Xgeva (denosumab)

What is Xgeva?

Xgeva® is a monoclonal antibody that prevents bone complications in myeloma patients. Our bodies have a delicate balance between cells that build bone (osteoblasts) and cells that break down bone (osteoclasts). For myeloma patients, signals sent by cancerous myeloma cells can disrupt this balance and lead to excess bone breakdown.

Xgeva targets and inhibits a protein called RANKL. In myeloma patients, RANKL proteins activate osteoclasts to break down bone. Therefore, Xgeva reduces serious bone problems and bone pain by restoring balance to your bones through RANKL inhibition¹. 

In a study of 1,718 newly diagnosed myeloma patients, Xgeva provided approximately 23 months of prevention from bone complications².  Xgeva was found to be as effective at preventing bone lesions as another medication called zoledronic acid (Reclast®, Zometa®)³. Taking Xgeva was also associated with a greater progression-free survival than zoledronic acid, suggesting Xgeva may also have an anti-myeloma effect.⁴

Who is a candidate for Xgeva?

Xgeva is approved to prevent bone-related events in adult patients with multiple myeloma. 

You cannot take Xgeva if you have severe, untreated hypocalcemia (low calcium levels in your blood). Xgeva can cause severe hypocalcemia, and fatal cases have been reported. If you have hypocalcemia, your doctors must treat this condition before starting Xgeva. 

Xgeva can cause loss of blood supply to the jawbone, also called osteonecrosis of the jaw. Therefore, you cannot take Xgeva if you have open or unhealed wounds from dental or mouth surgery. 

There are other reasons you may not be a candidate for Xgeva. Please see the package insert and ask your doctor for more information.

How is Xgeva given?

Xgeva is given as a subcutaneous injection (an injection under the skin), usually given once every 4 weeks. If you are taking Xgeva, your doctor may advise you to take calcium and vitamin D supplements to treat or prevent low calcium levels in your blood (hypocalcemia).

Potential side effects of Xgeva

Xgeva can cause severe side effects in some people. The most common side effects of Xgeva for multiple myeloma patients include:

• diarrhea,
• nausea, 
• low red blood cells (anemia), 
• low blood platelets (thrombocytopenia), 
• low levels of calcium (hypocalcemia), 
• back pain, 
• swelling of the lower legs or hands, 
• upper respiratory tract infections, 
• rash, 
• and headaches.
   

The most common serious side effect seen in clinical trials was pneumonia⁵. 

Two of the more serious side effects of Xgeva include:

• Hypocalcemia (low calcium levels). May cause muscle stiffness, twitching, spasms, cramps, or unusual feelings such as burning, tingling, or prickling (paresthesia). 
• Osteonecrosis of the jaw. May cause feel pain, numbness, unusual drainage, or swelling from the jaw, mouth, or teeth. 

For a complete list of side effects, please see the Xgeva package insert and consult the additional resources below.

Additional information on Xgeva

• The European Public Assessment Report (EPAR) on Xgeva
• FDA Label / Package Insert for Xgeva
• Amgen: Learn about Xgeva
• Denosumab versus zoledronic acid in bone disease treatment of newly diagnosed multiple myeloma: an international, double-blind, double-dummy, randomized, controlled, phase 3 study