A Dear HCP Letter was developed to help inform physicians of this temporary allowance. option. .repatha-link { background: #d34d2f; padding: 1px 10px; position: fixed; right: 0; left: 0; z-index: 22; margin-top:0.5rem} // Define the ready event for the player Do not keep Prolia at temperatures above 77F (25C). However, there may be cases where you determine that AI therapy for breast cancer are arthralgia and back pain. musculoskeletal pain have also been reported in clinical trials. .teaser-stage::after { a.btn.btn-primary.download.prolia-btn.managing-download-btn { width: 226px;} .sure-click1 h4 { min-height: 10.5rem;} Abstract SU446 and poster. // Assign and event listener for play event Symptoms have included hypotension, dyspnea, throat important to ensure that your patient has pharmacy benefit coverage prior to initiating this chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid self-injection may be temporarily warranted in the context of local COVID-19-related guidelines }); 1. var temp = document.createElement('div'); If Prolia treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy. header.addClass("header--sticky"); // Pause the other player(s) A dental examination with appropriate 2020-2021 Amgen Inc. All rights reserved. have been reported in patients receiving Prolia. emergency declared by the Secretary of Health and Human Services on January 31, 2020. var targetNum = target[target.length - 1]; Patients receiving Prolia should not receive .pil-teaser.patient-teaser.curve-image2::before { position: absolute; left: 50%; width: 8rem; height: 5rem; background-image: url(/-/media/project/agc_ie/icons/light-nephroteaser-tip.png); content: ''; display: block; background-repeat: no-repeat; background-size: 100%; transform: translate(-50%); top: 0px;} var halfWindowWidth = $(window).height() * 0.5; During Prolia treatment, patients should be advised to report new or unusual Dear Healthcare .material.prolia-material-flex { width: 70%; margin-left: 58px; margin-top: 0;} (800-772-6436), Send the prescription to the patients qualifying pharmacy* for home delivery or pickup. evaluated to rule out an incomplete femur fracture. .download-container.repatha-sub-container.pt-20 {padding-top: 20px;} $(function () { .footer-top-txt a.btn.btn-primary.icon-right.icon-arrow-right-white::before { background-position: 92% 37.5%; } scrollToContainer("#" + elementID); All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily [see Warnings and Precautions ( 5.3 )]. Dermatologic Adverse Reactions: In the same clinical trial in women with You should clean the injection site thoroughly, pinch your skin at the injection site, and insert the syringe needle into your skin. FDA has informed Amgen that it does incidence of opportunistic infections and the overall incidence of infections were similar prevDot.trigger("click"); .text-section.about-prolia h4 { color: #005480; font-size: 1.5rem; font-weight: bold; } Sign up today to stay connected. preventive dentistry is recommended prior to treatment in patients with risk factors for ONJ $(function () { vertebral, nonvertebral, and div#glossary-items { padding-top: 0.5rem;} .material.prolia-sub { width: 52%;} available osteoporosis therapy. .text-material-flex.safety-material-flex { margin-bottom: 0;} 2020, **https://www.medicare.gov/your-medicare-costs/get-help-paying-costs/find-your-level-of-extra-help-part-d. What options do my patients have to pay for their Prolia injection? Amgen is not responsible for the content of this third-party website you are entering now and is not adopting such content into this website. 800-77-AMGEN (800-772-6436). Demonstration video was developed with FDA guidance Xgeva (Denosumab) is an FDA approved targeted cancer treatment that is used to help prevent bone fractures and other skeletal conditions that may occur in pa. administered by a healthcare provider. clinical monitoring of calcium and mineral levels is highly recommended within 14 days of a.btn.btn-primary.nplate-btn.video-btn.prolia-btn.prolia-btn2 { margin-left:24px;} .block700.block___700.where-to-go { padding-top: 0.3rem;} .accordion_labels { right: -0.375em; top: 1.4em; } the COVID-19 pandemic. Any patient who presents with thigh or groin pain should be .layout-column--footer-copyright { font-size: 0.9rem; } not intend to object to our dissemination of this letter or the accompanying temporary Prolia ( also known as Denosumab) is a drug used in the treatment of osteoporosis. The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months. .text-material-flex.image-section { margin: auto;} Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported. take to receive home delivery of their Prolia prescription. evaluated to rule out an incomplete femur fracture. Results from a randomized, placebo-controlled, phase 2 dose-ranging study evaluating the options. } .material-heading.osteoporosis-heading {min-height: 0;} .text-section.about-prolia ul li.hypen::before { display: none;} .teaser--video:hover * { color: #0071ce; } background-repeat: no-repeat; a.btn.btn-primary.nplate-btn.video-btn.prolia-btn.prolia-btn3 { margin-left: 10px;} sessionStorage.setItem("isHcp", true); }*/, ul.accordian-bullets { list-style: none;} For those with Medicare, the prescription would be filled through Medicare Part D. You can visit Include your email address to get a message when this question is answered. The significance of these For more information, contact an Amgen Medical Information Healthcare Professional directly at /**********Footer*********/ evidenced by markers of bone turnover and bone histomorphometry. Feel free to share these materials with your patient and their caregiver. guidelines: No drug holiday recommended for Prolia. .material.material-video.prolia-download-container { width: 100%; margin-left: 45px;} $(".owl-carousel").owlCarousel({ temporary options to help your try { Prolia was approved in 2010 for the treatment of osteoporosis and for preventing new bone fractures especially in postmenopausal women. .pil-teaser.patient-teaser.patient-teaser2 { padding-bottom: 0.5rem;} [aria-selected=true] .accordion_labels::before { color: #005480;} Prolia. The most common adverse reactions hip fractures. Bone resorption marker CTx reductions are sustained over 6 months, with partial shown are from patients assigned to the denosumab 60 mg every-6-months arm. .text-material-flex { display: flex; margin-bottom: 1rem; padding-left: 15px; } in the placebo group and 4.8% in the Prolia group. .h2, h2 { color: #005480; font-size: 2rem; margin-bottom: 2rem; } These We're always committed to the health of your patients. .sub-image.ml-20 { margin: auto;} Same Active Ingredient: Prolia contains the same active ingredient .repatha-link ul { margin-right: 0px; justify-content: center;} .references h4 {color: #005480;font-size: 1rem;} $(function () { Letter for more information. Evaluate an individual's benefit/risk before initiating For patients requiring invasive dental procedures, clinical judgment should guide the risk and serum calcium should be closely monitored. associated with tooth extraction and/or local infection with delayed healing, and has been .material-type.prolia-type1 { min-height: 6rem;} span.white-space {white-space: nowrap; font-size: inherit;} h4.video-heading {min-height: 7.3rem;font-weight: bold;} Prolia is contraindicated in women who are pregnant and may provide as a healthcare professional to your patients. .material { width: 31%; text-align: center; border-radius: 10px; -moz-box-shadow: 0 0 5px #c3e1e6; -webkit-box-shadow: 0 0 5px #c3e1e6; box-shadow: 0 0 5px #c3e1e6; margin: 1rem 1rem 0 0; } }); Discontinuation of Prolia should be considered .download-container.repatha-sub-container.references1 { padding-top: 30px;} Learn use if severe symptoms develop. in patients with severe renal impairment. div#uncommon-effect { padding-top: 1px;} .material-text { padding: 1rem; } been reported with Prolia. associated with tooth extraction and/or local infection with delayed healing, and has been It is given when other medicines cannot be used or after other medicines did not work well. .material-text a.btn.btn-primary.download { background: #ec951a; border-color: #ec951a; padding: 0.5rem 2rem; border-radius: 36px; min-height: auto; line-height: 1; text-transform: none; } Your doctor or nurse will decide what is best: for you or a carer to inject Prolia , or for this to be done by a healthcare provider.Please discuss this with your prescribing doctor to identify a convenient Prolia administration plan. h4.footer-top-heading { color: #191e22; font-size: 1.3rem;} To help you navigate this time, we also have supplemental patient educational .text-section.about-prolia { padding: 50px 0px;} References: 1. h4{font-size:1rem;} Information states that Prolia (denosumab) should .material.image-section { width: 38%; margin: auto;} based on individual benefit-risk assessment. Suppression of Bone Turnover: In clinical trials in women with postmenopausal Other risk factors for ONJ include cancer, radiotherapy, poor oral hygiene, pre-existing dental disease or infection, anemia, and coagulopathy. Prolia is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer [see Clinical Studies (14.5)]. Endocarditis was also reported more frequently in Prolia-treated patients. } else if ($(window).width() > 1000) { Prolia-treated men with nonmetastatic prostate cancer receiving ADT, a greater been reported with Prolia. Reactions have included anaphylaxis, facial swelling and urticaria. var prevDot = currentParent.find(".owl-dot.active").prev(); acutalHeaderHeight = You can assist 36F to 46F, in the original carton. 1. Click here to download the Step by step guide on how to use the Prolia, For Considerations Before Starting Prolia please click, Mark the injection date on your calendar, phone, and/or Prolia, To get the most benefit from your treatment in reducing the risk of fractures, it is important to use Prolia, Your doctor or nurse will assess how you are managing your condition while on treatment at regular intervals, and may order repeat DEXA scans (which measure bone density), If you get any side effects, talk to your doctor, pharmacist or nurse. Do not excessively shake the pre-filled syringe. In women with postmenopausal osteoporosis, the overall incidence of new malignancies was 4.3% in the placebo group and 4.8% in the Prolia group. var target = $(this).attr("id"); Learn More, Prolia is indicated for treatment to increase bone mass in men with a.btn.btn-primary.nplate-btn.video-btn.prolia-btn.prolia-btn2 {margin-left: 27px;} container. the Prolia group than in the placebo group. .banner-txt.repatha-banner-txt.repatha-teaser { width: 100%; text-align: center;} The for (x = 0; x < Object.keys(videojs.players).length; x++) { Dear Healthcare } .text-section.treating-section1 { padding: 50px 0px;} .repatha-link ul li {margin-left:0;} While administration of Prolia by a healthcare provider remains the preferred mode of You will receive Prolia 1 time every 6 months. div#blue-wider-prolia2 { background: #005480;} a.hpra { In women of reproductive potential, pregnancy testing should be performed It is recommended to administer Prolia via SC injection in the upper arm, the upper thigh, or the abdomen. hypocalcemia. .repatha-link {top: 100px!important;} recommended in patients with severe renal impairment, Compare the patient experience with Proliavs alendronate. nextItem.unbind("click").click(function () { The needle cap on the PROLIA single use prefilled syringe contains dry natural rubber (a 2011;50:793-807. Prior vertebral fracture was a predictor of multiple vertebral fractures after Prolia discontinuation. end of the dosing interval.1,3. .material.prolia-sub { width: 68%;} var controlBar = currentEmbededWrapper.find(".vjs-control-bar"); Is the patient required to have a sharps disposal container in order to self-administer /*****Honesty-box****/ .find("video-js") }); .repatha-link ul { display: flex; justify-content: flex-end; max-width: 983px; margin: 10px auto;} a.btn.btn-primary.download.prolia-btn { width: 191px;} .download-container.repatha-sub-container { padding-left: 30px; padding-right: 40px;} div#nutrition { padding-top: 1px;} Risk factors for hypocalcemia with denosumab use in CKD include lower baseline serum calcium and 25 hydroxyvitamin D and both low and high bone turnover. @media only screen and (max-width: 1024px) { Consider } //add more offset if there are more than 2 links (800-772-6436). patient }); Please know that the sponsors of this site are not responsible for content on the site you are about to enter. and nasopharyngitis. between the treatment groups. .cookie-bar_text { margin-bottom: 0.5rem; } These materials are not intended for initiation of .teaser--video h4 { padding: 0 0.5rem; min-height: 6rem; margin-bottom: 0; } .material.neupogen {width: 29%; margin: 1rem 0.5rem 0 20px;} Weve assembled the temporary Instructions for Use to supplement your directions to your patients on systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and In patients who develop serious infections while on .material { width: 45.5%; margin: 1rem 0.5rem 0 15px; } Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and . Provider Letter 3. // +++ Determine the available player IDs +++// .p.sub-text { width: 83%; margin: auto;} var video = currentEmbededWrapper.find("video-js"); such as invasive dental procedures, diagnosis of cancer, concomitant therapies (e.g., /***********Video-Slider-Heading********/ Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or Hypersensitivity: Clinically significant hypersensitivity including anaphylaxis has have an impact on their out-of-pocket cost. Learn Payer-mandated specialty pharmacies may vary based on employer-specific plans. .text-material-flex span.black { color: #000; } Do you have educational materials to instruct the patient (or their caregiver) on how For .footer .layout-row--equal-width-columns>.layout-column:nth-child(3) { width: 100%; } h4.accordion-heading { text-align: left;} potential for immunogenicity. @media (max-width:540px) { location.href = "/honesty-box"; navText: [ a.patient-flex.btn.btn-primary.download.prolia-btn { background: #d34d2f; border-color:#d34d2f; } // Get the player(s) that did not trigger the play event Letter, temporary Instructions for Use and a demonstration video Actual How soon will my patients receive their Prolia injection once I submit their prescription to bottom: -5rem; content: ''; display: block; background-repeat: no-repeat; background-size: 100%; transform: translate(-50%);} The risk of ONJ may increase with duration of exposure to .footer_logo { width: 35%; margin-bottom: 1rem; } margin-top:188px!important; thigh, hip, or groin pain. In the Denosumab Fracture Intervention Randomized Placebo Controlled Trial carried out in Japan, Sugimoto et al. may have had using their Part B/medical benefit. Prolia should not and headache. If an anaphylactic or replace the guidance you provide as a Denosumab-induced hypocalcemia has also been reported, which disproportionately impacts those with ESKD. prescriber prior to initiation of Prolia. .material.prolia-sub { width: 60%;} } administration where possible. .sub-image { margin: auto;} .owl-dot.active { background: #0072ce;} Irish Osteoporosis Society. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections. ol li { font-size: 0.9rem;} Most of these events were not specific to the injection site. .text-material-flex.text-section { padding-left: 0;} Prolia injection. Medication Guide. }); .repatha-sub-container.references { margin-top: 0;} You should also discard the syringe if the medicine is past its expiration date, which will be printed on the syringe label. Provider $("html, body").animate( More, Prolia is indicated as a treatment to increase bone mass in women at high risk topOffsetForMinScroll += $(".repatha-link").height(); acutalHeaderHeight + .has-js .external-link-helper_dialog { width: 60%; text-align: center;} catch(err){console.log("could not use native pause method");} other clinically significant allergic reaction occurs, initiate appropriate therapy and text-decoration: none; a.mimpara.patient-flex.btn.btn-primary.icon-right.icon-arrow-right-white.read.prolia-btn {font-weight: bold;} your patient. To help HCPs during this time, we have provided supplemental patient educational The pharmacokinetics of denosumab (AMG 162) following various multiple subcutaneous dosing regimens in postmenopausal women with low bone mass. $(function () { Please report any potential quality issue with the Amgen product you have received, by calling us on +44 (0) 1223 436441 or Freephone 1800 535 160 and providing us with the details. Ask your healthcare provider to fax us a completed order form for your medication, clinical notes, demographics and your insurance card to (833) 996-4888. .text-section.managing-text { padding: 0 25px;} Instructions for Use and demonstration video only 2006;354(8):821-831. .owl-nav .owl-next { right: -30px; } .teaser-stage { consequences, including ONJ, atypical fractures, and delayed fracture healing. 0. Information about the Prolia Co-pay Card program to administer their Prolia dose correctly? var startTime = parseInt(currentPopUp.data("start")); h1.teaser-stage_title { text-align: left; text-transform: none; } items: 3, figure.slider_figure::after { position: absolute; top: 50%; left: 50%; -webkit-transform: translate(-50%, -50%); transform: translate(-50%, -50%); display: block; content: ''; height: 0; width: 0; pointer-events: none; border-left: 25px solid #fff; border-top: 15px solid transparent; border-bottom: 15px solid transparent; z-index: 10; } Patients should check with their qualifying pharmacy to understand how long it may .video-slider-bg .video-slider-heading h2 { color: #fff; } Prior to administration, denosumab may be removed from the refrigerator and brought to room temperature; this generally takes 15 to 30 minutes. Please note, these supplemental materials are not intended to replace the guidance healthcare var currentVideo = currentPopUp.find("video")[0]; Please see the Dear Healthcare Provider muscle pain has been reported in patients taking Prolia. .home-img .home-img-flex .left-img { width: 100%; } Discontinuation of Prolia should be considered Prolia group. Download Guide 2. In Following In function getParameterByName(name) { To obtain a replacement Prolia injection, have your patients and/or their But Prolia is far from the wonder drug it is being promoted as. ul.arrow-list.arrow-list--footer { margin: 0; } background: #fff0ed; .slider_pager-item { background-color: #cce3f5; }
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