April 28, 2017
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Prolia Patient Information including How Should I Take

What should I discuss with my health care provider before receiving Prolia (Prolia)?

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.

FDA pregnancy category X. This medication 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.

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.

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 (Prolia)?

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.

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.

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.

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.

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.

Side Effects Centers

Prolia - User Reviews

Prolia User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Prolia sorted by most helpful. Patient Discussions FAQs

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.

Healthy Bones

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