Repatha Approval History
- FDA approved: Yes (First approved August 27th, 2015)
- Brand name: Repatha
- Generic name: evolocumab
- Dosage form: Injection
- Company: Amgen Inc.
- Treatment for: High Cholesterol, Familial Heterozygous, High Cholesterol, Familial Homozygous, High Cholesterol
Repatha (evolocumab) is a monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) indicated for the treatment of patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or patients with atherosclerotic heart disease who require additional lowering of LDL-cholesterol.
The recommended dose of Repatha for adults with HeFH or atherosclerotic CVD is 140 mg every two weeks or 420 mg once a month. For adults with HoFH, the recommended dose is 420 mg once a month. Repatha is available as a single-use prefilled syringe, a single-use prefilled SureClick® autoinjector, or a single-use PushtronexTM system (on-body infusor with prefilled cartridge).
Common side effects with Repatha use include nasopharyngitis (common cold), upper respiratory tract infections, influenza, back pain, and injection site reactions like redness, pain or bruising. Allergic reactions, such as rash and hives, have been reported. Patients should stop using Repatha and seek emergency medical care if they experience symptoms of a serious allergic reaction, such as swelling of the lips, tongue or throat.
Development History and FDA Approval Process for Repatha
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