Denosumab (Xgeva®)

Other Names: Xgeva®

About This Drug

Denosumab is used to prevent and treat bone problems due to bone metastasis from cancer. It is also used to treat high calcium levels due to cancer. It is given as an injection under your skin (subcutaneously).

Possible Side Effects

  • Tiredness and weakness
  • Headache
  • Decreased appetite (decreased hunger)
  • Nausea and throwing up (vomiting)
  • Loose bowel movements (diarrhea)
  • Constipation (unable to move your bowels)
  • Electrolyte changes
  • Trouble breathing
  • Back pain
  • Swelling of your legs, ankles and/or feet
  • Decrease in red blood cells. This may make you more tired.

Note: Each of the side effects above was reported in 20% or greater of patients treated with denosumab. Not all possible side effects are included above.

Warnings and Precautions

  • Allergic reactions, including anaphylaxis are rare but may happen in some patients. Signs of allergic reaction to this drug may be swelling of the face, feeling like your tongue or throat are swelling, trouble breathing, rash, itching, fever, chills, feeling dizzy, and/or feeling that your heart is beating in a fast or not normal way. If this happens, do not take another dose of this drug. You should get urgent medical treatment.
  • Severe low calcium which can be life-threatening. You may experience numbness or tingling around your mouth or in your hands or feet. Other symptoms of low calcium are muscle stiffness, twitching, spasms, or cramps.
  • Osteonecrosis of the jaw. This is a breakdown of the jaw bone. It is a bad but rare health problem.Possible symptoms are:
    • pain, swelling, or infection of the gums
    • loose teeth
    • poor healing of the gums
    • numbness or the feeling that your jaw is heavy
  • Femoral bone fractures
  • High levels of calcium once treatment is complete in patients with growing skeletons
  • Risk of broken bones when treatment is stopped, especially if you have a history of fractures or osteoporosis. Do not stop treatment without first talking to your doctor.

Important Information

  • Take calcium and vitamin D supplements as your doctor recommends to decrease your risk of low calcium
  • Do not substitute or take at the same time Prolia®, which is another brand of denosumab.

Treating Side Effects

  • Drink plenty of fluids (a minimum of eight glasses per day is recommended).
  • If you throw up or have loose bowel movements, you should drink more fluids so that you do not become dehydrated (lack water in the body from losing too much fluid).
  • If you get diarrhea, eat low-fiber foods that are high in protein and calories and avoid foods that can irritate your digestive tracts or lead to cramping.
  • Ask your nurse or doctor about medicine that can lessen or stop your diarrhea.
  • To help with nausea and vomiting, eat small, frequent meals instead of three large meals a day. Choose foods and drinks that are at room temperature. Ask your nurse or doctor about other helpful tips and medicine that is available to help or stop lessen these symptoms.
  • To help with decreased appetite, eat high caloric food such as pudding, ice cream, yogurt and milkshakes.
  • Ask your doctor or nurse about medicines that are available to help stop or lessen constipation.
  • If you are not able to move your bowels, check with your doctor or nurse before you use enemas, laxatives, or suppositories.
  • Manage tiredness by pacing your activities for the day. Be sure to include periods of rest between energy-draining activities.
  • Keeping your pain under control is important to your well-being. Please tell your doctor or nurse if you are experiencing pain.
  • Tell your cancer doctor if you have any problems with your teeth or jaw before you start this drug. It is important that your dentist knows that you are on this drug. Give your dentist and your cancer doctor each other’s name and phone number so they may call each other if they have any questions.

Food and Drug Interactions

  • There are no known interactions of denosumab with food or with other medications.
  • Tell your doctor and pharmacist about all the medicines and dietary supplements (vitamins, minerals, herbs and others) that you are taking at this time. The safety and use of dietary supplements and alternative diets are often not known. Using these might affect your cancer or interfere with your treatment. Until more is known, you should not use dietary supplements or alternative diets without your cancer doctor's help.

When to Call the Doctor

Call your doctor or nurse if you have any of these symptoms and/or any new or unusual symptoms:

  • Fever of 100.5 F (38 C) or higher
  • Chills
  • Headache
  • Nausea that stops you from eating or drinking and/or is not relieved by prescribed medicines
  • Throwing up more than 3 times a day
  • Lasting loss of appetite or rapid weight loss of five pounds in a week
  • Loose bowel movements (diarrhea) 4 times a day or loose bowel movements with lack of strength or a feeling of being dizzy
  • No bowel movement in 3 days or when you feel uncomfortable
  • Weight gain of 5 pounds in one week (fluid retention)
  • Fatigue that interferes with your daily activities
  • Signs of allergic reaction: swelling of the face, feeling like your tongue or throat are swelling, trouble breathing, rash, itching, fever, chills, feeling dizzy, and/or feeling that your heart is beating in a fast or not normal way
  • Signs of osteonecrosis of the jaw such as pain, swelling or infection of the gums, loose teeth, poor healing of the gums, numbness or the feeling that your jaw is heavy
  • Signs of low calcium such as numbness or tingling around your mouth or in your hands or feet. Other symptoms of low calcium are muscle stiffness, twitching, spasms, or cramps.
  • New hip, thigh or groin pain, or other unexplained bone pain
  • If you think you may be pregnant

Reproduction Warnings

  • Pregnancy warning: This drug can have harmful effects on the unborn baby. Women of child bearing potential should use effective methods of birth control during your cancer treatment and for at least 5 months after treatment. Let your doctor know right away if you think you may be pregnant.
  • Breastfeeding warning: It is not known if this drug passes into breast milk. For this reason, women should talk to their doctor about the risks and benefits of breast feeding during treatment with this drug because this drug may enter the breast milk and cause harm to a breast feeding baby.
  • Fertility warning: Human fertility studies have not been done with this drug. Talk with your doctor or nurse if you plan to have children.

Revised: June 2018

This patient information was developed by Via Oncology, LLC © 2018. This information is not intended to be used as a substitute for professional medical advice, diagnosis, or treatment. You should not rely entirely on this information for your health care needs. Ask your own doctor or health care provider any specific medical questions that you have.

CLIENT acknowledges that the Via Pathways and Via Portal are information management tools only, and that Via Oncology, LLC has not represented the Via Pathways or Via Portal as having the ability to diagnose disease, prescribe treatment, or perform any other tasks that constitute the practice of medicine. The clinical information contained in the Via Pathways and Via Portal are intended as a supplement to, and not a substitute for, the knowledge, expertise, skill, and judgment of physicians, pharmacists and other healthcare professionals involved with patient care at CLIENT facilities.