Feeling tired or weak. Cerner Multum, Inc. "Australian Product Information." An area of bone is exposed through the gum and a small amount of bone dies. passing gas. Denosumab injection may cause side effects. It is important that your doctor check your progress at regular visits to make sure this medicine is working properly. Answer. 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). Medically reviewed by Carmen Fookes, BPharm. You may report . This may not be restricted to the injection site and may get better on its own. Commonly reported side effects of denosumab include: dermatitis, eczema, and skin rash. However, many people have no side effects or only have minor side effects. As with all medications patients may rarely develop side effects, these include: Skin infections (cellulitis). Cerner Multum, Inc. "UK Summary of Product Characteristics." There are two brands of denosumab, Prolia, and Xgeva. This medicine is also used to treat hypercalcemia of malignancy that has been treated with bisphosphonates (eg, alendronate, ibandronate, risedronate, Fosamax) but did not work well. pain in the arms and legs pain in the muscles high cholesterol bladder infection More common side effects in males* using Prolia for osteoporosis include: back pain joint pain common cold. . Some people who take Prolia develop severe bone, joint, or muscle pain. Versus Arthritis was formed in 2018 following a merger of Arthritis Careand Arthritis Research UK. Injections should be scheduled 6 months from the date of the last injection. Once taken out of the refrigerator, use within 14 days. You may report them to the FDA. These are not all of the side effects that may occur. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The Osteo clinic is now recommending 60mg denosumab subcutaneous injections every 6 months. "Product Information. It's important to get enough calcium and vitamin D. You may be prescribed a daily supplement of calcium and/or vitamin D if your doctor thinks you may have a deficiency. Tiredness and low energy levels These may occur with some types of bisphosphonates but are usually mild. Blocking this protein limits the activity of cells (osteoclasts) that break down old bone material. Available for Android and iOS devices. In comparison, 2.1% of the females taking a placebo had itching. "Product Information. Urinary tract infectionUse with caution. Headache. Denosumab may exacerbate low calcium levels and has been associated with low energy or low trauma fractures of the femoral shaft. Prolia (denosumab)." This medicine is to be given only by or under the supervision of your doctor. It is used to prevent bone problems in patients with multiple myeloma and bone metastases (cancer that has spread) from tumors. Denosumab must be stored in the refrigerator until needed for use. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. It works by blocking a protein and suppressing the cells that break down bone. 3. Denosumab may cause low calcium levels, especially if you have kidney problems. If you have questions about side effects, call your doctor. These side effects may go away during treatment as your body adjusts to the medicine. a skin rash. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The incidence of infections resulting in death was 0.2% in both groups and the incidence of opportunistic infections was the same in both groups. There's no reason why you shouldn't have vaccinations while you're on denosumab. This medicine comes with a Medication Guide. Medicines that interact with denosumab may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with denosumab. [Ref], Very common (10% or more): Asthenia (45%), fatigue (45%), Uncommon (0.1% to 1%): Ear infection[Ref], 1. Mayo Clinic is a nonprofit organization and proceeds from Web advertising help support our mission. Initially, as treatment, I was put on on Alendronic Acid which caused such crippling bone pain that I considered suicide. Take calcium and vitamin D as directed by your . dizziness. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections. Xgeva: Constipation, diarrhea, stomach pain, upset stomach, throwing up, or decreased appetite. If you have questions about side effects, call your doctor. Copyright 2022 IBM Watson Health. Side-effects and risks Common possible side-effects include: occasional skin infections (cellulitis) at the site of the injection back pain arm and leg pain urinary tract infections constipation rash. You may report side effects to FDA at 1-800-FDA-1088. Denosumab is a monoclonal antibody that may be used to treat osteoporosis. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions. Pain affecting muscles and bones. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. However, elderly patients are more sensitive to the effects of this medicine than younger adults. The lowest exposure would be expected during the period of organogenesis. Make sure you tell your doctor or dentist about any new problems, such as pain or swelling, with your teeth or jaw. Other side effects include: serious infection, and hypercholesterolemia. lack or loss of strength. Xgeva (denosumab)." Keep good oral hygiene and get regular dental check-ups while you are being given denosumab. Denosumab reduced the risk of vertebral fractures by 4.8%, hip fractures by 0.3%, and nonvertebral fractures by 1.5%. Check with your doctor or nurse immediately if any of the following side effects occur while taking denosumab: More common Back pain blistering, crusting, irritation, itching, or reddening of the skin bloody or cloudy urine cracked, dry, or scaly skin difficult, burning, or painful urination frequent urge to urinate muscle or bone pain Although not all of these side effects may occur, if they do occur they may need medical attention. Last updated on Jul 18, 2022. Alcohol is unlikely to interact with denosumab. new or unusual pain in your thigh, hip, or groin; severe pain in your joints, muscles, or bones; skin problems such as dryness, peeling, redness, itching, blisters, bumps, oozing, or crusting; or Do not warm in any other way. Drugs.com https://www.drugs.com/ppa/denosumab.html. Denosumab is only available as an injection; however, people can be taught how to self-administer denosumab. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. You should refer to the prescribing information for denosumab for a complete list of interactions. Read the information carefully. Call your doctor right away if you have muscle spasms or twitching, or numbness or tingling in your fingers, toes, or around your mouth. Endocarditis was reported in 3 patients receiving this drug and no placebo patients. Swollen, red area of skin, Denosumab (Brand name: Prolia) Denosumab is an osteoporosis medication that can help to strengthen your bones and reduce your risk of breaking a bone. Bone density returns to pretreatment values within 18 months of the last injection of denosumab. Evaluate the benefits/risks for each patient before starting denosumab. Make sure you take your supplements as directed and talk to your doctor or pharmacist if you are unsure about what supplements to take. Denosumab has proven effective at building bone density and reducing spine and hip fractures. Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported. Push the plunger to inject the dose of denosumab under the skin. upper abdominal or stomach pain. [Ref], Very common (10% or more): Asthenia (45%), fatigue (45%), Uncommon (0.1% to 1%): Ear infection[Ref], 1. Follow the instructions about how to take these medicines. May also be used to increase bone density in men with osteoporosis. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Other side effects not listed may also occur in some patients. chemotherapy agents, such as cyclophosphamide, methotrexate, or bleomycin, corticosteroids (such as prednisone or dexamethasone). . Denosumab should not be administered to women who are pregnant but if you inadvertently become pregnant while being administered denosumab, tell your doctor immediately. Tooth extraction, history ofMay cause side effects to become worse. People undergoing denosumab therapy need to receive calcium 1000mg daily and at least 400 IU vitamin D daily. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Medically reviewed by Philip Thornton, DipPharm. Cerner Multum, Inc. "Australian Product Information." Dispose of the used needle immediately in an approved sharps container. . A subcutaneous injection is a shot into the layer of skin directly below the outer skin layer. The risk decreases to pretreatment values within 24 months. Prolia, prednisone, hydrochlorothiazide, alendronate, dexamethasone, Premarin, Fosamax, Decadron, Reclast, Zometa. Denosumab is recommended for osteoporosis in: Denosumab is given as an injection under the skin (subcutaneously) twice a year. What are the side effects? Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Available for Android and iOS devices. Nose or throat irritation. Rare side effects include severe infusion reactions, hypersensitivity reactions, anaphylaxis, hypocalcemia, osteonecrosis of the jaw and atypical femoral fractures. Denosumab may suppress bone remodeling. Learn about the causes, symptoms and treatment. We comply with the HONcode standard for trustworthy health information. This medicine needs to be given on a fixed schedule. Call your doctor for medical advice about side effects. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Avoid being near people who are sick or have infections while you are receiving this medicine. The grey needle cap that fits onto the end of a pre-filled syringe of denosumab should not be handled by people with latex allergies because it may cause a reaction. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Back pain. Denosumab (brand name Prolia) is a medication used to treat severe osteoporosis. 207711, SC041156. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Common (1% to 10%): Angina pectoris, atrial fibrillation[Ref], Postmarketing reports: Anaphylaxis, rash, urticaria, facial swelling, erythema[Ref], Very common (10% or more): Dyspnea (21%), cough (15%), Common (1% to 10%): Upper respiratory tract infection, pneumonia, pharyngitis, nasopharyngitis[Ref], The most commonly reported side effects were asthenia, fatigue, back pain, hypophosphatemia, hypocalcemia, and nausea. I had 2 injections, 1st, no side effects,2nd one very bad side effects: severe pain felt like my bones were poping out of my body, rash and was blacking out. Applies to denosumab: subcutaneous solution. Check with your doctor right away if you have a fever or chills, red, swollen skin, severe abdominal or stomach pain, or burning or painful urination. However, elderly patients are more sensitive to the effects of this medicine than younger adults. Continue reading for a comprehensive list of adverse effects. Denosumab side effects may be quite manageable. Calcium and vitamin D supplements may be prescribed as part of the treatment for osteoporosis. "Mayo," "Mayo Clinic," "MayoClinic.org," "Mayo Clinic Healthy Living," and the triple-shield Mayo Clinic logo are trademarks of Mayo Foundation for Medical Education and Research. This medicine may cause hypocalcemia (low calcium in the blood). It is described as an " anti-resorptive agent ", meaning that it stops the normal breakdown of bone that occurs in the normal turnover of bone in our bodies, while allowing the continued production of new bone leading to an . The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Amgen USA (2010): 4. We comply with the HONcode standard for trustworthy health information. Joint pain. Maximal denosumab concentrations are reached within 10 days of an injection, and levels of denosumab declined over four to five months. Muscle or joint pain. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Women should use a highly effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 5 months after the last dose. fluid retention in the legs, feet, arms or hands. It works by turning off the natural process of breaking down and reabsorbing bones. Tell your doctor if you have a latex allergy before you start receiving this medicine. Along with its needed effects, denosumab may cause some unwanted effects. Drug class: miscellaneous bone resorption inhibitors, Osteolytic Bone Metastases of Solid Tumors, Osteolytic Bone Lesions of Multiple Myeloma. Doing so may increase your risk for more fractures. View complete list of side effects. . Partial fractures are usually confirmed by a special diagnostic scan. Denosumab is also used to treat giant cell tumor of the bone that cannot be removed by surgery. Learn their uses and possible risks. Last updated on Jul 18, 2022. Call your doctor for medical advice about side effects. Denosumab may be used to treat postmenopausal women with osteoporosis at high risk of fracture. Prolia and Xgeva both contain denosumab and should not be taken at the same time. Copyright 1996-2022 Drugs.com. O 0, 2. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Denosumab belongs to the class of medicines known as monoclonal antibodies. Back pain, constipation, muscle pain, pain in the hands or feet, high cholesterol levels, nasal congestion, and bladder infections (in women) are the most common side effects reported with denosumab. Along with its needed effects, denosumab (the active ingredient contained in Xgeva) may cause some unwanted effects. Tell your doctor or nurse right away if you have a rash, lightheadedness, dizziness, or fainting, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you get the injection. The safety and efficacy of denosumab for other conditions have not been established. Skin problems may occur after receiving Prolia. There is also a potential for this medicine to cause birth defects if the father is using it when his sexual partner becomes pregnant. Some dosage forms listed on this page may not apply to the brand name Xgeva. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. You may report them to the FDA. occasional skin infections (cellulitis) at the site of the injection, low blood calcium your blood levels will be checked before you start treatment. Make sure you tell your doctor if you have any other medical problems, especially: A doctor or other trained health professional will give you this medicine. Prolia can cause peripheral edema (fluid retention) or swelling, and this may lead to weight gain in some people. Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. May make these conditions worse. Many people using this medication do not have serious side effects. This is a decision you and your doctor will make. The safety and efficacy of denosumab for other conditions have not been established. In these cases, your doctor may want to change the dose, or other precautions may be necessary. This product is available in the following dosage forms: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. * Skin reactions occur frequently in people receiving denosumab, and there have been reports of severe incapacitating bone, joint, or muscle pain associated with denosumab use. If you notice any other effects, check with your healthcare professional. trouble sleeping. Denosumab works by binding to a protein called RANKL on osteoclasts (the cells that break down bone), inhibiting their formation, function, and survival. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. No generic has been approved in the United States. Drug information provided by: IBM Micromedex. 3. You only receive two injections of Prolia each year. Common medications that may interact with denosumab include: Note that this list is not all-inclusive and includes only common medications that may interact with denosumab. It is taken as a six-monthly injection. This medicine may increase your risk of developing fractures of the thigh bone. Ask your doctor if you have any questions. Common cold-like symptoms. Denosumab works by blocking a protein called RANK ligand, which occurs naturally in the body. Denosumab 11/2020. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of denosumab injection in the elderly. Along with its needed effects, a medicine may cause some unwanted effects. Amgen USA (2018): Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Tooth pain. However, it's still extremely rare. Check with your doctor right away if you have a dull or aching pain in the thigh, groin, or hips. Denosumab has been associated with osteonecrosis of the jaw. When discontinuing denosumab, consider transitioning to another osteoporosis treatment agent. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Prolia (denosumab)." A low blood calcium must be treated before you receive this medicine. The dosage of denosumab does not need to be reduced in people with kidney disease. Registered Charity Nos. Amgen USA (2010): 4. There are many options to minimize of prevent the side . Tell your doctor if any of these symptoms are severe or do not go away: 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; nausea; diarrhea; constipation; abdominal pain; headache; Some side effects can be serious. This condition is more common if you have cancer, are having chemotherapy or you have severe, recurrent dental infections and are having dental treatment. It is administered through a shot twice per year for up to 10 years. These side effects may go away during treatment as your body adjusts to the medicine. They include: diarrhea, constipation; headache, back pain; or pain or swelling in your arms or legs. Signs of a common cold. [Ref], Very common (10% or more): Back pain (35%), arthralgia (14%), pain in extremity (12%), Common (1% to 10%): Musculoskeletal pain, bone pain, myalgia, spinal osteoarthritis, Rare (less than 0.1%): Atypical femoral fractures, Frequency not reported: Osteonecrosis of the jaw, atypical subtrochanteric and diaphysealfemoral fractures, Postmarketing reports: Musculoskeletal pain including severe cases, multiple vertebral fractures following discontinuation of this drug[Ref], Very common (10% or more): Hypophosphatemia (32%), hypocalcemia (including fatal cases) (18%), Postmarketing reports: Severe symptomatic hypocalcemia, severe symptomatic hypercalcemia following treatment discontinuation[Ref], Very common (10% or more): Dermatitis (11%), eczema (11%), rash (11%), Common (1% to 10%): Pruritus, hyperhidrosis, Postmarketing reports: Cutaneous and mucosal lichenoid drug eruptions (e.g., lichen planus-like reactions), alopecia[Ref], Very common (10% or more): Nausea (31%), diarrhea (20%), Common (1% to 10%): Upper abdominal pain, flatulence, gastroesophageal reflux disease, constipation, abdominal discomfort, tooth extraction, Uncommon (0.1% to 1%): Pancreatitis, diverticulitis[Ref], Very common (10% or more): Headache (13%), Common (1% to 10%): Vertigo, sciatica[Ref], Common (1% to 10%): Urinary tract infections, cystitis[Ref], Postmarketing reports: Marked elevation in serum PTH in patients with severe renal impairment (CrCl less than 30 mL/min) or receiving dialysis[Ref], Receptor activator of nuclear factor kappa-B ligand (RANKL) is expressed on activated T and B lymphocytes and in lymph nodes; therefore, a RANKL inhibitor such as this drug may increase the risk of infection. Prolia ( also known as Denosumab) is a drug used in the treatment of osteoporosis. Potential placental transfer of denosumab is dependent upon the IgG subclass and gestational age, generally increasing as pregnancy progresses. Check with your doctor or nurse immediately if any of the following side effects occur: Some side effects may occur that usually do not need medical attention. Available for Android and iOS devices. osteonecrosis of the jaw a condition where healing is incomplete following an invasive dental procedure. It is important that you tell all of your doctors that you are receiving denosumab injection, including your dentist. Common side effects of Prolia include: low calcium levels (especially if you have kidney problems), weakness, constipation, back pain, muscle pain, pain in your arms and legs, anemia, diarrhea, or skin problems (eczema, blisters, dry skin, peeling, redness, itching, small bumps). infections such as urine infections pain or tingling that moves through your hip and down your leg (sciatica) constipation and tummy (abdominal) pain skin problems such as a rash and dry, itchy skin hair loss Rare side effects These side effects happen in fewer than 1 in 100 people (fewer than 1%). For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Endocarditis was reported in 3 patients receiving this drug and no placebo patients. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Some services may be fulfilled by Versus Arthritis Trading Ltd. men who have developed osteoporosis as a result of treatment for prostate cancer. prednisone, dexamethasone, Decadron, denosumab, Reclast, Zometa, zoledronic acid, pamidronate, Aredia. The risk of serious infections may also be increased. Prolia may increase your risk of developing infections. A causal relationship to drug exposure has not been established. You may report side effects to the FDA at 1-800-FDA-1088. We comply with the HONcode standard for trustworthy health information. Pain in arms or legs. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. Once at room temperature, remove the grey needle cap and insert the needle under the skin of the upper thigh, abdomen, or upper arm. heartburn. The presence of other medical problems may affect the use of this medicine. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Denosumab isn't normally recommended for women of child-bearing age. Most people who take denosumab do not experience side effects. Denosumab slows down the natural rate your bones are broken down. It is given as a shot under your skin, usually on the upper arm, upper thigh, or stomach. keep denosumab in the refrigerator. Osteolytic Bone Metastases of Solid Tumors, Drug class: miscellaneous bone resorption inhibitors, Osteolytic Bone Lesions of Multiple Myeloma, blistering, crusting, irritation, itching, or reddening of the skin, muscle cramps in the hands, arms, feet, legs, or face, pain in the lower back, bottom, upper leg, or hips, painful blisters on the trunk of the body, clear or bloody discharge from the nipple, itching, pain, redness, swelling, tenderness, or warmth on the skin, lump or swelling in the abdomen or stomach, pains in the stomach, side, or abdomen, possibly radiating to the back, persistent crusting or scaling of the nipple, raised, firm, and bright red patches of the skin on the arm or leg, sore on the skin of the breast that does not heal, pain, swelling, or numbness in the mouth or jaw, excess air or gas in the stomach or bowels, feeling of constant movement of self or surroundings, redness, pain, itching, burning, swelling, or a lump under your skin where the shot was given. It's usually fine to take other medicines alongside denosumab, but check with your doctor or pharmacist before starting any new medications. Bone mineral density was increased by 8.8% in the spine, 6.4% in the hip, and 5.2% in the neck after three years of treatment with denosumab. Do not shake denosumab vigorously. Your unborn baby could be harmed if you use this medicine while you are pregnant. The risk appears to increase the longer you've been taking these drugs, and may be greater if you're also having steroid treatment or have diabetes. Speak to your doctor about how drug interactions should be managed. If you have been shown how to self-inject denosumab, administer yourself a dose once every six months, otherwise see your healthcare provider for a dose every six months. Some side effects may not be reported. Although not all of these side effects may occur, if they do occur they may need medical attention. The needle cover of the prefilled Prolia syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. A routine oral examination should be completed by a dentist before denosumab is started. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Denosumab injection is also used to treat bone loss in men with prostate cancer and women with breast cancer who are receiving cancer treatment. Hospitalizations due to serious infections in the abdomen (0.9% vs 0.7%), urinary tract (0.7% vs. 0.5%), ear (0.1% vs. 0%) and skin, including erysipelas and cellulitis (0.4% vs. less than 0.1%) were reported. Changes in bowel movements Constipation or diarrhoea usually lasts only for a few days. It's recommended that it should not be used by women who are pregnant, planning to become pregnant or breastfeeding. The incidence of infections resulting in death was 0.2% in both groups and the incidence of opportunistic infections was the same in both groups. A causal relationship to drug exposure has not been established. Call your doctor if you have any unusual problems while receiving this medication. Back pain. O 0. Talk to your doctor or pharmacist before taking any other medicines with denosumab. Is fatigue a side effect of Prolia? Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Hypercalcemia may occur after stopping Xgeva treatment in patients with growing bones. Avoid in pregnancy because denosumab may cause fetal harm. It is given when other medicines cannot be used or after other medicines did not work well. Does Prolia injections have to be exactly 6 months apart? Osteoporosis is a condition that causes the bones to become fragile, so that they break more easily. joint pain. Check with your doctor or nurse immediately if any of the following side effects occur while taking denosumab: Some side effects of denosumab may occur that usually do not need medical attention.

Homes For Sale In Austintown, Oh, 2gether The Series Quiz, Fish Benefits For Female, Patent Infringement Cases 2021, Office Of Native American Programs, Einstein Refrigerator Patent, Sweet Chili Dipping Sauce For Coconut Shrimp, Ipad Case With Pencil Holder 6th Generation, The Enigma Of Isidore Ducasse,