Cancer from Solid Tumors and Bone Metastases

Understanding cancer spreading to bone

Metastatic cancer from solid tumors and bone metastases

Cancer cells from the primary (original) location of your tumor may travel through the bloodstream or lymphatic system and reach your bones. When these cells grow in the bone, they are called "bone metastases" (muh•TASS•tuh•seez).1

When cancer spreads to the bone, it can lead to bone break down, which can cause serious bone problems, that are: broken bones (fractures), a need for surgery to prevent or repair broken bones, a need for radiation treatments to the bone, and pressure on the spinal cord (spinal cord compression).


The Basics of Cancer from Solid Tumors Spreading to Bone

Understanding bone metastases from solid tumors

Bone metastases can happen in any bone in the body, but they are commonly found in the bones near the center of the body like the spine, ribs, skull, hips, and pelvis.1

Bone without metastases | beginning of metastases | bone with fully developed metastases

How often does cancer spread to the bone?

Cancer may spread to the bone in as many as 68% of men with advanced metastatic prostate cancer and in 73% of women with advanced metastatic breast cancer.2

The percentage of patients whose prostate, breast, and lung cancer may spread to bone These numbers are from autopsy studies of patients with cancer in select tumor types in which bone metastases are most common.

XGEVA® can prevent serious bone problems. XGEVA® was studied in patients with bone metastases from breast cancer, prostate cancer, and these types of other solid tumor cancers.3,4

  • 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
If cancer from solid tumors has spread to your bones, XGEVA® may be able to help.

If cancer from solid tumors has spread to your bones, XGEVA® can prevent serious bone problems.4

Find out how

The Results of Bone Metastases

What it means when cancer spreads to your bones

There are cells in your body that remove old bone and other cells that rebuild new bone. This ongoing process helps keep your bones strong.5

When cancer has spread to your bones, this process can become unbalanced. This can result in weaker bones and can cause serious bone problems, which are: broken bones (fractures), a need for surgery to prevent or repair broken bones, a need for radiation treatments to the bone, and pressure on the spinal cord (spinal cord compression).6

Talk with your doctor

XGEVA® can prevent serious bone problems in patients with solid tumors metastatic to the bone.4

Find out how

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.

References

  1. American Cancer Society web site. Bone metastasis. http://www.cancer.org/acs/groups/cid/documents/
    webcontent/003087-pdf.pdf. Accessed May 27, 2014.
  2. Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006;12(suppl 20):6243s-6249s.
  3. Data on file, Amgen.
  4. XGEVA® (denosumab) prescribing information, Amgen.
  5. Roodman GD. Mechanisms of bone metastasis. N Engl J Med. 2004;350:1655-1664.
  6. Mundy GR. Metastasis to bone: causes, consequences and therapeutic opportunities. Nat Rev Cancer. 2002;2:584-593.