These other prescription drugs could include: Your doctor will let you know whether youll need to take any other prescription medications with Prolia. Prolia is a brand-name prescription medication. Your side effects may vary from those listed below, depending on the condition youre using Prolia to treat. It is also contraindicated for use in people with hypocalcemia and in people with a past hypersensitivity to Prolia or to any of the ingredients in Prolia. Amgen, the manufacturer of Prolia, offers ways to help lower the cost of Prolia. Denosumab works by binding to a protein called RANKL on osteoclasts (the cells that break down bone), inhibiting their formation, function, and survival. In some cases, health care professionals may use the trade names Prolia or Xgeva when referring to the generic drug name denosumab. If you miss an appointment to get your Prolia injection, call your doctors office and reschedule the appointment as soon as possible. Keep all appointments with your doctor and the laboratory. Prolia isnt safe to take during pregnancy. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. It inhibits osteoclast formation, decreases bone resorption, increases bone mineral density (BMD), and reduces the risk of fracture. A service of the National Library of Medicine, National Institutes of Health. in adults and some adolescents to treat giant cell tumor of bone (GCTB; a type of bone tumor) that cannot be treated with surgery. A common example of metabolic bone disease is osteoporosis, which Prolia is approved to treat. Your doctor will monitor your BMD to know whether or not Prolia is working for you. Mayo Clinic does not endorse companies or products. However, after a 14-day period, if the medication is not used, it needs to be discarded. Prolia reaches a maximum concentration (Cmax) at about 10 days post-dose. However, the manufacturer of Prolia has stated that males taking this drug dont need to use contraception during treatment. They may be able to recommend ways to help reduce this side effect. Health care professionals should consider the risks of hypocalcemia with the use of Prolia in patients on dialysis. Before starting Prolia, talk with your doctor about the risks of stopping the drug if you need to. Review/update the Prolia is given by healthcare professionals as an injection under your skin (called a subcutaneous injection). Conclusion These data support the use of sequential teriparatide and denosumab to increase BMD in premenopausal women with severe osteoporosis. In fact, if your osteoporosis is under control while youre taking Prolia, and youre not having severe or bothersome side effects, you should continue taking the drug for as long as your doctor recommends. Prolia and Xgeva both contain the same active drug called denosumab. But the number of people taking Prolia for other uses who had femur fractures during clinical trials wasnt reported. Prolia and Fosamax both contain drugs to treat osteoporosis. Prolia is approved to treat osteoporosis in females whove gone through menopause. However, in some cases, if you have a high risk of fractures, your doctor may recommend treating your osteopenia with Prolia. In the study, about 81% of the females were treated for 2 years. But it may be effective when used for longer periods of time as well. Youll get Prolia injections in your doctors office once every 6 months. In this study, the females bone mineral density (BMD) was measured. Aromatase inhibitors are a class of drugs that are often used for adjuvant treatment of breast cancer. This is because alcohol can affect how your body absorbs calcium, which your body needs in order to have strong, healthy bones. These habits can help decrease your risk of oral infections and the need for dental surgery. 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. Your side effects may vary from those listed below, depending on the condition youre using Prolia to treat. This patient information sheet applies only to approved uses of the drug. Because of this, its recommended that you use birth control while taking this drug. In comparison, only 1.8% of the people taking a placebo (no active drug) had headaches. 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. However, Xgeva is approved for the following uses: Prolia and Xgeva are each given as injections under your skin (called subcutaneous injections). Females taking Reclast had a 0.6% increase in BMD in their hip bone after 12 months of treatment. But sometimes its used off-label for this condition. 10 years of denosumab treatment in postmenopausal women with osteoporosis: Results from the phase 3 randomised . The medication should come to room temperature before it is administered, which usually takes 15 to 30 minutes. If youre concerned about getting kidney stones during Prolia treatment, talk with your doctor. you should know that denosumab injection is available under the brand names Prolia and Xgeva. Theyll be able to help you weight the risks and benefits of treatment. The following information describes dosages that are commonly used or recommended. Prolia should be kept in its original carton until it is ready for use. With bone loss, you have an increased risk of fractures. 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. See your dentist regularly. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. This condition may also be painful. AHFS Patient Medication Information. privacy practices. Good oral hygiene habits, such as brushing and flossing your teeth, should be followed while youre taking Prolia. Rarely, your doctor may give you the option to self-inject Prolia at home. Theyll recommend the treatment thats right for you, based on your specific health needs. The trials showed no increased risk or any difference in safety for older people taking Prolia compared with younger people taking the drug. Note: Sex and gender exist on spectrums. If you drink alcohol, talk with your doctor to see if theres a safe amount of alcohol you can drink while youre taking Prolia. But you bones arent as weak and brittle as they would be with osteoporosis. (With nonmetastatic prostate cancer, the cancer hasnt spread out of the prostate to other parts of the body.). 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. For example, some of the generic forms come as tablets that are taken by mouth once daily instead of once weekly. Prolia can cause mild or serious side effects. ), Clinical trials also showed that 2.5% of the females taking Prolia reported a rash. It is used in the following types of cancer: These uses are approved for the Prolia brand of denosumab. You may opt-out of email communications at any time by clicking on For more information, see How Prolia injection is administered below. 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. Theyll recommend whether Prolia is a good option for you based on this exam. Youll get Prolia injections once every 6 months at your doctors office. It belongs to a class of medications called monoclonal antibodies. These lists contain examples of serious side effects that can occur with Prolia, with Reclast, or with both drugs (when taken individually). This inflammation can eventually lead to joint damage. However, its not known how many people taking Prolia during clinical trials had an allergic reaction to the drug. If youre interested in finding an alternative to Prolia, talk with your doctor. Drug information provided by: Merative, Micromedex. Even if you stop using Prolia after just one shot, or you skip one dose of Prolia, your risk of fracture may be increased. For females taking Reclast, their spinal BMD was increased by 1.1% after 12 months of treatment. females with osteoporosis whove gone through, males or females with osteoporosis thats caused by taking certain, females who are receiving adjuvant treatment** for, swelling in your arms or legs, which may cause weight gain, stomach problems, such as upper belly pain. (People with these conditions have swelling in their joints or other areas of their body that is eased by taking steroids.). This study showed that over 3 years of treatment, 3.7% of people taking Prolia had a hip fracture. Prolia may not be right for you if you have certain medical conditions or other factors affecting your health. What special precautions should I follow? However, there are other metabolic bone diseases that Prolia isnt approved to treat. to treat bone loss in women with breast cancer who are receiving certain medications that increase their risk for fractures. Portions of this document last updated: Feb. 01, 2023. This medicine is only given in a clinic, doctor's office, or other health care setting and will not be stored at home. Your doctor will determine the best dosage to fit your needs. And there is a biosimilar medication of Prolia available called denosumab. For example, of people taking Prolia, serious (but not deadly) side effects were seen in: For information about the serious side effects that Prolia may cause, see the section Prolia side effects above. Your doctor may recommend other treatment options that you can use if Prolia doesnt work for you or if you decide to stop using the drug. The following information is provided for clinicians and other healthcare professionals. Symptoms of a mild allergic reaction can include: A more severe allergic reaction is rare but possible. Generics and biosimilars usually cost less than brand-name medications. Youll get Prolia injections from a healthcare professional at your doctors office. Prolia should not be heated or warmed in any other manner. Prolia comes as a solution inside prefilled syringes that each hold 60 mg of the drug. With the exception of one rib fracture patient, for whom the nature of trauma was unknown, all rib . Visit your doctor or health care professional for regular checks on your progress. However, biosimilars are considered to be just as safe and effective as the original medication. A generic drug is an exact copy of the active drug in a brand-name medication. With osteoporosis, your bones become weak and brittle. The actual price youll pay for either drug depends on your insurance plan, your location, and whether you receive the drug from a pharmacy or medical office. Prolia is approved to increase bone mass in females taking adjuvant therapy for breast cancer with an aromatase inhibitor. Below are examples of these side effects. (With off-label use, a drug is used to treat a condition that its not approved to treat.). However, your doctor will ultimately prescribe the smallest dosage that provides the desired effect. (This is especially true if the supplements are taken long term.) In comparison, 2.1% of the females taking a placebo had itching. The drug is also approved to treat Pagets disease of the bone. . It is administered through a shot twice per year for up to 10 years. In postmenopausal women with low bone mineral density (BMD), 60mg of denosumab decreases bone turnover; e.g. When Prolia is used in these patients, adequate calcium and vitamin D supplementation and frequent blood calcium monitoring, possibly more often than is already being conducted, may help decrease the likelihood or severity of these risks. In clinical trials, Prolia also increased bone mineral density (BMD) in females with osteoporosis whod gone through menopause. Off-label use is when a drug thats approved to treat one condition is used to treat a different condition. No, kidney stones werent reported as a side effect of Prolia in clinical trials. With osteoporosis, your bones become weak and brittle. 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. Juvenile Pagets disease, which is a metabolic bone disease thats caused by a genetic problem. In comparison, 4.2% of people taking risedronate reported skin side effects. But it was reported that no one taking Prolia for steroid-induced osteoporosis had jaw necrosis (death of tissue in the jawbone). Prolia can be injected under the skin of your: Prolia injections should be given once every 6 months. Denosumab is indicated for postmenopausal women with osteoporosis at high risk of fracture, or for patients who have failed or are intolerant to other available osteoporosis therapies . Talk to your doctor about the risks of receiving denosumab injection. the unsubscribe link in the e-mail. Write a review. It is given by a health care professional in a hospital or clinic setting. Talk to your health care professional about any concerns you may have, including possible alternative treatments. After 6 months, youll need to get another dose of Prolia so that the medication can continue to work. But call 911 if your symptoms feel life threatening, or if you think youre having a medical emergency. Prolia and Reclast havent been directly compared in clinical studies as treatment options for males with osteoporosis or for people with osteoporosis thats caused by steroids. You can use Prolia over a long period of time. This is because as we age, our hormones change. To help prevent pregnancy, its recommended that you use contraception while youre taking Prolia. 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. When denosumab injection (Xgeva) is used to treat giant cell tumor of bone, or high calcium levels caused by cancer, 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 after the first three doses. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Fosamax is available as a generic medication, alendronate. It works by blocking androgens (male hormones), such as testosterone. A decrease in bone mineral density is common in patients with Williams syndrome. lump or swelling in the abdomen or stomach. Preliminary results from a separate internal FDA study investigating the risk of hypocalcemia suggest that patients on dialysis treated with Prolia are at substantial risk for severe and symptomatic hypocalcemia, including hospitalization and death. Is the ketogenic diet right for autoimmune conditions? In comparison, 3.3% of males taking a placebo had skin side effects. Some males were given injections of Prolia, while other males were given injections of a placebo (no active drug). Having an infection in your mouth can also increase your risk of jaw necrosis. All Rights Reserved. However, alcohol can increase your risk of both osteoporosis and bone fractures. Hajdu-Cheney syndrome, which is also metabolic bone disease thats caused by a genetic problem. Femur fractures can cause pain to your hip, groin, or thigh. Prolia is given as an injection under your skin (called a subcutaneous injection). The use of Prolia and Fosamax in treating osteoporosis has been directly compared in a clinical study. 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). Use of the terms female and male in this article refers to sex assigned at birth. In fact, in postmarketing studies of Prolia, some people reported having severe bone, joint, or muscle pain, which may have occurred in their hip. Mild allergic reaction is rare but possible mouth once daily instead of once weekly symptoms feel life,... 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