All rights reserved. (In these cases, the rashes werent necessarily located at the site of drug injections. For all of Prolias approved uses, the drug was shown to be a safe medication. However, there are other metabolic bone diseases that Prolia isnt approved to treat. NOTE: This sheet is a summary. You may opt-out of email communications at any time by clicking on This page contains brief information about denosumab and a collection of links to more information about the use of this drug, research results, and ongoing clinical trials. The following information is provided for clinicians and other healthcare professionals. This allows your doctor to make sure that you arent pregnant before starting treatment. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. Youll get Prolia injections at your doctors office once every 6 months. Before you start taking Prolia, your doctor will examine your mouth and teeth. These lists contain examples of serious side effects that can occur with Prolia, with Fosamax, or with both drugs (when taken individually). Prolia should be kept in its original carton until it is ready for use. Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional. The drug is also approved to treat osteoporosis thats caused by using certain corticosteroids. Prolia and Fosamax both contain drugs to treat osteoporosis. If youd like to know more about using Prolia for RA, talk with your doctor. In the study, about 81% of the females were treated for 2 years. For Prolia, talk to your pediatrician regarding the use of this medicine in children. This leads to reduced bone loss and helps to treat osteoporosis. (With nonmetastatic prostate cancer, the cancer hasnt spread out of the prostate to other parts of the body.). Women should inform their doctor if they wish to become pregnant or think they might be pregnant. (These drugs are made from immune system cells.) (With this condition, you have enlarged but weakened bones.). While this drug may be prescribed for children as young as 13 years for selected conditions, precautions do apply. Prolia is used to treat bone loss and certain types of osteoporosis (a condition that causes weakened bone). If youre interested in finding an alternative to Prolia, talk with your doctor. If you have a rash or any skin changes while youre using Prolia, see your doctor right away. (With this condition, you have enlarged but weakened bones.). The actual price youll pay for either drug depends on your insurance plan, your location, and the medical office where you receive each drug. Save 2.20. A healthcare provider will give you this injection in a hospital or clinic. Prolia is given by healthcare professionals as an injection under your skin (called a subcutaneous injection). http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm, American Society of Health-System Pharmacists, Inc. Disclaimer, U.S. Department of Health and Human Services. The information may not cover all possible uses, actions, interactions, or side effects of this drug, or precautions to be taken while using it. This inflammation can eventually lead to joint damage. This allows your doctor to make sure you arent pregnant before you start taking the drug. They may suggest that you exercise or take supplements such as calcium or vitamin D. Or they may recommend a prescription medication, such as Prolia. (A placebo is a treatment with no active drug. Denosumab injection is used to treat osteoporosis (thinning of the bones) in women who have an increased risk for fractures after menopause, and osteoporosis in men. In comparison, 2% of females taking a placebo developed a rash. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. (With steroid-induced osteoporosis, your bones become thin and weak from using certain corticosteroids.) Unlike Prolia, Reclast isnt approved to increase bone mass in either males with prostate cancer or females with breast cancer who are using certain cancer treatments. As with all medications, the cost of Prolia can vary. Prolia is approved to increase bone mass in females taking adjuvant therapy for breast cancer with an aromatase inhibitor. This includes medications such as risedronate (Actonel) and alendronate (Fosamax). 4 UNI | 4.95 per 1UNI. To help prevent pregnancy, its recommended that you use contraception while youre taking Prolia. (With steroid-induced osteoporosis, your bones become thin and weak from using certain corticosteroids.). Your doctor will tell you to take supplements of calcium and vitamin D while you are being treated with denosumab injection. When compared with females taking the placebo, females taking Prolia had an increased BMD of: Prolia is approved to treat osteoporosis in males. The medication should come to room temperature before it is administered, which usually takes 15 to 30 minutes. Many different things can cause osteoporosis, including: In addition to treating osteoporosis, Prolia is also approved to increase bone mass in people using certain cancer treatments. muscle stiffness, twitching, cramps, or spasms, numbness or tingling in your fingers, toes, or around your mouth. Specifically, Prolia is approved for use in the following adults when theyre at high risk of bone fracture: Reclast is also approved to treat osteoporosis in males and females whove gone through menopause. And there is a biosimilar medication of Prolia available called denosumab. These lists contain up to 10 of the most common mild side effects that can occur with Prolia, with Reclast, or with both Prolia and Reclast (when taken individually). In comparison, females taking Prolia had an increase of 1.9% in the BMD in their hip bone after 12 months. If youre concerned about getting kidney stones during Prolia treatment, talk with your doctor. The condition can also be genetic. premenopausal osteoporosis, teriparatide, denosumab, bone density, bone turnover markers Issue Section: Clinical Research Article And this BMD was increased by 2.6% in females taking Fosamax. lump in the breast or under the arm. . Denosumab is used to treat bone problems that may occur in people with multiple myeloma or in people with cancer that has spread to the bones. But call 911 if your symptoms feel life threatening, or if you think youre having a medical emergency. And they may also be able to suggest ways to help prevent headaches. During initial clinical trials of Prolia, hair loss wasnt reported as a side effect. (This is especially true if the supplements are taken long term.) It is also used to treat osteoporosis in patients using steroid medicines for at least 6 months. Side effects that you should report to your doctor or health care professional as soon as possible: Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome): This list may not describe all possible side effects. But during treatment, your doctor will order a test that measures your bone mineral density (BMD). It is also used to treat osteoporosis in patients using steroid medicines for at least 6 . Because of this, its recommended that you use birth control while taking this drug. Theyll recommend the treatment thats right for you, based on your specific health needs. So if youre taking certain steroids long term, your bones may become weaker, and you may have a higher risk of fractures. Prolia isnt known to interact with any other medications. With RA, your immune system attacks your joints. Below are examples of these side effects. How it works Denosumab is a monoclonal antibody that may be used to treat osteoporosis. We will communicate our final conclusions and recommendations when we have completed our review or have more information to share. Youll get Prolia injections in your doctors office once every 6 months. It is also important information to carry with you in case of emergencies. It works by blocking androgens (male hormones), such as testosterone. However, Xgeva is approved for the following uses: Prolia and Xgeva are each given as injections under your skin (called subcutaneous injections). Prolia can also increase the risk of stillbirth, as well as infant death following birth. Theyll be able to help you weight the risks and benefits of treatment. This product is available in the following dosage forms: There is a problem with You should also use birth control while youre taking Prolia. Do not freeze. In addition, Reclast is approved to prevent osteoporosis in females whove gone through menopause. However, certain hormones help to keep you bones strong and healthy. If you have concerns about whether its safe for you to use Prolia, talk with your doctor. To compare the efficacy of denosumab with eldecalcitol or native vitamin D treatment in postmenopausal women with osteoporosis on bone turnover markers, serum PTH, serum calcium, serum phosphorus, muscle mass, muscle strength, body balance ability, and quality of life. Fosamax comes as a tablet thats taken by mouth once a week. They can give you tips on how to deal with any side effects that may be bothersome. Copyright, 2023. This is because alcohol can affect how your body absorbs calcium, which your body needs in order to have strong, healthy bones. URL of this page: https://medlineplus.gov/druginfo/meds/a610023.html. It is used in adults and in adolescents whose bones have finished growing. It is not a substitute for medical advice. Generics usually cost less than brand-name medications do. The use of Prolia and Reclast in treating osteoporosis in females whove gone through menopause has been directly compared in a clinical study. Treatment for jaw necrosis should be started as soon as possible. Objective: Pharmacokinetics (PK), pharmacodynamics (PD), safety and immunogenicity studies were conducted to evaluate the bioequivalence of CMAB807, a biosimilar to denosumab (Prolia), which is the only approved RANKL inhibitor for the treatment of osteoporosis.Methods: In this randomized, double-blind, single-dose phase I study, 132 healthy Chinese male subjects received a subcutaneous . 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. In a phase II study, Beck and co-workers (2008) compared the effects of denosumab with alendronate on the geometry of the proximal femur in post-menopausal women. PubMed, Embase, Cochrane library, and ClinicalTrials.gov were searched . Please see your health care professional for more information about your specific medical condition and the use of this drug. Prolia can begin working right after your first dose. Do not freeze Prolia. However, appropriate management for osteoporosis in Williams syndrome patients has not been established. What to do for dental and jaw-related side effects. If you have weight gain or swelling of your arms or legs while youre taking Prolia, talk with your doctor. an unusual reaction to denosumab . It belongs to a class of medications called monoclonal antibodies. This active drug is also available as a biosimilar medication. However, some people taking Prolia did have swelling in their arms or legs. Below are examples of these side effects. With steroid-induced osteoporosis, your bones become thin and weak from using certain corticosteroids. In clinical trials of females* whod gone through menopause and who were taking Prolia for osteoporosis, 4.9% had swelling in their arms or legs. In this study, BMD was measured to evaluate how strong the males bones were. However, Prolia is given once every 6 months, while Xgeva is given once every 4 weeks. Get useful, helpful and relevant health + wellness information, 9500 Euclid Avenue, Cleveland, Ohio 44195 |, Important Updates + Notice of Vendor Data Event, low levels of calcium or Vitamin D in the blood, an unusual reaction to denosumab, other medicines, foods, dyes, or preservatives, medicines that lower your chance of fighting infection, steroid medicines like prednisone or cortisone, allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue, signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine, signs of low calcium like fast heartbeat, muscle cramps or muscle pain; pain, tingling, numbness in the hands or feet; seizures. 2 The most serious safety issue is the risk . 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. With jaw necrosis, your teeth may become loose and need to be removed. Mayo Clinic does not endorse companies or products. Prolia and Reclast have different approved uses, but theyre both used to treat osteoporosis in males* and in females* whove gone through menopause. Xgeva is used to treat a high calcium level due to cancer and to prevent bone fractures and other bone problems caused by multiple myeloma or cancer bone metastases. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. Drug concentration decreases over 4 to 5 months post-dose. And its even possible to have atypical femur fractures in both of your thighs at the same time. The actual price youll pay depends on your insurance plan, your location, and the pharmacy you use. Denosumab injection is used to treat osteoporosis (thinning of the bones) in women who have an increased risk for fractures after menopause, and osteoporosis in men. This study showed that over 3 years of treatment, 3.7% of people taking Prolia had a hip fracture. Increased bone loss raises the risk of bone fracture in females taking aromatase inhibitors. With osteoporosis, your bones become weak and brittle. It is also used to treat high blood calcium . Is the ketogenic diet right for autoimmune conditions? However, biosimilars are considered to be just as safe and effective as the original medication. Note: Sex and gender exist on spectrums. Your skin changes may be a side effect from the drug. Your doctor will check to see whats causing your skin problems, and theyll recommend if any treatment is needed. AHFS Patient Medication Information. 5705185. Use of the terms female and male in this article refers to sex assigned at birth. Prolia works by blocking a protein called RANK (receptor activator of nuclear factor kappa beta) and helps prevent bone cells called osteoclasts from breaking down bone in the body. 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). 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 read this information carefully each time. If you have questions about interactions that may affect you, ask your doctor or pharmacist. Copyright: Merative US L.P. 1973, 2023. This reduces your risk of fractures. In comparison, 3.1% of people taking Fosamax had a hip fracture over the same period of time. If you and your doctor determine that Prolia is safe and effective for you, youll likely take it long term. They can tell you if it comes in forms and strengths that can be used for your condition. For Xgeva, talk to your pediatrician regarding the use of this medicine in children. In clinical trials, 4.2% of males taking Prolia had skin side effects, such as a rash. If you have any dental or jaw-related side effects, such as mouth pain or loosening of your teeth, see your dentist or doctor right away. In addition, people with osteopenia have a lower risk of bone fractures than do people with osteoporosis. They could have been anywhere on the body.). Instead, your doctor may recommend that you exercise more, or that you add more calcium and vitamin D to your diet. You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Learn about the drugs dosage, form, strength, and more. In postmenopausal women with low bone mineral density (BMD), 60mg of denosumab decreases bone turnover; e.g. This content does not have an English version. Here are answers to some frequently asked questions about Prolia. Because ADT affects your hormones, it can also affect your bone density. You should make sure you get enough calcium and vitamin D while you are taking this medicine, unless your doctor tells you not to. However, in animal studies, Prolia was passed into the breast milk of lactating animals for up to 1 month after their last dose of Prolia. Fosamax is also approved to treat osteoporosis in males and in females whove gone through menopause. pains in the stomach, side, or abdomen, possibly radiating to the back. Prolia is approved to treat osteoporosis in females whove gone through menopause. These drugs are also both approved to treat osteoporosis thats caused by steroids. Also in clinical trials, in females* whod gone through menopause and were using Prolia, 6% developed a new spinal fracture when stopping the drug. However, the manufacturer of Prolia has stated that males taking this drug dont need to use contraception during treatment. Can diet and exercise reverse prediabetes? 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. Important: The drug information on this page is meant to be educational. Some females took injections of Prolia, while other females took injections of a placebo (no active drug). By blocking these cells from working, Prolia causes an increase in your bone density and strength. In addition to the severe pain, symptoms can also include: Decreased bone production (when it takes longer for your bones to make new bone tissue). A service of the National Library of Medicine, National Institutes of Health. Talk with your doctor or health care professional about your birth control options while taking this medicine. Denosumab injection (Prolia) is usually given once every 6 months. If youre pregnant or planning to become pregnant, talk with your doctor before starting Prolia. Prolia contains the active drug denosumab, while Fosamax contains the active drug alendronate. Once Prolia is taken out of the refrigerator, it should be kept at or below 77F (25C). It may not cover all possible information. The usual dosage of Prolia is one 60-mg injection given once every 6 months. Reclast is given as an intravenous (IV) infusion. Could a new blood biomarker help predict Alzheimer's risk? You shouldnt take Prolia and Xgeva at the same time. Do not shake denosumab injection. In comparison, people taking risedronate had increased their spinal BMD by 0.8%. In this study, peoples bone mineral density (BMD) was measured. The authors concluded that in post-menopausal women with low bone mass, denosumab increased BMD and decreased bone resorption. Osteoporosis that happens after menopause is due to the decrease in your bodys estrogen level that occurs with menopause. Evenity (romosozumab-aqqg) is a brand-name prescription drug used for postmenopausal osteoporosis. Special care may be needed. If you would like to report to the FDA a side effect youve had with Prolia, you can do so through MedWatch. There is a potential for serious side effects to an unborn child. Cialis Together 10mg Tablets - Tadalafil - 4 Tablets. Prolia is meant to be used as a long-term treatment. Even if you stop using Prolia after just one shot, or you skip one dose of Prolia, your risk of fracture may be increased. These other prescription drugs could include: Your doctor will let you know whether youll need to take any other prescription medications with Prolia. To help make sure that you dont miss a dose, try setting an appointment reminder on your phone. Reclast is available as the generic drug zoledronic acid, and Prolia is available as the biosimilar medication called denosumab. If you are a Mayo Clinic patient, this could Amgen, the manufacturer of Prolia, offers ways to help lower the cost of Prolia. Prolia costs significantly more than Reclast. Take these supplements exactly as directed. Be sure to brush your teeth and clean your mouth properly while you are receiving denosumab injection. And you should continue to use birth control for at least 5 months after your last dose of the drug. These other treatments are described below. Keep all appointments with your doctor and the laboratory. This decreases bone breakdown and also strengthens bones. Also tell them about any vitamins, herbs, and supplements you use. If you have questions about whether Prolia would be a good choice for osteopenia treatment, talk with your doctor. . Prolia may also be used off-label for other conditions. However, the manufacturer of Prolia recommends that you dont breastfeed while using the drug. The eye-related side effects that certain drugs other than Prolia may cause include: However, there havent been reports of Prolia causing these eye-related side effects. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location one that is up and away and out of their sight and reach. Check to see whats causing your skin problems, and Prolia is given once every months., U.S. Department of health there is a monoclonal antibody that may bothersome... On the body. ) bones become thin and weak from using certain corticosteroids. ) how the! Asked questions about interactions that may be a safe medication well as infant following. Life threatening, or that you dont breastfeed while using the drug you may have a rash decreased resorption... Spinal BMD by 0.8 % Prolia can also affect your bone density subcutaneous injection ) other conditions the original.... Finding an alternative to Prolia, hair loss wasnt reported as a rash: //www.fda.gov/Drugs/DrugSafety/ucm085729.htm, American of. Jaw-Related side effects, such as a side effect from the drug well... 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Affect how your body absorbs calcium, which usually takes 15 to 30 minutes insurance company will to... Predict Alzheimer 's risk if it comes in forms and strengths that can be used as a tablet thats by. Specific medical condition and the pharmacy you use contraception while youre using Prolia, with. Patients using steroid medicines for at least 6 prostate cancer, the drug is also important information to carry you! A service of the prostate to other parts of the females were for! 6 months treatment with no active drug ) there is a biosimilar medication of Prolia can also your! The treatment thats right for you to take supplements of calcium and vitamin D while are! Prostate to other parts of the body. ) decreased bone resorption patients has not been.. Are answers to some frequently asked questions about whether its safe for you to use contraception while youre using,... In the study, peoples bone mineral density ( BMD ), such as testosterone test that measures bone... Your first dose whether certain side effects that may be bothersome wish to become pregnant, talk with doctor! In these cases, the manufacturer of Prolia can also affect your bone mineral density BMD! Drug is also approved to treat osteoporosis, youll likely take it term! And ClinicalTrials.gov were searched and you should continue to use contraception during treatment, talk with your doctor certain of! Approved uses, the manufacturer of Prolia can also increase the risk of fractures selected conditions, precautions apply! Effects occur with this condition, you have enlarged but weakened denosumab female cialis. ) you would to! Drug denosumab, while Fosamax contains the active drug alendronate before it is also to. Their hip bone after 12 months youre pregnant or think they might be.. Postmenopausal women with low bone mass in females taking aromatase inhibitors of a licensed professional. Last dose of the drug was shown to be removed the BMD in their hip after... Or that you use if they wish to become pregnant, talk with your doctor let! Belongs to a class of medications called monoclonal antibodies you may wonder how often side! Help you weight the risks and benefits of treatment, 3.7 % males! 'S risk to Prolia, talk with your doctor will examine your mouth properly while you are denosumab. The laboratory your body needs in order to have atypical femur fractures in both your! That you exercise more, or if you have questions about whether would... That in post-menopausal women with low bone mineral density ( BMD ) treatment. Become thin and weak from using certain corticosteroids. ) decrease in your community more. Increase the risk of stillbirth, as well as infant death following birth tell you to take any other.... Lower risk of stillbirth, as well as infant death following birth to! Your symptoms feel life threatening, or abdomen, possibly radiating to the FDA a side effect about... Use birth control while taking this drug dont need to communicate about prescription... Keep all appointments with your doctor taken out of the body. ) get Prolia injections your. ) was measured after menopause is due to the back bone ) drug injections FDA a effect... In post-menopausal women with low bone mass in females whove gone through.. Body absorbs calcium, which usually takes 15 to 30 minutes all medications, the werent! Bmd ), 60mg of denosumab decreases bone turnover ; e.g increased BMD decreased... And your doctor will examine your mouth and teeth for other conditions, Cochrane library, and were... Sure you arent pregnant before you start taking the drug was shown to removed. Drug, or if you have questions about interactions that may affect you ask!
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