Denosumab (Generic Name)

Other Names: Xgeva®, Prolia®

About this drug

This drug used to stop and treat bone problems and breaks due to bone metastasis from a solid tumor. It is also used to stop and treat osteoporosis. The drug is given by a shot under the skin (subcutaneous injection).

Possible side effects (more common)

  • Rash
  • Skin and tissue irritation may involve redness, pain, warmth, or swelling at the site of the shot.
  • Weakness that interferes with your daily activities
  • Muscle, joint and back pain or soreness
  • Fatigue
  • Nausea
  • Feeling short of breath
  • Cough
  • Headache
  • Loose bowel movements (diarrhea) that may last for a few days
  • Decreased calcium and phosphate. Your blood will be checked for these changes as needed.

Possible side effects (less common)

  • Swelling of your legs, ankles and/or feet.
  • Bone pain
  • High levels of cholesterol. Your blood will be checked by the doctor.
  • Very low levels of calcium.  Your blood will be checked by the doctor.  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.
  • You may experience persistent pain or slow healing of the mouth or jaw after dental procedures

Possible side effects (rare)

  • Cataracts
  • Osteonecrosis (oss-tee-oh-ne-KRO-sis) of the jaw. This is a breakdown of the jaw bone. It is a serious but rare issue.  Symptoms may include:
    • Pain, swelling, or infection of the gums
    • Teeth may become loose
    • Poor healing of the gums
    • Numbness or the feeling of heaviness in the jaw

Treating side effects

  • Low calcium - You should take at least 1000mg of calcium and 400 IU of Vitamin D pills each day. There are 2 types of calcium pills: calcium carbonate and calcium citrate.  Ask your doctor which type and how much you should take.
  • Tell your oncologist 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 telephone number so they may call each other if they have any questions.
  • Keep your teeth and mouth very clean. Brush your teeth and tongue with a soft toothbrush after each meal and at bedtime.
  • Use a mirror to check your teeth and gums daily for any changes, such as sores or bleeding gums. If you notice any change, tell your cancer doctor right away.
  • Do not put anything on a rash unless your doctor or nurse says you may. Keep the area around the rash clean and dry. Ask your doctor for medicine if your rash bothers you.
  • See your eye doctor if you have any vision changes.  Tell your eye doctor that you are getting denosumab.  Ask your doctor or nurse about medicines that are available to help stop or lessen constipation, loose bowel movements, muscle pain, or cough.

Food and drug interactions

  • There are no known interactions of denosumab with food. This drug may interact with other medicines. 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.
  • Denosumab may cause other drugs that lower your immunity to be more harmful to your immune system.  This may raise your risk of infection.

When to call the doctor

Call your doctor or nurse right away if you have any of these symptoms:

  • Fever of 100.5 F (38 C) or above
  • Chills 
  • Rash or itching
  • Numbness or tingling around your mouth or in fingers, toes, arms, or legs
  • Muscle stiffness, twitching, spasms, or cramps
  • Pain in your lower back
  • Loose bowel movements (diarrhea) more than 4 times a day or loose bowel movements with weakness or feeling lightheaded
  • Nausea that stops you from eating or drinking
  • Throwing up more than 3 times a day
  • Jaw pain, numbness, swelling, or fluid draining from your jaw, mouth, or teeth.

Call your doctor or nurse as soon as possible if any of these symptoms happen:

  • Swelling of legs, ankles, or feet
  • Cough
  • Blurred vision or other changes in eyesight
  • Extreme weakness that interferes with normal activities
  • Headaches, loose bowel movements, nausea, and/or rash not relieved by prescribed medicines

Reproduction concerns (Prolia®)

  • Pregnancy warning:  This drug should not be used in pregnant women because the risks outweigh the benefits to the unborn baby, so effective methods of birth control should be used by both men and women during treatment and for at least one year after your treatment is done. 
    Genetic counseling is available for you to talk about the effects of this drug therapy on future pregnancies. Also, a genetic counselor can look at the possible risk of problems in the unborn baby due to this medicine if an exposure happens during pregnancy.
  • Breast feeding warning: Women should not breast feed during treatment because this drug could enter the breast milk and badly harm a breast feeding baby.

Reproduction concerns (Xgeva®)

  • Pregnancy warning:  This drug may have harmful effects on the unborn baby, so effective methods of birth control should be used by both men and women during your treatment with this drug and for at least 5 months after treatment is done.
    Genetic counseling is available for you to talk about the effects of this drug therapy on future pregnancies. Also, a genetic counselor can look at the possible risk of problems in the unborn baby due to this medicine if an exposure happens during pregnancy.
  • Breast feeding 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 badly harm a breast feeding baby.

 

Revised July 2014

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