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(den oh' sue mab)
- to treat osteoporosis (a condition in which the bones become thin and weak and break easily) 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 medication treatments for osteoporosis.
- to treat men who have an increased risk for fractures (broken bones) or who cannot take or did not respond to other medication treatments for osteoporosis.
- treat osteoporosis that is caused by corticosteroid medications in men and women who will be taking corticosteroid medications for at least 6 months and have an increased risk for fractures or who cannot take or did not respond to other medication treatments for osteoporosis.
- to treat bone loss in men who are being treated for prostate cancer with certain medications that cause bone loss,
- to treat bone loss in women with breast cancer who are receiving certain medications that increase their risk for fractures.
- to reduce the risk of fractures in people who have multiple myeloma (cancer that begins in the plasma cells and causes bone damage), and in people who have certain types of cancer that began in another part of the body but has spread to the bones.
- in adults and some adolescents to treat giant cell tumor of bone (GCTB; a type of bone tumor) that cannot be treated with surgery.
- to treat high calcium levels that are caused by cancer in people who did not respond to other medications.
Before receiving denosumab injection,
- tell your doctor and pharmacist if you are allergic to denosumab (Prolia, Xgeva), any other medications, latex, or any of the ingredients in denosumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- you should know that denosumab injection is available under the brand names Prolia and Xgeva. You should not receive more than one product containing denosumab at the same time. Be sure to tell your doctor if you are being treated with either of these medications.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: angiogenesis inhibitors such as axitinib (Inlyta), bevacizumab (Avastin), everolimus (Afinitor, Zortress), pazopanib (Votrient), sorafenib (Nexavar), or sunitinib (Sutent); bisphosphonates such as alendronate (Binosto, Fosamax), etidronate, ibandronate (Boniva), pamidronate, risedronate (Actonel, Atelvia), zoledronic acid (Reclast); cancer chemotherapy medications; medications that suppress the immune system such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), methotrexate (Otrexup, Rasuvo, Trexall, Xatmep), sirolimus (Rapamune), and tacrolimus (Astagraf XL, Envarsus, Prograf); steroids such as dexamethasone, methylprednisolone (A-Methapred, Depo-Medrol, Medrol, Solu-Medrol), and prednisone (Rayos); or medications used to lower your calcium levels, such as cinacalcet (Sensipar). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had a low level of calcium in your blood. Your doctor will probably check the level of calcium in your blood before you begin treatment and will probably tell you not to receive denosumab injection if the level is too low.
- tell your doctor if you are receiving dialysis treatments or if you have or have ever had anemia (condition in which the red blood cells do not bring enough oxygen to all the parts of the body); cancer; any type of infection, especially in your mouth; problems with your mouth, teeth, gums, or dentures; dental or oral surgery (teeth removed, dental implants); any condition that stops your blood from clotting normally; any condition that decreases functioning of your immune system; surgery on your thyroid gland or parathyroid gland (small gland in the neck); surgery to remove part of your small intestine; problems with your stomach or intestine that make it difficult for your body to absorb nutrients; polymyalgia rheumatica (disorder that causes muscle pain and weakness); diabetes, or parathyroid or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to have a negative pregnancy test before starting treatment with denosumab injection. You should not become pregnant while you are receiving denosumab injection. You should use a reliable method of birth control to prevent pregnancy while you are receiving denosumab injection and for at least 5 months after your final treatment. If you become pregnant while receiving denosumab injection, or within 5 months of your treatment, call your doctor immediately. Denosumab may harm the fetus.
- you should know that denosumab injection may cause osteonecrosis of the jaw (ONJ, a serious condition of the jaw bone), especially if you have dental surgery or treatment while you are receiving this medication. A dentist should examine your teeth and perform any needed treatments, including cleaning or fixing ill-fitted dentures, before you start to receive denosumab injection. Be sure to brush your teeth and clean your mouth properly while you are receiving denosumab injection. Talk to your doctor before having any dental treatments while you are receiving this medication.
- red, dry, or itchy skin
- oozing or crusty blisters on skin
- peeling skin
- back pain
- pain in your arms
- swelling of arms or legs
- muscle or joint pain
- abdominal pain
- muscle stiffness, twitching, cramps, or spasms
- numbness or tingling in your fingers, toes, or around your mouth
- hives, rash, itching, difficulty breathing or swallowing, swelling of the face, eyes, throat, tongue or lips,
- fever or chills
- redness, tenderness, swelling or warmth of area of skin
- fever, cough, shortness of breath
- ear drainage or severe ear pain
- frequent or urgent need to urinate, burning feeling when you urinate
- severe abdominal pain
- painful or swollen gums, loosening of the teeth, numbness or heavy feeling in the jaw, poor healing of the jaw
- unusual bleeding or bruising
- nausea, vomiting, headache, and decreased alertness after stopping denosumab and for up to 1 year afterwards