Indication

XGEVA® is a prescription medicine used to prevent fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with multiple myeloma and in patients with bone metastases from solid tumors.

XGEVA® is a prescription medicine used to prevent fracture, spinal cord compression, or the need for radiation or surgery to bone in patients(see more)

XGEVA® is a prescription medicine used to prevent fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with multiple myeloma and in patients with bone metastases from solid tumors.

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Is XGEVA® right for you? 

Read on to learn what it is, how it works, and what to expect during treatment

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Ask your doctor about treatment with XGEVA®.

These questions can help.

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Ask your doctor about treatment with XGEVA®.

These questions can help.

What is XGEVA® (denosumab)?

XGEVA® is a bone-targeting medicine used to prevent serious bone problems

Serious bone problems are defined as broken bones (fracture), spinal cord compression, or the need for radiation or surgery to the bone.

XGEVA®, also called denosumab, is prescribed for people with bone metastases from breast, prostate, and other solid tumors (cancer) and for people with multiple myeloma.

XGEVA® is not chemotherapy or other treatment for your cancer. XGEVA® is also not Prolia® (denosumab), which is used to treat different medical conditions. Do not take XGEVA® if you are currently taking Prolia®.

Learn more about serious bone problems here.

Talk with your doctor to see if XGEVA® may be right for you.

This conversation starter can help

How does XGEVA® work?

Your bones are constantly changing, always breaking down and rebuilding to stay strong. Certain cells, called osteoclasts (OS•tee•oh•clasts), are designed to break down old bone, while other cells, called osteoblasts (OS•tee•oh•blasts), build bone back up.

XGEVA® works to restore balance in your bones

Click on the tabs below to learn more.

Tap on the tabs below to learn more.

Cancer cells in the bone can disrupt the balance between bone breakdown and buildup.

Cancer cells send signals to bone buildup cells that start a chain reaction. These signals tell the bone buildup cells to increase the signals they send to the bone breakdown cells.

More signals to bone breakdown cells means that bone breakdown speeds up, which weakens bone and can lead to serious bone problems.

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In people with multiple myeloma, the bone breakdown and bone buildup are not balanced due to abnormal signals from cancer cells. The diagram below explains how this can lead to serious bone problems, and how XGEVA® works to prevent them.

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How can XGEVA® help?

XGEVA® taken once every 4 weeks can help prevent serious bone problems

Click on the tabs below to see how XGEVA® helped people with different types of cancer.

Tap on the tabs below to see how XGEVA® helped people with different types of cancer.

ALL SOLID TUMORS, INCLUDING BREAST AND PROSTATE CANCER

XGEVA® provides superior protection against serious bone problems
compared with ZA in people with solid tumors that spread to bone

XGEVA® was compared with zoledronic acid (ZA), another commonly used bone-targeting medicine,
in a combined analysis of three clinical studies including 5,723 people who had breast, prostate, and
other types of solid tumors with bone metastases.

XGEVA® prevented serious bone problems
for more than 2 years

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To see clinical results for your type of cancer, click the tabs below.

To see clinical results for your type of cancer, click the tabs below.

BREAST CANCER ONLY

XGEVA® was proven superior at preventing serious bone problems
for more than 2 years

XGEVA® was compared with zoledronic acid (ZA), another commonly used bone-targeting medicine, in
a clinical study of 2,046 women with breast cancer and bone metastases.

At 27 months,

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taking XGEVA® had not experienced
a serious bone problem

Approximately 5 out of 10 patients on ZA had not experienced a serious bone problem at 26.4 months.

Women treated with XGEVA®

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were 18% less likely to have
serious bone problems than with ZA

PROSTATE CANCER ONLY

XGEVA® provided superior prevention from serious bone problems
versus ZA

XGEVA® was compared with zoledronic acid (ZA), another commonly used bone-targeting medicine, in
a clinical study of 1,901 men with prostate cancer and bone metastases.

At 20.7 months,

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taking XGEVA® had not experienced
a serious bone problem

Approximately 5 out of 10 patients taking ZA had not experienced a serious bone problem at 17.1 months.

Men treated with XGEVA®

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were 18% less likely to have
serious bone problems than with ZA

OTHER CANCER TYPES (SOLID TUMORS)

XGEVA® prevented serious bone problems in people with other
solid tumors

XGEVA® was compared with zoledronic acid (ZA), another commonly used bone-targeting medicine, in a clinical trial of 1,597 people with solid tumors (other than breast or prostate cancer).

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XGEVA® prevented
serious bone problems
6 months longer than ZA

Half of people had not experienced a serious bone problem at:

  • 21.4 months with XGEVA®
  • 15.4 months with ZA

In the same clinical trial, but including patients with multiple myeloma (1,776 people), XGEVA® prevented serious bone problems.

Half of people had not experienced a serious bone problem at:

  • 20.5 months with XGEVA®
  • 16.3 months with ZA

Click tab below to see results
in multiple myeloma.

Tap the tab below to see results
in multiple myeloma.

MULTIPLE MYELOMA

XGEVA® helps prevent serious bone problems in people
with multiple myeloma

In a clinical study of 1,718 patients, XGEVA® given every 4 weeks was compared with another bone-targeting agent, zoledronic acid (ZA). The clinical study measured the time to the first serious bone problem and compared the results between XGEVA® and ZA. XGEVA® was shown to not be worse than ZA.

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Half of people taking XGEVA® went at least 22.8 months without experiencing a serious bone problem and half of people taking ZA went at least 24 months

Serious bone problems and pain

XGEVA® given every 4 weeks was compared with ZA in women with breast cancer and bone metastases

Serious bone problems cause many women with breast cancer to feel pain

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More than 4 out of 5 women
with a serious bone problem
experienced bone pain

Time to worsening of pain was reported in studies of
XGEVA® compared with ZA

XGEVA® does not treat pain; it is used to prevent serious bone problems.

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compared with 5.8 months for ZA

Women with breast
cancer taking XGEVA®
went
3.9 months longer
before experiencing
moderate to severe pain
than those taking ZA

  • A similar analysis done in patients with other tumor types and bone
    metastases did not find as much of a difference
    • In prostate cancer: XGEVA® 5.8 months vs ZA 4.9 months, which is a
      0.9-month difference
    • In solid tumor-only cancer: XGEVA® 4.7 months vs ZA 3.7 months, which is
      a 1-month difference
  • These values show how long it took for patients’ pain to worsen
  • The study was not designed to show a reduction in pain. It is not known if
    the difference between these two groups was due to either drug. Patients
    self-reported pain using a predetermined scale. Your results may vary. Please
    talk to your doctor about what these results may mean for you

Ready to find out if XGEVA® is right for you?

Talk with your doctor. This conversation starter can help

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What are the
possible side effects?

Side effects have been reported; some of them have been serious.

Read on to learn about some of the most common and serious side effects.

Here are some of the most common side effects seen in clinical trials 

In people with bone metastases from breast, prostate, and other solid tumors:

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

The most common serious side effect was shortness of breath.

In people with multiple myeloma:

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

The most common serious side effect was pneumonia.

These are not all the possible side effects of XGEVA®

Other side effects have been reported. It is important to be aware of them and look
for signs and symptoms.

Learn about other serious side effects that are possible with XGEVA®

Click on the tabs below.

Tap on the tabs below.

OSTEONECROSIS OF THE JAW

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Osteonecrosis of the jaw

Severe jaw bone problems called osteonecrosis (os•tee•oh•neh•CROW•sis) of the jaw (ONJ) may happen when you take XGEVA®.

The majority of patients who developed ONJ had a history of risk factors. Read about symptoms and risk factors below.

Call your doctor if you have any of these symptoms:

  • Soft tissue swelling and redness
  • Loose teeth
  • Jaw pain
  • Infection of gums or jaw
  • Slow healing after dental work

Risk factors for ONJ:

  • Tooth extraction
  • Dental implants
  • Gingivitis or inflammatory dental disease
  • Use of dentures or other dental appliances

In studies of people with bone involvement, the rate of severe jaw problems was higher the longer they were being treated with XGEVA®.

For good oral hygiene, the American Dental Association (ADA) suggests that you:

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  • Brush twice daily
  • Rinse with fluoride
  • Replace toothbrush every 3-4 months
  • Floss regularly
  • Clean dentures daily
  • Visit your dentist regularly

Your doctor should examine your mouth before you start and while
you are taking XGEVA®. Tell your dentist that you are taking XGEVA®.
Open this handy dental health tool to bring to your dentist appointments.

HYPOCALCEMIA

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Hypocalcemia

Low calcium levels in the blood, known as hypocalcemia (hi•po•cal•SEE•me•ah), have been seen in people taking XGEVA®.

Your doctor will test your blood calcium levels before starting you on XGEVA® and while you
are in treatment.

  • If your calcium levels are low, your doctor may give you vitamin D and calcium supplements to
    help raise your calcium levels. Hypocalcemia can be life-threatening, so be sure to take these
    supplements as prescribed

Call your doctor if you have any stiffness, twitching, spasms, or cramps in your muscles.

THIGH BONE FRACTURES

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Thigh bone fractures

Unusual thigh bone fracture has been reported. Your thigh bone may be at
risk for breaking. It may break from minimal or no impact.

Call your doctor if you have new or unusual pain in your hip, groin, or thigh.

FRACTURES OF THE SPINE

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After stopping XGEVA®: increased risk of broken
bones in the spine

Risk for breaking bones in the spine is higher after stopping XGEVA®.
If you have a history of broken bones (fractures) or osteoporosis, your
risk may be higher.

Risk for breaking bones in the spine is higher after stopping XGEVA®.
If you have a history of broken bones (fractures) or osteoporosis, your
risk may be higher.

Be sure to discuss your potential risk for broken bones in
the spine before you stop taking XGEVA®.

Be sure to review the full Important Safety Information provided below.

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You can access CO-PAY ASSISTANCE, recipes, and nurse support
when you sign up for XGEVA® Cares. Sign up here.

Learn what to expect when you begin treatment with XGEVA®.

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Starting XGEVA®