What is the indication and dosage for Repatha (evolocumab) in patients with high cholesterol?

From the Guidelines

Repatha (evolocumab) is indicated for adults with established cardiovascular disease or heterozygous familial hypercholesterolemia who require additional LDL cholesterol lowering despite maximally tolerated statin therapy, with a standard dosage of 140 mg subcutaneously every 2 weeks or 420 mg once monthly. The medication works by inhibiting PCSK9, a protein that reduces the liver's ability to remove LDL cholesterol from the blood, resulting in a 50-70% reduction in LDL cholesterol levels 1. Key points to consider when prescribing Repatha include:

• The medication should be used in conjunction with maximally tolerated statin therapy 1
• Patients should continue their prescribed statin therapy while using Repatha 1
• The medication should be stored refrigerated but allowed to warm to room temperature for 30 minutes before injection 1
• Common injection sites include the abdomen, thigh, or upper arm, and the site should be rotated with each injection 1
• Repatha has been shown to reduce the risk of major adverse cardiovascular events, including cardiovascular death, myocardial infarction, and stroke, in patients with established cardiovascular disease 1. It is also approved for homozygous familial hypercholesterolemia, with a recommended starting dose of 420 mg once monthly 1. Overall, Repatha is a valuable treatment option for patients who require additional LDL cholesterol lowering despite maximally tolerated statin therapy, and its use should be considered in accordance with current clinical guidelines and evidence-based recommendations 1.

From the FDA Drug Label

To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults with established cardiovascular disease 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 The recommended dosage of REPATHA is either 140 mg every 2 weeks OR 420 mg once monthly administered subcutaneously

The indication for Repatha (evolocumab) in patients with high cholesterol is to reduce the risk of major adverse cardiovascular events and to reduce LDL-C as an adjunct to diet and other LDL-C-lowering therapies. The recommended dosage for Repatha is either 140 mg every 2 weeks or 420 mg once monthly administered subcutaneously 2. Key points:

• Repatha is used to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease
• Repatha is used to reduce LDL-C in adults with primary hyperlipidemia, including HeFH
• The recommended dosage is either 140 mg every 2 weeks or 420 mg once monthly administered subcutaneously

From the Research

Indication and Dosage for Repatha (Evolocumab)

The indication and dosage for Repatha (evolocumab) in patients with high cholesterol are as follows:

• Repatha is administered subcutaneously at a dosage of 140 mg every 2 weeks or 420 mg once monthly 3, 4, 5.
• It is used to treat primary hypercholesterolemia or mixed dyslipidemia and homozygous familial hypercholesterolemia, particularly in patients unable to reach LDL-C goals despite treatment with statins with or without other lipid-lowering therapies and in patients who do not tolerate or are not able to receive statins 3.
• Repatha is also approved for the treatment of hypercholesterolemia in patients with heterozygous (HFe) and homozygous (HFo) familial hypercholesterolemia 4.

Efficacy of Repatha

The efficacy of Repatha in reducing LDL-C levels has been demonstrated in several studies:

• In patients with primary hypercholesterolemia or mixed dyslipidemia, Repatha reduced LDL-C levels by 54.8 to 76.3% compared to placebo 3.
• In patients with heterozygous familial hypercholesterolemia, Repatha reduced LDL-C levels by 59.2 to 61.3% compared to placebo 5.
• In patients with homozygous familial hypercholesterolemia, Repatha reduced LDL-C levels by approximately 30% compared to placebo 3.

Safety and Tolerability

The safety and tolerability of Repatha have been evaluated in several studies:

• Repatha was well tolerated, with rates of adverse events similar to placebo 5.
• The most common adverse events reported with Repatha were nasopharyngitis, influenza, upper respiratory tract infection, and headache 6.
• Long-term treatment with Repatha was associated with a low rate of cardiovascular events, with an adjudicated cardiovascular event rate of 2.7% per year 6.