You should not use Repatha Pushtronex if you are allergic to it. We are increasingly dependent on information technology systems, infrastructure and data security. Your care provider will show you the best places on your body to inject Repatha Pushtronex or place the on-body infusor. Evolocumab is used along with a proper diet to help lower "bad" cholesterol (LDL) in the blood. Repatha Pushtronex System Prices and Coupons - WebMD A serious danger of taking Repatha (evolocumab) includes a possibly life-threatening allergic reaction. O OncologyOKC Networker Messages 29 No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Repatha injection: Side effects, cost, dosage, generic, and more Continue reading, The cost for Repatha (evolocumab) subcutaneous solution (140 mg/mL) is about $258.00 for one of the 140 mg single-use prefilled autoinjectors or a prefilled syringe. PCSK9 inhibitors. The system's development which is based on the SmartDose technology . This is a brand name drug and a generic may be available. Approval in the statin-intolerant population tested in GAUSS-2 and GAUSS-3 would expand the indication to a modestly broader population.Amgen is sponsoring a large cardiovascular-outcomes trial it hopes will settle the big PCSK9-inhibitor question in the medical community, whether the LDL-C-lowering shown by these drugsevolocumab in this casecan translate to fewer CV events. Repatha Pushtronex System | Prescription Discount Pricing - OptionRx If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Use the missed dose within 7 days after that injection was due, but skip the missed dose if you are more than 7 days late. Angioplasty & Stent Procedure. Pushtronex & SureClick Dosing Options | Repatha (evolocumab) Top-line results from such a trial, called FOURIER, which randomized about 27,500 patients with clinical cardiovascular disease, \"are anticipated in the second half of 2016,\" according to the company. In the U.S., Repatha is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) over age 13, who require additional lowering of LDL-C.1 The effect of Repatha on cardiovascular morbidity and mortality has not been determined. Repatha is the poster child for waste. This medication comes as a solution that's given by subcutaneous injection. I do it at least three times a year and actively look for Statin injury. This domain provided by markmonitor.com at 2013-11-22T19:45:38Z (8 Years, 234 Days ago), expired at 2022-11-22T19:45:38Z (0 Years, 130 Days left). PDF 2023 Prior Authorization Criteria 3 Inject. Set Dosage 3.5ML of 420MG/3.5ML / 3.5 Cartridge. The FDA approval of the Pushtronex system offers another delivery option to patients who need the additional LDL cholesterol lowering that Repatha can provide.". Use a different place each time you give an injection. Chart note states: Medication: Repatha Pushtronex system 420mg/3.5ml placed on abdomen- right side and infused over 9 minutes. http://bit.ly/2QCAJgMPlease keep reading for Approved Use and Important Safety Info.Click SHOW MORE to jump to a section:Start: (00:00)Prepare: (1:25)Get Ready: (3:56)Inject: (5:12)Finish: (7:10)Important Safety Information: (9:10)Visit our Frequently Asked Questions page for more answers.Frequently Asked Questions: http://bit.ly/3bRvTVBIMPORTANT SAFETY INFORMATION Do not use Repatha if you are allergic to evolocumab or to any of the ingredients in Repatha. * Call 1-844-REPATHA ( 1-844-737-2842) SHARE Hours of operation: 8 AM-11 PM ET Repatha side effects: What they are and how to manage them Repatha (evolocumab) is a prescription brand-name medication. The formulation prescribed will depend on personal preferences and doctor recommendations. What is REPATHA PUSHTRONEX SYSTEM? A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Adverse reactions from a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha-treated and placebo-treated patients, respectively. AccessGUDID - DEVICE: Repatha Pushtronex System (00355513770019) We perform a substantial amount of our commercial manufacturing activities at a few key facilities and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. Allergic reactions:Hypersensitivity reactions (e.g. Top-line results from the approximately 27,500-patient event-driven FOURIER study are anticipated in first quarter of 2017. Other side effects, which could be serious in some people, include high blood sugar levels (diabetes), respiratory tract infections, urinary tract infections (UTI), high blood pressure, and influenza (flu). Please share. It's a type of drug called a PCSK9 inhibitor, and it contains the active drug evolocumab. Pushtronex System: Indications, Side Effects, Warnings - Drugs.com Repatha is available as a 140mg/mL single-use prefilled syringe, a 140mg/mL single-use prefilled SureClick autoinjector, and the 420mg/3.5mL single-use Pushtronex system. Evolocumab is used along with a proper diet to help lower "bad" cholesterol (LDL) in the blood. On December 31, 2019, Amgen discontinued sales of the product bearing the old . Lipid Management in Renal Transplant Recipients Using Evolocumab. Keep holding the stretched or pinched skin. Repatha.com-Medicine Site Copyright 1996-2022 Cerner Multum, Inc. Reflecting shorter-term results in a prior trial, the phase 3 Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3 (GAUSS-3) trial \"met its coprimary end points,\" Amgen said in a statement aimed at the investment community[1].It means that one of its highest-profile products, #evolocumab (#Repatha), already on the market, cut mean LDL-C levels significantly further than treatment with ezetimibe over 24 weeks in patients who had been intolerant of statin therapy due to \"muscle-related side effects,\" which usually means pain or spasms.\"There were no new safety findings,\" the company said.As is customary in such announcements, relative outcomes implying a significant difference were provided without specific numbers. Brand Name: Repatha Pushtronex System Version or Model: 9002870 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: AMGEN INC. Primary DI Number: 00355513770019 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 039976196 * Terms of Use prellenados por - Translation into English - examples Spanish | Reverso Patients are able to perform moderate physical activities (such as walking, reaching or bending) as the 420 mg of Repatha is delivered subcutaneously. In the US, Crestor is the fourth top drug by sales at $5,502,148,010 annually (according to IMS National Prescription Audit, IMS Health) and Lipitor was at Lipitor $7.2 billion. The most common side effects of Repatha include: runny nose, sore throat, symptoms of the common cold, flu or flu-like symptoms, back pain, high blood sugar levels (diabetes), and redness, pain, or bruising at the injection site. Repatha (Evolocumab Injection, for Subcutaneous Injection - RxList Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. You are encouraged to report negative side effects of prescription drugs to the FDA. The U.S. Wholesale Acquisition Cost (WAC) price of Repatha is $14,100 annually, whether it is delivered monthly via Pushtronex system or every two weeks via SureClick autoinjector. Repatha is given under the skin (subcutaneously), every 2 weeks or 1 time each month. Store Repatha Pushtronex in the refrigerator in its original carton and protect from light and heat. Ask your healthcare provider or pharmacist for more information. In a 52-week trial, adverse reactions led to discontinuation of treatment in 2.2% of Repatha-treated patients and 1% of placebo-treated patients. Prescriber has assessed the severity of the patient's baseline symptoms of dizziness, lightheadedness, 3. Why Does Repatha Cause Back Pain - HealthyBackClub.net Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts or rebates. Repatha Pushtronex System Prices and Coupons Evolocumab is used along with a proper diet to help lower "bad" cholesterol (LDL) in the blood. The needle covers on the single-dose prefilled syringes and the inside of the needle caps on the single-dose prefilled SureClick autoinjectors contain dry natural rubber. Each single-use Pushtronex system (on-body infusor with prefilled cartridge) delivers a 3.5 mL solution containing 420 mg evolocumab, acetate (4.2 mg), polysorbate 80 (0.35 mg), proline (89 mg) in Water for Injection, USP. Effective Date: Jan. 1, 2023. Ask your pharmacist about using a SingleCare discount card on your Repatha Pushtronex System prescription. Learn more about this drug here . The most common injection site reactions were erythema, pain, and bruising. Repatha Pushtronex System Overview: Uses and Storage | RxSaver The WebMDRx coupon or cash price may be less than your co-pay. Ask your doctor or pharmacist if you have questions, or call the manufacturer at 1-844-737-2842. Do not use if the medicine has changed colors or has particles in it. The most common allergic reactions were rash (1.0% versus 0.5% for Repathaand placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%). Allergic reactions occurred in 5.1% and 4.7% of Repatha-treated and placebo-treated patients, respectively. Throw away after one use, even if there is still some medicine left inside. FDA Approves First And Only Single Monthly Injection For A - Amgen You may report side effects to FDA at 1-800-FDA-1088. The Repatha Pushtronex system consists of a single-use, battery-powered infusor and a prefilled cartridge containing a 420-mg dose of evolocumab. "Repatha is the only PCSK9 inhibitor with an approved monthly dose, and now the only one with a monthly single-dose administration. Read the full instructions befor. This study will be conducted over one year. You should not stop using Repatha Pushtronex without your doctor's advice, or your LDL cholesterol levels may increase. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. High Cholesterol (LDL-C) Treatment | Repatha (evolocumab) Pushtronex System Single-dose on-body infusor with prefilled cartridge 5-minute at-home self-injection with hands-free device Lights and sounds when you start and finish your dose Hidden needle Can inject into your stomach or thigh, or inject into your arm if assisted Tell your doctor about all your current medicines and any medicine you start or stop using. Through its own research and development efforts, as well as partnerships,Amgenis building a robust cardiovascular portfolio consisting of several approved and investigational molecules in an effort to address a number of today's important unmet patient needs, such as high cholesterol and heart failure. Do not heat a syringe or injection device. Repatha Pushtronex System is a PCSK9 Inhibitors class medication which is produced by AMGEN. Medically reviewed by Drugs.com on Oct 28, 2022. #1 Is code 96377 the correct code for application of the Repatha Pushtronex System. Hidden 27-gauge needle Delivers the 140 mg/dL dose subcutaneously in up to 15 seconds Once a month Repatha Pushtronex System Single-dose on-body infusor with prefilled cartridge 420 mg/3.5 mL subcutaneous injection Hidden 29-gauge needle Steady delivery of the 420 mg/3.5 mL dose subcutaneously in up to 5 minutes Uses Before taking Warnings Dosage Side effects Storage FAQ Uses of Pushtronex System: It is used to lower cholesterol. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Out-of-pocket costs to patients will vary depending on insurance status and eligibility for patient assistance. Repatha Pushtronex is available in a prefilled syringe, a SureClick prefilled autoinjector, or a Pushtronex on-body infusor with prefilled cartridge. Get emergency medical help if you have signs of an allergic reaction: hives, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat. For a comprehensive listing of all plans see: 2023 Summary of Companies, Lines of Business, Networks & Benefit Plans. Topcon SL-D2 Medical Equipment Instruction manual PDF View/Download In a pool of placebo- and active-controlled trials, as well as open-label extension studies that followed them, a total of 1,988 patients treated with Repathahad at least one LDL-C value <25 mg/dL. Pull the orange cap off only when you are ready to inject. The device, which was developed in partnership with West Pharmaceutical Services, features SmartDose technology platform. Dropping an injection device can cause it to break. Applications in other countries are pending. The scientific information discussed in this news release relating to new indications is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration or European Commission for the products. Repatha.com is a Medicine website . Evolocumab, a human monoclonal antibody for proprotein convertase subtilisin-kexin type 9 (PCSK9), lowers LDL-C via an entirely different mechanism compared with statins or ezetimibe.The approvals of evolocumab and a competing PCSK9 inhibitor alirocumab (#Praluent, #Sanofi/Regeneron) indicated them for LDL-C lowering in conjunction with maximally tolerated statins. FDA Approves Amgen's Pushtronex System | Healthcare Packaging 3:15 Min Call your healthcare provider for medical advice about side effects. Set Dosage Details. Continue reading, Repatha can be left unrefrigerated for up to 30 days at room temperature between 68F to 77F (20C to 25C) as long as it is kept in its original box and is not kept somewhere that gets hotter than 77F (25C), for example, a car glove box. Patients and 1 % of Repatha-treated patients and 1 % of Repatha-treated and placebo-treated patients results from the approximately event-driven. 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