peptide injectable for cholesterol FAQ

However, Sanofi-Regeneron recently announced that it would lower the wholesale price of alirocumab to less than $8,000 a year, a figure an outside group deemed to be cost-effective. But there was a condition: pharmacy benefit managers would be required to grant appropriate access to alirocumab to eligible patients. This potential pricing structure change could mean more people will be able to afford these drugs in the future, says Dr. Cannon. The ODYSSEY Outcomes results also reaffirmed the importance of lowering LDL for preventing repeat heart attacks. In addition, it's a good reminder to people with worrisomely high LDL values who have not had a heart attack to pay close attention to their cholesterol, Dr. Cannon says. And if you're in that smaller, high-risk group of people who are good candidates for a PCSK9 inhibitor, being proactive can make a difference. "We found that if a patient gets directly involved in arguing with the pharmacy benefit manager and challenging the denial, that's often more successful than the doctor alone," says Dr. Cannon.

Image: © Shidlovski/Getty Images Three years ago, the FDA approved two drugs that lower harmful LDL cholesterol values dramatically — by more than 50%. The drugs, alirocumab (Praluent) and evolocumab (Repatha), belong to a new category of medications known as PCSK9 inhibitors. Both are given by a self-administered injection once or twice a month. They're intended for people whose cholesterol levels remain stubbornly high, despite making lifestyle changes (such as diet and exercise) and taking the maximum dose of a high-potency statin and other cholesterol-lowering drugs. In the past two years, results from two large studies found that both PCSK9 inhibitors lowered the risk of serious heart-related events such as heart attack and stroke by 15%. "Now we know that this class of drugs will prevent cardiovascular events, and in some settings, lower the risk of dying," says cardiologist Dr. Christopher Cannon, professor of medicine at Harvard Medical School. Results from the recent alirocumab study, known as the ODYSSEY Outcomes trial, were especially encouraging, he noted.

There is a savings coupon available from the manufacturer that may allow you to pay as little as $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at www.leqvio.com/savings-and-support.

Leqvio is a liquid that is injected under the skin by a health care provider in a health care setting. Each injection can be given into the thigh, stomach, or outer area of the upper arm. Once you have started Leqvio, your second dose will be given 3 months after your first dose. Then you will receive a dose every 6 months.

LDL cholesterol levels in people with HeFH. After about 18 months, the people who used Leqvio had their LDL cholesterol levels decrease by an average of 40%. The people who used placebo, on the other hand, had their LDL cholesterol levels increase by an average of 8%. LDL cholesterol levels in people with heart disease. After about 18 months, the people who used Leqvio had their LDL cholesterol levels decrease by an average of 46%-51%. The people who used placebo, on the other hand, had their LDL cholesterol levels increase by an average of 1%-4%.

If Leqvio is working for you, it should start to lower your LDL cholesterol levels within the first 3 months. Most people will see the largest drop in their levels during this time. If you continue to receive your injections on the appropriate schedule, your LDL cholesterol should stay at this new, lower level. Make sure to keep all of your appointments for Leqvio injections. If you miss an appointment for an injection, call to reschedule as soon as possible. Your LDL cholesterol levels may start to rise again if you do not get your doses on the schedule prescribed by your health care provider.

Leqvio is approved for use to lower low-density lipoprotein (LDL) cholesterol in people with high levels. If you still have high LDL cholesterol even though you eat a low cholesterol diet and exercise, your health care provider may discuss Leqvio with you.

Leqvio is a type of medicine called a specialty medicine. This means that it may require prior authorization from your insurance company. Each dose of Leqvio will be administered by a health care provider in a healthcare setting. Depending on your insurance, the medicine will either be shipped to you or to your health care provider. If it is shipped to you, you will need to bring it with you to your appointment.

Hyperlipidemia or dyslipidemia, often referred to as high cholesterol, is a common condition that occurs more often as people age. People with this condition have high levels of certain types of fats in the blood. Although these fats play an important role in the body, over time, high levels can increase a person’s risk for heart disease, stroke, heart attack, and other issues. One of these fats – low-density lipoprotein (LDL) cholesterol – is known as “bad” cholesterol because it can build up in the arteries, eventually causing heart disease. Triglycerides are another type of fat that can cause health issues when levels get too high. A different type of fat – high-density lipoprotein (HDL) cholesterol – is known as “good” cholesterol because it helps the liver to use and get rid of LDL (“bad”) cholesterol. In most adults, hyperlipidemia is caused by a combination of diet, lifestyle, and health issues. For example:

There are no known interactions between Leqvio and other medicines. But, it is still important for your health care provider to be aware of all the prescription and over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you take or have recently taken.

Three studies were done to see if Leqvio was safe and effective for lowering LDL cholesterol levels in certain adults:

It is well understood that using statins to keep your LDL cholesterol levels at the target level will lower your risk for heart disease, heart attack, and stroke. But Leqvio works in a very different way than statins. Clinical studies show that Leqvio can reduce LDL cholesterol levels by a large amount. These studies only lasted for 18 months, which wasn’t long enough to see if Leqvio reduced the risk of a heart attack or stroke. Although it is likely that the large drop in LDL cholesterol levels from Leqvio will help to reduce the risk of these serious health events, no clinical studies have been done to confirm whether this is true.

One possible side effect of Leqvio is a skin reaction at the injection site, which may involve redness, itching, or pain. Your health care provider should be careful not to inject the drug into skin that is sensitive for any reason, such as from a sunburn, a skin rash, or an infection. Make sure to let them know if a certain injection site has been more painful for you during previous injections so that they can try a different injection site instead. These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. If you experience anything that you think may be caused by Leqvio, you can also report side effects to the FDA at 800-FDA-1088.

It’s possible that Repatha could reduce plaque (fatty deposits) in your arteries. Repatha belongs to a class of medications known as PCSK9 inhibitors. These types of drugs are relatively new, and researchers are still learning about how they work and what conditions they may be able to treat. In a study, Repatha used with a statin reduced artery plaque better than a placebo used with a statin. However, more research is needed to fully understand the effects of PCSK9 inhibitors, such as Repatha, on plaque in your arteries. If you have questions about reducing plaque in your arteries, talk with your doctor.

No, Repatha isn’t a statin. Repatha belongs to a class of medications called PCSK9 inhibitors. Statins lower cholesterol by preventing your liver from making new cholesterol. PCSK9 inhibitors, on the other hand, help your body get rid of cholesterol by blocking a certain protein in your liver that allows cholesterol to build up in your blood. For more information, see the “How Repatha works” section below. Your doctor may prescribe Repatha along with a statin drug. If you have questions about the differences between Repatha and statin drugs, talk with your doctor.

Repatha is not known to affect your kidneys or liver. In clinical trials, people taking Repatha didn’t have liver side effects, including changes in their levels of liver enzymes. There were also no examples of people developing kidney disease during Repatha treatment. In addition, since Repatha was released onto the market, there are no reports that it causes kidney or liver side effects. However, kidney or liver side effects can occur with statin drugs. Your doctor may prescribe a statin for you to use with Repatha. If you have questions about side effects of Repatha or other medications you may take with it, talk with your doctor or pharmacist. They can review your medications and determine if you have an increased risk for any side effects because of other drugs you’re taking.

Whether you take Repatha with other drugs, including statins, depends on the condition you’re using Repatha to treat. For treating primary hyperlipidemia (high cholesterol), including heterozygous familial hypercholesterolemia (HeFH), in adults, Repatha may be used alone. It may also be used with other cholesterol-lowering drugs, such as a statin. For children with HeFH, Repatha should be used with other cholesterol-lowering drugs. For treating homozygous familial hypercholesterolemia (HoFH) in adults and children, Repatha should be used with other treatments for high cholesterol. This could include a statin, or it could be another type of cholesterol-lowering medication. It could also include treatments besides medications, such as LDL apheresis. (LDL apheresis uses a machine to filter LDL cholesterol out of your blood.) Repatha and statins have some side effects in common. However, statins can also cause other side effects, including joint pain, pancreatitis, and rhabdomyolysis (a serious condition that breaks down muscle tissue). To learn more about other drugs that may be used with Repatha, see the “Repatha use with other drugs” section below. If you have questions about other treatments that may be used with Repatha, talk with your doctor.

No, Repatha won’t cure your condition. Repatha treats several types of high cholesterol. It also reduces the risk of heart attack, stroke, and the need for certain heart surgeries in adults with heart disease. However, Repatha isn’t a cure. There is currently no known cure for any of the conditions that Repatha is approved to treat. If you have questions about how Repatha works to treat your condition, talk with your doctor.