To operate, administer, enroll me in, and/or continue my participation in Amgen’s Repatha ® information program and related activities to provide me with Personal information, including my personal health information, for the following purposes only: I authorize Amgen and its contractors and business partners (“Amgen”) to use and/or disclose my Uses and Disclosure of Personal Information As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C.In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization.As with all therapeutic proteins, there is potential for immunogenicity with Repatha ®. Immunogenicity: Repatha ® is a human monoclonal antibody. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha ® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).Īdverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha ® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha ®, 8.2% placebo), nasopharyngitis (7.8% Repatha ®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha ®, 4.8% placebo).Īmong the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha ® compared with 7.7% in patients that received placebo. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha ®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha ®, treat according to the standard of care, and monitor until signs and symptoms resolve.Īdverse Reactions in Primary Hyperlipidemia: The most common adverse reactions (>5% of patients treated with Repatha ® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.įrom a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha ®-treated and placebo-treated patients, respectively. Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha ®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha ®. ††All claims were approved with an attestation only through CoverMyMeds.Ĭontraindications: Repatha ® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha ®. These statistics are subject to change and are based upon a multitude of factors that can influence turnaround time. **Data from Januthrough December 31, 2022, measuring time between when a complete ePA is submitted to the health plan and determination is received by the HCP. CoverMyMeds is a registered trademark of CoverMyMeds LLC. §Amgen ®, the marketer of Repatha ®, has entered into a fee-for-service arrangement with CoverMyMeds to provide a differentiated ePA experience after you have chosen to prescribe Repatha ®. Those phases are 1) Deductible, 2) Initial coverage, 3) Coverage gap, 4) Catastrophic. Medicare Part D drug coverage is divided into four phases, each with a different cost-sharing amount. †The patient out-of-pocket costs can vary throughout the year depending on which phase of the Part D benefit the patient is currently in. *Subject to eligible criteria and program maximums. NRx, new prescription PCSK9, proprotein convertase subtilisin/kexin type 9 PCSK9i proprotein convertase subtilisin/kexin type 9 inhibitor.
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