. 2020 Nov 16;77(23):1949-1956. doi: 10.1093/ajhp/zxaa285. EVENITY is indicated for the treatment of osteoporosis in Romosozumab targets and inhibits the protein sclerostin, thereby preventing inhibition of bone formation by allowing Wnt to bind to LDL receptor-related proteins 5 and 61,2. Unable to load your collection due to an error, Unable to load your delegates due to an error. Hypocalcemia: Hypocalcemia may occur. Conclusions: The overall incidence of new malignancies was 4.3% in the placebo group and 4.8% in the Prolia group. 2017 Aug;101:77-87. doi: 10.1016/j.bone.2017.04.005. 8600 Rockville Pike doi: 10.7554/eLife.76228. A practical consideration for patients is that the available formulation contains half the recommended monthly dose (210 mg). Recommended Dietary Allowance (RDA): 600 units daily (males and females 70 years of age) or 800 units daily (males and females 71 years of age) (IOM 2011). Monitor patients for signs and symptoms of hypocalcemia, particularly in patients with severe renal impairment or receiving dialysis. The fractures may occur anywhere along the femoral shaft (may be bilateral) and commonly occur with minimal to no trauma to the area. Same Active Ingredient: Prolia contains the same active ingredient (denosumab) found in XGEVA. To review the clinical pharmacology, efficacy, and safety of romosozumab, a humanized monoclonal antibody with a novel mechanism of action for monthly injection, and its place in the management of osteoporosis. [, Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A: Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY. Please see Prolia full Prescribing Information, including Medication Guide. Clipboard, Search History, and several other advanced features are temporarily unavailable. In patients predisposed to hypocalcemia and disturbances of mineral metabolism, including treatment with other calcium-lowering drugs, clinical monitoring of calcium and mineral levels is highly recommended within 14 days of Prolia injection. Osteoporos Int. Romosozumab is associated with skeletal defects in the offspring of rats given romosozumab and is detected in the excreted milk9. Patient may experience joint pain or headache. A dental examination with appropriate preventive dentistry is recommended prior to treatment in patients with risk factors for ONJ such as invasive dental procedures, diagnosis of cancer, concomitant therapies (e.g. Correct hypocalcemia prior to initiation of therapy (contraindicated in patients with uncorrected hypocalcemia). This information should not be interpreted without the help of a healthcare provider. -. 2018 Sep 1;103(9):3183-3193. doi: 10.1210/jc.2017-02163. Mechanism of action. Romosozumab. osteoporotic fracture, or multiple Read More risk factors for fracture; or patients Consider interruption of therapy based on benefits/risks. Starting with anabolic (teriparatide or romosozumab) and subsequently switching to antiresorptive is the best treatment sequence, so it could be the . Reactions have included angioedema, erythema multiforme, and urticaria The risk or severity of adverse effects can be increased when Romosozumab is combined with Amivantamab. Monitor patients for consequences, including ONJ, atypical fractures, and delayed fracture healing. Disclaimer, National Library of Medicine FOIA 12.1 Mechanism of Action . Amgen Field Representatives are here to answer any questions you may have or to schedule a visit. One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions: Results of the FRAME Extension Study. Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving EVENITY. Romosozumab (EVENITY) is a humanized monoclonal antibody designed to target sclerostin. Romosozumab binds sclerostin, which keeps it from blocking the signaling pathway for new bone formation. Romosozumab, sold under the brand name Evenity, is a medication used to treat osteoporosis. This activity will detail the mechanism of action of romosozumab at a molecular level and its adverse event profile and reviews important considerations pertinent for healthcare team members in . Romosozumab (Evenity) is in a class called sclerostin inhibitors and is considered an anabolic agent. official website and that any information you provide is encrypted 2018 Jun;10(5-6):105-115. doi: 10.1177/1759720X18775936. ( 11, 12) in treatment-nave postmenopausal women with osteoporosis, romosozumab significantly improved bone mass and The incidence of opportunistic infections and the overall incidence of infections were similar between the treatment groups. romosozumab, an anti-sclerostin monoclonal antibody, is a bone-forming agent with a novel mechanism of actiona dual effect of activating both modeling-based and remodeling-based bone formation while reducing bone resorption. 13.1 . EVENITY is contraindicated in patients with a history of systemic hypersensitivity to romosozumab or to any component of the product formulation. The drug has to be given by monthly subcutaneous injections. Romosozumab has also been studied as sequential therapy in . Romosozumab is a humanized monoclonal antibody indicated for the treatment of osteoperosis in postmenopausal women at high risk of fracture and patients who have failed in other treatments or are intolerant to other osteoperosis therapies9. Romosozumab is a subcutaneously injected humanized monoclonal antibody that inhibits the secreted protein sclerostin9. When sclerostin binds to receptors on osteoblasts it reduces their activity, thereby inhibiting bone formation. PMC risk factors for fracture; or patients Despite no significant differences in baseline cardiovascular risk factors between groups, a numerical increase in serious cardiovascular adverse events was demonstrated with romosozumab in randomized trials with no discernable etiology. 2013;8(12):136. Produced by osteocytes (bone cells), it inhibits bone formation (making new bone). Disclosure MBB is the chair of the American Board of Internal Medicine (ABIM) Rheumatology Board and the ABIM Rheumatology Board Exam Committee. 2018 Feb;178(2):R33-R44. 2022 Jan-Dec;18:17455057221125577. doi: 10.1177/17455057221125577. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with Prolia. The presence of antibodies against romosozumab can reduce the availability of romosozumab by 22%, and 63% in the case of neutralizing antibodies9. Romosozumab is a humanized monoclonal antibody (IgG2). Review our medical disclaimer. It reduced the fracture risk: hip (40%), and nonvertebral . Organogenesis. [, Lobo ED, Hansen RJ, Balthasar JP: Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci. N Engl J Med. . The anabolic effect of EVENITY wanes after 12 monthly doses of therapy. Remove 2 syringes from carton and allow to sit at room temperature for at least 30 minutes before administration. Romosozumab also demonstrates a faster and larger increase in bone density than teriparatide4. Refrigerate at 2C to 8C (36F to 46F) in the original carton to protect from light. In women of reproductive potential, pregnancy, Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia, Helps reduce osteoclast-mediated bone resorption. The https:// ensures that you are connecting to the Monoclonal antibodies are generally not protein bound5,6. Sclerostin is a promising therapeutic target for oral inflammation and regenerative dentistry. bone mineral density; osteoporosis; romosozumab; sclerostin. Bethesda, MD 20894, Web Policies Keywords: It is a humanized monoclonal IgG directed against sclerostin that is one of the primary factors responsible for bone metabolism. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009). This article describes mechanism of action, clinical studies, pharmacological properties, and safety of romosozumab. 2017 Sep 30;390(10102):1585-1594. doi: 10.1016/S0140-6736(17)31613-6. an antiresorptive agent should be considered. 13 NONCLINICAL TOXICOLOGY 13.1. For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. In postmenopausal women with osteoporosis, However, denosumab and romosozumab may also have an antiresorptive effect, raising concerns about ONJ development in patients. Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). CTX, P1NP, and bone mineral density (BMD) return to baseline within ~12 months of discontinuing therapy. Signs/symptoms of hypersensitivity; signs/symptoms of adverse cardiovascular events; serum calcium. Limitations of use: The anabolic effect of romosozumab wanes after 12 monthly doses of therapy. Animal Toxicology and/or Pharmacology . 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING . of vertebral, nonvertebral, and hip fractures. Before [, Tabrizi MA, Tseng CM, Roskos LK: Elimination mechanisms of therapeutic monoclonal antibodies. Discuss specific use of drug and side effects with patient as it relates to treatment. Have patient report immediately to prescriber signs of a heart attack (chest pain; pain in arms, back, neck, jaw, or abdomen; shortness of breath; cold sweats; severe dizziness; passing out; or severe nausea or vomiting); signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes); signs of low calcium (muscle cramps or spasms, numbness and tingling, or seizures); groin, hip, or thigh pain; jaw edema; or jaw pain (HCAHPS). If continued osteoporosis therapy is necessary following discontinuation of romosozumab, consider initiation of antiresorptive therapy (eg, bisphosphonate or denosumab) (Cosman 2016; Saag 2017; manufacturers labeling). Ensure adequate calcium supplementation. See this image and copyright information in PMC. Romosozumab was granted FDA approval on April 9,20197. Whatever the mechanism, romosozumab should not be used in patients . Accessibility Drug created at October 20, 2016 20:55 / Updated at June 03, 2022 07:24. Clinical studies of romosozumab have shown that this agent is one of the most potent bone anabolic agents in development to date. Unlike bisphosphonates ( alendronate, zoledronic . If a patient experiences a myocardial infarction or stroke during therapy, romosozumab should be discontinued. Close, Prolia is indicated for the treatment of postmenopausal women Bookshelf 13 NONCLINICAL TOXICOLOGY . -, Geusens P. New insights into treatment of osteoporosis in postmenopausal women. (Brand name: Evenity) Romosozumab is a new injectable drug treatment for some women with osteoporosis. Easily compare up to 40 drugs with our drug interaction checker. Therefore, the duration of EVENITY use should be limited to 12 monthly Romosozumab (Evenity) - Uses, Dose, Side effects, MOA. HHS Vulnerability Disclosure, Help 2014 Jan 30;370(5):412-20. doi: 10.1056/NEJMoa1305224. Efficacy and Safety of Romosozumab Among Postmenopausal Women With Osteoporosis and Mild-to-Moderate Chronic Kidney Disease. government site. 4.7% of the patients developed neutralizing antibodies9. The absence of an interaction does not necessarily mean no interactions exist. Romosozumab's inhibition of sclerostin also inhibits the increase in RANKL dependant increases in osteoclast activity and bone resorption1,2. When this monoclonal antibody binds to sclerostin, sclerostin cannot bind to the LRP-5 and LRP-6 receptors and is unable to exert its inhibitory effect. Type 1-collagen C telopeptide (a bone resorption marker) temporarily increases above baseline levels within 3 months of discontinuation, then returns to baseline within ~12 months. More studies are needed to determine the ideal setting in which romosozumab may be used to optimize osteoporosis treatment. Miller PD, Adachi JD, Albergaria BH, Cheung AM, Chines AA, Gielen E, Langdahl BL, Miyauchi A, Oates M, Reid IR, Santiago NR, Vanderkelen M, Wang Z, Yu Z. J Bone Miner Res. Reactions have included anaphylaxis, facial swelling and urticaria. In the clinical studies, patients tolerated romosozumab well with no major safety signals reported. In postmenopausal women with Read More osteoporosis, Do not shake. Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Areas covered: Herein, the authors highlight the available data on romosozumab for the treatment of osteoporosis. Lewiecki EM, Dinavahi RV, Lazaretti-Castro M, Ebeling PR, Adachi JD, Miyauchi A, Gielen E, Milmont CE, Libanati C, Grauer A. J Bone Miner Res. Other risk factors for ONJ include cancer, radiotherapy, poor oral hygiene, pre-existing dental disease or infection, anemia, and coagulopathy. Romosozumab is not indicated in pregnancy, lactation, or pedatric patients9. Bone. Most of these events were not specific to the injection site. Routine oral exam is recommended prior to initiation of therapy; patients should maintain good oral hygiene during treatment. Romosozumab in postmenopausal women with low bone mineral density. Romosozumab has impressive anti-fracture effects in postmenopausal women with high risk for fragility fracture. Close, Prolia is indicated for the treatment of postmenopausal women new research presented at acr convergence, the american college rheumatology's annual meeting, reveals that romosozumab, an osteoporosis drug, produces substantial gains in bone mineral density. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus and urticaria. 12.1 Mechanism of Action . Study selection and data extraction: EVENITY has a dual effect that increases bone formation and decreases bone resorption to a lesser extent1, EVENITY is a humanized monoclonal antibody that binds and inhibits sclerostin, a regulatory factor in bone metabolism1, IMPORTANT SAFETY INFORMATION FOR EVENITY, POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH, EVENITY may increase the risk of myocardial infarction, stroke and cardiovascular death. postmenopausal women at high risk for fracture, defined as a history of Expert Opin Biol Ther. 2019 Jun 5;14(1):59. doi: 10.1007/s11657-019-0608-z. Figure 2 Mechanism of action of romosozumab. Sequential therapy with romosozumab for 1 year followed by denosumab in the second year reduced vertebral fractures by 75% as compared to the group that received placebo for 1 year and denosumab in the second year. [, Solling ASK, Harslof T, Langdahl B: The clinical potential of romosozumab for the prevention of fractures in postmenopausal women with osteoporosis. Administer calcium supplement. The .gov means its official. Read More The site is secure. Subcutaneous bioavailability is 50 to 70%1,2. The effect of romosozumab on fracture healing remains unclear. 12.3 Pharmacokinetics . This site needs JavaScript to work properly. 2006 Jan;11(1-2):81-8. doi: 10.1016/S1359-6446(05)03638-X. It rapidly increases bone formation and . Consider risk/benefits of therapy in patients requiring invasive dental procedures. Ensure adequate supplementation with calcium and vitamin D during therapy and monitor calcium levels closely, particularly in patients predisposed to hypocalcemia (eg, severe renal impairment and/or receiving dialysis). Notes: Romosozumab is a human monoclonal antibody that binds sclerostin (an inhibitor of Wnt pathway signaling). A patient's weight will affect their level of romosozumab exposure9. The canonical Wnt--catenin signaling pathway, The canonical Wnt--catenin signaling pathway and the effects of inhibition through loss of, Mechanism of action of romosozumab. MeSH If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of Prolia. The significance of these findings and the effect of long-term treatment are unknown. Keywords: It is a humanized monoclonal antibody that targets sclerostin. 12.2 Pharmacodynamics . Side effects. Prolia is contraindicated in women who are pregnant and may cause fetal harm. Has not been characterized; expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG. Potential risk of myocardial infarction, stroke and cardiovascular death. 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