Prolia® injection

Prolia® injection is a brand of denosumab that treats osteoporosis. Osteoporosis weakens your bones, making them more susceptible to fractures. Xgeva® is another brand of denosumab that treats high calcium levels caused by cancer and prevents bone breaks. A healthcare provider will administer this injection in a hospital or clinic.

DENOSUMAB (den oh sue mab) slows bone breakdown. Prolia 60mg injection treats osteoporosis in women after menopause, in men, and in people who take corticosteroids for 6 months or more. Xgeva treats high calcium levels due to cancer and prevents bone fractures and other bone problems caused by multiple myeloma or cancer bone metastases. Xgeva also treats giant cell tumors of the bone.

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

They need to know if you have any of these conditions:

• dental disease
• surgery or tooth extraction
• infection
• kidney disease
• low levels of calcium or Vitamin D in the blood
• malnutrition
• being on hemodialysis
• skin conditions or sensitivity
• thyroid or parathyroid disease
• an unusual reaction to denosumab, other medicines, foods, dyes, or preservatives
• pregnancy or trying to get pregnant
• breast-feeding

This medicine is for injection under the skin. A health care professional will administer it in a hospital or clinic setting. A special MedGuide will provide you with information before each treatment. Be sure to read this information carefully each time.

For Prolia 60mg injection, consult your pediatrician regarding the use of this medicine in children. Special care may be needed. For Xgeva, consult 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.

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.

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
• feeling 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