Denosumab injection (Prolia) is used to treat osteoporosis (a condition in which the bones become thin and weak and break easily) in men and in women who have undergone menopause ('change of life;' end of menstrual periods), who have an increased risk for fractures (broken bones) or who cannot take or did not respond to other medications for osteoporosis. Denosumab injection (Prolia) is also used to treat bone loss in men with prostate cancer and in women with breast cancer who are receiving certain treatments that increase their risk for fractures. Denosumab injection (Xgeva) is used to reduce fractures from certain types of cancer that began in another part of the body but has spread to the bones. Denosumab injection (Xgeva) is also used in adults and some adolescents to treat giant cell tumor of bone (GCTB; a type of bone tumor) that cannot be treated with surgery or if surgery is not possible. Denosumab injection is in a class of medications called RANK ligand inhibitors. It works by decreasing bone breakdown and increasing bone strength and density (thickness).
Denosumab injection comes as a solution (liquid) to be injected subcutaneously (under the skin) in your upper arm, upper thigh, or stomach area. It is usually injected by a doctor or nurse in a medical office or clinic. When denosumab injection (Prolia) is used to treat osteoporosis or to treat bone loss in men with prostate cancer and women with breast cancer, it is usually given once every 6 months. When denosumab injection (Xgeva) is used to reduce fractures from cancer that has spread to the bones, it is usually given once every 4 weeks. When denosumab injection (Xgeva) is used to treat giant cell tumor of bone, it is usually given every 7 days for the first three doses (on day 1, day 8, and day 15) and then once every 4 weeks starting 2 weeks later after the first three doses.
Your doctor will tell you to take supplements of calcium and vitamin D while you are being treated with denosumab injection. Take these supplements exactly as directed.
When denosumab injection (Prolia) is used to treat osteoporosis or bone loss, your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with denosumab injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Unless your doctor tells you otherwise, continue your normal diet.
If you miss an appointment to receive an injection of denosumab, you should call your healthcare provider as soon as possible. The missed dose should be given as soon as it can be rescheduled. When denosumab injection (Prolia) is used for osteoporosis or bone loss, after you receive the missed dose, your next injection should be scheduled 6 months from the date of your last injection.
red, dry, or itchy skin
oozing or crusty blisters on skin
pain in your arms
muscle or joint pain
muscle stiffness, twitching, cramps, or spasms
numbness or tingling in your fingers, toes, or around your mouth
difficulty breathing or swallowing
swelling of the face, throat, tongue, or lips
fever or chills
redness, tenderness, swelling or warmth of area of skin
ear drainage or severe pain
frequent or urgent need to urinate
burning feeling when you urinate
pain, numbness, swelling, or drainage from mouth, teeth, or jaw
slow healing of the mouth or jaw
severe abdominal pain
ongoing pain that begins in the stomach area, but may spread to the back
fast heart rate
Denosumab injection may increase the risk that you will break your thigh bone(s) You may feel pain in your hips, groin, or thighs for several weeks or months before the bone(s) break, and you may find that one or both of your thigh bones have broken even though you have not fallen or experienced other trauma. It is unusual for the thigh bone to break in healthy people, but people who have osteoporosis may break this bone even if they do not receive denosumab injection. Denosumab injection may also cause broken bones to heal slowly and may impair bone growth and prevent teeth from coming in properly in children. Talk to your doctor about the risks of receiving denosumab injection.
Denosumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not shake denosumab injection. Store it in the refrigerator and protect it from light. Do not freeze. Denosumab injection can be kept at room temperature for up to 14 days. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to be sure it is safe for you to receive denosumab injection and to check your body's response to denosumab injection.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 01/15/2014
AHFS® Consumer Medication Information. © Copyright, 2014. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.