Prolia (Prolia, Biosimilars of Prolia)

This medication guide is specific to Prolia and its Biosimilars.

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

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

Denosumab is also used in people who are at high risk for broken bones because of certain medicines or cancer treatments.

Denosumab may also be used for reasons not mentioned in this medication guide.

Denosumab can cause many serious side effects. Contact your doctor immediately if you experience a fever, chills, pain or burning during urination, severe stomach pain, cough, shortness of breath, skin issues, numbness or tingling, severe or unusual pain, or dental problems.

You should not receive denosumab if you have very low levels of calcium in your blood (hypocalcemia). Severe low blood calcium can result in a life-threatening condition, hospitalization, or death. Discuss this risk with your doctor.

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while receiving denosumab and for at least 5 months after your last dose. Inform your doctor if you become pregnant.

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

Tell your doctor if you have or have ever had:

• a weak immune system (caused by disease or by using certain medicines);
• hypoparathyroidism;
• surgery on your small intestines;
• low levels of calcium in your blood (hypocalcemia);
• thyroid or parathyroid surgery (glands located in your neck);
• any condition that makes it hard for your body to absorb nutrients from food (malabsorption);
• if you are scheduled for a dental procedure;
• if you cannot take daily calcium and vitamin D;
• if you are taking medicine that lowers your blood calcium levels; or
• kidney disease (or if you are on dialysis).

Denosumab may cause very low levels of calcium in your blood (hypocalcemia), which can lead to a life-threatening condition, hospitalization, or death. Talk with your doctor about this risk.

This medicine may cause jaw bone problems (osteonecrosis). The risk 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.

May harm an unborn baby. Do not use if you are pregnant or plan to become pregnant. You may need a pregnancy test before starting this treatment. Use effective birth control while receiving denosumab and for at least 5 months after your last dose. Tell your doctor if you become pregnant or think you may be pregnant.

Do not breastfeed while receiving this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Prolia may cause serious side effects. Call your doctor immediately if you have:

• new or unusual pain in your thigh, hip, or groin;
• severe bone pain, severe joint or muscle pain;
• jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work;
• skin problems--dryness, peeling, redness, itching, rash, blisters, bumps, oozing, or crusting; or
• low blood calcium--muscle spasms or contractions, numbness or tingling (around your mouth, or in your fingers and toes).

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

• fever, chills;
• swollen, painful, tender, warm, or red skin;
• pain and burning when you urinate;
• increased or urgent need to urinate;
• severe stomach pain; or
• cough, shortness of breath.

Common side effects of Prolia may include:

• pain and burning when you urinate;
• lung infection (cough, shortness of breath);
• headache;
• back pain, muscle or joint pain;
• increased blood pressure;
• cold symptoms such as stuffy or runny 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 the FDA at 1-800-FDA-1088.

Denosumab is injected under the skin. A healthcare provider will give you this injection.

Denosumab is usually given once every 6 months.

Your blood will need to be tested often. 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 denosumab. Follow your doctor's instructions.

Your risk of bone fractures can increase if you stop, skip or delay receiving denosumab. Do not stop receiving this medicine without first talking to your doctor.

Call your doctor if your symptoms do not improve, or if they get worse.

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.

After you have taken denosumab out of the refrigerator, you may keep it at room temperature for up to 14 to 63 days, depending on the brand form. Store in the original container away from heat and light.

Call your doctor for instructions if you miss an appointment for your denosumab injection. You should get your missed injection as soon as possible.

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

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

Other drugs may interact with denosumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.

Find detailed information on biosimilars for this medication.