denosumab (Prolia)
What is the most important information I should know about Prolia?
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.
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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.
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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.
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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. |
What should I discuss with my health care provider before receiving Prolia?
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You should not receive denosumab if you are allergic to it, or if you have low levels of calcium in your blood (hypocalcemia). |
To make sure you can safely use Prolia, tell your doctor if you have any of these other conditions:
- kidney disease (or if you are on dialysis);
- a weak immune system (caused by disease or by using certain medicines);
- a history of hypoparathyroidism (decreased functioning of the parathyroid glands);
- a history of thyroid surgery;
- a history of surgery to remove part of your intestine;
- any condition that makes it hard for your body to absorb nutrients from food (malabsorption); or
- if you are allergic to latex.
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.
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FDA pregnancy category C. It is not known whether denosumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. |
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of denosumab on the baby.
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It is not known whether denosumab passes into breast milk or if it could harm a nursing baby. However, this medication may slow the production of breast milk. You should not breast-feed while receiving denosumab. |
How is Prolia given?
Denosumab is injected under the skin of your stomach, upper thigh, or upper arm. A healthcare provider will give you this injection.
Prolia is usually given once every 6 months. Follow your doctor's instructions.
Your doctor may have you take extra calcium and vitamin D while you are being treated with denosumab. Take only the amount of calcium and vitamin D that your doctor has prescribed.
Pay special attention to your dental hygiene. Brush and floss your teeth regularly while receiving this medication. You may need to have a dental exam before you begin treatment with Prolia. Follow your doctor's instructions.
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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. |
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If you keep your medication at home, store it in the original container in a refrigerator. Protect from light and do not freeze. |
You may take the medicine out of the refrigerator and allow it to reach room temperature before the injection is given. Do not heat the medicine before using.
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After you have taken Prolia out of the refrigerator, you may keep it at room temperature for up to 14 days. Store in the original container away from heat and light. |
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Do not shake the prefilled syringe or you may ruin the medicine. Do not use the medication if it looks cloudy or has particles in it. Call your doctor for a new prescription. |
Each prefilled syringe of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
Do not share this medication with another person, even if they have the same symptoms you have.
What happens if I overdose?
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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. |
What are the possible side effects of Prolia?
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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. |
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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.
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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:
- weakness;
- constipation;
- back pain, muscle pain; or
- pain in your arms or legs.
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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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