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. Copyright, 2022. Brand name: Prolia 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088). such as inflammation of your skin (dermatitis), rash, and eczema have been reported. Do not start, stop, or change the dose of have low blood calcium; or are pregnant or plan to become pregnant, as Prolia may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia. Prolia is an injection medication. Monoclonal antibodies are made to target and destroy only certain cells in the body. Prolia is a prescription medicine used to treat osteoporosis (thinning and weakening of bone) in women after menopause who are at high risk for fracture, meaning women who have had a fracture related to osteoporosis, or who have multiple risk factors for fracture. Generic name: Denosumab Injection (Prolia) [den-OH-sue-mab] This medicine may cause jawbone problems. The typical injection dosage is one syringe every 6 months. The drug is administered as a twice-a-year injection that is administered under ones upper arm, upper thigh or abdomen. URL of this page: https://medlineplus.gov/druginfo/meds/a610023.html. AHFS Patient Medication Information. Duplication for commercial use must be authorized by ASHP. Prolia is an injection that will be given to you by a healthcare professional. Xgeva contains the same medicine as Prolia. Skin problems. Take good care of your teeth and gums while you receive Prolia. It is important for you to practice good mouth care during treatment with Prolia. Denosumab injection (Prolia) is usually given once every 6 months. If you are pregnant or may be pregnant. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Prolia is a prescription medicine used to 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. Talk with the doctor. You must check Take these supplements exactly as directed. Maximal Prolia concentrations are reached within 10 days of an injection, and levels of Prolia declined over four to five months. Prolia is injected under your skin (subcutaneous). What side effects can this medication cause? Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. When you remove Prolia from the refrigerator, Prolia must be kept at room temperature [up to 77F (25C)] in the original carton and must be used within 14 days. Prolia is a monoclonal antibody and Boniva is a bisphosphonate. Check with your This medicine may lower blood calcium levels. 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. slightly. hives, rash, itching, difficulty breathing or swallowing, swelling of the face, eyes, throat, tongue or lips, redness, tenderness, swelling or warmth of area of skin, frequent or urgent need to urinate, burning feeling when you urinate, painful or swollen gums, loosening of the teeth, numbness or heavy feeling in the jaw, poor healing of the jaw, nausea, vomiting, headache, and decreased alertness after stopping denosumab and for up to 1 year afterwards. have happened in people who take Prolia. Prolia (denosumab) is a treatment for women with osteporosis who have not had success with other treatments. If you receive Prolia, you should not receive XGEVA. For the spine, my T-score increased from -2.8 to -2.3. Prolia is a medicine that may affect the ability of your body to fight infections. If you have questions about side effects, call your doctor. The most common side effects of Prolia in patients with corticosteroid-induced osteoporosis are back pain, high blood pressure, lung infection (bronchitis), and headache. any drug without checking with your doctor. Talk with your doctor if any of these apply to you, or if you have questions. Summary: Prolia is a prescription medicine used to treat symptoms of osteoporosis and to increase bone mass in patients receiving certain types of cancer. are breastfeeding or plan to breastfeed. Prolia is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well. Bone Matters. Denosumab (Xgeva) is administered at a dose of 120mg every four weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen for bone metastasis from solid tumors. It has controlled the development of new tumors since April 2016. WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Treat osteoporosis (thinning and weakening of bone) in women after menopause (change of life) who: are at high risk for fracture (broken bone), cannot use another osteoporosis medicine or other osteoporosis medicines did not work well. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of your face, lips, or tongue; rash; itching; or hives. 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). You will receive Prolia 1 time every 6 months. 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. Prolia is a medicine that may affect the ability of your body to fight infections. Prolia works by preventing the development of cells that remove old bone. Prolia is an injectable medication that works by disrupting the activation of osteoclasts to slow down bone loss. Some people have developed unusual fractures in their thigh bone. Ask your doctor how long to use birth control. Prolia's typical dosage is 60 mg given every 6 months. Medicare Costs For Prolia Injections Your Medicare costs will depend on who administers your Prolia injection and your Medicare plan. tell your doctor if you have or have ever had a low level of calcium in your blood. Read the information carefully and ask your doctor or pharmacist if you have any questions. Any new or strange groin, hip, or thigh pain. 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. Take calcium and vitamin D as you were told by your doctor. Prolia is given by healthcare professionals as an injection under your. Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported. It may be given to you for other reasons. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 6. Prolia is a so-called. The femoral neck and total femur did not change. Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying Prolia. Unrelated to bisphosphonates, denosumab might be used in people who can't take a bisphosphonate, such as some people with reduced kidney function. Prolia is also used to treat glucocorticoid-induced osteoporosis in men and women at high risk of bone fracture. I discontinued it due to sever joint and bone pain. Please see Prolia full Hypoc alcemia: Hypocalcemia may worsen with the use of Prolia , especially in patients with severe renal impairment. Your doctor may tell you to see your dentist before you start Prolia. 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. doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: All drugs may cause side effects. I received information the Medicare will accept 96401 . Do not take denosumab injection (prolia) if you are pregnant. Keep Prolia in the original carton to protect from light. Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported. How quickly does Prolia start to work? Where is Prolia injected? Denosumab injection comes as a solution (liquid) to be injected subcutaneously (under the skin) in your upper arm, upper thigh, or stomach area. had parathyroid or thyroid surgery (glands located in your neck). Related information Osteoporosis Osteoporosis is a condition that causes the bones to become fragile, so that they break more easily. Take calcium and vitamin D as your doctor tells you to. Prolia is used to increase bone mass in men with osteoporosis with a high risk of bone fracture, and in women and men with a high risk of bone fracture caused by receiving treatments for certain types of cancer. Prolia was approved in 2010 for the treatment of osteoporosis and for preventing new bone fractures especially in postmenopausal women. Review pharmacology about DENOSUMAB (PROLIA): Side effects, uses, dose (INJECTION), warnings, precautions, benefits, indications, mechanism of action (MOA). Severe jaw bone problems may happen when you take Prolia. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh. advice about side effects. Call your doctor if you have any unusual problems while receiving this medication. It's recommended as a first-choice medication for certain people with osteoporosis. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. may occur. problems. or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well. Talk with your doctor before starting Prolia treatment. for breast cancer that has not spread to other parts of the body. Each pack contains one pre-filled syringe. What is this medicine? Prolia 60 mg/ml Injection is used for the treatment of osteoporosis (a condition where bone density reduces and bones becomes weak and fragile) in men and postmenopausal women who are at high risk for fractures and have failed to respond to other medication treatments for osteoporosis. Prolia is injected two times per year. [3] It prevents bone-dissolving osteoclast cells from forming. All Rights Reserved. It works by turning off the natural process of breaking down and reabsorbing bones. The Unusual thigh bone fractures. However, you should not flush this medication down the toilet. This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Before you give a Prolia injection, make sure you are trained by a health professional to master the technique. Call your doctor right away if Received various answers in reference to which administration code is the correct code to us for J0897. Signs of an allergic reaction, like rash; Signs of low calcium levels like muscle cramps or spasms, Signs of infection like fever, chills, very bad. Prolia is also used to help prevent bone fractures in people with breast or prostate cancer who are taking certain medications. Response and effectiveness. 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. Talk with your doctor before starting Prolia treatment. You should take calcium and vitamin D as your doctor tells you to while you receive Prolia. Injectable Prolia Osteoporosis Update By Juliann Schaeffer Aging Well Vol. The risk may be higher with longer use, cancer, dental problems, ill-fitting dentures, anemia, blood Prolia is an injection that will be given to you by a healthcare professional. From the WebMD Archives June 2, 2010 -- The FDA has approved twice-a-year Prolia (denosumab) injections to treat osteoporosis in patients at high risk of fracture. You should not receive more than one product containing denosumab at the same time. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The most common side effects are joint and muscle pain in the arms or legs. A pregnancy test will be done before you start denosumab injection (prolia) to show that you are NOT pregnant. I will be receiving my 60th and final. Very bad infections have been reported with use of denosumab injection (prolia). Do not use Prolia for a condition for which it was not prescribed. Prolia is a medication that is used to help treat osteoporosis and increase bone mass in people who have weakened or fragile bones. What should I know about storage and disposal of this medication? levels have stayed low for weeks or months after use of denosumab injection (prolia). Denosumab (brand name Prolia) is a medicine used to treat osteoporosis. These are not all the possible side effects of Prolia. what signs you had. You may also report side effects at https://www.fda.gov/medwatch. 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. Do not shake denosumab injection. Prolia is a prescription medicine used to increase bone mass in men with osteoporosis who are at high risk for fracture. Serious infections. There may be drug take-back programs in your area. These are not all the possible side effects of Prolia. What are the possible side effects of Prolia? Prolia is a medicine that may affect the ability of your body to fight infections. 0. Instead, the best way to dispose of your medication is through a medicine take-back program. Another common osteoporosis medication is denosumab (Prolia, Xgeva). What part of the body is Prolia injected? My concern is that this might be why you're in so much pain, have shrunk in size, etc as your x-rays appear . If you have low blood calcium before you start receiving Prolia, it may get worse during treatment. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported. Inactive ingredients: sorbitol, acetate, polysorbate 20, Water for Injection (USP), and sodium hydroxide. Your doctor may prescribe Prolia if: You are a man or woman with low bone density at risk for developing osteoporosis You have been diagnosed with osteoporosis skin that looks red or swollen and is hot or tender to touch, fever, shortness of breath, cough that will not go away, frequent or urgent need to urinate or burning feeling when you urinate. Prolia is also used to increase bone mass in people receiving specific breast cancer or prostate cancer treatments. Call your doctor or get medical Call your doctor for medical advice about side effects. Your low blood calcium must be treated before you receive Prolia. Keep all appointments with your doctor and the laboratory. Visit www.fda.gov/medwatch, orcall1-800-FDA-1088. Denosumab (brand name Prolia) is a medication used to treat severe osteoporosis. Denosumab injection (Prolia) is used 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. Some people who take Prolia develop severe bone, joint, or muscle pain. 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 cause other side effects. What special dietary instructions should I follow? Denosumab injection (Prolia) is used 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. in your skin, lower stomach area (abdomen), bladder, or ear may happen. However, many people have no side effects or only have minor side effects. Prolia is given as an injection under the skin. 4 P. 6. One cannot safely stop Prolia injections without transitioning to a bisphosphonate as there is a 5-15% chance of rebound fractures occurring in the vertebrae in particular within a very short space of time after the last missed injection. It is not known if Prolia passes into your breast milk. If you have any infection, are taking. Women on teriparatide or abaloparatide need to give themselves a daily injection. 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. Prolia (denosumab) is used to treat and slow down bone loss to help maintain strong bones and reduce the risk of fractures, usually due to osteoporosis (weak and brittle bones). The American Society of Health-System Pharmacists, 4500 East-West Highway, Suite 900, Bethesda, Maryland. It may harm them. Be sure to tell your doctor if you are being treated with either of these medications. You are encouraged to report negative side effects of prescription drugs to the FDA. This information is intended only for U.S. healthcare professionals. have been told by your doctor that your blood calcium level is too low. Denosumab injection (Prolia) is usually given once every 6 months. Each pack contains one pre-filled syringe with a needle guard. 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. Prolia is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well. If you need to store denosumab injection (prolia) at home, talk with your doctor, nurse, or pharmacist about how to store it. to treat bone loss in women with breast cancer who are receiving certain medications that increase their risk for fractures. This may help to protect healthy cells from . Hear from others, just like you, who have seen real bone-strengthening results with Prolia. Do not stop, skip or delay taking Prolia without first talking with your doctor. This medicine may cause harm to an unborn baby. 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. Unless your doctor tells you otherwise, continue your normal diet. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. Your doctor, nurse or pharmacist will show you or your carer how to use Prolia. Prolia is a medicine that may affect the ability of your body to fight infections. Low calcium levels in your blood (hypocalcemia). You may need to go to the hospital for treatment. Warm temperatures will affect how Prolia works. This includes your doctors, nurses, pharmacists, and dentists. [1] You may ask, why would this drug ever be reported using 96401? It's also used in men and women to combat other conditions that weaken bone. 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. 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. Denosumab is delivered by shallow injections, just under the skin, every six months. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections. You should not become pregnant while you are receiving denosumab injection. You will receive Prolia 1 time every 6 months. Keep Prolia in a refrigerator at 36F to 46F (2C to 8C) in the original carton. 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. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome). Prolia is used to treat osteoporosis in women after menopause and in men, and in people who are taking corticosteroids for 6 months or more. 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 breast-feeding or plan to breast-feed. Have a dental exam before starting denosumab injection (prolia). If your symptoms or health problems do not get better or if they become worse, call your doctor. The most common side effects of Prolia in women being treated for osteoporosis after menopause are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection. Here's an overview of the tests and procedures used. Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying Prolia. Last updated July 31, 2019. Denosumab injection (Prolia) is used 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. If you miss an appointment to receive an injection of denosumab, you should call your healthcare provider as soon as possible. Medication Guide. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections. This leads to reduced bone loss and helps to treat osteoporosis. For women with osteoporosis after menopause at high risk for fracture, PROLIA IS PROVEN TO HELP REDUCE THE RISK OF FRACTURE. It may also be higher if you have dental work, chemo, radiation, or take other drugs that may cause jawbone If you miss a dose of Prolia, you should receive your injection as soon as you can. The drug's typical dosage is the same regardless of why Prolia is prescribed. If treatment with denosumab injection (prolia) is stopped, skipped, or delayed, the chance of a broken bone is raised. If you miss a dose of Prolia, you should receive your injection as soon as you can. Women must use birth control while taking denosumab injection (prolia) and for some time after the last dose. Be ready to tell or show what was Prolia is a clear, colourless to slightly yellow solution for injection provided in a ready to use pre-filled syringe. After your treatment with Prolia is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased. 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. 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