Alert

denosumab (Prolia)

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.

Prolia can cause many serious side effects. Call your doctor at once if you have a fever, chills, pain or burning when you urinate, severe stomach pain, cough, shortness of breath, skin problems, numbness or tingling, severe or unusual pain, or skin problems.

Do not use if you are pregnant. Use effective birth control while using Prolia, and for at least 5 months after you stop.

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 or bone loss in men and women who have a high risk of bone fracture. Prolia is sometimes used in people whose bone fracture is caused by certain medicines or cancer treatments.

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 healthcare 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); or
  • if you are pregnant.

While you are using Prolia, you should not receive Xgeva, another brand of denosumab.

Tell your doctor if you have ever had:

  • kidney disease (or if you are on dialysis);
  • a weak immune system (caused by disease or by using certain medicines);
  • hypoparathyroidism (decreased functioning of the parathyroid glands);
  • thyroid surgery;
  • any condition that makes it hard for your body to absorb nutrients from food (malabsorption);
  • a latex allergy;
  • if you are scheduled for a dental procedure; or
  • if you cannot take daily calcium and vitamin D.

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.

The risk of osteonecrosis is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.

You may need to have a negative pregnancy test before starting this treatment.

Do not use Prolia if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 5 months after your last dose. Tell your doctor right away if you become pregnant.

You should not breastfeed 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 carton in a refrigerator. Protect from light and do not freeze. Do not shake the prefilled syringe.

You may take the carton out of the refrigerator and allow it to reach room temperature before the injection is given.

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.

Each prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it 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 calcium level --muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

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, wheezing, feeling short of breath.

Common side effects may include:

  • bladder infection (painful or difficult urination);
  • lung infection (cough, shortness of breath);
  • headache;
  • back pain, muscle pain, joint pain;
  • increased blood pressure;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • high cholesterol; 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 affect Prolia, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines 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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