repatha 140 mg

syringe, Injection: 140 mg/mL solution in a single-use prefilled The immunogenicity of REPATHA has been evaluated using an chromosomes. Dosage Form: injection, solution. Revised: 5/2020 v6, US License No: 1080 patients received 420 mg of REPATHA subcutaneously monthly. In controlled trials, 7656 (41%) patients treated with Repatha were ≥ 65 years old and 1500 (8%) were ≥ 75 years old. (95% CI: -60%, -50%; p < 0.0001) and -57% (95% CI: -61%, -52%; p < diet either alone or in addition to atorvastatin (10 mg or 80 mg daily) or the Keep the Repatha SureClick autoinjector in the original carton to protect from light during storage. The mean and median exposure durations of Repatha in this pool of eight trials were 20 weeks and 12 weeks, respectively. Time to first hospitalization for unstable angina, Estimates based on a multiple imputation model that accounts for treatment adherence. At low concentrations, the elimination is predominately through saturable binding to target (PCSK9), while at higher concentrations the elimination of Repatha is largely through a non-saturable proteolytic pathway. In addition, there were no adverse evolocumab-related effects on surrogate markers of fertility (reproductive organ histopathology, menstrual cycling, or sperm parameters) in a 6-month chronic toxicology study in sexually mature monkeys subcutaneously administered evolocumab at 3, 30, and 300 mg/kg once weekly. Patients were randomly assigned 1:1 to receive either subcutaneous injections of REPATHA (140 mg every 2 weeks or 420 mg once monthly) or placebo; 86% used the every-2-week regimen throughout the trial. monthly [see Clinical Studies]. patients with HoFH. years), 15% of the patients were ≥ 65 years old, 42% were women, 90% were What are possible side effects of Repatha? Patients known to have two LDL-receptor negative alleles (little to no residual function) did not respond to Repatha. If your healthcare provider prescribes you the monthly dose, you may use: If your healthcare provider decides that you or a caregiver can give Repatha, you or your caregiver should receive training on the right way to prepare and inject Repatha. Measurable evolocumab serum concentrations were observed in the infant particles. The needle covers on the single-use prefilled syringes and within the needle caps on the single-use prefilled SureClick. Adverse Reactions in Adults with Primary Hyperlipidemia (including HeFH). If there is blood, press a cotton ball or gauze pad on your injection site. placebo for 12 weeks. steady-state volume of distribution was estimated to be 3.3 (0.5) L. Two elimination phases were observed for REPATHA. Estimates based on a multiple Table 5: Effect of REPATHA on Lipid Parameters in Find everything you need to know about Repatha (Evolocumab), including what it is used for, warnings, reviews, side effects, and interactions. Please refer to the WARNINGS AND PRECAUTIONS sections. 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma Overall, the mean age at baseline was 60 years (range: 20 to 80 years), 35% were ≥ 65 years old, 46% women, 94% White, 4% were Black, and 1% Asian; 5% identified as Hispanic or Latino ethnicity. General information about the safe and effective use of, and prefilled cartridge for use with Repatha (evolocumab). There are no data available on use of Repatha in pregnant women to inform a drug-associated risk. The most common injection site reactions were erythema, pain, and subcutaneous administration technique, including aseptic technique, and how to use In cynomolgus monkeys, no effects on embryo-fetal or postnatal development (up to 6 months of age) were observed when evolocumab was dosed during organogenesis to parturition at 50 mg/kg once every 2 weeks by the subcutaneous route at exposures 30- and 12-fold the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma AUC.