Denosumab (Xgeva, Biosimilars of Xgeva)

This medication guide is specific to Xgeva and its Biosimilars.

Denosumab is used to prevent bone problems in people with multiple myeloma or tumors that have spread to the bone.

Denosumab is also used in adults and children at least 12 years and older with a fully matured bone structure to treat giant cell tumor of bone that cannot be removed with surgery.

Denosumab is also used to treat high calcium levels in the blood caused by cancer when a specific type of medicine used to lower blood calcium levels has not worked.

Denosumab may also be used for purposes not listed in this medication guide.

You should not receive denosumab if you have low levels of calcium in your blood (hypocalcemia). Your low blood calcium must be treated before you can receive denosumab.

You should not take denosumab if you are allergic to it or if you have low calcium levels in your blood (hypocalcemia). Your low blood calcium must be treated before you can receive denosumab.

You should not use any other medicines that contain denosumab while you are taking this medicine.

Tell your doctor if you have or have ever had:

• low levels of calcium in your blood (hypocalcemia);
• osteoporosis or broken bones;
• 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 be fatal. Discuss this risk with your doctor.

This medicine may cause problems with the jaw bone (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, existing dental issues, or those treated with steroids, chemotherapy, or radiation. Ask your doctor about your individual risk.

May harm an unborn baby. Do not use if you are 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. Inform your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using 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.

Denosumab may cause serious side effects. Call your doctor right away if you have:

• new or unusual pain in your thigh, hip, or groin;
• jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work; or
• low blood calcium—muscle spasms or contractions, numbness or tingling (around your mouth, or in your fingers and toes).

After you stop using denosumab, tell your doctor if you have symptoms of high calcium levels (hypercalcemia) such as confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss.

Common side effects of denosumab may include:

• tiredness, lack of energy;
• rash, shortness of breath;
• abnormal blood tests;
• nausea, vomiting, diarrhea, constipation, loss of appetite;
• headache, back or joint pain, pain or swelling in your arms or legs; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

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

Denosumab is usually given once every 4 weeks. You may need to receive additional doses depending on the condition being treated. Follow your doctor's instructions.

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 an oral examination before you begin treatment with denosumab. Follow your doctor's instructions.

Your risk of bone fractures can increase when you stop using denosumab. 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 medicine.

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 Xgeva injection.

Seek emergency medical attention 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 affect denosumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Find detailed information on Biosimilars of Xgeva for this medication.