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Medications and Drugs

Brand Names: Prolia

Generic Name: denosumab (Prolia) (Pronunciation: den OH sue mab)

What is denosumab (Prolia) (Prolia)?

Denosumab is a monoclonal antibody. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

The Prolia brand of denosumab is used to treat osteoporosis in postmenopausal women who have high risk of bone fracture.

Prolia is also used to increase bone mass in women and men with a high risk of bone fracture caused by receiving treatments for certain types of cancer.

This medication guide provides information about the Prolia brand of denosumab. Xgeva is another brand of denosumab used to prevent bone fractures and other skeletal conditions in people with tumors that have spread to the bone.

Denosumab may also be used for purposes not listed in this medication guide.

What are the possible side effects of Prolia (Prolia)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious infections may occur during treatment with Prolia. Call your doctor right away if you have signs of infection such as:

  • severe itching, burning, rash, blistering, peeling, or dryness of the skin;
  • swelling, pain, tenderness, warmth, or redness anywhere on your body;
  • pain or burning when you urinate, blood in your urine;
  • severe stomach pain;
  • ear pain or drainage, trouble hearing;
  • fever, chills, night sweats;
  • cough, feeling short of breath;
  • pinpoint purple or red spots under your skin; or
  • flu symptoms, weight loss.

Call your doctor at once if you have a serious side effect such as:

  • numbness or tingly feeling around your mouth or in your fingers or toes, fast or slow heart rate, muscle cramps or contraction, overactive reflexes; or
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

Less serious side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about Prolia (Prolia)?

Prolia can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

This medication guide provides information about the Prolia brand of denosumab. Xgeva is another brand of denosumab used to prevent bone fractures and other skeletal conditions in people with tumors that have spread to the bone.

You should not receive denosumab if you are allergic to it, or if you have low levels of calcium in your blood (hypocalcemia).

Before you receive this medication, tell your doctor if you have kidney disease (or if you are on dialysis), a weak immune system, a history of hypoparathyroidism or thyroid surgery, a history of intestinal surgery, a condition that makes it hard for your body to absorb nutrients from food, or if you are allergic to latex.

Serious infections may occur during treatment with Prolia. Call your doctor right away if you have signs of infection such as: severe skin irritation; swelling or redness anywhere on your body; pain or burning when you urinate; severe stomach pain; ear pain, trouble hearing; cough, feeling short of breath; purple or red spots under your skin; or fever, chills, night sweats, flu symptoms, or weight loss.

Some people using denosumab have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving denosumab. You may need to stop using the medicine for a short time.



Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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