6 mins read

Denosumab (Osenvelt, Wyost, Xgeva) is used to prevent certain cancer-related bone problems and treat bone tumors or high calcium levels. It prevents the breakdown of bone by blocking certain cell signals, which helps reduce the amount of calcium released from your bones into your bloodstream and helps prevent certain cancer-related bone problems and bone tumor growth. Common side effects include tiredness, nausea, diarrhea, headache, back pain, and anemia. Serious side effects include low calcium levels, severe jawbone problems, and thigh bone fractures.

Uses

What is denosumab used for?

Denosumab (Osenvelt, Wyost, Xgeva) is commonly used for the following conditions.

  • Prevention of bone-related problems in patients with multiple myeloma 
  • Treatment of certain types of tumors in your bone (giant cell tumor of bone)
  • High calcium levels (hypercalcemia) caused by cancer

Denosumab may also be used for other conditions as determined by your health care provider.

How does denosumab work (mechanism of action)?

Denosumab prevents the breakdown of bone by blocking certain cell signals, which helps reduce the amount of calcium released from your bones into your bloodstream. This process also helps prevent certain cancer-related bone problems and bone tumor growth.

How is denosumab supplied (dosage forms)?

Brands and other names

  • Osenvelt
  • Wyost
  • Xgeva

Dosage forms and strengths

Denosumab is available in an injectable form that is given by a health care provider.

How should I store denosumab?

Denosumab is usually given by a health care provider in a hospital or clinic. If you will store denosumab at home, follow the instructions given by your health care provider.

Side Effects

What are the most common side effects of denosumab?

The most common side effects of denosumab are listed below. These side effects may vary depending on the condition that is being treated. Tell your health care provider if you have any of these side effects that bother you.

  • Tiredness
  • Nausea or vomiting
  • Diarrhea
  • Anemia
  • Back or joint pain
  • Fluid retention in the limbs
  • Infection in the nose or throat
  • Rash
  • Headache
  • Shortness of breath
  • Loss of appetite
  • Low calcium levels and other electrolyte changes (see below)

There may be other side effects of denosumab that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of denosumab?

While less common, the most serious side effects of denosumab are described below, along with what to do if they happen.

Severe Allergic Reactions. Denosumab may cause allergic reactions, which can be serious. Stop using denosumab and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Low Calcium Levels (Hypocalcemia). Denosumab can cause low calcium levels, which can be serious. Low calcium levels can cause a rare but dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium, or take some medicines for other heart rhythm problems. Stop using denosumab and call your health care provider if you have any of the following symptoms.

  • Changes in your heart rate or rhythm, such as a fast or skipping heartbeat
  • Fainting
  • Numbness, tingling, or a burning sensation in your arms, feet, or face (paresthesia)
  • Muscle pain or spasms
  • Seizures

Severe Jawbone Problems (Osteonecrosis). Denosumab can rarely cause severe jawbone problems, also called osteonecrosis of the jaw. In this condition, your jawbone may get damaged due to reduced blood flow. You may be at a higher risk if you are undergoing certain dental procedures (such as a tooth extraction or dental implants), have poor oral health, or have cancer or certain other conditions. You may be told to see a dentist before starting denosumab and to practice good mouth care. Call your health care provider right away if you have any of the following symptoms of jaw osteonecrosis.

  • Jaw pain or discomfort
  • Mouth sores
  • Loose teeth

Unusual Thigh Bone Fractures. Denosumab can cause stress fractures or tiny cracks in the thigh bones. Notify your health care provider right away if you develop new or unusual pain or swelling in your thigh, hip, or groin. 

Warnings & Precautions

Who should not use denosumab?

Allergies to Ingredients. People who are allergic to any of the following should not use denosumab.

  • Denosumab
  • Osenvelt
  • Wyost
  • Xgeva
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in denosumab.

Low Blood Calcium. People with hypocalcemia (low blood calcium) should not get denosumab until calcium levels have been corrected.

What should I know about denosumab before using it?

Do not use denosumab unless it has been prescribed to you by a health care provider. Use it as prescribed.

Do not share denosumab with other people, even if they have the same condition as you. It may harm them.

Denosumab is usually given by a health care provider in a hospital or clinic. 

Brush your teeth daily and follow any dental hygiene recommendations from your health care provider. Tell your dentist you are using denosumab before having any dental work done. 

Talk to your health care provider if you plan on stopping denosumab. Your risk of having a broken bone may increase if you stop denosumab without your health care provider’s supervision.

Talk to your health care provider before starting denosumab. Your health care provider may prescribe calcium and vitamin D to help prevent low calcium levels. 

What should I tell my health care provider before using denosumab?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if denosumab is right for you.

In particular, make sure that you discuss any of the following.

Other Medicines and Supplements. Denosumab may interact with other medicines and supplements. Before using denosumab, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Kidney problems
  • History of dental surgery or tooth extraction
  • Use of dental appliances such as braces and retainers
  • Diabetes
  • Gum infections
  • Osteoporosis
  • History of fractures

Pregnancy. Denosumab may cause harm to your fetus. Tell your health care provider if you are pregnant or plan to become pregnant. If you can become pregnant, your health care provider may ask you to use birth control during denosumab treatment and for at least five months after stopping denosumab.

Breastfeeding. It is not known if denosumab passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use denosumab while breastfeeding.

Interactions

Does denosumab interact with foods or drinks?

There are no known interactions between denosumab and foods or drinks.

It is unknown if drinking alcohol will affect denosumab, but heavy drinking can slow your immune response and make it harder for your body to fight infections (or cancer for antineoplastics).

Does denosumab interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking denosumab.

  • A corticosteroid, such as dexamethasone, methylprednisolone, or prednisone, which is a medicine for certain inflammatory conditions
  • A medicine that suppresses your immune system, such as cyclosporine (Gengraf, Neoral, Sandimmune, and others) and methotrexate (Trexall and others)
  • Another medicine that contains denosumab, such as Jubbonti, Prolia, or Wyost

This may not be a complete list of medicines that can interact with denosumab. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much denosumab?

If you or someone else has used too much denosumab, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of denosumab?

Denosumab is usually given by a health care provider in a hospital. Your health care provider will make sure you are receiving denosumab as scheduled. If you miss an appointment to get your denosumab dose, call to make another appointment as soon as possible.