• Praluent is a brand (trade) name for alirocumab which is a human monoclonal antibody that may be used to treat high cholesterol.
• Praluent (alirocumab) works by binding to a protein in the liver called proprotein convertase subtilisin kexin 9 (PCSK9) inhibiting its binding to low-density lipoprotein receptors (LDLR) on the surface of liver cells. LDLR is the primary receptor that clears circulating LDL. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels.
• Praluent belongs to the class of medications known as PCSK9 inhibitors.

• May be used in addition to diet to treat adults with high cholesterol (primary hyperlipidemia), including high cholesterol that occurs because of genetic reasons such as Heterozygous Familial Hypercholesterolemia [HeFH]). Approved for use as add-on therapy for people with Homozygous Familial Hypercholesterolemia.
• May be used to reduce the risk of a heart attack (myocardial infarction) stroke, or unstable angina requiring hospitalization, in adults with established cardiovascular disease.
• Reduces the amount of low-density lipoprotein cholesterol (LDL-C) circulating in the blood.
• May be used alone or in combination with other medications such as statins or ezetimibe.
• Two dosage forms are available: a single-use pre-filled syringe and a pre-filled pen.
• Two strengths of pen and prefilled syringe are available: 75 mg/mL and 150mg/mL.
• The usual starting dose is 75mg every 2 weeks injected subcutaneously (under the skin). An alternative starting dose is 300mg once every 4 weeks (monthly) for people who desire less frequent dosing. If either response is inadequate, the dosage may be adjusted to 150mg every 2 weeks.
• Weight gain or weight loss has not been reported as a side effect of Praluent in clinical trials.
• Monoclonal antibodies, such as Praluent, tend to have few drug interactions and are unlikely to cause liver or kidney damage.
• No overall differences in safety or efficacy were observed in elderly patients.
• No dosage adjustment is needed for mild to moderately impaired liver or kidney disease.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Nasopharyngitis, injection site reactions (such as pain, redness, or swelling), influenza, urinary tract infections, diarrhea, bronchitis, muscle pain or spasms, sinusitis, and cough are the most commonly reported side effects.
• Praluent has little effect on triglyceride levels which is why Praluent is often prescribed with statins that do lower triglyceride levels.
• LDL-C levels should be measured within 4 to 8 weeks of the initial dose of 75mg every 2 weeks. If the response is inadequate, adjust the dose to the maximum of 150mg every two weeks and measure levels again within 4 to 8 weeks. If Praluent is being given as 300mg every 4 weeks, measure LDL-C just before the next dose, because LDL-C levels can vary significantly with 4 weekly dosings. If the response is inadequate, adjust the dose to the maximum of 150mg every two weeks and measure levels again within 4 to 8 weeks.
• Must be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Praluent can be kept at room temperature (up to 25°C [77°F]) in the original carton and must be used within 30 days. Throw away Praluent that has been left at room temperature for more than 30 days. Do not freeze. Do not shake.
• There have been reports of serious hypersensitivity reactions occurring with Praluent. Monitor for any signs of a rash or anaphylaxis and discontinue Praluent if they occur.
• Liver enzyme elevations have also been reported. Increases in serum transaminases of more than 3 times the upper limit occurred in 1.7% of patients compared with 1.4% taking placebo (an inactive treatment).
• There is a potential for immunogenicity (antibody formation) with Praluent. The long-term consequences of continuing Praluent in the presence of anti-drug antibodies are unknown. Some patients experienced a decrease in Praluent efficacy.
• The safety of using Praluent in children has not been established.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• As with all other cholesterol-lowering medication, Praluent should be administered in conjunction with lifestyle changes including a cholesterol-lowering diet and a weight management plan.
• Regular exercise is also important as well as avoiding smoking.
• Praluent is injected under the skin usually every two weeks (but some people may prefer once a month) into your stomach area (abdomen), thigh, or upper arm and you can learn to give yourself injections at home.
• Praluent is available as an auto-injector or prefilled syringe. An autoinjector is a device that typically contains one prefilled dose of medicine in a spring-loaded syringe. You, or your caregiver, can learn to give this medicine at home. Many patients prefer autoinjectors over single-use syringes as they are easier to use and may cause less worry.
• If you have been shown how to self-inject Praluent, administer yourself a dose once every two weeks or monthly depending on what your doctor has prescribed, otherwise see your healthcare provider for a dose every month. If you forget a dose, schedule it in for as soon as you can, then continue with your regular dosing schedule.
• Immediately before administration, take one or two Praluent injections out of the refrigerator, depending on if you have been prescribed 150mg (one injection) or 300mg (requires two injections), and leave on a flat surface, away from children and pets, to warm up to room temperature for around 30 to 40 minutes. Do not warm in any other way (such as by putting in hot water). Praluent at room temperature reduces the risk of stinging. Inspect the injection for any discoloration or particulate matter and do not use it if the liquid is cloudy, contains particles, or is discolored. The liquid in Praluent should be clear, colorless, or have a slightly yellow tinge. Check the expiry date on the side of the injection and do not use Praluent if it has expired. Do not shake Praluent.
• Praluent is best administered into the front of your thighs or the lower part of your abdomen, avoiding the area around your belly button (stay an inch away from your belly button). If somebody else is giving you your injection they can also administer it into the outer area of your upper arm. Change your injection site every time you give yourself a dose so that you are not injecting into the same spot each time.
• Only inject into clear, healthy skin. Do not inject into any areas that are bruised, tender, red, scaly, or hard. You should also not inject any scars, stretch marks, or areas of psoriasis.
• If you feel pain when you inject Praluent, placing an ice pack on the area of skin where you inject Praluent for a few minutes before and after the injection can help reduce this pain.
• To inject the Praluent pre-filled pen, first, wash your hands then clean the injection site with an alcohol wipe and let the area dry. Twist off the blue cap and discard it. Hold the pen in a fist grip at a 90-degree angle (straight up and down) to your preferred injection site and press firmly against your skin until the yellow safety cover is no longer visible. If needed, pinch the skin up and hold it firmly around the injection site. Keep holding the pen in this position. Push the green or gray button at the top of the pen, then immediately release the green or gray button. The pen should click and the injection will start, which may take up to 20 seconds to complete. You need to keep the pen in position until it has finished. The injection has finished when the whole window has turned completely yellow. You can now remove the pen from your skin and discard it in an FDA-approved sharps bin.
• To inject the Praluent pre-filled syringe, first, wash your hands then clean the injection site with an alcohol wipe and let the area dry. Remove the needle cap and discard it. With your other hand pinch the skin of the injection site to make a firm bump. Hold the pen in a fist grip at a 45-degree angle and insert the needle into the small bump, making sure you push the needle in all the way. Put your first two fingers on the finger grips of the syringe and with your thumb on the top of the plunger slowly push down the plunger as far as it can go. Once it is fully depressed you should leave the injection in place for another 5 seconds to make sure all of the medicine has been injected. Once the injection is completed you can remove the injection from your skin by pulling the injection out at the same angle as the injection was inserted. Discard the syringe in an FDA-approved sharps bin.
• If you miss a dose of Praluent and it is within 7 days of your scheduled dose, administer it as soon as possible. If it is longer than 7 days since the missed dose, just resume your normal dosing schedule. Do not double the dose. If you have questions about your dose or when to administer it, call your doctor.
• Praluent lowers LDL cholesterol in the blood which slows down the formation of the fatty deposits in the arteries which reduces your risk of a heart attack (myocardial infarction), stroke, or unstable angina requiring hospitalization. Because the accumulation of fatty deposits in the arteries is a process that happens over time. If you want to prevent the slow, consistent future build-up of the fatty deposits then you need to take Praluent regularly and long term.
• There is no interaction between drinking alcohol and Praluent so an occasional drink with Praluent is acceptable; however, binge drinking of alcohol is known to cause an increase in lipid levels.
• Praluent should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. If removed from the refrigerator, Praluent can be kept at room temperature (up to 25°C [77°F]) in the original carton and must be used within 30 days. Throw away Praluent that has been left at room temperature for more than 30 days. Do not freeze. Do not shake. Do not put the prefilled pen or syringe back in the refrigerator after it has reached room temperature.
• If you are pregnant or intend to become pregnant, tell your doctor as it is not known if Praluent will harm an unborn baby. Also, talk to your doctor about breastfeeding your baby while you are self-administering Praluent.

• Following a single subcutaneous injection of Praluent, maximal suppression of free PCSK9 occurred within 4 to 8 hours and the average time to maximum serum concentrations were 3 to 7 days. Levels of LDL-C and other lipid markers drop quickly, well within 4 weeks but it may take up to one year for any noticeable differences in cardiovascular outcomes to be seen.
• Praluent significantly reduced the risk of death from coronary heart disease, non-fatal MI, stroke, and unstable angina requiring hospitalization in the Study 1 trial which followed 18,924 adults for up to 5 years. The incidence rate per 100 patient-years of the combined composite endpoint was 3.3 to 3.8 with Praluent compared with 3.9 to 4.4 with placebo (an inactive treatment).
• Several studies have investigated its effect on lipids. After 24 weeks the mean percent change from baseline for LDL-C was -47% to -58%, For total-C was -30% to -36%, for Non-HDL-C was -42% to -49% and for Apo B was -40% to -50%.
• Praluent is a long-term medication. As soon as you stop taking it LDL-C levels will increase again.

There are currently no documented interactions with Praluent, according to the product information.

Praluent is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

Although the mean half-life of Praluent is reduced to 12 days when administered with a statin, this difference is not clinically meaningful and does not impact dosing recommendations.

You should refer to the prescribing information for Praluent for any updates or newly noted interactions.