Similar articles. Repatha 140 mg solution for injection in pre-filled syringe. The judge gave Regeneron and Sanofi 30 days to appeal before the injunction went into effect. Increasing liver LDLR levels results in associated … PCSK9 is a serine protease that destroys LDLR in the liver, resulting in decreased LDL-C clearance and increased plasma LDL-C Evolocumab binds selectively to PCSK9 and prevents circulating PCSK9 from binding to the low density lipoprotein receptor (LDLR) on the liver cell surface, thus preventing PCSK9-mediated LDLR degradation. This drug is available at a middle level co-pay. ... 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 14.1 Prevention of Cardiovascular Events Repatha ® helps the liver clear LDL bad cholesterol by limiting the actions of a protein called PCSK9—and less PCSK9 means less LDL in your blood.  Evolocumab received approval from Health Canada on September 10, 2015. commonly, these are "non-preferred" brand drugs or specialty Mechanism of action. Repatha (Evolocumab): Second PCSK9 Inhibitor Approved by the FDA for Patients with Familial Hypercholesterolemia. Most Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). commonly, these are "preferred" (on formulary) brand drugs. informational and educational purposes only. CLINICAL PHARMACOLOGY Mechanism of Action Evolocumab is a human monoclonal IgG2 directed against human proprotein convertase subtilisin kexin 9 … On October 26, 2018 Amgen announced a 60% cut in price and the drug now costs $5,850 per year. This drug is available at the lowest co-pay. European drug market entries 2015 with new mechanisms of action. By clicking send, you acknowledge that you have permission to email the recipient with this information. restrictions. View the formulary and any restrictions for each plan. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvcmVwYXRoYS1ldm9sb2N1bWFiLTEwMDAwMDI=, View explanations for tiers and Evolocumab is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface. mcg/mL (420 mg), At low concentrations: Elimination is predominately through saturable binding to target, PCSK9, At higher concentrations: Elimination of evolocumab is largely through a nonsaturable proteolytic pathway, Remove prescribed dose from refrigerator at least 30 minutes before administration; this helps administer the entire dose and minimizes injection discomfort, Do not heat syringe, autoinjector, or on-body infuser (eg, microwave or hot water); let them warm to room temperature on their own, Do not leave in direct sunlight; keep in original carton until administered, Available as 140-mg/mL prefilled syringe or autoinjector; also available as 420-mg/3.5-mL on-body infusor, 420 mg dose: Give three 140-mg SC injections consecutively within 30 minutes OR over 9 minutes using the single-use on-body infusor with refilled cartridge, Clean injection site with alcohol wipe and let dry, Do not inject in areas of skin that are bruised, red, tender, or hard, Avoid injecting in scars or stretch marks, See prescribing information for images depicting injection technique for the various devices, Refrigerate at 2-8°C (36-46°F) in the original carton, Alternatively, may store at room temperature (20-25°C [68-77°F]) in the original carton; however, under these conditions, drug must be used within 30 days; if not used within the 30 days, discard, Do not expose to temperatures >25°C (77°F).
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