Swing the door to the left. NDC 72511-770-01 Use the medicine within 30 days if it is kept at room temperature. The safety profile of Repatha in this trial was generally consistent with the safety profile described above in the 12- and 52-week controlled trials involving patients with primary hyperlipidemia (including HeFH). The data described below reflect exposure to Repatha in 8 placebo-controlled trials that included 2651 patients treated with Repatha, including 557 exposed for 6 months and 515 exposed for 1 year (median treatment duration of 12 weeks). You should not use Repatha if you are allergic to evolocumab. The following additional adverse reactions have been identified during post-approval use of Repatha. Figure 3. Remove the on-body infusor and prefilled cartridge carton from the refrigerator. Evolocumab is not approved for use by anyone younger than 13 years old. Do not use an injection device that has been dropped onto a hard surface, even if you cannot see a break in it. 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. Adverse Reactions in Eight Pooled Controlled Trials (Seven 12-Week Trials and One 52-Week Trial). There is no information regarding the presence of evolocumab in human milk, the effects on the breastfed infant, or the effects on milk production. Adverse Reactions Occurring in Greater than 1% of Repatha, -treated Patients and More Frequently than with, Adverse Reactions in Eight Pooled Controlled Trials (Seven 12, Repatha is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous administration. Check that the name Repatha appears on the carton label. We comply with the HONcode standard for trustworthy health information -. The safety and effectiveness of Repatha in combination with diet and other LDL-C-lowering therapies in adolescents with HoFH who require additional lowering of LDL-C were established based on data from a 12-week, placebo-controlled trial that included 10 adolescents (ages 13 to 17 years old) with HoFH [see Clinical Studies (14.3)]. Throw away the used on-body infusor in a sharps container. You may be shown how to use injections at home. Evolocumab is a human monoclonal IgG2 directed against human proprotein convertase subtilisin kexin type 9 (PCSK9). The recommended subcutaneous dosage of Repatha in adults with established cardiovascular disease or in adults with primary hyperlipidemia (including HeFH) is either 140 mg every 2 weeks OR 420 mg once monthly, based on patient preference for dosing frequency and injection volume. The mean baseline LDL-C was 143 mg/dL. Repatha is used together with a low-fat diet and other cholesterol-lowering medications in people with homozygous or heterozygous familial hypercholesterolemia (inherited types of high cholesterol). Repatha dosing information. Read the patient information for those medicines. 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. Use a puncture-proof "sharps" container (ask your pharmacist where to get one and how to throw it away). These differences are not clinically meaningful. The median follow-up duration was 26 months. What if I cannot open the cartridge door to insert the cartridge? You will need to wear the device for about 9 minutes to get the full dose. Adverse Reactions Occurring in Greater than or Equal to 3% of Repatha, treated Patients and More Frequently than with Placebo in, Table 2. Always hold the prefilled syringe by the syringe barrel. Use Repatha SureClick autoinjector, read this important information: Make sure the medicine in the window is clear and colorless to slightly yellow. Read and carefully follow all instructions for using this product. Put the used syringe in a FDA-cleared sharps disposal container right away after use. Store at 2°C to 8°C (36°F to 46°F). 140 mg/mL Do not freeze. beep and see a red blinking light when it is on my body? 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. Uses: Adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) requiring additional lowering of LDL-C, Repatha dosage information (in more detail). You may hear beeps that mean your injection has started. For additional results, see Table 4 and Figure 3. are breastfeeding or plan to breastfeed. Prefilled Syringe What do I do if the loaded on-body infusor status light continuously flashes red and I hear beeps? The proportions of patients who discontinued treatment due to local injection site reactions in Repatha-treated patients and placebo-treated patients were 0.1% and 0%, respectively. Usual Adult Dose of Repatha for Homozygous Familial Hypercholesterolemia: -420 mg subcutaneously once a month Let your skin dry. In a 52-week, double-blind, randomized, placebo-controlled trial (Study 3 [DESCARTES, NCT01516879]), 599 patients received 420 mg of Repatha subcutaneously once monthly [see Clinical Studies (14.2)]. Keep the on-body infusor and prefilled cartridge in the original carton to protect from light or physical damage. Make sure all of the adhesive is attached to your skin. Seit Oktober 2017 in 14-tägigem Abstand erneut 140 mg … It may take up to 15 seconds to inject this medicine using a prefilled syringe or a SureClick autoinjector. In seven pooled 12-week, double-blind, randomized, placebo-controlled trials, 993 patients received 140 mg of Repatha subcutaneously every 2 weeks and 1059 patients received 420 mg of Repatha subcutaneously monthly.