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Denosumab (Injection)

Denosumab (den-OSE-ue-mab)

Treats osteoporosis, bone cancer, bone loss, and bone-related problems in patients who have cancer.

Brand Name(s):

Prolia, Xgeva

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. You should not receive this medicine 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.
  • Prolia® is usually given once every 6 months. Xgeva® is usually given once every 4 weeks.
  • Your doctor may also give you vitamin D and calcium supplements. Follow your doctor's instructions about how to take these medicines.
  • Do not use Prolia® and Xgeva® together.
  • 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.

  • Some foods and medicine can affect how denosumab works. Tell your doctor if you are using medicine that weakens your immune system, such as 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 to keep from getting pregnant. If you receive Xgeva®, continue the birth control for at least 5 months after the last dose.
  • Tell your doctor if you are breastfeeding, or if you have kidney disease, anemia, blood clotting problems, cancer, or low blood calcium levels. Tell your doctor if you have had surgery or problems with your digestive system that might keep your body from absorbing nutrients, or if you have had problems or surgery on your thyroid or parathyroid glands.
  • This medicine may cause the following problems:
    • Low calcium levels in your blood
    • Jaw problems
    • Broken thigh bone
    • Infection
    • Skin infection or problems
  • You must have regular dental exams while you are being treated with this medicine. Tell your dentist that you are using this medicine. Do not have a tooth pulled or have other dental work.
  • The needle cover of the syringe of Prolia® contains dry natural rubber. Tell your doctor if you have a latex allergy.
  • 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, or red skin rash
  • Changes in how much or how often you urinate, painful urination
  • Chest pain, fast or uneven heartbeat
  • Fever, chills, cough, sore throat, and body aches
  • Heavy feeling in the jaw, loose teeth or other teeth problems
  • Muscle spasms or twitching, numbness or tingling in your fingers, toes, or lips
  • Pain, swelling, or numbness in the mouth or jaw
  • Redness, pain, itching, burning, swelling, or a lump under your skin where the shot was given
  • Trouble breathing
  • Unusual pain in your thigh, groin, or hip

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

  • Headache, back, muscle, or joint 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


Last Updated: 4/4/2014

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