Repatha prescribing information
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Repatha Prescribing Information
Introduction to Repatha (Evolocumab)
Repatha, also known by its generic name evolocumab, is a monoclonal antibody developed by Amgen. It targets proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that regulates low-density lipoprotein (LDL) receptors. By inhibiting PCSK9, Repatha enhances the liver's ability to remove LDL cholesterol (LDL-C) from the blood, thereby significantly reducing LDL-C levels .
Indications and Usage
Hypercholesterolemia Treatment
Repatha is primarily indicated for patients with hypercholesterolemia, particularly those whose condition has not been adequately controlled by statins and other lipid-lowering therapies. It is effective in treating both primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia . Additionally, it is approved for use in adults and adolescents aged 12 years and older with homozygous familial hypercholesterolemia, in combination with other lipid-lowering therapies.
Dosage and Administration
Repatha is administered subcutaneously, with two primary dosing regimens: 140 mg every two weeks or 420 mg once monthly. These dosages have been shown to be effective in reducing LDL-C levels across various patient populations, including those on statin therapy, statin-intolerant patients, and those receiving it as monotherapy.
Clinical Efficacy
LDL-C Reduction
Clinical trials have demonstrated that Repatha significantly reduces LDL-C levels. In 12-week phase III trials, it was more effective than placebo and ezetimibe, with treatment differences ranging from -54.8% to -76.3% compared to placebo and -36.9% to -47.2% compared to ezetimibe. In patients with homozygous familial hypercholesterolemia, Repatha reduced LDL-C levels by approximately 30% when added to statins with or without ezetimibe.
Long-term Efficacy and Tolerability
The efficacy of Repatha has been maintained in long-term studies, and it has been well tolerated by patients. No serious adverse reactions have been reported, making it a valuable treatment option for patients unable to achieve LDL-C goals with statins alone or those who are statin-intolerant .
Safety and Side Effects
Cognitive Function
One of the concerns with lipid-lowering therapies is their potential impact on cognitive function. However, clinical studies have shown that Repatha does not adversely affect cognitive function, making it a safe option for long-term use.
Cardiovascular Benefits
Repatha has also been shown to significantly reduce blood lipid levels and prevent coronary atherosclerosis, thereby contributing to the management of cardiovascular and cerebrovascular diseases.
Conclusion
Repatha (evolocumab) is a highly effective and well-tolerated treatment for hypercholesterolemia, particularly in patients who cannot achieve their LDL-C targets with statins alone or who are statin-intolerant. Its ability to significantly reduce LDL-C levels and its favorable safety profile make it a valuable addition to the arsenal of lipid-lowering therapies.
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