Praluent injection: Side effects, cost, dosing, and more Health ConditionsHealth ConditionsAlzheimer's & DementiaAnxietyArthritisAsthma & AllergiesBreast CancerCancerCardiovascular HealthCOVID-19Dermatology & SkincareDiabetesEnvironment & SustainabilityExercise & FitnessEye HealthHeadache & MigraineHealth EquityHIV & AIDSHuman BiologyInflammatory Bowel DiseaseLeukemiaLGBTQIA+Men's HealthMental HealthMultiple Sclerosis (MS)NutritionParkinson's DiseasePsoriasisSexual HealthWomen's HealthDiscoverNewsLatest NewsOriginal SeriesMedical MythsHonest NutritionThrough My EyesNew Normal HealthPodcastsHow to understand chronic painWhat is behind vaccine hesitancy?The amazing story of hepatitis C, from discovery to cureNew directions in dementia researchCan psychedelics rewire a depressed, anxious brain?Why climate change matters for human healthToolsGeneral HealthDrugs A-ZHealth HubsHealth ToolsBMI Calculators and ChartsBlood Pressure Chart: Ranges and GuideBreast Cancer: Self-Examination GuideSleep CalculatorHealth ProductsAffordable Therapy OptionsBlood Pressure MonitorsDiabetic SuppliesFitness TrackersHome GymsGreen Cleaning ProductsHow to Shop for CBDQuizzesRA Myths vs FactsType 2 Diabetes: Managing Blood SugarAnkylosing Spondylitis Pain: Fact or FictionConnectAbout Medical News TodayWho We AreOur Editorial ProcessContent IntegrityConscious LanguageNewslettersSign UpFollow UsMedical News TodayHealth ConditionsDiscoverToolsConnectSubscribe Praluent injection alirocumab Medically reviewed by Victor Nguyen, PharmD, MBA — By Patricia Weiser, PharmD — Updated on September 3, 2022 What is Praluent Praluent is a brand-name prescription medication. It’s FDA-approved to:Decrease the risk of heart attack, stroke, and unstable angina that requires a hospital stay. (“Unstable angina” is a type of chest pain.) For this purpose, Praluent is used in adults who already have heart disease.Decrease low-density lipoprotein (LDL), which is also known as “bad” cholesterol, in adults with primary hyperlipidemia (high cholesterol). This includes adults with either of the following inherited conditions:heterozygous familial hypercholesterolemiahomozygous familial hypercholesterolemia To learn more about Praluent’s uses, see the “Praluent uses” section below. Drug details Praluent contains the active drug alirocumab. Praluent belongs to a group of drugs known as PCSK9 inhibitors. They work in the liver to help remove LDL cholesterol from the blood. Praluent comes as a liquid solution in a single-dose prefilled pen. Praluent is given as a subcutaneous injection, which is given just under the skin. You or your caregiver will be trained on how to inject Praluent at home. The drug is typically given once every 2 weeks or once every 4 weeks. The drug is available in two strengths: 75 milligrams/milliliter (mg/mL) and 150 mg/mL. Effectiveness For information about the effectiveness of Praluent, see the “Praluent uses” section below. Praluent generic or biosimilar Praluent is a biologic drug that’s only available as a brand-name medication. It doesn’t currently come in a generic or biosimilar form. A biologic drug is made from living cells, not from chemicals like other drugs. Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication. Biologics, on the other hand, can’t be copied exactly. Therefore, instead of a generic, biologics have biosimilars. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe. Praluent side effects Praluent can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Praluent. These lists do not include all possible side effects. For more information about the possible side effects of Praluent, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be bothersome. Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Praluent, you can do so through MedWatch. Mild side effects Mild side effects* of Praluent can include:injection site reaction (skin redness or discoloration, itching, swelling, or pain at the site of the injection)symptoms like those of the common cold,† such as sore throat, runny nose, or sneezingthe flu or symptoms like those of the flu,† such as fever, body aches, or fatigue (lack of energy)urinary tract infection (UTI)†diarrheamuscle pain or spasms (muscle cramps)†very low level of low-density lipoprotein (LDL),† commonly known as “bad” cholesterolincreased levels of liver enzymes, which can be a sign of liver damage Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist. * This is a partial list of mild side effects from Praluent. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Praluent’s prescribing information. † For more information on this side effect, see “Side effect details” below. The cold- and flu-related side effects are grouped together in the section “Respiratory illnesses.” Serious side effects Serious side effects from Praluent aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects can include:Allergic reaction (see “Side effect details” below). Side effect details You may wonder about certain side effects or how often side effects occur with this drug. Here’s some detail on certain side effects this drug may or may not cause. Allergic reaction Allergic reactions can occur with Praluent use. In clinical trials of Praluent, this side effect occurred in:8.6% of people who used Praluent7.8% of people who used a placebo (treatment with no active drug) Some of the allergic reactions can be severe and require care in a hospital. Severe allergic reactions During clinical trials of Praluent, the most common side effect that caused people to stop treatment was serious allergic reaction. About 0.6% of people treated with Praluent had allergic reactions that led them to stop taking the drug. This was compared with 0.2% of people who used a placebo. Symptoms of a severe allergic reaction can include:swelling under your skin, typically in your eyelids, lips, hands, or feetswelling of your tongue, mouth, or throattrouble breathing If you have any of these symptoms while using Praluent, call 911 or your local emergency number. Mild allergic reactions While using Praluent, mild allergic reactions may also occur. Symptoms of a mild allergic reaction can include:skin rashitchinessflushinghives (a type of raised, itchy skin rash) If you have any of these symptoms while using Praluent, call your doctor right away because the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency. Muscle pain and muscle cramps Some people may experience muscle-related side effects while taking Praluent. These include muscle pain and spasms (muscle cramps). In clinical trials for treating primary hyperlipidemia (high cholesterol), people used Praluent or a placebo (treatment with no active drug). Here are the percentages of people who had muscle-related side effects:PraluentPlaceboMuscle pain4.2%3.4%Muscle spasms3.1%2.4% In a clinical study for reducing the risk of heart attack, stroke, and unstable angina (a type of chest pain), muscle pain was reported in:5.6% of people who took Praluent5.3% of people who took a placebo It’s not known how often muscle cramps may have occurred in these studies. In addition, it’s not known how many of these study participants were also taking statins. Muscle pain and spasms are possible side effects of other cholesterol-lowering drugs, such as statins. Praluent is sometimes taken with a statin to treat high cholesterol that can’t be lowered with a statin alone. To learn more, see the “Praluent use with other treatments” section below. If you experience muscle pain or muscle spasms while taking Praluent, talk with your doctor. They may be able to suggest ways to help ease these side effects. Respiratory illnesses Respiratory illnesses are side effects of Praluent. These include cold-like symptoms, the flu, flu-like symptoms, bronchitis, and sinus infection. Cold-like symptoms In clinical studies for treating primary hyperlipidemia (high cholesterol), the most common side effects of Praluent were symptoms like those of the common cold. These may include sore throat, runny nose, or sneezing. Cold-like symptoms were reported in:11.3% of people who used Praluent11.1% of people who used a placebo (treatment with no active drug) In a clinical trial for reducing the risk of heart disease complications (heart attack, stroke, unstable angina), 6% of people who took Praluent experienced common cold symptoms. Out of the people who took a placebo, 5.6% had cold-like symptoms. Flu and flu-like symptoms The flu and flu-like symptoms are also side effects of Praluent. In clinical studies of Praluent for the treatment of primary hyperlipidemia, the flu was reported in:5.7% of people who used Praluent4.6% of people who used a placebo Praluent is also used to decrease the risk of heart attack, stroke, and unstable angina (a type of chest pain). It’s not known how often flu and flu-like symptoms may have occurred in clinical studies of people who took Praluent for this purpose. Symptoms of the flu can include:feverbody achesfatigue (lack of energy)cold-like symptoms, such as sore throat, runny nose, or sneezing Talking with your doctor If you have any of the above symptoms while using Praluent, talk with your doctor. They may be able to suggest ways to help you feel more comfortable. Urinary tract infection Urinary tract infection (UTI) can occur as a side effect of Praluent. In clinical trials studying Praluent for the treatment of primary hyperlipidemia (high cholesterol), UTIs occurred in:4.8% of people using Praluent4.6% of people who took a placebo (treatment with no active drug) Praluent is also used to decrease the risk of heart attack, stroke, and unstable angina (a type of chest pain). It’s not known how often UTIs may have occurred in clinical studies of people who took Praluent for this purpose. Symptoms of a UTI can include pain or burning during urination. If you have symptoms of a UTI while using Praluent, talk with your doctor. They may test your urine to see if you have a UTI and prescribe an antibiotic to treat it if needed. Very low level of LDL cholesterol Some people may develop very low levels of low-density lipoprotein (LDL) while taking Praluent. LDL is commonly known as “bad” cholesterol. A very low level of “bad” cholesterol may sound like a good thing. However, research has linked very low levels of LDL cholesterol to an increased risk of developing diabetes. And in some cases, low levels may eventually cause a heart attack or stroke. LDL levels are measured in milligrams per deciliter (mg/dL). If you don’t have heart disease or aren’t at risk for it, a typical LDL level is 129 mg/dL or less. If you do have heart disease or are at risk for it, a typical LDL level is less than 100 mg/dL. There isn’t general agreement on what is considered a very low LDL level. But some studies have shown an increased risk of stroke when LDL is less than 50 mg/dL. Talk with your doctor about what levels are safe for you. A very low level of LDL cholesterol typically doesn’t cause any symptoms. Therefore, you likely won’t know if your level is low unless your doctor gives you a cholesterol test. Studies on the treatment of high cholesterol In clinical studies of Praluent for the treatment of primary hyperlipidemia (high cholesterol), it’s not known how often very low LDL levels may have occurred. However, very low LDL levels were seen more often with higher strengths of Praluent. Very low LDL levels occurred more frequently in people who took 150 milligrams (mg) of Praluent every 2 weeks or 300 mg every 4 weeks. In people who took 75 mg of Praluent every 2 weeks, very low LDL levels occurred less often. Studies on decreasing the risk of certain heart problems Praluent is also used to decrease the risk of heart attack, stroke, and unstable angina (a type of chest pain). A clinical trial studied Praluent for this purpose. About 7.7% of people taking 75 mg of Praluent every 2 weeks had very low LDL levels. These were defined as two cholesterol readings of less than 15 mg/dL. As a result, this group of people was switched to a placebo (treatment with no active drug). In the trial, Praluent was compared with a placebo. People who took a placebo didn’t experience very low LDL. This is because the placebo didn’t contain medication that could lower LDL levels. Checks of your LDL level While taking Praluent, it’s important to have your LDL level checked as recommended by your doctor. This is done as a blood test. Weight loss or weight gain (not side effects) Weight changes weren’t a side effect reported in clinical studies of Praluent. If you experience sudden weight loss or gain, be sure to talk with your doctor. Praluent vs Repatha You may wonder how Praluent compares with other medications that are prescribed for similar uses. Here we look at how Praluent and Repatha are alike and different. Ingredients Praluent contains the active drug alirocumab. Repatha contains the active drug evolocumab. Both Praluent and Repatha belong to a class of drugs called PCSK9 inhibitors. (A class of drugs is a group of medications that work in a similar way.) Uses The Food and Drug Administration (FDA) has approved Praluent and Repatha to:Reduce the risk of heart attack and stroke in adults with a history of heart disease.Decrease low-density lipoprotein (LDL), which is also known as “bad” cholesterol, in adults with primary hyperlipidemia (high cholesterol). This includes adults with either of the following inherited conditions:heterozygous familial hypercholesterolemiahomozygous familial hypercholesterolemia Praluent is also FDA-approved to reduce the risk of unstable angina (chest pain) that requires a hospital stay in adults with a history of heart disease. (“Unstable angina” is a type of chest pain.) Repatha is also FDA-approved to reduce the need for heart bypass surgery in adults with a history of heart disease. For more information on the uses of Praluent, see the “Praluent uses” section below. To learn more about Repatha’s uses, talk with your doctor. Drug forms and administration Both Praluent and Repatha are liquid solutions given as a subcutaneous injection. This is an injection given just under the skin. You or your caregiver will be trained on how to inject either drug at home. Praluent comes in a single-dose prefilled pen. The drug is typically given once every 2 weeks or once every 4 weeks. Repatha comes in three forms. One is a prefilled single-dose syringe. The second is a SureClick autoinjector. The third form is a Pushtronex system. With this system, an infuser is attached to your body to give you your dose. Repatha is typically given once every 2 weeks or once every 4 weeks. Side effects and risks Praluent and Repatha both contain PCSK9 inhibitor drugs. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects. Mild side effects These lists contain up to 10 of the most common mild side effects that can occur with either Praluent or Repatha, as well as mild side effects that both drugs may share.Can occur with Praluent:very low level of LDL cholesterolincreased levels of liver enzymes, which can be a sign of liver damageCan occur with Repatha:high blood sugarback painCan occur with both Praluent and Repatha:injection site reaction (skin redness or discoloration, itching, swelling, or pain at the site of the injection)muscle pain and muscle spasms (muscle cramps)urinary tract infection (UTI)the flu or symptoms like those of the flu,† such as fever, body aches, or fatigue (lack of energy)symptoms like those of the common cold,† such as sore throat, runny nose, or sneezing Serious side effects This list contains an example of a serious side effect that can occur with either Praluent or Repatha.Can occur with both Praluent and Repatha:allergic reaction Effectiveness Praluent and Repatha have different FDA-approved uses, but they’re both used to:reduce the risk of heart attack and stroke in certain adultstreat primary hyperlipidemia in certain adults These drugs haven’t been directly compared in clinical studies. Individually, studies have found both Praluent and Repatha to be effective for the above approved uses. Costs Praluent and Repatha generally cost about the same. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use. Praluent and Repatha are both biologic drugs that are available only as brand-name medications. They don’t currently come in a biosimilar form. A biologic drug is made from living cells, not from chemicals like other drugs. Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication. Biologics, on the other hand, can’t be copied exactly. Therefore, instead of a generic, biologics have biosimilars. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe. And like generics, biosimilars tend to cost less than brand-name medications. Alternatives to Praluent Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Praluent, talk with your doctor. They can tell you about other medications that may work well for you. Note: Some of the drugs listed here are prescribed off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is prescribed to treat a different condition. Alternatives for reducing the risk of heart attack stroke and unstable angina that requires a hospital stay in adults with heart disease Praluent is used to reduce the risk of heart attack, stroke, and unstable angina that requires a hospital stay in adults with heart disease. Other drugs are available for this purpose, and examples include:evolocumab (Repatha)*statins, such as:rosuvastatin (Crestor)atorvastatin (Lipitor)simvastatin (Zocor) * Evolocumab belongs to the same drug class (PCSK9 inhibitors) as Praluent. A drug class is a group of medications that work in a similar way. At this time, evolocumab is the only other PCSK9 inhibitor besides Praluent approved by the Food and Drug Administration (FDA). Alternatives for lowering LDL cholesterol in adults with primary hyperlipidemia Examples of other drugs that may be used to decrease low-density lipoprotein (LDL)* in adults with primary hyperlipidemia (high cholesterol) include:statins,† such as:rosuvastatin (Crestor)atorvastatin (Lipitor)simvastatin (Zocor)fibrates, such as:fenofibrate (Tricor)gemfibrozil (Lopid)ezetimibe (Zetia) * LDL cholesterol is also known as “bad” cholesterol. † Statin drugs are the most commonly prescribed alternative for the purpose mentioned above. Praluent dosage The Praluent dosage your doctor prescribes will depend on:the type and severity of the condition you’re using Praluent to treatyour preference for your dosing frequency Typically, your doctor will start you on the lower dosage of Praluent. They may adjust it over time to reach the dosage that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect. The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs. Drug forms and strengths Praluent comes as a liquid solution in a prefilled single-dose pen.* The drug is available in two strengths: 75 milligrams/milliliter (mg/mL) and 150 mg/mL. Praluent is given as a subcutaneous injection. This is an injection given just under the skin. You or your caregiver will be trained on how to inject Praluent at home. For more information, see the “How to use Praluent” section below. * Praluent is no longer available in a prefilled syringe. Dosage for reducing the risk of heart attack stroke and unstable angina that requires a hospital stay in adults with heart disease Praluent is approved to reduce the risk of heart attack, stroke, and unstable angina that requires a hospital stay in adults with heart disease. Praluent may be prescribed in one of these dosages:75 mg once every 2 weeks150 mg once every 2 weeks300 mg once every 4 weeks The usual starting dosage of Praluent is a 75-mg injection every 2 weeks. If you prefer less frequent dosing, talk with your doctor about the monthly option for Praluent. This involves an alternate starting dosage of 300 mg every 4 weeks.* After 4 to 8 weeks of treatment, your doctor will check your level of low-density lipoprotein (LDL). This is also known as “bad” cholesterol. If your LDL level is high, your doctor may change your dosage to a 150-mg injection every 2 weeks or 300 mg once every 4 weeks.* * If your doctor prescribes this dosage, you’ll receive two separate 150-mg injections in a row. You’ll need to use a new pen for each injection. Dosage for lowering LDL cholesterol in adults with primary hyperlipidemia Praluent is approved to decrease low-density lipoprotein (LDL)* in adults with primary hyperlipidemia (high cholesterol). This includes adults with an inherited condition called heterozygous familial hypercholesterolemia (HeFH). The dosage details for this use are the same as those in the above section, “Dosage for reducing the risk of heart attack stroke and unstable angina that requires a hospital stay in adults with heart disease.” If you have HeFH and regularly have a procedure called LDL apheresis, see “Dosage for HeFH” right below. * LDL cholesterol is also known as “bad” cholesterol. Dosage for HeFH Some people with HeFH regularly have a procedure called LDL apheresis. It’s done to remove excess cholesterol from the blood. People with HeFH may have LDL apheresis every 1 or 2 weeks. The recommended Praluent dosage for adults with HeFH who receive LDL apheresis is a 150-mg injection every 2 weeks. The timing of the injection and LDL apheresis doesn’t matter. Dosage questions Below are answers to some questions you may have about taking Praluent. What if I miss a dose If you miss your dose of Praluent, take it within 7 days of the missed dose. (You can take your missed dose up to 7 days late.) Then take Praluent according to your regular dosing schedule. If you miss your Praluent dose by more than 7 days, the instructions depend on your dose schedule:If you take Praluent every 2 weeks and miss a dose by more than 7 days, don’t take a dose. Instead, wait until your next scheduled Praluent dose is due.If you take Praluent every 4 weeks and miss a dose by more than 7 days, go ahead and take the dose as soon as possible. Then start a new monthly schedule based on this date. To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. Will I need to use this drug long term Praluent is meant to be used as a long-term treatment. If you and your doctor determine that Praluent is safe and effective for you, you’ll likely use it long term. Praluent cost As with all medications, the cost of Praluent can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use. It’s important to note that you may have to get Praluent at a specialty pharmacy, depending on what your insurance company requires. This type of pharmacy carries only specialty drugs. Specialty drugs may be expensive or may require help from healthcare professionals to be used safely and effectively. Keep in mind that you may be able to get a 90-day supply of Praluent. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor or your insurance company. Before approving coverage for Praluent, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered. If you’re not sure if you’ll need to get prior authorization for Praluent, contact your insurance company. Financial and insurance assistance If you need financial support to pay for Praluent, or if you need help understanding your insurance coverage, help is available. A MyPraluent Copay Card and a MyPraluent Patient Assistance Program are available for Praluent. For more information and to find out if you’re eligible for support, call 844-PRALUENT (844-772-5836) or visit the drug website. Mail-order pharmacies Praluent may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home. If recommended by your doctor, you may be able to receive a 90-day supply of Praluent, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications. If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options. Biosimilar version Praluent is available only as a brand-name biologic medication. It isn’t available in a generic or biosimilar form. A biologic drug is made from living cells, not from chemicals like other drugs. Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication. Biologics, on the other hand, can’t be copied exactly. Therefore, instead of a generic, biologics have biosimilars. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe. Praluent and alcohol There are no known interactions between alcohol and Praluent. However, over time, drinking too much alcohol can cause liver damage. And liver-related problems, such as increased levels of liver enzymes, are possible side effects of Praluent. (These increased levels can be a sign of liver damage.) It isn’t clear if the people who had increased levels of liver enzymes in Praluent’s clinical trials were also taking drugs called statins. Praluent is sometimes taken with a statin, and statins themselves can raise the risk of liver damage. Therefore, if you take a statin with Praluent, drinking too much alcohol could further increase your risk for liver damage. And if you drink a lot of alcohol while taking Praluent without a statin, your risk for liver damage could still increase. Before using Praluent, talk with your doctor. They can advise you on whether it’s safe for you to drink alcohol during your treatment. Praluent uses The Food and Drug Administration (FDA) approves prescription drugs such as Praluent to treat certain conditions. Praluent for reducing the risk of heart attack stroke and unstable angina that requires a hospital stay in adults with heart disease Praluent is FDA-approved to reduce the risk of heart attack, stroke, and unstable angina that requires a hospital stay. (“Unstable angina” is a type of chest pain.) For this purpose, Praluent is approved for use in adults with a history of heart disease. Heart disease refers to any condition that affects the heart. Sometimes heart disease has a genetic (inherited) cause. But certain factors can increase the risk of heart disease. These include smoking, poor diet choices, and not exercising enough. You can see our cardiovascular health hub for details about heart disease. Praluent may be prescribed for adults who:have coronary heart disease, peripheral vascular disease, or other heart diseasepreviously had a heart attackpreviously had a stroke or similar cerebrovascular disease If you have heart disease, a high level of low-density lipoprotein (LDL) can increase your risk for complications, such as heart attack or stroke. Praluent helps reduce this risk by lowering your LDL level. (LDL cholesterol is also known as “bad” cholesterol.) Effectiveness for reducing the risk of heart attack stroke and unstable angina that requires a hospital stay in adults with heart disease In a clinical study, Praluent was effective at reducing the risk of heart attack or stroke in adults with heart disease. The drug was also effective at reducing the need for a hospital stay to treat unstable angina. The 18,924 people in the study were randomly assigned to receive either 75 milligrams (mg) of Praluent every 2 weeks or a placebo every 2 weeks. A placebo is a treatment that contains no active drug. All of the people had a history of heart disease and most (89%) were already being treated with a statin. The researchers compared the effectiveness of Praluent with that of the placebo. They did this by measuring the time it took for any of the following complications of heart disease to occur:heart attackstrokeunstable angina requiring a hospital staydeath from coronary heart disease (CHD) After about 4 years of follow-up, these complications occurred in:9.5% of people who took Praluent (If 100 people took Praluent for 1 year, 3.5 of them would experience one of these complications.)11.1% of people who took a placebo (If 100 people took a placebo for 1 year, 4.2 of them would experience one of these complications.) The results of this study showed that Praluent was significantly more effective than a placebo at reducing certain heart disease complications in adults. Praluent for lowering LDL cholesterol in adults with primary hyperlipidemia Praluent is also FDA-approved to decrease low-density lipoprotein (LDL) in adults with primary hyperlipidemia (high cholesterol). LDL cholesterol is also known as “bad” cholesterol. The adults include those with inherited conditions called heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH). For this purpose, Praluent may be used alone, with a balanced diet, or with other medications that lower LDL cholesterol. Examples of the medications include statins and ezetimibe (Zetia). LDL cholesterol level Your body needs LDL, but excess amounts can build up in blood vessel walls, making them narrow. This buildup of LDL cholesterol is known as atherosclerosis. The condition reduces blood flow and increases the risk of heart attack or stroke. Praluent lowers your LDL level by helping your body get rid of LDL cholesterol more effectively than usual. An LDL level of 100 mg/dL to 129 mg/dL is considered good for people with no health problems. But this range is considered borderline high for people with heart disease. People with heart disease should usually have a lower LDL goal of 70 mg/dL. Talk with your doctor to find out what your LDL goal should be. You can also see our cholesterol hub for details about cholesterol levels. Effectiveness for lowering LDL cholesterol in adults with primary hyperlipidemia In a clinical study, Praluent effectively decreased LDL cholesterol in adults with primary hyperlipidemia. They were already taking statins and possibly other medications to lower cholesterol, but their LDL level was still high. The adults were randomly assigned to take 150 milligrams (mg) of Praluent every 2 weeks or a placebo every 2 weeks. (A placebo is a treatment with no active drug.) At baseline (before the study began), the average LDL level was 122 mg/deciliter (dL). After 24 weeks, on average, adults had the following changes in their LDL level from baseline:58% reduction in adults who took Praluent1% increase in people who took a placebo In another clinical trial for primary hyperlipidemia, Praluent was compared with ezetimibe (Zetia) in people who were already taking statins. People were randomly assigned to take Praluent or ezetimibe in addition to their statin medications. At baseline, the average person’s LDL level was 107 mg/dL. After 24 weeks, on average, people had the following reductions in their average LDL level from baseline:48% reduction in people who took Praluent20% reduction in people who took ezetimibe Praluent and children Praluent is FDA-approved for use in adults. The safety and effectiveness of Praluent in children isn’t known. How to use Praluent You should use Praluent according to your doctor’s or healthcare professional’s instructions. Praluent is a liquid solution that comes in a prefilled single-dose pen. The drug comes packaged in cartons of one or two pens. Praluent is administered as a subcutaneous injection, which is given just under the skin. Administration of a medication is the way it’s given. In this case, it’s the act of giving yourself the injection. Before you start treatment, your healthcare professional will show you or your caregiver how to inject the drug at home. The manufacturer of Praluent also has a helpful video and instructions for use. Before injecting Praluent You should store unopened cartons of Praluent in the refrigerator. (To learn more, see the “Praluent expiration storage and disposal” section below.) Before use, take the Praluent carton out of the refrigerator and wait 30 to 40 minutes until it warms to room temperature. Don’t place Praluent in direct sunlight or heat it up in the microwave. You may want to set an alarm to remind you when 30 to 40 minutes have passed. Where to inject Praluent Praluent injections are given just under the skin in these areas of the body:top of the thighabdomen (belly), avoiding the 2-inch area surrounding your navelouter side of your upper arm, but only a caregiver can give you the injection in this spot Keep in mind that you should choose a different injection site each time you use Praluent. This will help reduce injection site side effects, such as pain and irritation. (To learn more, see the “Praluent side effects” section above.) Your doctor may have you take Praluent every 2 weeks or every 4 weeks. If you take the drug monthly, you’ll have two separate injections in a row. You’ll need to use a different pen and injection site for the second injection. If you use other injectable medications, such as insulin, don’t inject Praluent at the same injection site. When to use Your doctor may have you take Praluent every 2 weeks or every 4 weeks. You can inject the medication at any time of day. To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. How Praluent works The Food and Drug Administration (FDA) has approved Praluent to reduce the risk of certain complications in adults with a history of heart disease:heart attackstrokeunstable angina (a type of chest pain) that requires a hospital stay Heart disease refers to any condition that affects the heart. Sometimes heart disease has a genetic (inherited) cause. But certain factors can increase the risk of heart disease. These include smoking, poor diet choices, and not exercising enough. If you have heart disease, a high level of low-density lipoprotein (LDL) can increase your risk for complications, such as heart attack or stroke. Praluent helps reduce this risk by lowering your LDL level. (LDL cholesterol is also known as “bad” cholesterol.) Praluent is also FDA-approved to lower LDL cholesterol in adults with primary hyperlipidemia (high cholesterol). This includes adults with inherited conditions called heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH). Your body needs LDL, but excess amounts can build up in blood vessel walls, making them narrow. This buildup of LDL cholesterol is known as atherosclerosis. The condition reduces blood flow and increases the risk of heart attack or stroke. What Praluent does Praluent lowers the level of LDL by helping your liver get rid of LDL more effectively than usual. Praluent contains the active drug alirocumab. This is a type of drug called a PCSK9 inhibitor. The mechanism of action of PCSK9 inhibitors is blocking the ability of an enzyme known as PCSK9 from doing its job. (An enzyme is a protein that aids chemical changes in your body.) The PCSK9 enzyme is in the liver. By blocking the enzyme’s action, Praluent causes the liver to effectively remove more LDL cholesterol from the blood than usual. How long does it take to work Praluent starts working when the dose is injected. Blood test results are the only way to tell if Praluent is working to lower your LDL cholesterol. After 4 to 8 weeks of Praluent treatment, your doctor will order a lipid panel. This blood test checks your cholesterol levels. If your LDL level remains high or borderline high, your doctor may adjust your Praluent dose. Praluent expiration storage and disposal When you get Praluent from the pharmacy, the pharmacist will add an expiration date to the label on the package. This date is typically 1 year from the date they dispensed the medication. The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about how to properly dispose of it. Storage Praluent comes in cartons that contain one or two prefilled pens. Be sure to keep the pens in their original carton to protect them from light. You should store Praluent in a refrigerator (36°F to 46°F/2°C to 8°C). Don’t freeze the drug. If you need to, you can store Praluent at room temperature (up to 77°F/25°C) for no longer than 30 days. After that, the drug shouldn’t be used and should be thrown away. Don’t put Praluent back in the refrigerator once it has been warmed to room temperature. Disposal Right after you’ve used a Praluent pen, dispose of it in an FDA-approved sharps disposal container. This helps prevent others, including children and pets, from taking the drug by accident or harming themselves with the needle. You can buy a sharps container online, or ask your doctor, pharmacist, or health insurance company where to get one. This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication. Praluent interactions Praluent isn’t known to interact with any other medications, herbs, supplements, or foods. Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe. To be safe, before taking Praluent, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist. Common questions about Praluent Here are answers to some frequently asked questions about Praluent. How long does Praluent stay in your system It should take your body about 14 weeks (about 98 days) to get Praluent out of your system. This timing is based on the drug’s half-life. A half-life is the amount of time it takes for the body to eliminate half of a drug’s dose. Is Praluent a statin No, Praluent isn’t a statin. Praluent is a type of drug known as a PCSK9 inhibitor. A statin is a type of drug called an HMG-CoA reductase inhibitor. Praluent and statins work differently. Praluent works in the liver to help remove low-density lipoprotein (LDL) from the blood. (LDL cholesterol is also known as “bad” cholesterol.) The drug does this by blocking the action of an enzyme known as PCSK9. An enzyme is a protein that aids chemical changes in your body. Statins slow down how quickly the liver makes new cholesterol. They do this by blocking the action of an enzyme called HMG-CoA reductase. Your doctor may prescribe Praluent in addition to a statin, especially if your high cholesterol has been hard to control. To learn more, see the “Use with other treatments” section below. If you have questions about Praluent and statins, talk with your doctor. Could Praluent affect my kidneys or liver Increased liver enzyme levels are a possible side effect of Praluent. This can be a sign of liver damage. However, in clinical trials this side effect was mild. Your doctor will likely have you get blood tests to monitor for this side effect. The kidneys and liver aren’t involved in breaking down Praluent and clearing it out of your body. As a result, the drug shouldn’t significantly affect those organs. People with mild to moderate liver damage were given a single dose of Praluent. Researchers found that the drug wasn’t cleared from the body any differently than in people with a healthy liver. This means that Praluent didn’t seem to affect their liver. Also, Praluent wasn’t studied in people with severe kidney or liver damage, so its effects aren’t known for those groups. If you have other questions about taking Praluent and kidney or liver health, talk with your doctor. Will Praluent cure my condition No, Praluent isn’t a cure for your condition. There isn’t currently a cure for any of the conditions that Praluent is used to treat. Praluent can be used to decrease low-density lipoprotein (LDL), which is also known as “bad” cholesterol, in adults with high cholesterol. The drug can also be used to reduce the risk of heart attack, stroke, and unstable angina that requires a hospital stay. For this purpose, Praluent is used in adults who already have heart disease. If you’re wondering if Praluent is right for you, talk with your doctor. Why do I have to talk with my doctor before stopping Praluent treatment If you stop Praluent treatment, your low-density lipoprotein (LDL) level may rise. (LDL cholesterol is also known as “bad” cholesterol.) High cholesterol levels may put you at risk for heart attack, stroke, or other heart disease. If you’re thinking about stopping your Praluent treatment, it’s important that you first talk with your doctor. They may recommend a cholesterol medication other than Praluent. Praluent use with other treatments Praluent is approved to decrease the risk of heart attack, stroke, and unstable angina that requires a hospital stay. (“Unstable angina” is a type of chest pain.) For this purpose, Praluent is used in adults who already have heart disease. Praluent can be used in addition to other medications as prescribed by your doctor. Praluent is also approved to decrease low-density lipoprotein (LDL), which is also known as “bad” cholesterol, in adults with high cholesterol. For this purpose, Praluent may be used alone, with a balanced diet, or with other medications that lower LDL cholesterol. Praluent works by helping your body get rid of LDL cholesterol more effectively than usual. To lower your LDL cholesterol level further, your doctor may also prescribe other cholesterol drugs. These drugs work differently than Praluent. Some examples include ezetimibe (Zetia) and statins such as atorvastatin (Lipitor). As part of a balanced diet, your doctor may recommend that you limit high-cholesterol foods, such as red meat. To learn about other foods that can raise or lower cholesterol, you can refer to this article. If you have questions about taking Praluent with other medications or what to include in a balanced diet, talk with your doctor. Praluent and pregnancy It’s not known if Praluent is safe to use while pregnant. This is because there isn’t enough data to determine the safety of Praluent’s use in pregnant people. In studies of pregnant animals, Praluent didn’t seem to cause harmful effects. However, animal studies don’t always reflect what could happen in humans. Praluent and fertility Clinical studies haven’t tested Praluent’s effects on fertility (the ability to become pregnant or make someone pregnant). However, no harmful effects were found in animals given the drug during studies that lasted 6 months. Talking with your doctor If you’re pregnant or planning to become pregnant, talk with your doctor. They can discuss the benefits and possible risks of using Praluent during pregnancy. Praluent and birth control It’s not known if Praluent is safe to use while pregnant. This is because the drug hasn’t been studied during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Praluent. For more information about taking Praluent during pregnancy, see the “Praluent and pregnancy” section above. Praluent and breastfeeding It isn’t known if Praluent is safe to use while breastfeeding. If you’re breastfeeding or planning to breastfeed, talk with your doctor before using Praluent. They can review the risks and benefits of the drug with you. Praluent precautions Before taking Praluent, talk with your doctor about your health history. Praluent may not be right for you if you have certain medical conditions or other factors affecting your health. These include:Allergic reaction. Praluent may cause severe allergic reactions that can require urgent medical attention. Praluent is contraindicated (should not be used in any circumstance) if you’ve had an allergic reaction to Praluent or any of its ingredients. Ask your doctor what other medications are better options for you.Pregnancy. It’s not known if Praluent is safe to use while pregnant. For more information, see the “Praluent and pregnancy” section above.Breastfeeding. It isn’t known if Praluent is safe to use while breastfeeding. For more information, see the “Praluent and breastfeeding” section above. Note: For more information about the potential negative effects of Praluent, see the “Praluent side effects” section above. Praluent overdose Do not use more Praluent than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose. What to do in case you take too much Praluent If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away. Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.CholesterolHeart DiseaseStrokeCardiovascular / CardiologyPharmacy / PharmacistDrugsMedically reviewed by Victor Nguyen, PharmD, MBA — By Patricia Weiser, PharmD — Updated on September 3, 2022 Latest newsWhat sets 'SuperAgers' apart? Their unusually large neuronsOmega-3 may provide a brain boost for people in midlifeSeasonal affective disorder (SAD): How to beat it this fall and winterCDC: Monkeypox in the US 'unlikely to be eliminated in the near future'Why are more women prone to Alzheimer's? 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