Denosumab (den-OSE-ue-mab)

Treats osteoporosis, bone cancer, hypercalcemia, and other bone problems in patients who have cancer.

Brand Name(s):

Prolia, Xgeva

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in your upper arm, upper thigh, or stomach.
• A nurse or other health provider will give you this medicine.
• You may receive other medicines (including calcium supplements, Vitamin D) to prevent unwanted effects.
• 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:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 5 months after the last dose.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, diabetes, gum disease, or a history of fractures. Tell your doctor if you have problems with your thyroid, parathyroid, or digestive system.
• This medicine may cause the following problems:
  • Increased risk of broken thigh bone
  • Increased risk of infections
  • Serious skin reactions
  • Severe bone, joint, or muscle pain
• 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 receiving this medicine. Practice good oral hygiene.
• Do not suddenly stop using this medicine without checking first with your doctor. Doing so may increase your risk for more fractures. Talk to your doctor about other medicines that you can take.
• 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
• Lightheadedness, dizziness, fainting
• 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
• Sudden and severe stomach pain, nausea, vomiting
• Unusual pain in your thigh, groin, or hip

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

• Arm or leg pain
• Diarrhea
• Redness, pain, itching, burning, swelling, or a lump under your skin where the shot was given
• 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