Call your pharmacist for new medicine. The difference between Repatha and placebo in mean percent change in LDL-C from baseline to Week 12 was -55% (95% CI: -60%, -50%; p < 0.0001) and -57% (95% CI: -61%, -52%; p ˂ 0.0001) for the 140 mg every 2 weeks and 420 mg once monthly dosages, respectively. Gather all materials needed for your injection and then wash your hands well with soap and water. Keep out of the sight and reach of children. Prior to use, allow Repatha to warm to room temperature for at least 30 minutes for the single-use prefilled autoinjector or single-use prefilled syringe and for at least 45 minutes for the single-use on-body infusor with prefilled cartridge. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Praluent vs Repatha: What's the difference? In any above cases, use a new on-body infusor and prefilled cartridge and call 1-844-Repatha (1-844-737-2842) or visit One Amgen Center Drive Figure 3. Repatha® SureClick® A healthcare provider who knows how to use the on-body infusor should be able to answer your questions. Manufactured by: Repatha (evolocumab) is a human monoclonal antibody. Check the expiration date on the Repatha prefilled syringe carton: Clean your injection site with an alcohol wipe. If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. Keep the stretch (stomach area method only). Repatha is also used to help lower the risk of stroke, heart attack, or other heart complications in people with heart or blood vessel problems caused by plaque build-up or hardening in the arteries (also called atherosclerosis, or arteriosclerosis). Type BF Applied Part Amgen Inc. On-Body Infusor Sterilized Using Ethylene Oxide Store in Carton to Protect from Light. 140 mg/mL Do not use extra medicine to make up a missed dose. Patients whose sera tested positive for binding antibodies were further evaluated for neutralizing antibodies; none of the patients tested positive for neutralizing antibodies. After 4 weeks of background statin therapy, the mean baseline LDL-C ranged between 77 and 127 mg/dL across the five background therapy arms. No test of humoral immunity in infant monkeys was conducted with evolocumab. Follow your doctor's dosing instructions very carefully. Dosage Form: injection, solution. © 2015-2016,2018-2019 Amgen Inc. If there is blood, press a cotton ball or gauze pad on your injection site. Do not use if the medicine has changed colors or has particles in it. Seit Oktober 2017 in 14-tägigem Abstand erneut 140 mg … No U.S. standard of potency. The on-body infusor and prefilled cartridge must be kept in the refrigerator 36°F to 46°F (2°C to 8°C). Adverse Reactions in Patients with Homozygous Familial Hypercholesterolemia. -420 mg subcutaneously once a month Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. To securely attach the on-body infusor, prepare and clean an injection site that is less likely to have body hair, or you can trim the area. Study 5 (RUTHERFORD-2, NCT01763918) was a multicenter, double-blind, randomized, placebo-controlled, 12-week trial in 329 patients with HeFH on statins with or without other lipid-lowering therapies. - Heben Sie die Packungsbeilage auf. During a 3-month toxicology study of 10 and 100 mg/kg once every 2 weeks evolocumab in combination with 5 mg/kg once daily rosuvastatin in adult monkeys, there were no effects of evolocumab on the humoral immune response to keyhole limpet hemocyanin (KLH) after 1 to 2 months exposure. Study 3 (DESCARTES, NCT01516879) was a multicenter, double-blind, randomized, placebo-controlled, 52-week trial that included 901 patients with hyperlipidemia who received protocol-determined background lipid-lowering therapy of a cholesterol-lowering diet either alone or in addition to atorvastatin (10 mg or 80 mg daily) or the combination of atorvastatin 80 mg daily with ezetimibe. These conditions can cause high blood levels of LDL cholesterol, and can also cause plaque to build up inside your arteries. For additional results, see Table 5. Hatte erhebliche Gewichtszunahmen von 8 kg, daher wieder abgesetzt. Get emergency medical help if you have signs of an allergic reaction to Repatha: hives, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat. Sie sollten deswegen generell vor der Behandlung mit einem neuen … Warning: Do not expose the on-body infusor for Repatha to Magnetic Resonance (MR) Environment (e.g., MRI). (see side panel for additional storage information) Do Not Freeze or Shake. Always check the label of your single-use prefilled autoinjector, single-use prefilled syringe, or single-use on-body infusor with prefilled cartridge to make sure you have the correct medicine and the correct dose of Repatha before each injection. Available for Android and iOS devices. Do not shake this medicine. Swing the door to the left. Most patients were on a high- (69%) or moderate-intensity (30%) statin therapy at baseline, and 5% were also taking ezetimibe. Before you use a Single-Use Repatha Prefilled Syringe, read this important information: On a clean, well-lit, flat work surface, place: If someone else is giving you the injection, they can also use the outer area of the upper arm. Keep out of the sight and reach of children. While wearing the on-body infusor, you may perform moderate activities such as walking, bending, or reaching. Available for Android and iOS devices. are pregnant or plan to become pregnant. Subscribe to newsletters for the latest medication news, new drug approvals, alerts and updates. Serious adverse events occurred in 24.8% and 24.7% of Repatha-treated and placebo-treated patients, respectively.