PROLIA (Denosumab)

What is this medication?

Prolia 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.

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 is used in adults to treat osteoporosis or bone loss in people who:

• are at high risk for broken bones; and who cannot use another osteoporosis medicine or these medicines did not work well.

Prolia is sometimes used in people whose bone fracture is caused by certain medicines or cancer treatments.

Prolia is also used to treat glucocorticoid-induced osteoporosis in men and women at high risk of bone fracture.

How should I use this medication?

Prolia is injected under the skin. 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 Prolia. 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 this medicine.

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, skip or delay using Prolia. Do not stop using this medicine without first talking to your doctor.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep 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 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.

How should I store this medication?

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.

Throw away a prefilled syringe after one use, even if there is still medicine left inside.

What are the possible side effects of using this medication?

Get emergency medical help if you have signs of an allergic reaction to Prolia:

• hives,
• itching,
• rash;
• difficulty breathing,
• feeling light-headed;
• swelling of your face, lips, tongue, or throat.

Prolia may cause serious side effects. 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;
• swelling, pain, tenderness, warmth, or redness anywhere on your body;
• pain and burning when you urinate, painful urination;
• increased or urgent need to urinate;
• severe stomach pain; or
• cough, wheezing, shortness of breath.

• bladder infection (painful or difficult urination);
• lung infection (cough, shortness of breath);
• headache;
• back pain, muscle or 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 interact with denosumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.