Repatha (evolocumab) is a medicine that lowers “bad” cholesterol, also known as LDL (low-density lipoprotein). Repatha was FDA-approved in 2015. It is used in adults with heart disease to decrease the risk of heart attack, other problems with the blood vessels of the heart, and stroke. Repatha is also approved in adults and children over 10 who have high LDL, or genetic high cholesterol conditions called heterozygous familial hypercholesterolemia or homozygous familial hypercholesterolemia. It can be used with other cholesterol-lowering medicines and healthy diet changes.
How Does Repatha Work for High Cholesterol?
People can have high cholesterol for a number of reasons, including their diet, exercise habits, or genetic conditions. Keeping your cholesterol low, specifically the LDL, is one of the most important ways to prevent and treat heart disease and strokes. Repatha works by attaching to a protein in the body called PCSK9 (proprotein convertase subtilisin kexin type 9). PCSK9 normally acts on the liver’s LDL receptors by lowering the liver’s ability to remove LDL from the blood. Repatha is a PCSK9 inhibitor, which means that it blocks the action of the PCSK9 protein, therefore allowing the liver to remove LDL from the bloodstream.
How Was Repatha Studied for Lowering LDL Cholesterol?
Clinical studies were done to test if Repatha was safe and effective for lowering cholesterol in people with heart disease or high cholesterol. The studies focused on adults with heart disease and on adults and children (ages 10-17) with high cholesterol due to genetic conditions called homozygous familial hypercholesterolemia or heterozygous familial hypercholesterolemia. In one study, the effects of Repatha on major events like death from heart disease, heart attack, or stroke were studied among people with heart disease. Other studies looked at the effect of Repatha on cholesterol levels over time. Repatha was compared with a placebo containing no medicine and against other cholesterol medicines, including statins and ezetimibe. The studies included people who were White, Black, or Asian, including those who identified as Hispanic or Latino.
What Benefits Were Seen With Repatha?
The effects of Repatha were extensively studied in various populations. In adults with heart disease already on statins, Repatha significantly reduced heart-related events, including deaths, heart attacks, and strokes.
Repatha in adults with heart disease
| About how much did LDL levels go down? | |
| Repatha 140 mg every 2 weeks or 420 mg alone | 59% |
| Placebo | 5% |
The effects of Repatha were also studied in people who had high LDL and other cholesterol issues, some of whom were taking other cholesterol medicines. The studies lasted 12 to 80 weeks. Compared to a placebo and ezetimibe, the average decrease in LDL was greater with Repatha.
Repatha in adults with high LDL
| About how much did LDL levels go down? | |
| Repatha 140 mg every 2 weeks or 420 mg alone | 54% to 56% |
| Repatha 140 mg every 2 weeks or 420 mg monthly with statins and some also taking ezetimibe | 47% to 63% |
| Ezetimibe alone | 17% to 19% |
| Placebo | None (1% to 8% increase) |
Repatha in adults with heterozygous familial hypercholesterolemia
| About how much did LDL levels go down? | |
| Repatha 140 mg every 2 weeks or 420 mg | 56% to 62% |
| Placebo | 1% decrease to 4% increase |
Repatha in children with heterozygous familial hypercholesterolemia
| About how much did LDL levels go down? | |
| Repatha 420 mg | 44% |
| Placebo | 6% |
Repatha in adults and children with homozygous familial hypercholesterolemia
| About how much did LDL levels go down? | |
| Repatha 420 mg | 20% to 22% |
| Placebo | None (9% increase) |
What Types of Medicine Interactions Can Happen?
Taking a high-dose statin can possibly lower the amount of Repatha in the body. Based on the clinical studies, this does not impact the effectiveness of Repatha.
How Can I Get Repatha?
To get Repatha, you need a prescription from a health care provider. Primary care providers and cardiologists (heart doctors) often prescribe this medicine. Depending on your insurance, you may need to get this medicine from a specialty pharmacy, or your local pharmacy may be able to order it for you if they do not keep it in stock. If you have insurance, check out the Repatha savings card (https://www.repatha.com/enrollment).
How Do I Use Repatha?
Repatha is injected under the skin once every 2 weeks or once every month, depending on your dosage. It comes in a pre-filled syringe or two injection device options. You can ask your health care provider to show you how to use Repatha before you use it for the first time. Read the instructions for use, which you can get from your pharmacist.
How Can I Tell if Repatha Is Working?
You can tell Repatha is working when your LDL falls. In the studies, LDL lowering was noted as soon as the first 12 weeks after starting Repatha, but there may be further reduction in later months.
How Can I Prevent Side Effects or Tell if a Side Effect Is Happening?
Side effects like cold/flu-like symptoms, back pain, and high blood sugar have occurred in people taking Repatha. Skin reactions where you inject Repatha, such as redness, pain, or bruising, can occur. Injecting in a different spot each time and taking Repatha out of the refrigerator 30 to 45 minutes (depending on which injection device you have) before giving your dose helps prevent these skin reactions. Tell your health care provider if you have any side effect that bothers you. Your health care provider may recommend short-term use of over-the-counter pain medications to help with these temporary side effects.Let your health care provider know if you have a latex allergy, since some of the injection devices have a latex-like needle cover that may cause an allergic reaction if you have a latex allergy.
The safety of Repatha is unknown for those who are pregnant or breastfeeding. Tell your health care provider if you become pregnant or are breastfeeding. If you are pregnant or are breastfeeding while taking Repatha, you can take part in an ongoing safety study by calling 800-77-AMGEN (800-772-6436).
Reports of side effects are very important and are used to add information to the prescribing information. You don’t need to be certain that something you experienced was caused by Repatha. If you think you have a side effect caused by Repatha, you can report it by calling 800-FDA-1088 (800-332-1088).
A Repatha Savings Card from the drugmaker may allow you to pay as little as $5 for your Repatha prescription. Whether you are eligible depends on the type of insurance plan you have, and if your insurance covers Repatha. You can find out more at https://www.repatha.com/repatha-cost or by calling 844-737-2842 to ask for assistance with the savings offer.
