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Denosumab

(den-oh-SOO-mab)

Trade/other name(s): Xgeva, Prolia

Why would this drug be used?

This is drug is used (as Xgeva) to help treat cancer (besides multiple myeloma) that has spread to the bones, usually along with other treatments such as chemotherapy. It lowers the risk of fractures and other bone problems.

It can also be used in adults and in teens whose bones have fully formed to treat giant cell tumor of bone.

Denosumab is also used (as Prolia) to treat osteoporosis (bone thinning) in women after menopause and men. It is also used to strengthen weak bones in men on hormone therapy for prostate cancer and women on drugs called aromatase inhibitors for breast cancer.

This drug is also being studied for other uses.

How does this drug work?

Some cancers that can spread to the bones (such as breast cancer) can cause the breakdown of bone. This can lead to fractures and other problems.

Denosumab stops bone cells called osteoclasts from breaking down the hard mineral structure of bone by blocking the activity of a substance called RANK ligand. This slows the growth of tumors in the bone. It also slows the release of calcium into the blood, which can lower calcium levels in the body.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have any mouth or teeth problems, or if you plan to have dental work in the near future. This drug has been linked to serious damage of the jawbone in some people, especially if they have had recent dental work (see “Precautions” below).
  • If you have kidney problems. This drug is more likely to cause problems with calcium levels in patients with poor kidney function.
  • If you have any other medical conditions such as liver disease (including hepatitis), heart disease, congestive heart failure, lung disease, diabetes, gout, or infections. You may need closer monitoring of these conditions while being treated.
  • If you have low blood calcium levels. This may be worsened by denosumab (see “Precautions” below).
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. This drug could harm the fetus if a woman is taking it at the time of conception or during pregnancy (see “Precautions” below).
  • If you are breast-feeding. This drug might pass into breast milk and affect the baby. Breast-feeding is not recommended during treatment with this drug.
  • About any other prescription or over-the-counter drugs or supplements you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

No serious interactions with other drugs are known at this time, but this does not necessarily mean that none exist. Research on interactions with other drugs is incomplete at this time.

Check with your doctor, nurse, or pharmacist about all of your medicines, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether some foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Denosumab is given as an injection under the skin (subcutaneous, or SQ). The usual dose for treating people with cancer that has spread to bones is 120 milligrams (mg) every 4 weeks, although the dose may need to be lower in people with kidney problems.

The dose is the same when it is used to treat giant cell tumor of the bone, except that additional injections are given after 1 and 2 weeks during the first month of treatment.

This drug is also used to treat osteoporosis (in people without cancer) and strengthen bones in people treated with certain hormone drugs for breast or prostate cancer. When it is used for this reason, it is given at a lower dose and less often (usually every 6 months).

Your doctor may recommend that you take a multi-vitamin (with vitamin D) and a calcium supplement each day to lower the chance of low calcium levels.

Precautions

In rare cases, this drug can damage the jaw bones, a condition called osteonecrosis of the jaw (ONJ). Most cases have been in people who had certain dental procedures recently such as having a tooth pulled while taking the drug. Your doctor may recommend that you get a thorough dental exam before you start taking this drug. Talk with your dentist about the best ways to prevent problems while on this drug. While you are getting treatment, check with your doctor before having any dental procedures done. Tell your doctor if you notice loose teeth or swollen gums, or if you have pain, swelling, drainage, or numbness in your jaw.

This drug could lead to low blood calcium levels (hypocalcemia). This is more common in patients with severe kidney problems. Low calcium can cause symptoms such as muscle twitching, spasms, or cramps; muscle or joint pains; changes in sensations on the face, hands or feet; confusion; or seizures. Tell your doctor right away if you notice any of these symptoms.

Your doctor will test your blood often during your treatment, looking at the levels of calcium, phosphate, and other chemicals. Based on the test results, your doctor may need to change your treatment plan. Be sure to keep all your appointments for lab tests and doctor visits.

Report any skin rashes to the doctor, especially if there are signs of infection such as redness, tenderness, or pus.

Unusual breakage of the large bone of the upper leg (femur) has happened very rarely in people taking this drug, even in people who had no injury. Tell your doctor if you notice aching or pain in the thigh, hip, or groin. Fracture may be more likely if a person is also taking steroids (such as prednisone, hydrocortisone, or methylprednisolone).

Rarely, severe allergic reactions (anaphylaxis) have been reported, with trouble breathing, tightness in the throat, swelling of the face and mouth, faintness, dizziness, and hives (raised itchy bumps on the skin). Get emergency help and tell your doctor or nurse right away if you notice these symptoms.

Avoid pregnancy while taking this drug and for some time afterward. The drug could harm the fetus. Women who could become pregnant should use effective birth control during treatment with this drug and for at least 5 months after the last dose. Check with your doctor about what kinds of birth control can be used with this medicine. Tell your doctor right away if you become pregnant.

Possible side effects

You will probably not have most of the following side effects, but if you have any, talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • Nausea
  • Diarrhea
  • Fatigue (tiredness)
  • Weakness
  • Shortness of breath
  • Low blood phosphate levels

Less common

  • Cough
  • Headache
  • Low blood calcium levels (could lead to muscle pain, cramps, twitches, or spasms; abnormal sensations on the face, hands, or feet; or seizures)*

Rare

  • Infections, which can be serious
  • Skin rashes*
  • Allergic reactions with hives, low blood pressure, swelling in the face, mouth, or throat*
  • Damage to bones in jaw*
  • Fracture (breakage) of the femur*
  • Death due to extremely low calcium levels or serious infection*

*See “Precautions” section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2010.

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.


Last Medical Review: 08/22/2014
Last Revised: 08/22/2014