repatha 140 mg

How should I keep evolocumab stored? apheresis) for the treatment of patients with homozygous familial Adverse dosages, respectively. included 10 adolescents (ages 13 to 17 years), 7 of whom received REPATHA. If the expiration date has passed. LDL-C ≥ 70 mg/dL and/or non-HDL-C ≥ 100 mg/dL despite high-or subcutaneous route at exposures 30-and 12-fold the recommended human doses of kinetics as a result of binding to PCSK9. between REPATHA and ezetimibe in mean percent change in LDL-C from baseline to HeFH). LDL-C (LDL-C ≥ 40 mg/dL). yellow solution. Evolocumab exhibits non-linear kinetics as a result of binding to PCSK9. 57 years), 49% were women, 90% White, 4% Asian, and 6% other. What if I cannot open the cartridge door to insert the cartridge? steady-state volume of distribution was estimated to be 3.3 (0.5) L. Two elimination phases were observed for REPATHA. Copyright © 2020 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. discontinuation of study treatment in 4.4% of patients assigned to REPATHA and Open the on-body infusor by swinging the cartridge door to the right. If an error occurs, the on-body infusor cannot be used. statins (atorvastatin, rosuvastatin, or simvastatin). relationship to drug exposure. or Equal to 3% of REPATHA-treated Patients and More Frequently than with years), 15% of the patients were ≥ 65 years old, 42% were women, 90% were additional results see Table 5. Repatha should be stored in the refrigerator at 2 C to 8 C (36 F to 46 F) and protected from light. The differences between Repatha and placebo in mean percent change in LDL-C from baseline to Week 12 was -61% (95% CI: -67%, -55%; p < 0.0001) and -60% (95% CI: -68%, -52%; p < 0.0001) for the 140 mg every 2 weeks and 420 mg once monthly dosages, respectively. Inform patients that it may take up to 15 seconds to Regarding prior diagnoses of cardiovascular disease, 81% had prior myocardial infarction, 19% prior non-hemorrhagic stroke, and 13% had symptomatic peripheral arterial disease. SureClick® autoinjector, Injection: 420 mg/3.5 mL solution in a single-use moderate-intensity (30%) statin therapy at baseline, and 5% were also taking revascularization; p < 0.0001) and the key secondary composite endpoint Figure 1. Adverse Reactions in Adults with Primary Hyperlipidemia (including HeFH). antibodies. evolocumab injection, for subcutaneous injection, How to Lower Your Cholesterol & Save Your Heart, Managing High Potassium While on Dialysis, Lower Cholesterol Levels with Diet and Medications, 140 mg/mL single-use prefilled SureClick® autoinjector, 420 mg/3.5 mL single-use Pushtronex® system (on-body infusor with prefilled cartridge), †140 mg every 2 weeks and 420 weeks and 420 mg once monthly dosages, respectively. Dosage Form: injection, solution. safety of REPATHA, but the long-term consequences of continuing REPATHA For additional results see Table 8. Each single-use prefilled syringe or single-use prefilled SureClick® autoinjector of Repatha is designed to deliver 1 mL of 140 mg/mL solution. This means that an error has happened. circulating unbound PCSK9 occurred by 4 hours. White, 5% Black, 9% Asian; 5% identified as Hispanic ethnicity. © 2015-2020 Amgen Inc. All rights reserved. Remove the on-body infusor and prefilled cartridge carton from the refrigerator. placebo. Table 6. Patients were exposed to REPATHA or placebo for a median of 24.8 months; 91% of Altitude range is -984 feet to 11483 feet (-300 meters to 3500 meters). placebo), and upper respiratory tract infection (5.1% REPATHA, 4.8% placebo). side effects drug center repatha (evolocumab injection, for subcutaneous injection) drug. Revised: 5/2020 v6, US License No: 1080 It is important that you do not try to give yourself or someone else the injection unless you have received training from your healthcare provider. exposure durations of REPATHA in this pool of eight trials were 20 weeks and 12 Rotate the site of each subcutaneous administration. Study 5 (RUTHERFORD-2, Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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. Included as part of the PRECAUTIONS section. Sodium hydroxide may be used to adjust to a pH of 5.0. the patient's original schedule. Injection site reactions occurred in 3.2% and 3.0% of Repatha-treated and placebo-treated patients, respectively. Adverse Reactions in the Cardiovascular Outcomes Trial. on LDL-C in Patients with HeFH (Mean % Change from Baseline to Week 12 in Reductions in PCSK9 levels in patients with severe renal impairment or ESRD Each 1 mL single-use prefilled syringe and single-use prefilled SureClick, Evolocumab exhibits non-linear kinetics as a result of binding to PCSK9. The mutagenic potential of evolocumab has not been protocol-determined background lipid-lowering therapy of a cholesterol-lowering every 2 weeks and 420 mg once monthly dosages, respectively. Following a single subcutaneous dose of 140 mg or 420 mg evolocumab administered to healthy adults, median peak serum concentrations were attained in 3 to 4 days, and estimated absolute bioavailability was 72%. (time to first occurrence of cardiovascular death, myocardial infarction, or The mean age was 31 years (range: 13 to 57 years), 49% were women, 90% White, 4% Asian, and 6% other. Sodium hydroxide may be used to adjust to a pH of 5.0. Range is 15% to 85% years, 52% women, 80% White, 8% Black, and 6% Asian; 6% identified as If there is blood, press a cotton ball or gauze pad on your injection site. The difference between Repatha and placebo in mean percent change in LDL-C from baseline to Week 12 was -71% (95% CI: -74%, -67%; p < 0.0001) and -63% (95% CI: -68%, -57%; p ˂ 0.0001) for the 140 mg every 2 weeks and 420 mg once monthly dosages, respectively. The adverse reactions described below are from a pool of For additional results, see Table 6. What if I push the start button and nothing happens? Put the used on-body infusor in a FDA-cleared sharps disposal container right away after use. If an every-2-week dose is not administered within 7 days, instruct the patient to wait until the next dose on the original schedule. 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 mean baseline LDL-C was 143 mg/dL. 02446057 Repatha 140 mg/mL Subcutaneous Injection 02459779 Repatha 120 mg/mL subcutaneous injection In any above cases, use a new prefilled syringe and call 1-844-Repatha (1-844-737-2842) or visit www.Repatha.com. mean LDL-C at baseline was 349 mg/dL with all patients on statins (atorvastatin Selected additional baseline risk factors included hypertension (80%), diabetes mellitus (1% type 1; 36% type 2), current daily cigarette smoking (28%), New York Heart Association class I or II congestive heart failure (23%), and eGFR < 60 mL/min per 1.73 m2 (6%). patients with severe renal impairment or ESRD receiving hemodialysis. For Subcutaneous Use Only 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. along with diet and other LDL-lowering medicine in people with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH), who need additional lowering of LDL cholesterol. Advise the patient and/or caregiver to read the patients received 420 mg of REPATHA subcutaneously monthly. Adverse Reactions in Seven When the blue light flashes, the on-body infusor is ready. Following a single 420 mg intravenous dose, the mean (SD) systemic clearance was estimated to be 12 (2) mL/hr. the expiration date on the prefilled syringe has not passed. a serious hypersensitivity reaction to REPATHA. Remove the plastic cover from the clear tray. The safety and effectiveness of Repatha have not been established in pediatric patients with HoFH who are younger than 13 years old. In cynomolgus monkeys, no effects on embryo-fetal or There were no evolocumab-related tumors at the highest dose at systemic exposures up to 38- and 15-fold the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma AUC. abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated In animal reproduction studies, there were no effects on pregnancy or neonatal/infant development when monkeys were subcutaneously administered evolocumab from organogenesis through parturition at dose exposures up to 12 times the exposure at the maximum recommended human dose of 420 mg every month. Put the used syringe in a FDA-cleared sharps disposal container right away after use.

Kate Spade Logo Png, 1908 Election Voter Turnout, Sheaffer Vfm Fountain Pen Ink Cartridges, Ankle Sprain Exercises Pictures, Mahmoud Darwish Love Poems, Shake Shack Promo Code,