DENOSUMAB (den oh SUE mab) prevents weakened bones caused by cancer. It may also be used to treat noncancerous bone tumors that cannot be removed by surgery. It can also be used to treat high calcium levels in the blood caused by cancer. It works by blocking a protein that causes bones to break down quickly. This slows down the release of calcium from bones, which lowers calcium levels in your blood. It also makes your bones stronger and less likely to break (fracture).

How should I use this medication?

This medication is for injection under the skin. It is given by your care team in a hospital or clinic setting. A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 13 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Bone, joint, or muscle pain -Low calcium level—muscle pain or cramps, confusion, tingling, or numbness in the hands or feet -Osteonecrosis of the jaw—pain, swelling, or redness in the mouth, numbness of the jaw, poor healing after dental work, unusual discharge from the mouth, visible bones in the mouth Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Cough -Diarrhea -Fatigue -Headache -Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Dental disease -Having surgery or tooth extraction -Infection -Kidney disease -Low levels of calcium or vitamin D in the blood -Malnutrition -On hemodialysis -Skin conditions or sensitivity -Thyroid or parathyroid disease -An unusual reaction to denosumab, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Other medications containing denosumab This medication may also interact with the following: -Medications that lower your chance of fighting infection -Steroid medications, such as prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. You may need blood work while taking this medication. This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. You should make sure you get enough calcium and vitamin D while you are taking this medication, unless your care team tells you not to. Discuss the foods you eat and the vitamins you take with your care team. Some people who take this medication have severe bone, joint, or muscle pain. This medication may also increase your risk for jaw problems or a broken thigh bone. Tell your care team right away if you have severe pain in your jaw, bones, joints, or muscles. Tell your care team if you have any pain that does not go away or that gets worse. Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 5 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 5 months after the last dose. Your care team can help you find the option that works for you.