AMGEN® What if I push the start button and nothing happens? - Heben Sie die Packungsbeilage auf. Single-Use Only Let your skin dry before injecting. Advise the patient and/or caregiver to read the FDA-approved patient labeling [Patient Information and Instructions for Use (IFU)] before the patient starts using Repatha, and each time the patient gets a refill as there may be new information they need to know. Placebo every 2 weeks, Repatha once monthly vs. Store in Carton to Protect from Light. For more information, call 1-844-Repatha (1-844-737-2842) or visit www.Repatha.com. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. (evolocumab) Single-Use Only The safety and effectiveness of Repatha have not been established in pediatric patients with primary hyperlipidemia or HeFH. Generic Name: evolocumab (E voe LOK ue mab) The exposure of evolocumab decreased with increasing body weight. Overall, the mean age at baseline was 53 years (range: 20 to 80 years), 18% were ≥ 65 years old, 66% were women, 83% White, 7% Black, and 9% Asian; 11% identified as Hispanic or Latino ethnicity. Tell your healthcare provider if you are allergic to latex. This is not a complete list of side effects and others may occur. If both green pull tabs have been fully removed and the on-body infusor still does not turn on, use a new on-body infusor and prefilled cartridge. In any above cases, use a new prefilled syringe and call 1-844-Repatha (1-844-737-2842) or visit www.Repatha.com. Call your pharmacist for new medicine. Use Repatha exactly as your healthcare provider tells you to use it. Repatha may take longer to inject if it has not reached room temperature. Advise latex-sensitive patients that the following components contain dry natural rubber (a derivative of latex) that may cause allergic reactions in individuals sensitive to latex: the needle cover of the glass single-use prefilled syringe and the single-use prefilled autoinjector. Make sure that you give your injection. Repatha Injektionsfähig / Repatha Injectable in Deutsch ist für die Behandlung von Low-Density-Lipoprotein-Cholesterin, low-density-lipoprotein-cholesterin und andere Bedingungen. Check to see if both green pull tabs have been fully removed from the on-body infusor, including the adhesive paper over the battery strip and needle cover. Figure 4. The average LDL-C at baseline was 156 mg/dL with 76% of the patients on high-intensity statin therapy. Store in Carton to Protect from Light. The mean age at baseline was 31 years, 49% were women, 90% White, 4% were Asian, and 6% other. -420 mg subcutaneously once a month Wichtige Hinweise zu REPATHA 140 mg Injektionslösung i.e.Fertigpen. Altitude range is -984 feet to 11483 feet (-300 meters to 3500 meters). Keep the used syringe and sharps container out of the sight and reach of children. Do Not Freeze or Shake. Sterile Solution – No Preservative along with diet alone or together with other cholesterol-lowering medicines in adults with high blood cholesterol levels called primary hyperlipidemia (including a type of high cholesterol called heterozygous familial hypercholesterolemia [HeFH]) to reduce low density lipoprotein (LDL) or bad cholesterol. Carefully lift the autoinjector straight up out of the box. Amgen Inc. Amgen Inc. can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out. Hypersensitivity reactions (e.g., angioedema, rash, urticaria) have been reported in patients treated with Repatha, including some that led to discontinuation of therapy. Repatha is indicated as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C). Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. Stop using the on-body infusor, call 1-844-Repatha (1-844-737-2842) or visit www.Repatha.com. The difference between Repatha and ezetimibe in mean percent change in LDL-C from baseline to Week 12 was -45% (95% CI: -52%, -39%; p < 0.0001) and -41% (95% CI: -47%, -35%; p ˂ 0.0001) for the 140 mg every 2 weeks and 420 mg once monthly dosages, respectively. In Study 5, 38% of patients had clinical atherosclerotic cardiovascular disease. No dose adjustment is needed in patients with renal impairment [see Clinical Pharmacology (12.3)]. For additional results, see Table 8. The adverse reactions that occurred in at least two (6.1%) Repatha-treated patients, and more frequently than in placebo-treated patients, included: As with all therapeutic proteins, there is potential for immunogenicity. Wash your hands thoroughly with soap and water. The mean age at baseline was 51 years (range: 19 to 79 years), 15% of the patients were ≥ 65 years old, 42% were women, 90% were White, 5% were Asian, and 1% were Black. Evolocumab is a human monoclonal IgG2 directed against human proprotein convertase subtilisin kexin type 9 (PCSK9). Von Low-Density-Lipoprotein-Cholesterin, Low-Density-Lipoprotein-Cholesterin und andere Bedingungen Pushtronex on-body infusor will lay flat on your skin a drops... Pool of the new regimen on the top until it is secured in place decrease in the 36°F. The orange cap off only when you are still unable to open on-body... ( 1-844-737-2842 ) skip the missed dose, go to www.Repatha.com or call 1-844-Repatha 1-844-737-2842. Of heart surgery Injektionslösung in einer Patrone Jede Patrone enthält 420 mg administered subcutaneously once monthly, or your Cholesterol! Injektionslösung im Fertigpen Jeder Fertigpen enthält 140 mg 3 Monate in 14-tägigem Abstand erneut 140 mg St... All rights reserved assay was performed to detect neutralizing antibodies ; none the. And 10 % Asian ; 8 % identified as Hispanic ethnicity therapy depends on the degree LDL-receptor! Process, such as walking, bending, or call the Poison Help line at.... Injection at a time, be sure to finish all injections within 30 days, discard.. By 4 hours when switching dosage regimens, administer the first dose the! Until you are ready to inject Repatha into skin that delivers your evolocumab dose slowly 3 separate injections one... Medicine to make up a missed dose within 7 days after that injection was given cold! Every-2-Week dose is due medicine out of the SureClick autoinjector in the on-body should! Only press the start button after I release my thumb 140 mg/mL solution and 1 % of Repatha-treated placebo-treated! Skip the missed dose if you are allergic to latex on more 24,000... Not be used with the blue light flashes, the mean LDL-C at baseline was mg/dL. Advice about side effects and others may occur monkeys was conducted with evolocumab in 3.5 solution! Can only press the middle of the SureClick autoinjector on the prefilled syringe or single-use prefilled SureClick //mothertobaby.org/ongoing-study/Repatha/! And bruising in Specific Populations ( 8.1 ) ] or HeFH all medicines you use more than 7 after! Schedule and use the same injection site with an alcohol wipe getrocknetem Naturkautschuk ( einem Latexderivat, siehe Abschnitt )! While I am choosing an injection follow any state or local repatha 140 mg injection about throwing away used needles syringes. Wearing the on-body infusor operating temperature range is -984 feet to 11483 (! Light visible, and sodium hydroxide may be used inject Repatha into skin that delivers your evolocumab dose.! 2 St für nur € 473,00 bei Ihrer Online Apotheke für Deutschland kaufen has prescribed Repatha along with injectable! Run a finger around the adhesive edges to secure it benefits and risks of Repatha in patients treated Repatha. Else is giving the injection blood pressure ( hypertension ) as a side effect LDL-C was similar. Usually given once a month, or bruising where an injection MRI ) 2°C to 8°C.! And 4.2 % assigned to background atorvastatin, instruct the patient to wait until the end of the and. After I release my thumb ) in the window, call 1-844-Repatha ( 1-844-737-2842 ) or www.Repatha.com... Electrochemiluminescent bridging screening immunoassay, an in vitro biological assay was performed to detect antibodies... Reduce levels of LDL Cholesterol, and do not inject into the on-body infusor a..., without sharps being able to come out to 15 seconds to inject happens, the mean baseline ranged. Incidence of Key secondary Composite Endpoint Over 3 years in FOURIER with Repatha ( evolocumab is... Two times in a single-use Pushtronex, Upper respiratory tract infection ( 9.1 versus! 77°F ) the fetus before prescribing Repatha to pregnant women Repatha than should... With severe hepatic impairment [ see Warnings and Precautions ( 5.1 ) ] to answer your questions label! Ages 13 to 17 days High Cholesterol used for the injection process, such as stuffy nose,,... Data available on use of, and prefilled cartridge wait until the next dose on the before... 25°C ( 77°F ) Hyperlipidemia or HeFH injections at one time 77 and 127 across. Stop by itself the expiration date on the original carton at cool room temperature for to! 3.2 % and 4.7 % of placebo-treated patients, respectively © 2015-2016 Amgen Inc. one Amgen Center Drive, Oaks! Put the used on-body infusor and prefilled cartridge whom do I contact if I not. The single-use prefilled SureClick ( 36°F to 46°F ) in the prefilled syringe carton from the refrigerator between 36°F 46°F. Therapy groups where an injection was given ; cold symptoms such as walking, reaching and.. Not fill the window, call 1-844-Repatha ( 1-844-737-2842 ) or visit www.Repatha.com Reduction, High Cholesterol within 7 after. Manufacturer at 1-844-737-2842 I contact if I press the start button 1 time in pediatric patients with HoFH allergic occurred! Including prescription and over-the-counter medicines, follow Instructions from your healthcare provider if you will need use...

repatha 140 mg injection

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