Prolia is a prescription medication used to treat osteoporosis. Prolia is also used to treat bone loss in patients receiving certain treatments for prostate cancer as breast cancer.
Prolia belongs to a group of drugs called RANK ligand inhibitors. These work by decreasing the breakdown of bone and increasing bone strength and thickness.
This medication comes in an injectable form to be given under the skin (subcutaneously) and is given once every 6 months.
Common side effects of Prolia include red, dry, and itchy skin, back pain, and headache.
Prolia is used to treat osteoporosis in postmenopausal women. Prolia is used to increase bone mass in men who are at an increased risk for a bone fracture. It is also used to treat bone loss in men with prostate cancer and women with breast cancer receiving certain cancer treatments.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Serious side effects have been reported with Prolia. See the "Drug Precautions" section.
Common side effects of Prolia include the following:
- red, dry, itchy skin
- back pain
- pain in arms or legs
- joint pain
- muscle pain
- increase in cholesterol
- urinary tract infections
This is not a complete list of Prolia side effects. Ask your doctor or pharmacist for more information.
Tell your doctor if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-pperscription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.
Serious side effects have been reported with Prolia including the following:
- anaphylaxis. Anaphylaxis is a severe, life-threatening allergic reaction. Seek immediate medical attention if you experience any of the following symptoms: swelling of the lips, tongue, or throat, difficulty breathing, dizziness, or itching.
- hypocalcemia. Hypocalcemia refers to low levels of calcium in the blood. Tell your doctor if you experience any of the following symptoms of hypocalcemia: muscle stiffness or spasms, dizziness, or numbness in the fingers. Your doctor may check your calcium level in your blood before you use Prolia to make sure it is not too low. Your doctor should also instruct you to take calcium and vitamin D supplements during treatment to make sure your calcium does not get too low.
- osteonecrosis of the jaw. Osteonecrosis is a serious bone disease that can degrade bone and limit its function. It typically occurs after tooth extraction or local infection. You should have a dental exam before you start treatment with Prolia.
- fractures of the femur. While Prolia is intended to prevent fractures, patients using the drug have experienced fractures. Tell your doctor if you notice any new thigh, hip, or groin pain.
- infection. Tell your doctor if you notice any signs of infection such as a cough, runny nose, sore throat, or fever.
- skin reactions. Tell your doctor if you develop a rash or develop itching, burning, or redness of the skin.
- bone, joint, and muscle pain. Stop taking Prolia and tell your doctor if you experience pain in the joints, or deeper in the muscle or bone.
- decreased bone remodeling. It is not known if Prolia use over a long period of time slows the healing of broken bones.
Do not use Prolia if you:
- are allergic to Prolia or any of its ingredients
- have an infection
- are pregnant
- have low calcium levels
Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Prolia, there are no specific foods you must exclude from your diet when receiving this medication.
Before taking Prolia, tell your doctor about all of your medical conditions. Especially tell your doctor if you:
- Are allergic to Prolia or any of its ingredients
- Have had recent dental work, or plan to have dental work or a tooth extraction in the future
- Have been told you have low calcium levels in your blood
- Have kidney problems
- Are unable to take calcium or vitamin D supplements
- Have been told you have trouble absorbing vitamins or minerals in your stomach or intestines
- Are taking a medicine known as Xgeva (denosumab). Denosumab is marketed as Xgeva and Prolia, and patients receiving either one of these medications should not receive the other
- Have an active infection
- Have had thyroid or parathyroid (glands located in your neck) surgery
- Are pregnant or are plan to become pregnant
- Are breastfeeding or plan to breastfeed
- Tell your dentist that you are receiving Prolia before you have dental work done
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify possible risks of an unborn baby when a medication is taken during pregnancy.
Prolia falls into category X. It has been shown that women taking Prolia during pregnancy may have babies born with problems. There are no situations in which the benefits of the medication to the mother outweigh the risks of harm to the baby. These medications should never be used by pregnant women.
Tell your doctor if you are breastfeeding or plan to breastfeed.
It is not known if Prolia crosses into human milk. Because many medications can cross into human milk and because the possiblity for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risks of using Prolia.
Take Prolia exactly as prescribed.
Prolia comes in injectable form to be given under the skin by a healthcare professional anywhere from weekly to every 6 months, depending on the condition being treated.
If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Prolia at the same time.
Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The dose your doctor recommends may be based on the following:
- the condition being treated
- othe medical conditions you have
- other medications you are taking
- how you respond to this medication
The recommended dose of Prolia (denosumab) is 60 mg injected under the skin in the upper arm, upper thigh, or abdomen every 6 months.
If Prolia is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.