Xgeva (Denosumab)

  • XGEVA contains denosumab, a protein (monoclonal antibody) that works to slow down bone destruction caused by cancer spreading to the bone (bone metastasis) or by giant cell tumour of bone.
  • XGEVA is used in adults with advanced cancer to prevent serious complications caused by bone metastasis (e.g. fracture, pressure on the spinal cord or the need to receive radiation therapy or surgery).
  • XGEVA is also used to treat giant cell tumour of bone, which cannot be treated by surgery or where surgery is not the best option, in adults and adolescents whose bones have stopped growing.

Garvan J. Lynch
Superintendent Pharmacist

MBA (Public Health)

What Xgeva Is Used For:

  • Prevention of skeletal-related events (need for radiation, fracture due to cancer in the bone, surgery to the bone, or compression of the spinal cord) in patients with multiple myeloma and bone metastases from solid tumors.
  • Treatment of giant cell tumor of the bone.
  • Note: If a drug has been approved for one use, doctors sometimes elect to use this same drug for other problems if they believe it might be helpful.

How Xgeva Is Given:

  • As a subcutaneous injection in the upper arm, upper thigh, or abdomen.  A subcutaneous injection is a shot into the layer of skin directly below the outer skin layer.
  • There is no pill form of Xgeva.
  • The amount of Xgeva you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition you have.  Your doctor will determine your dose and schedule.

Side Effects:

The following are common (occurring in greater than 30%) side effects for patients taking Xgeva:

  • Fatigue
  • Muscle weakness
  • Decreased levels of phosphorus in your blood (hypophosphatemia)
  • Nausea

These are less common side effects (occurring in 10-29%) for patients receiving Xgeva:

  • Diarrhea
  • Shortness of breath
  • Low levels of calcium in your blood (hypocalcemia).
  • Cough
  • Joint pain
  • Headache
  • Limb pain
  • Back pain
  • Eczema
  • Rash

Osteonecrosis of the jaw has been reported rarely in patients with cancer receiving treatment regimens that include bone modifying agents.  Many of the reported cases were associated with dental procedures, such as removal of a tooth.  A dental examination with appropriate preventative dentistry should be considered prior to treatment with denosumab, particularly in patients with additional risk factors (ie cancer, chemotherapy, corticoseroids, poor oral hygiene). Invasive dental procedures should be avoided during treatment.

Not all side effects are listed above, some that are rare are not listed here.  However, you should always inform your health care provider if you experience any unusual symptoms.

Contact your health care provider immediately, day or night, if you should experience the following:

  • Difficulty breathing
  • Chest pain
  • Swelling of the face/throat
  • Confusion

The following symptoms require medical attention, but are not an emergency.  Contact your health care provider within 24 hours after noticing any of the following:

  • Muscle stiffness, twitching, spasms, or cramps (signs of low blood calcium)
  • Pain, numbness, swelling of or drainage from the jaw, mouth or teeth.
  • Any signs or symptoms of infection, especially involving the skin (redness, drainage, pain)
  • Fever of 100.4° F (38° C)
  • Fatigue and extreme tiredness (unable to perform self-care activities)
  • Nausea that interferes with eating and is not relieved by medications prescribed by your doctor.
  • Vomiting (more than 4-5 episodes within a 24-hour period).
  • Always inform your health care provider if you experience any unusual symptoms.

Precautions:

  • Do not use both Xgeva and Prolia at the same time. 
  • Before starting Xgeva treatment, make sure you tell your doctor about any other medications you are taking. Do not take aspirin or products containing aspirin unless your doctor permits this.
  • Xgeva may enhance the negative effects of immuno-suppressants.  Specifically, the risk for serious infections may be increased.  Notify your doctor of any immuno-suppressive medication you are taking. 
  • Do not receive any kind of vaccination without your doctor's approval while taking Xgeva.
  • Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. 
  • For both men and women: Do not conceive a child (get pregnant) while taking Xgeva.
  • It is not known whether Xgeva is excreted into human milk.  Because of the potential for serious adverse reactions in nursing infants from Xgeva, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

Self-Care Tips:

  • Take a calcium and vitamin D supplement as necessary to treat and/or prevent low blood calcium levels. 
  • Perform proper, thorough oral hygiene and routine dental care.  Inform your dentist that you are being treated with denosumab.
  • Avoid invasive dental procedures.
  • Inform your physician or dentist if you experience persistent pain and/or slow healing of the mouth or jaw following invasive dental procedures.
  • Drink at least 2 to 3 litres of fluid every 24 hours, unless you are instructed otherwise, as it is important to avoid becoming dehydrated.
  • Paracetamol may help relieve discomfort from fever, headache and generalized aches and pains, however talk with your doctor prior to taking it.
  • To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
  • Maintain good nutrition.

Monitoring and Testing:

  • You will be checked regularly by your doctor while you are taking Xgeva, to monitor side effects and check your response to therapy.  Periodic blood work will be obtained to monitor the function of your organs (such as your kidneys and liver), as deemed necessary by your doctor.

How Xgeva Works:

Cancer cells that spread to the bone can secrete substances that can cause cells in the bone called osteoclasts to dissolve or "eat away" a portion of the bone.  The process, during which osteoclasts break down bone and then release those minerals such as calcium from bone fluid into the blood, is called "bone resorption".  These tumors or lesions in the bone weaken the bone and can lead to complications, referred to as "skeletal related events." Some of the complications (skeletal related events) that can result from this bone breakdown are bone pain, fractures, and the need for additional procedures such as radiation therapy to reduce pain or surgery to fix or stabilize an affected bone.  Bone resorption also releases growth factors that may cause growth of tumors.

Receptor activator of nuclear factor kappa-B ligand (RANKL) is a type of protein that is important in bone metabolism.  This natural and necessary protein is found on oteoblasts (cells that are responsible for bone formation) and serves to activate osteoclasts (cells involved in bone resorption - as described above).  By inhibiting RANKL we may be able to decrease bone resorption and therefore decrease bone loss and hypercalcemia.

Xgeva binds to RANKL, a protein that is essential for the formation, function and survival of osteoclasts, the cells responsible for bone resorption.  Xgeva inhibits osteoclast formation, function and survival thereby, decreasing bone resorption and increasing bone mass and strength of the bone. 

References:

https://www.medicines.org.uk/emc/product/4675/smpc#gref

https://www.medicines.org.uk/emc/product/4675/pil#gref

https://www.xgeva.com

http://chemocare.com/chemotherapy/drug-info/Xgeva.aspx

https://www.ema.europa.eu/en/documents/product-information/xgeva-epar-product-information_en.pdf

https://www.rxlist.com/xgeva-drug.htm#indications

https://www.medicalnewstoday.com/articles/326581#about

https://www.medicines.ie/medicines/xgeva-34257/patient-info

 

 

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