Prepare 1a remove 1 repatha sureclick autoinjector from the package. Read more primary hyperlipidemia including heterozygous familial hypercholesterolemia. Prior to use, allow repatha to warm to room temperature for at least 30 minutes for the singleuse prefilled autoinjector or singleuse prefilled syringe and for at least. Who familial hypercholesterolemia consultation group. Repatha can also be stored at room temperature 68f to 77f. Policy document for praluent and repatha carefirst formulary. The effect of zetia on cardiovascular morbidity and mortality has not been determined. The recommended subcutaneous dosage of repatha in patients with hofh is 420 mg once monthly. Repatha sureclick patient information leaflet pil emc.
Repatha comes as a singleuse 1 time prefilled autoinjector sureclick autoinjector, as a singleuse prefilled syringe or as a singleuse pushtronex system onbody infusor with prefilled cartridge. Highlights of prescribing information an initial dose. Find instructions on how to inject repatha evolocumab. Repatha is indicated as an adjunct to diet, alone or in combination with other lipidlowering therapies e.
Alternatively, repatha can be kept at room temperature at 68f to 77f 20c to 25c in the original carton. In adults with established cardiovascular disease, repatha. Singledose prefilled pen 150 mgml important information the device is a singledose disposable pen. Rotate the site of each subcutaneous administration. Learn about pcsk9 inhibitor mechanism of action repatha. Humalog administeredby subcutaneous injection should generally be used in regimens with an intermediateor longacting insulin. Remove 1 repatha sureclick autoinjector from the package. Highlights of prescribing information the recommended dose. Most people experienced their greatest drop in ldl with repatha in as little as 4 weeks. Insert generic drug name here monograph evolocumab repatha national drug monograph december 2015 va pharmacy benefits management services, medical advisory panel, and visn pharmacist executives.
Repatha evolocumab injection, for subcutaneous use initial u. Anaphylaxis anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, andor angioedema of the throat or tongue, has been. The praluent pen contains medicine prescribed by your healthcare provider. Sections or subsections omitted from the full prescribing information are not listed. Migraine the safety of emgality has been evaluated in 2586 patients with migraine who received at least one dose of emgality, representing 1487 patientyears of exposure. Insert the needle into the fold of skin with a quick dartlike motion. Combined f2 and f3 repatha praluent cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice. Inject the medicine at a 45 angle if you can only pinch 1 inch of skin. Highlights of prescribing information the recommended dose of. Repatha is an injectable prescription medicine used in adults with cardiovascular disease to reduce the risk of heart attack, stroke, and certain types of heart surgery. The recommended subcutaneous dosage of repatha in adults with established cardiovascular disease or in adults with primary hyperlipidemia including heterozygous familial hypercholesterolemia hefh is either 140 mg every 2 weeks or 420 mg once monthly, based on patient preference for dosing frequency and injection volume.
Sanofi us and regeneron provide these links as a service to. Repatha is a breakthrough medicine that reduces your risk of having a heart attack or stroke for real. Highlights of prescribing information these highlights do not include all the information needed to usegilenya safely and effectively. No formal drugdrug interaction studies have been conducted for repatha. Repatha evolocumab injection, for subcutaneous use. By clicking on this link, you will be leaving this sanofi us and regeneron website and going to another, entirely independent, website. Carefully lift the autoinjector straight up out of the box. We identified more adverse drug event reports for evolocumab than for. Nucala mepolizumab for injection nucala mepolizumab injection. A single room temperature exposure event is allowable within the shelf life, and the room temperature exposure duration must not exceed 30 days. High cholesterol ldlc treatment repatha evolocumab. Highlights of prescribing information these highlights do not include all the information needed to use ofev safely and effectively. Veltassa should not be used as an emergency treatment for lifethreatening hyperkalemia because of its delayed onset of action see clinical pharmacology 12. Repatha fda prescribing information, side effects and uses.
Please see important safety information and full prescribing. Carefirst bluecross blueshield is the shared business name of carefirst of maryland, inc. Repatha is a clear to opalescent, colorless to pale yellow solution. Full prescribing information 1 indications and usage dupixent is indicated for the following diseases. Tymlos is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. The printed package leaflet of the medicinal product must state the name and. Protect repatha from direct light and do not expose to temperatures above 25c 77f. Highlights of prescribing information these highlights do not include all the information needed to use praluent safely and effectively. Unitedhealthcare pharmacy clinical pharmacy programs. Full prescribing information 1 indications and usage tecfidera is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome. If needed, praluent may be kept at room temperature up to 77f 25c for a maximum of 30 days in original carton to protect from light. Alirocumab praluent monograph october 2015 draft updated version may be found at.
Repatha is given under the skin subcutaneously, every 2 weeks or 1 time each month. Each vial of nucala should be used for a single patient, and any remainder of the contents. Bla 125522 to firm 08 27 food and drug administration. You can help by reporting any side effects you may get. Sanofi us and regeneron provide these links as a service to their website visitors and users. Highlights of prescribing information these highlights do not. Pcsk9i sgm f1 and exchange repatha praluent p2018 cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. The highest dose tested 250mgkg was associated with a plasma exposure cave,ss 38 or 18times that in humans at the recommended human dose rhd for migraine120mg or episodic cluster headache. In patients with hofh, measure ldlc levels 4 to 8 weeks after starting repatha, since response to. Learn about pcsk9 inhibitor repatha evolocumab and how it reduces risk of stroke and myocardial infarction in your patients with established cv disease.
The most common adverse reaction that led to repatha treatment discontinuation and occurred at a rate greater than placebo was myalgia 0. Policy document for praluent and repatha carefirst. Do not coadminister repatha with other injectable drugs at the same administration site. Product monograph including patient medication information prpraluent alirocumab injection solution for subcutaneous injection 75 mgml and 150 mgml proprotein convertase subtilisin kexin type 9 pcsk9 inhibitor sanofiaventis canada inc. All criteria below must be met in order to obtain coverage of praluent and repatha. Repatha is a sterile, clear to opalescent, colorless to pale yellow solution available as follows. This will allow quick identification of new safety information. Adverse reactions occurring in greater than or equal to 3% of repatha treated.
Insert the needle into the skin using a 45 to 90 degree angle. Jeder fertigpen enthalt 140 mg evolocumab in 1 ml losung. Do not use if the solution is cloudy or discolored or contains particles. See the end of section 4 for how to report side effects. Veltassa should not be used as an emergency treatment for life. Alternatively, for patients and caregivers, repatha can be kept at room temperature at. Do not use repatha if you are allergic to evolocumab. Coverage duration coverage is available for 12 months and may be renewed. Repatha evolocumab is a pcsk9 proprotein convertase subtilisin kexin type 9 inhibitor. Nplate product monograph page 6 of 67 of the 630 adult patients who received nplate in itp clinical studies, the study duration adjusted thromboticthromboembolic rate in subjects with age 65 years. Full prescribing information 1 indications and usage copaxone is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. Gilenyafingolimod capsules, for oral use initial u. Tymlos is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who.
Highlights of prescribing information these highlights do not include all the information needed to use humalog safely and effectively. Lovaza omega3acid ethyl esters capsules are supplied as 1gram transparent, softgelatin capsules filled with lightyellow oil and bearing the designation gs fh2. Prior to use, allow repatha to warm to room temperature for at least 30 minutes for the singleuse prefilled autoinjector or singleuse prefilled syringe and for at least 45 minutes for the singleuse onbody infusor with prefilled cartridge. Current warnings in prescribing information not only understate the findings in these new. Specialty pharmacy clinical policy bulletins aetna non.
Learn about praluent, a pcsk9 inhibitor, that is approved to help reduce the risk of certain cv events in adults with established cardiovascular disease. Specialty pharmacy clinical policy bulletins aetna. Highlights of prescribing information an initial dose of 600. Store repatha in the refrigerator 36f to 46f until youre ready to use it. Combined f2 and f3 repatha praluent cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. In patients with hofh, measure ldlc levels 4 to 8 weeks after starting repatha, since response to therapy will depend on the degree of ldlreceptor function. Bla 125522 to firm 08 27 highlights of prescribing information these highlights do not include all the information needed to use repatha safely and effectively. The safety and efficacy of repatha in pediatric patients 18 years or less have not been established 16. Prior approval is required to ensure the safe, clinically appropriate and cost effective use of repatha while maintaining optimal therapeutic outcomes. Program prior authorization medication repatha evolocumab markets in scope arizona, california, hawaii, maryland, nevada, new jersey, new york, new york epp, rhode island, pennsylvania chip, south carolina issue date 52015 pharmacy and therapeutics approval date 122019.
The humalog u100 kwikpen, humalog u100 tempo penand. Allow praluent to warm to room temperature for 30 to 40 minutes prior to use. Ldl bad cholesterol was dramatically reduced at 12 weeks. Benefix coagulation factor ix recombinant for intravenous use, lyophilized powder for reconstitution initial u. Zetia has not been studied in fredrickson type i, iii, iv, and v dyslipidemias. Full prescribing information 1 indications and usage veltassa is indicated for the treatment of hyperkalemia. Instructions for use praluent prahluent alirocumab.
This medicinal product is subject to additional monitoring. Repatha 140 mg injektionslosung im fertigpen repatha 420 mg. Highlights of prescribing information these highlights do not include all the information needed to use benefix safely and effectively. Learn about how repatha evolocumab works and mechanism of action of this pcsk9 inhibitor, and how it can help patients. Repatha evolocumab is a pcsk9 proprotein convertase subtilisin kexin type 9 inhibitor antibody indicated. Information for the user repatha 140 mg solution for injection in prefilled pen evolocumab this medicine is subject to additional monitoring. Put the original package with any unused autoinjectors back in the refrigerator. Inject the medicine at a 90 angle if you can pinch 2 inches of skin. Repatha is indicated to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease.
1151 955 1323 1496 4 535 1293 1137 717 885 1492 1247 410 429 1122 768 1310 133 1145 517 123 678 95 1011 1533 1472 251 461 791 639 313 1117 394 913 1296 312 1060