Treats osteoporosis (thinning of the bones). Also treats bone loss and bone-related problems in patients who have cancer.
Xgeva, ProliaThere may be other brand names for this medicine.
When This Medicine Should Not Be Used:You should not receive this medicine if you have had an allergic reaction to denosumab, or if you are pregnant. You should not receive Prolia if you have very low calcium in your blood (hypocalcemia).
How to Use This Medicine:
- Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is usually given as a shot under the skin of your upper arm, upper thigh, or stomach.
- A nurse or other trained health professional will give you this medicine.
- 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. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
If a dose is missed:
- 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.
- Make sure your doctor knows if you are using medicines that weaken your immune system, such as a steroid or cancer medicine.
Warnings While Using This Medicine:
- Using this medicine while you are pregnant can harm your unborn baby. The medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away. Use an effective form of birth control to keep from getting pregnant.
- Make sure your doctor knows if you are breastfeeding, or if you have kidney disease.
- This medicine could lower the amount of calcium in your blood. Your doctor should make sure your calcium levels are high enough before you start treatment. Make sure your doctor knows 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. You might have low calcium levels if you have had these conditions.
- Call your doctor right away if you have develop any signs of low calcium levels, such as muscle spasms or twitching, or numbness or tingling in your fingers, toes, or lips.
- Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine could cause jaw problems, especially if you have a tooth pulled or have other dental work. Tell your doctor or dentist if you develop pain, swelling, or other problems in your mouth or jaw. Make sure your doctor knows about dental problems that you already have or if you wear dentures. Also tell your doctor if you have cancer, anemia, or blood clotting problems, because you could be more likely to develop jaw problems.
- Avoid people who are sick or have infections, because this medicine may make you more likely to get an infection. Check with your doctor right away if you have a fever or chills, severe abdominal or stomach pain, or burning or painful urination.
- Skin infections or problems may occur. Check with your doctor right away if you have a skin rash, red or swollen skin, blistering, crusting, irritation, itching, or cracked or scaly skin.
- The needle cover of the syringe of Prolia contains dry natural rubber. Tell your doctor if you have a latex allergy.
- This medicine may increase your risk of breaking a thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.
- Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to 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
- 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
- Pain, swelling, or numbness in the mouth or jaw
- Redness, pain, itching, burning, swelling, lump under your skin where the shot was given
- Unusual pain in your thigh, groin, or hip
If you notice these less serious side effects, talk with your doctor:
- Back pain, muscle or joint pain
- 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
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