denosumab (Prolia)

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Pronunciation: den OH sue mab

Brand: 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.

You should not receive denosumab 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.

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

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

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.

Denosumab 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.

Denosumab 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. This medicine may also slow the production of breast milk. You should not breast-feed while using 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.

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.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving denosumab.

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.

Your risk of bone fractures can increase when you stop using Prolia. Do not stop using this medicine without first talking to your doctor.

If you keep this medicine 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.

Do not shake the prefilled syringe or you may ruin the medicine. Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist 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.

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.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Do not share this medicine with another person, even if they have the same symptoms you have.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose or miss an appointment for your Prolia injection. You should receive your missed injection as soon as possible.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving Prolia?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of Prolia?

Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash; difficult breathing, feeling light-headed; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • new or unusual pain in your thigh, hip, or groin;
  • severe pain in your joints, muscles, or bones;
  • skin problems such as dryness, peeling, redness, itching, blisters, bumps, oozing, or crusting; or
  • low levels of calcium in your blood (hypocalcemia) --numbness or tingly feeling around your mouth or in your fingers or toes, muscle tightness or contraction, overactive reflexes.

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

  • fever, chills, night sweats;
  • swelling, pain, tenderness, warmth, or redness anywhere on your body;
  • pain or burning when you urinate;
  • increased or urgent need to urinate;
  • severe stomach pain; or
  • cough, feeling short of breath.

Common side effects may include:

  • bladder infection (painful or difficult urination);
  • 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.

What other drugs will affect Prolia?

Other drugs may interact with denosumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about denosumab (Prolia).

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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