XGEVA® as a treatment for giant cell tumor of bone (GCTB)

XGEVA® is a prescription medicine used to treat adults and some skeletally mature adolescents with giant cell tumor of bone that cannot be surgically removed (unresectable) or when surgery is likely to result in severe morbidity, such as loss of limbs or joint removal.

XGEVA® is the first and only FDA-approved treatment for giant cell tumor of bone (GCTB).1

GCTB: a rare, aggressive benign tumor2,3

GCTB is a benign, or non-cancerous, tumor. There are approximately 300 to 800 new cases of GCTB per year in the US.4 Even though it is not cancerous, GCTB can cause damage in the area in which it occurs. It can lead to the breakdown of bone and expand into the surrounding soft tissues.3

How XGEVA® works in GCTB

Bone is constantly being built and broken down in your body. Cells that break down bones are called osteoclasts [os-tee-uh-klasts]. A chemical, called RANK Ligand (RANKL), sends signals to the osteoclasts that cause them to increase the breakdown of your bone.5

GCTB acts in a similar way to osteoclasts. RANK Ligand sends signals to the GCTB that cause it to grow and lead to bone breakdown.1-3 XGEVA® works on the RANKL to stop the activity of osteoclasts and GCTB and slows down bone breakdown.1-3

  • RANK Ligand, or RANKL, attaches to GCTB.

  • RANKL sends signals to GCTB that causes it to grow and damage the bone.

  • XGEVA® binds to RANKL and slows bone breakdown and GCTB growth.1

XGEVA® administration1

XGEVA® is given as a single shot under the skin into the upper arm, upper thigh, or abdomen.1

The recommended dose of XGEVA® is 120 mg administered every 4 weeks, with additional 120 mg doses on Days 8 and 15 of the first month of therapy.1

Calcium and vitamin D should be administered as necessary to treat or prevent hypocalcemia.1

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. XGEVA® (denosumab) prescribing information, Amgen.
  2. Turcotte RE. Giant cell tumor of bone. Orthop Clin North Am. 2006;37:35-51.
  3. Mendenhall WM, Zlotecki RA, Scarborough MT, Gibbs CP, Mendenhall NP. Giant cell tumor of bone. Am J Clin Oncol. 2006;29:96-99.
  4. Data on file, Amgen.
  5. Roodman GD. Mechanisms of bone metastasis. N Engl J Med. 2004;350:1655-1664.