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 Prolia if you have low levels of calcium in your blood (hypocalcemia).
Prolia can harm an unborn baby or cause birth defects. Do not use if you are pregnant.
Before you receive Prolia, 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 Prolia 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 using Prolia. You may need to stop using the medicine for a short time.
Before using this medicine?
You should not use Prolia if you are allergic to denosumab, or if you have low levels of calcium in your blood (hypocalcemia).
While you are using Prolia, you should not use Xgeva, another brand of denosumab.
To make sure Prolia is safe for you, tell your doctor if you have:
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.
Prolia may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, gum infection, or slow healing after dental work.
Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
Prolia can harm an unborn baby or cause birth defects. Do not use Prolia if you are pregnant. Tell your doctor right away if you become pregnant during treatment.
It is not known whether denosumab passes into breast milk or if it could harm a nursing baby. This medicine may also slow the production of breast milk. You should not breast-feed while using this medicine.
