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Denosumab is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause (in women), as you age, if someone in your family has osteoporosis, or if you take certain medications (such as prednisone) for long periods. This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Denosumab belongs to a class of drugs called monoclonal antibodies. It prevents certain cells in the body (osteoclasts) from breaking down bone. This monograph is about the following denosumab products: denosumab, denosumab-bbdz, denosumab-bmwo, denosumab-bnht, and denosumab-nxxp.

Denosumab may cause serious (rarely fatal) low calcium levels and may also worsen low calcium levels, especially if you have kidney problems. You may also be at increased risk if you have a history of low blood calcium levels (hypocalcemia), thyroid/parathyroid problems/surgery, or stomach/intestinal problems (such as malabsorption/surgery). Take calcium and vitamin D as directed by your doctor to help prevent low levels of calcium. Your doctor will order blood tests before your first injection and during treatment to monitor you closely. Tell your doctor right away if you have any symptoms of low calcium such as severe muscle spasms/cramps, mental/mood changes (such as irritability or confusion), numbness/tingling (especially around lips/mouth or in fingers/toes), fast/irregular heartbeat, severe dizziness/fainting, or seizures.

See also Warning and Precautions sections.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Denosumab can affect your immune system. You may be more likely to get a serious infection, such as a skin, ear, stomach/gut, or bladder infection. Tell your doctor right away if you develop any signs of infection, such as: fever/chills, red/swollen/tender/warm skin (with or without pus), severe abdominal pain, ear pain/discharge, trouble hearing, frequent/painful/burning urination, pink/bloody urine.

Tell your doctor right away if you have any serious side effects, including: jaw pain, new or unusual thigh/hip/groin pain, bone/joint/muscle pain.

After your treatment with denosumab is stopped, you may be at increased risk for bone fracture, including bones in your spine. Do not stop using this medication without first talking with your doctor. If your treatment is stopped, talk with your doctor about other medicines you can take.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Denosumab can cause skin problems such as dryness, peeling, redness, itching, small bumps/patches, or blisters. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash or if any of these symptoms last or get worse.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.