What Is XGEVA® (denosumab)?

XGEVA® is a prescription medicine used to prevent serious bone problems* in patients with bone metastases from solid tumors
XGEVA® is not used to prevent these bone problems in patients with multiple myeloma

XGEVA® (denosumab) is the #1 prescribed bone-targeting agent by oncologists based on a database of electronic health records in oncology *Serious bone problems are:

  • Broken bones (fractures)1

    Broken bones may be painful and often do not heal when your cancer has spread to your bones. In patients with cancer that has spread to bone, broken bones occur most commonly in the ribs, spine, pelvis, and thigh bone. Fractures in weight-bearing bones such as the spine or thigh often require surgery.2-4

  • A need for surgery to prevent or repair broken bones1

    Surgery is used to fix a broken bone or prevent a bone from breaking. Physical therapy may be necessary after surgery.2,5,6

  • A need for radiation treatments to the bone1

    Radiation is most often used to lessen pain. A common schedule of radiation is 10 treatments over 2 weeks.7-10

  • Pressure on the spinal cord (spinal cord compression)1

    Spinal cord compression must be addressed immediately as it is an emergency. It is most commonly associated with breast, lung, and prostate tumors that have spread to the bone.11-13

The Benefits of XGEVA® Treatment

When cancer from solid tumors spreads to bone,
XGEVA® helps protect against serious bone
problems longer14

XGEVA® was shown to be better at preventing serious bone problems longer than zoledronic acid, the generic name of ZOMETA®*, in patients whose breast cancer, prostate cancer, or cancer from other types of solid tumors had spread to bone.1,14,15

XGEVA® delayed serious bone problems 8.2 months longer than zoledronic acid in patients with bone metastases from breast cancer, prostate cancer, and other types of solid tumors or multiple myeloma.14

XGEVA® delayed serious bone problems 8.2 months longer than zoledronic acid in patients with bone metastases. XGEVA® delayed serious bone problems 8.2 months longer than zoledronic acid in patients with bone metastases.

XGEVA® is not approved for use to prevent these serious bone problems in patients with multiple myeloma.

In one study in patients who had experienced a serious bone problem, such as a fracture prior to starting the study, XGEVA® may have prevented another serious bone problem from happening.14

Cancer spread to bone

It's important for you to know if your cancer has spread
to the bone, and also how you can help protect yourself
from serious bone problems caused by bone metastases.

Understand what it means when cancer spreads to the bone

How XGEVA® Works Video

When cancer has spread to your bone, it can produce
signals that increase the rate at which bone is broken
down, leading to a weakened bone16,17

In healthy bone, there are cells that remove old bone and other cells that rebuild bone. A key signal helps regulate this process.16 When cancer spreads to bone, there are higher levels of this key signal produced, which increases the rate at which bone is broken down in that area.16,17

Over time, these bones can weaken. This can lead to serious bone problems, such as fracture. XGEVA® blocks this key signal and may interrupt the process.1,16,17

Watch the video below to learn more about how bone metastases from a solid tumor can affect your bones and how XGEVA® can help.

In healthy normal bone a balanced process keeps bones strong. Bone-removing cells break down old bone, and bone-building cells form new bone.

Normally, this breakdown and rebuilding occur at a balanced rate.

When cancer from solid tumors spreads to the bone and forms bone metastases, this balance is thrown off.

The cancer in your bone produces signals that increase the rate at which bone is broken down or rebuilt, leading to a weakened bone.

This can lead to serious bone problems that are broken bones (fractures), surgery to bone, a need for radiation treatments, and pressure on the spinal cord (spinal cord compression).

XGEVA®, also known as denosumab, is a prescription medicine that can help prevent fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with bone metastases from solid tumors.

XGEVA® is not used to prevent these bone problems in patients with multiple myeloma.

Do not take XGEVA® if you have low blood calcium (hypocalcemia) or are allergic to denosumab or any of its ingredients. XGEVA® can significantly lower the calcium levels in your blood and some deaths have been reported. Severe jaw bone problems and unusual thigh bone fracture have been reported. You should not become pregnant while taking XGEVA® because XGEVA® can harm your unborn baby. Patients with bones that are not fully matured may develop high blood calcium levels after they stop taking XGEVA®, that can be serious.

Please see additional Important Safety Information later in this video.

When cancer spreads to bone, there are higher levels of a key signal produced, which increases the rate of bone breakdown in the area where the cancer has spread.

XGEVA® works by blocking this signal and interrupting the breakdown of bone.

There is important safety information to consider when using XGEVA®.

Do not take XGEVA® if you have low blood calcium (hypocalcemia). Your low blood calcium must be treated before you receive XGEVA®. XGEVA® can significantly lower the calcium levels in your blood and some deaths have been reported. Take calcium and vitamin D as your doctor tells you to. Tell your doctor right away if you experience spasms, twitches, cramps, or stiffness in your muscles or numbness or tingling in your fingers, toes, or around your mouth.

Do not take XGEVA® if you are allergic to denosumab or any of the ingredients of XGEVA®. Serious allergic reactions have happened in people who take XGEVA®. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of the face, lips, or tongue, rash; itching; or hives.

What is the most important information you should know about XGEVA®?

XGEVA® contains the same medicine as Prolia® (denosumab). If you are taking XGEVA® do not take Prolia®.

Severe jaw bone problems (osteonecrosis)

Severe jaw bone problems may happen when you take XGEVA®. Your doctor should examine your mouth before you start, and while you are taking XGEVA®. Tell your dentist that you are taking XGEVA®. It is important for you to practice good mouth care during treatment with XGEVA®. In studies of patients with bone metastases, the rate of severe jaw problems was higher the longer they were being treated with XGEVA®.

Unusual thigh bone fracture

Unusual thigh bone fracture has been reported. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.

Risk of high calcium levels in patients who are still growing

Patients with bones that are not fully matured are at a greater risk to develop high blood calcium levels after they stop taking XGEVA®, that can be serious.

Possible harm to your unborn baby

You should not become pregnant while taking XGEVA®. Tell your doctor right away if you are pregnant, plan to become pregnant, or suspect you are pregnant. XGEVA® can harm your unborn baby. Women of child bearing age should use highly effective contraception while taking XGEVA® and for at least 5 months after the last dose of XGEVA®.

Tell your doctor if you:

  • Are taking a medicine called Prolia® (denosumab) because it contains the same medicine as XGEVA®
  • Have symptoms of low blood calcium such as muscle stiffness or cramps
  • Have symptoms of severe jaw bone problems such as pain or numbness
  • Have ongoing pain or slow healing after dental surgery
  • Have symptoms of high blood calcium such as nausea, vomiting, headache, and decreased alertness
  • Are pregnant, plan to become pregnant, suspect you are pregnant, or breastfeeding

While taking XGEVA®, you should:

  • Take good care of your teeth and gums and visit a dentist as recommended
  • Tell your dentist that you are taking XGEVA®
  • Tell your doctor if you plan to have dental surgery or teeth removed
  • Women of child bearing age should use highly effective contraception while taking XGEVA® and for at least 5 months after the last dose of XGEVA®

What are the possible side effects of XGEVA®?

The most common side effects in patients receiving XGEVA® for the prevention of serious bone problems were tiredness/weakness, low phosphate levels in your blood, and nausea. The most common serious side effect of XGEVA® was shortness of breath.

These are not all the possible side effects of XGEVA®. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

To learn more about how XGEVA® can help prevent serious bone problems in people with solid tumors such as breast and prostate cancer, whose cancer has spread to the bone, talk to your doctor to see if XGEVA® is right for you.

Please see the Full Prescribing Information available on this web page.

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XGEVA® Clinical Data

The XGEVA® clinical study program included more than
5,600 patients with bone metastases from solid tumors,
like breast and prostate cancer1,14

In a study of 2,046 patients with bone metastases from breast cancer, XGEVA® lowered the chance of serious bone problems* by 18% more than zoledronic acid.1,18

In a study of 1,901 patients with bone metastases from prostate cancer, XGEVA® lowered the chance of serious bone problems by 18% more than zoledronic acid.1,19

In a study of 1,776 patients with bone metastases from other solid tumors, (excluding breast and prostate cancer) or multiple myeloma, XGEVA® was no better than zoledronic acid in lowering the chance of serious bone problems.1,20

XGEVA® is not used to prevent serious bone problems in patients with multiple myeloma.

*Serious bone problems are: broken bones (fractures), need for surgery to prevent or repair broken bones, need for radiation to the bone, and pressure on the spinal cord (spinal cord compression).

XGEVA® can prevent serious bone problems, and was studied in patients with bone metastases from breast cancer, prostate cancer, and these types of other solid tumor cancers1,21:

  • Non-small cell lung cancer (12%)
  • Renal cancer (2%)
  • Small cell lung cancer (2%)
  • Cancer types with less than 5% of patients included:
  • Bladder cancer
  • Cervical cancer
  • Colon cancer
  • Endometrial cancer
  • Esophageal cancer
  • Gastric cancer
  • Head and neck cancer
  • Melanoma
  • Neuroendocrine/carcinoid cancer
  • Non-Hodgkin's lymphoma
  • Ovarian cancer
  • Pancreatic cancer
  • Rectal cancer
  • Soft tissue sarcoma
  • Thyroid cancer

XGEVA® (denosumab) Injection

XGEVA® administration: 1 injection, every 4 weeks1

XGEVA® is an injection given every 4 weeks XGEVA® is an injection given every 4 weeks XGEVA® is given as a single shot under the skin in the upper
arm, upper thigh, or abdomen.1

  • Given once every 4 weeks in your doctor's office
  • Is not infused through your vein

Important Safety Information

Do not take XGEVA® if you have low blood calcium (hypocalcemia). Your low blood calcium must be treated before you receive XGEVA®. XGEVA® can significantly lower the calcium levels in your blood and some deaths have been reported. Take calcium and vitamin D as your doctor tells you to. Tell your doctor right away if you experience spasms, twitches, cramps, or stiffness in your muscles or numbness or tingling in your fingers, toes, or around your mouth.

Do not take XGEVA® if you are allergic to denosumab or any of the ingredients of XGEVA®. Serious allergic reactions have happened in people who take XGEVA®. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of the face, lips, or tongue, rash; itching; or hives.

What is the most important information you should know about XGEVA®?

XGEVA® contains the same medicine as Prolia® (denosumab). If you are taking XGEVA® do not take Prolia®.

Severe jaw bone problems (osteonecrosis)

  • Severe jaw bone problems may happen when you take XGEVA®. Your doctor should examine your mouth before you start, and while you are taking XGEVA®. Tell your dentist that you are taking XGEVA®. It is important for you to practice good mouth care during treatment with XGEVA®. In studies of patients with bone metastases, the rate of severe jaw problems was higher the longer they were being treated with XGEVA®.

Unusual thigh bone fracture

  • Unusual thigh bone fracture has been reported. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.

Risk of high calcium levels in patients who are still growing

  • Patients with bones that are not fully matured are at a greater risk to develop high blood calcium levels after they stop taking XGEVA®, that can be serious.

Possible harm to your unborn baby

  • You should not become pregnant while taking XGEVA®. Tell your doctor right away if you are pregnant, plan to become pregnant, or suspect you are pregnant. XGEVA® can harm your unborn baby. Women of child bearing age should use highly effective contraception while taking XGEVA® and for at least 5 months after the last dose of XGEVA®.

Tell your doctor if you:

  • Are taking a medicine called Prolia® (denosumab) because it contains the same medicine as XGEVA®
  • Have symptoms of low blood calcium such as muscle stiffness or cramps
  • Have symptoms of severe jaw bone problems such as pain or numbness
  • Have ongoing pain or slow healing after dental surgery
  • Have symptoms of high blood calcium such as nausea, vomiting, headache, and decreased alertness
  • Are pregnant, plan to become pregnant, suspect you are pregnant, or breastfeeding

While taking XGEVA®, you should:

  • Take good care of your teeth and gums and visit a dentist as recommended
  • Tell your dentist that you are taking XGEVA®
  • Tell your doctor if you plan to have dental surgery or teeth removed
  • Women of child bearing age should use highly effective contraception while taking XGEVA® and for at least 5 months after the last dose of XGEVA®

What are the possible side effects of XGEVA®?

  • The most common side effects in patients receiving XGEVA® for the prevention of serious bone problems were tiredness/weakness, low phosphate levels in your blood, and nausea. The most common serious side effect of XGEVA® was shortness of breath.

These are not all the possible side effects of XGEVA®. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Indication and Limitation of Use

XGEVA® is a prescription medicine used to prevent fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with bone metastases from solid tumors.
XGEVA® is not used to prevent these bone problems in patients with multiple myeloma.

Please see Full Prescribing Information.

Important Safety Information

Do not take XGEVA® if you have low blood calcium (hypocalcemia). Your low blood calcium must be treated before you receive XGEVA®. XGEVA® can significantly lower the calcium levels in your blood and some deaths have been reported. Take calcium and vitamin D as your doctor tells you to. Tell your doctor right away if you experience spasms, twitches, cramps, or stiffness in your muscles or numbness or tingling in your fingers, toes, or around your mouth.

Do not take XGEVA® if you are allergic to denosumab or any of the ingredients of XGEVA®. Serious allergic reactions have happened in people who take XGEVA®. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of the face, lips, or tongue, rash; itching; or hives.

What is the most important information you should know about XGEVA®?

XGEVA® contains the same medicine as Prolia® (denosumab). If you are taking XGEVA® do not take Prolia®.

Severe jaw bone problems (osteonecrosis)

  • Severe jaw bone problems may happen when you take XGEVA®. Your doctor should examine your mouth before you start, and while you are taking XGEVA®. Tell your dentist that you are taking XGEVA®. It is important for you to practice good mouth care during treatment with XGEVA®. In studies of patients with bone metastases, the rate of severe jaw problems was higher the longer they were being treated with XGEVA®.

Unusual thigh bone fracture

  • Unusual thigh bone fracture has been reported. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.

Risk of high calcium levels in patients who are still growing

  • Patients with bones that are not fully matured are at a greater risk to develop high blood calcium levels after they stop taking XGEVA®, that can be serious.

Possible harm to your unborn baby

  • You should not become pregnant while taking XGEVA®. Tell your doctor right away if you are pregnant, plan to become pregnant, or suspect you are pregnant. XGEVA® can harm your unborn baby. Women of child bearing age should use highly effective contraception while taking XGEVA® and for at least 5 months after the last dose of XGEVA®.

Tell your doctor if you:

  • Are taking a medicine called Prolia® (denosumab) because it contains the same medicine as XGEVA®
  • Have symptoms of low blood calcium such as muscle stiffness or cramps
  • Have symptoms of severe jaw bone problems such as pain or numbness
  • Have ongoing pain or slow healing after dental surgery
  • Have symptoms of high blood calcium such as nausea, vomiting, headache, and decreased alertness
  • Are pregnant, plan to become pregnant, suspect you are pregnant, or breastfeeding

While taking XGEVA®, you should:

  • Take good care of your teeth and gums and visit a dentist as recommended
  • Tell your dentist that you are taking XGEVA®
  • Tell your doctor if you plan to have dental surgery or teeth removed
  • Women of child bearing age should use highly effective contraception while taking XGEVA® and for at least 5 months after the last dose of XGEVA®

What are the possible side effects of XGEVA®?

  • The most common side effects in patients receiving XGEVA® for the prevention of serious bone problems were tiredness/weakness, low phosphate levels in your blood, and nausea. The most common serious side effect of XGEVA® was shortness of breath.

These are not all the possible side effects of XGEVA®. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Indication and Limitation of Use

XGEVA® is a prescription medicine used to prevent fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with bone metastases from solid tumors.
XGEVA® is not used to prevent these bone problems in patients with multiple myeloma.

Please see Full Prescribing Information.

*ZOMETA® is a registered trademark of Novartis AG Corporation.


References

  1. XGEVA® (denosumab) prescribing information, Amgen.
  2. Wedin R. Surgical treatment for pathologic fracture. Acta Orthop Scand Suppl. 2001;72:1-29.
  3. Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006;12(suppl 20):6243s-6249s.
  4. Sathiakumar N, Delzell E, Morrisey MA, et al. Mortality following bone metastasis and skeletal-related events among men with prostate cancer: a population-based analysis of US Medicare beneficiaries, 1999-2006. Prostate Cancer Prostatic Dis. 2011;14:177-183.
  5. Moore RE, Lackman RD. Metastatic bone disease. UPOJ. 2010;20:117-120.
  6. Torbert JT, Lackman RD. Pathologic fractures. In: Pignolo RJ, Keenan MA, Hebela NM, eds. Fractures in the Elderly: A Guide to Practical Management. 1st ed. New York, NY: Springer Science and Business Media; 2011:43-53.
  7. Zhu Y-J. Palliative radiotherapy for painful bone metastases: short-course or long-course? Ann Palliat Med. 2012;1:78-80.
  8. Lutz ST, Chow EL, Hartsell WF, Konski AA. A review of hypofractionated palliative radiotherapy. Cancer. 2007;109:1462-1470.
  9. Ben-Josef E, Shamsa F, Williams AO, Porter AT. Radiotherapeutic management of osseous metastases: a survey of current patterns of care. Int J Radiat Oncol Biol Phys. 1998;40:915-921.
  10. Mercadante S. Malignant bone pain: pathophysiology and treatment. Pain. 1997;69:1-18.
  11. Osborn JL, Getzenberg RH, Trump DL. Spinal cord compression in prostate cancer. J Neurooncol. 1995;23:135-147.
  12. Nielsen OS, Munro AJ, Tannock IF. Bone metastases: pathophysiology and management policy. J Clin Oncol. 1991;9:509-524.
  13. Levack P, Graham J, Collie D, et al, the Scottish Cord Compression Study Group. Dont wait for a sensory level  listen to the symptoms: a prospective audit of the delays in diagnosis of malignant cord compression. Clin Oncol. 2002;14:472-480.
  14. Lipton A, Fizazi K, Stopeck AT, et al. Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: a combined analysis of 3 pivotal, randomised, phase 3 trials. Eur J Cancer. 2012;48:3082-3092.
  15. ZOMETA® (zoledronic acid) prescribing information, Novartis Pharmaceuticals Corp.
  16. Roodman GD. Mechanisms of bone metastasis. N Engl J Med. 2004;350:1655-1664.
  17. Mundy GR. Metastasis to bone: causes, consequences and therapeutic opportunities. Nat Rev Cancer. 2002;2:584-593.
  18. Stopeck AT, Lipton A, Body J-J, et al. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010;28:5132-5139.
  19. Fizazi K, Carducci M, Smith M, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011;377:813-822.
  20. Henry DH, Costa L, Goldwasser F, et al. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011;29:1125-1132.
  21. Data on file, Amgen.