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What is Prolia and how is it used?
Prolia is a prescription medicine used to:
- Treat osteoporosis (thinning and weakening of bone) in women after menopause (“change of life”) who:
- Increase bone mass in men with osteoporosis who are at high risk for fracture.
- Treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least 6 months and are at high risk for fracture.
- Treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.
- Treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.
It is not known if Prolia is safe and effective in children.
What are the most important side effects and other facts about Prolia?
If you receive Prolia, you should not receive Xgeva®. Prolia contains the same medicine as Xgeva (denosumab).
Prolia can cause serious side effects including:
- Serious allergic reactions. Serious allergic reactions have happened in people who take Prolia. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction. Symptoms of a serious allergic reaction may include:
- Low calcium levels in your blood (hypocalcemia). Prolia may lower the calcium levels in your blood. If you have low blood calcium before you start receiving Prolia, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:
- spasms, twitches, or cramps in your muscles
- numbness or tingling in your fingers, toes, or around your mouth
- Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take Prolia. Your doctor should examine your mouth before you start Prolia. Your doctor may tell you to see your dentist before you start Prolia. It is important for you to practice good mouth care during treatment with Prolia. Ask your doctor or dentist about good mouth care if you have any questions.
- Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.
- Increased risk of broken bones, including broken bones in the spine, after stopping Prolia. After your treatment with Prolia is stopped, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop taking Prolia without first talking with your doctor. If your Prolia treatment is stopped, talk to your doctor about other medicine that you can take.
- Serious infections. Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen if you take Prolia. Inflammation of the inner lining of the heart (endocarditis) due to an infection also may happen more often in people who take Prolia. You may need to go to the hospital for treatment if you develop an infection. Prolia is a medicine that may affect the ability of your body to fight infections. People who have a weakened immune system or take medicines that affect the immune system may have an increased risk for developing serious infections. Call your doctor right away if you have any of the following symptoms of infection:
- Skin problems. Skin problems such as inflammation of your skin (dermatitis), rash, and eczema may happen if you take Prolia. Call your doctor if you have any of the following symptoms of skin problems that do not go away or get worse:
- Bone, joint, or muscle pain. Some people who take Prolia develop severe bone, joint, or muscle pain.
Call your doctor right away if you have any of these side effects.
Other side effects of Prolia
Prolia may cause serious side effects.
- It is not known if the use of Prolia over a long period of time may cause slow healing of broken bones.
The most common side effects of Prolia in women who are being treated for osteoporosis after menopause are:
The most common side effects of Prolia in men with osteoporosis are:
The most common side effects of Prolia in patients with glucocorticoid-induced osteoporosis are:
The most common side effects of Prolia in patients receiving certain treatments for prostate or breast cancer are:
- joint pain
- back pain
- pain in your arms and legs
- muscle pain
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Prolia.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Prolia?
- Prolia is an injection that will be given to you by a healthcare professional. Prolia is injected under your skin (subcutaneous).
- You will receive Prolia 1 time every 6 months.
- You should take calcium and vitamin D as your doctor tells you to while you receive Prolia.
- If you miss a dose of Prolia, you should receive your injection as soon as you can.
- Take good care of your teeth and gums while you receive Prolia. Brush and floss your teeth regularly.
- Tell your dentist that you are receiving Prolia before you have dental work.
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Prolia Contraindications, Pregnancy Safety and Drug Interactions
Do not take Prolia if you:
- have been told by your doctor that your blood calcium level is too low.
- are pregnant or plan to become pregnant.
- are allergic to denosumab or any of the ingredients in Prolia. See the end of this Medication Guide for a complete list of ingredients in Prolia.
Before taking Prolia, tell your doctor about all of your medical conditions, including if you:
- are taking a medicine called Xgeva (denosumab). Xgeva contains the same medicine as Prolia.
- have low blood calcium.
- cannot take daily calcium and vitamin D.
- had parathyroid or thyroid surgery (glands located in your neck).
- have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome).
- have kidney problems or are on kidney dialysis.
- are taking medicine that can lower your blood calcium levels.
- plan to have dental surgery or teeth removed.
- are pregnant or plan to become pregnant. Prolia may harm your unborn baby.
Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start treatment with Prolia.
- You should use an effective method of birth control (contraception) during treatment with Prolia and for at least 5 months after your last dose of Prolia.
- Tell your doctor right away if you become pregnant while taking Prolia.
- are breastfeeding or plan to breastfeed. It is not known if Prolia passes into your breast milk. You and your doctor should decide if you will take Prolia or breastfeed. You should not do both.
Know the medicines you take. Keep a list of medicines with you to show to your doctor or pharmacist when you get a new medicine.
Prolia (denosumab) is a treatment for women with osteporosis who have not had success with other treatments. It's also used in men and women to combat other conditions that weaken bone. Prolia can cause serious side effects, including severe allergic reaction. Prolia is an injection medication.
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