush for 2 minutes each time you brush
    • Floss your teeth every day
    • Eat a healthy diet and limit sugar
    • Visit your dentist regularly

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.