Denosumab injection

What is this medication?

DENOSUMAB (den oh sue mab) slows bone breakdown. Prolia is used to treat osteoporosis in women after menopause and in men, and in people who are taking corticosteroids for 6 months or more. Xgeva is used to treat a high calcium level due to cancer and to prevent bone fractures and other bone problems caused by multiple myeloma or cancer bone metastases. Xgeva is also used to treat giant cell tumor of the bone.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Prolia, XGEVA

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 medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for injection under the skin. It is given by a health care professional 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.

For Prolia, talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. For Xgeva, talk to your pediatrician regarding the use of this medicine in children. While this drug 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?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• other medicines containing denosumab

This medicine may also interact with the following medications:

• medicines that lower your chance of fighting infection
• steroid medicines like 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?

Visit your doctor or health care professional for regular checks on your progress. Your doctor or health care professional may order blood tests and other tests to see how you are doing.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug may decrease your body's ability to fight infection. 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 medicine, unless your doctor tells you not to. Discuss the foods you eat and the vitamins you take with your health care professional.

See your dentist regularly. Brush and floss your teeth as directed. Before you have any dental work done, tell your dentist you are receiving this medicine.

Do not become pregnant while taking this medicine or for 5 months after stopping it. Talk with your doctor or health care professional about your birth control options while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• bone pain
• breathing problems
• dizziness
• jaw pain, especially after dental work
• redness, blistering, peeling of the skin
• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine
• signs of low calcium like fast heartbeat, muscle cramps or muscle pain; pain, tingling, numbness in the hands or feet; seizures
• unusual bleeding or bruising
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation
• diarrhea
• headache
• joint pain
• loss of appetite
• muscle pain
• runny nose
• tiredness
• upset stomach

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.

Where should I keep my medication?

This medicine is only given in a clinic, doctor's office, or other health care setting and 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.