When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to denosumab or if you are pregnant.

How to Use This Medicine:
Injectable

• A doctor or other health professional will give you this medicine. This medicine is usually given as a shot under the skin of your upper arm, upper thigh, or stomach.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use Prolia® and Xgeva® together. They contain the same medicine.
• Some medicines can affect how denosumab works. Tell your doctor if you are also using medicine that weakens your immune system, including a steroid or cancer medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control. Women who are being treated with Xgeva® should continue using birth control for at least 5 months after the last dose.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, diabetes, gum disease, or an allergy to latex. Tell your doctor if you have problems with your thyroid, parathyroid, or digestive system.
• This medicine may cause the following problems:
  
  • Low calcium levels in your blood
  • Increased risk of broken thigh bone
  • Increased risk of infections
  • Serious allergic reactions, including rash
• This medicine can cause jaw problems. You must have regular dental exams while you are being treated with this medicine. Tell your dentist that you are using this medicine. Practice good oral hygiene.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Chest pain, fast or uneven heartbeat, trouble breathing
• Fever, chills, cough, sore throat, body aches
• Muscle spasms or twitching, numbness or tingling in your fingers, toes, or lips
• Pain or burning during urination, change in how much or how often you urinate
• Pain, swelling, heavy feeling, or numbness in your mouth or jaw, loose teeth or other teeth problems
• Severe bone, joint, or muscle pain
• Unusual pain in your thigh, groin, or hip

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Diarrhea, nausea
• Tiredness or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088