See the “How Trulicity works” section … Asked for comment on this development, Dr Michael Rocco (Cleveland Clinic, OH), senior author of a recent PCSK9 inhibition review , also pointed to the loss of competition in the … Three patients (0.7%) treated with PRALUENT 300 mg Q4W discontinued treatment due to local injection site reactions versus no patients (0%) in the other 2 treatment groups. 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. There have been reports of serious hypersensitivity reactions occurring with Praluent. 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. PRALUENT can help adults with cardiovascular … © Praluent Patient Information is supplied by Cerner Multum, Inc. and Praluent Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights. Adverse reactions led to discontinuation of treatment in 5.3% of patients treated with PRALUENT and 5.1% of patients treated with placebo. In a 48-week placebo-controlled trial evaluating PRALUENT 300 mg every 4 weeks (Q4W) and 75 mg Q2W, in which all patients received an injection of drug or placebo every 2 weeks to maintain the blind, local injection site reactions were reported more frequently in patients treated with PRALUENT 300 mg Q4W as compared to those receiving PRALUENT 75 mg Q2W or placebo (16.6%, 9.6%, and 7.9%, respectively). View complete list of side effects. The recommended starting dose for Praluent is 75 mg administered subcutaneously once every 2 weeks. I … I have been on Repatha for about 14 months now. The following adverse reactions have been reported during postapproval use of PRALUENT. 3 Stars. The phase IV clinical study is created by eHealthMe based on reports of 18,069 people who have side effects when taking Praluent … 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. Adverse reactions reported in at least 2% of PRALUENT-treated patients, and more frequently than in placebo-treated patients, are shown in Table 1. Change your injection site every time you give yourself a dose so that you are not injecting into the same spot each time. Keep holding the pen in this position. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. 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). Sanofi US Corporation https://www.drugs.com/pro/praluent.html. 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. 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. Do not shake Praluent. what drives weight gain is the number of calories taken in not the number of grams taken in so an 1800 calorie diet from carbs fat or from protein will affect your weight … My LDL that I get tested every 6 months is is a very low 24 thanks to Praluent… Corn will allow faster weight gain for a bovine than grass as it is higher in calories than grass-more protein. There is a potential for immunogenicity (antibody formation) with Praluent. LDLR is the primary receptor that clears circulating LDL. Does Repatha cause weight lose or weight gain? Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Few patients discontinued treatment because of these reactions (0.2% versus 0.4% for PRALUENT and placebo, respectively), but patients receiving PRALUENT had a greater number of injection site reactions, had more reports of associated symptoms, and had reactions of longer average duration than patients receiving placebo. Praluent (alirocumab) injection is a PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor antibody indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-cholesterol (LDL-C). There are currently no documented interactions with Praluent, according to the … By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels. Consult your doctor before breastfeeding. In an analysis of ezetimibe-controlled trials in which 864 patients were exposed to PRALUENT for a median of 27 weeks and 618 patients were exposed to ezetimibe for a median of 24 weeks, the types and frequencies of common adverse reactions were similar to those listed above. Updated 11/2020. Get emergency medical help if you have signs of an allergic reaction: hives, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat. Report . home Do not freeze. If you are pregnant or intend to become pregnant, tell your doctor as it is not known if Praluent will harm an unborn baby. Increases in serum transaminases to greater than 3 times the upper limit of normal occurred in 1.7% of patients treated with PRALUENT and 1.4% of patients treated with placebo. alirocumab for solution for subcutaneous injection, How to Lower Your Cholesterol & Save Your Heart, Praluent (Alirocumab for Solution for Subcutaneous Injection). It is unknown if Praluent would affect a fetus. 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. Available for Android and iOS devices. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. Our Praluent (alirocumab) injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Drug information provided by: IBM Micromedex US Brand Name. You should refer to the prescribing information for Praluent for any updates or newly noted interactions. You can now remove the pen from your skin and discard it in an FDA-approved sharps bin. Find information about common, infrequent and rare side effects of Praluent Syringe Subcutaneous. 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. … Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locater Tool Including 24 Hour, Pharmacies. This is because of how it works in the body. Allergic reactions were reported more frequently in patients treated with PRALUENT than in those treated with placebo (8.6% versus 7.8%). 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. Praluent (alirocumab) [Package insert]. That came after trials showed they can dramatically … Tell your doctor all medications and supplements you use. Two dosage forms are available: a single-use pre-filled syringe and a pre-filled pen. Weight loss. In a cardiovascular outcomes trial, 5.5% (504/9091) of patients treated with PRALUENT 75 mg and/or 150 mg every 2 weeks (Q2W) had anti-drug antibodies (ADA) detected after initiating treatment compared with 1.6% (149/9097) of patients treated with placebo. Heart experts had high expectations for Repatha, and a related drug called alirocumab (Praluent). 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 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. Also, talk to your doctor about breastfeeding your baby while you are self-administering Praluent. Regular exercise is also important as well as avoiding smoking. Push the green or gray button at the top of the pen, then immediately release the green or gray button. Weight increased is found among people who take Praluent, especially for people who are female, 60+ old, have been taking the drug for 1 - 6 months. There are currently no documented interactions with Praluent, according to the product information. The Flu 3. In a pool of ten placebocontrolled and active-controlled trials of patients treated with PRALUENT 75 mg and/or 150 mg Q2W as well as in a separate clinical study of patients treated with PRALUENT 75 mg Q2W or 300 mg every 4 weeks (including some patients with dose adjustment to 150 mg Q2W), the incidence of detecting ADA and NAb was similar to the results from the trial described above. In the placebo-controlled and active-controlled primary hyperlipidemia trials using an every 2 week or every 4 week dosing interval, 914 PRALUENT-treated patients had two consecutive calculated LDL-C values <25 mg/dL, and 335 had two consecutive calculated LDL-C values <15 mg/dL. The pen should click and the injection will start, which may take up to 20 seconds to complete. As soon as you stop taking it LDL-C levels will increase again. You, or your caregiver, can learn to give this medicine at home. 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. Select one or more newsletters to continue. In a cardiovascular outcomes trial, local injection site reactions were reported in 3.8% of patients treated with PRALUENT versus 2.1% patients treated with placebo, and led to permanent discontinuation in 26 patients (0.3%) versus 3 patients (<0.1%), respectively. If you forget a dose, schedule it in for as soon as you can, then continue with your regular dosing schedule. Do not warm in any other way (such as by putting in hot water). The most common adverse reactions leading to treatment discontinuation in patients treated with PRALUENT were allergic reactions (0.6% versus 0.2% for PRALUENT and placebo, respectively) and elevated liver enzymes (0.3% versus <0.1%). If somebody else is giving you your injection they can also administer it into the outer area of your upper arm. If you’ve had a potentially life-threatening heart event such as a heart attack or a stroke, your chances of suffering another one are 1 in 3.*. The data in Table 1 are derived from 9 primary hyperlipidemia placebo-controlled trials that included 2476 patients treated with PRALUENT 75 mg and/or 150 mg every 2 weeks, including 2135 exposed for 6 months and 1999 exposed for more than 1 year (median treatment duration of 65 weeks). Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. May be used alone or in combination with other medications such as statins or ezetimibe. Monoclonal antibodies, such as Praluent, tend to have few drug interactions and are unlikely to cause liver or kidney damage. The safety of suing Praluent in children has not been established. Copyright 1996-2021 Drugs.com. Hair loss or thinning of the hair Other side effects not listed may also occur in some patients. Backache 3. (Originally I had lost 12 pounds playing Pickleball). 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Although Trulicity is not a weight-loss drug, people taking it may lose weight. Several studies have investigated its effect on lipids. Praluent (alirocumab) injection is a PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor antibody indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-cholesterol (LDL-C). If you notice any other effects, check with your healthcare professional. A Common Cold 2. General Information. Reduces the amount of low-density lipoprotein cholesterol (LDL-C) circulating in the blood. 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. 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 is a human monoclonal antibody that may be used to reduce LDL-C levels in people with primary hyperlipidemia and also to reduce the risk of a heart attack, stroke, or unstable angina requiring hospitalization, in adults with established cardiovascular disease. Call your doctor for … The drugs must be … 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. Praluent has little effect on triglyceride levels which is why Praluent is often prescribed with statins which do lower triglyceride levels. Weight gain or weight loss has not been reported as a side effect of Repatha (evolocumab) in clinical trials comparing Repatha to placebo (dummy or inert) pills… Posted 7 months … Praluent is a long-term medication. Because the accumulation of fatty deposits in the arteries is a process that happens over time. Persistent ADA responses, defined as at least 2 consecutive post-baseline samples with positive ADA separated by at least a 16-week period, were observed in 0.7% of patients treated with PRALUENT and 0.4% of patients treated with placebo. Reactions At The Site Of The Injection 4. Side effects requiring immediate medical attention. Because PRALUENT dosing was decreased or discontinued in the event of two consecutive LDL-C values <15 mg/dL in this trial, the effects of prolonged very low LDL-C with PRALUENT are unknown. An alternative starting dose is 300mg once every 4 weeks (monthly) for people who desire less frequent dosing. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The long-term consequences of continuing PRALUENT treatment in the presence of ADA are unknown. Some of the dosage forms listed on this page may not apply to the brand name Praluent. 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 experienced, these tend to have a Less Severe expression 1. LDL-C values <25 mg/dL and <15 mg/dL were observed more frequently in patients treated with the PRALUENT 150 mg Q2W or 300 mg Q4W dosing regimens. The drugs, which include evolocumab (Repatha) and alirocumab (Praluent), were approved in the United States in 2015. Neutralizing antibody (NAb) responses were observed in 0.5% of patients treated with PRALUENT and in <0.1% of patients treated with placebo. Copyright © 2021 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Twist off the blue cap and discard it. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. If experienced, these tend to have a Less Severe expression 1. If you experience sudden weight loss or gain, be sure to … Check the expiry date on the side of the injection and do not use Praluent if it has expired. Table 1: Adverse Reactions Occurring in Greater Than or Equal to 2% of PRALUENTTreated Patients and More Frequently Than with Placebo. “I'm a 73 year old man and I've been doing the 75mg Praluent injections now for almost 4 years with no side effects. Only inject into clear, healthy skin. If needed, pinch the skin up and hold it firmly around the injection site. Memory loss is found among people who take Praluent, especially for people who are female, 60+ old, have been taking the drug for 1 - 6 months. If you have questions about your dose or when to administer it, call your doctor. Interactions. In the primary hyperlipidemia trials, liver-related disorders (primarily related to abnormalities in liver enzymes) were reported in 2.5% of patients treated with PRALUENT and 1.8% of patients treated with placebo, leading to treatment discontinuation in 0.4% and 0.2% of patients, respectively. Tell your doctor if you are pregnant or plan to become pregnant before receiving Praluent. Throat Irritation I used it for 6 months, and gain a lot of weight without changing the diet, even do more exercise, a lot of joint pain, not affect my LDL at all.
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