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Praluent (alirocumab) is a human monoclonal antibody. It works by helping the liver reduce levels of "bad" cholesterol (low-density lipoprotein, or LDL) circulating in your blood.
Praluent is used in adults with heart disease to reduce the risk of heart attack, stroke, and certain types of chest pain conditions (unstable angina) requiring hospitalization.
Praluent is used together with a low-fat diet, alone or together with other cholesterol-lowering medicines in adults with high blood cholesterol levels called primary hyperlipidemia (including a type of high cholesterol called heterozygous familial hypercholesterolemia), an inherited type of high cholesterol. This condition can cause high blood levels of LDL cholesterol, and can also cause plaque to build up inside your arteries.
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
You should not use Praluent if you are allergic to alirocumab.
To make sure Praluent is safe for you, tell your doctor about all your medical conditions or allergies.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether alirocumab passes into breast milk or if it could harm a nursing baby. You should not breastfeed while using Praluent.
Praluent is not approved for use by anyone younger than 18 years old.
Use Praluent exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Praluent is injected under the skin once every 2 to 4 weeks. A healthcare provider may teach you how to properly use the medication by yourself.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.
If you use Praluent only once every 4 weeks, you will give yourself 2 separate injections at the same time. Use a new syringe or injection pen for each injection. Give each injection into a different place on your body.
You may need frequent blood tests.
Do not shake this medicine. Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors, or has particles in it. Call your pharmacist for new medicine.
Store this medicine in the refrigerator, do not freeze. Protect from light and high heat.Take the medicine out of the refrigerator and allow it to reach room temperature for 30 to 40 minutes before injecting your dose. Do not heat an injection pen or prefilled syringe, and do not leave the pen at room temperature for longer than 30 days.
Each injection pen or prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.
Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
Praluent is only part of a complete treatment program that also includes diet, statin medication, and regular blood testing. Follow your doctor's instructions very closely.
You should not stop using Praluent without your doctor's advice, or your LDL cholesterol levels may increase.
Usual Adult Dose of Praluent for Heterozygous Familial Hypercholesterolemia:
Initial dose: 75 mg subcutaneous injection every 2 weeks
Maximum dose: 150 mg subcutaneous injection every 2 weeks, if the LDL-C response to initial dose is inadequate
Comments: Measure LDL-C levels within 4 to 8 weeks of initiation or titration to assess response; adjust the dose, if needed.
Uses: 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-C
Usual Adult Dose of Praluent for Cardiovascular Risk Reduction:
Initial dose: 75 mg subcutaneously every 2 weeks
Maximum dose: 150 mg subcutaneously every 2 weeks, if the LDL-C response to initial dose is inadequate
Comments: Measure LDL-C levels within 4 to 8 weeks of initiation or titration to assess response; adjust the dose, if needed.
Uses: 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-C
Give an injection within 7 days after the missed dose. Then give the next injection 2 to 4 weeks after the missed dose was due, to put you back on your regular injection schedule.
If you are more than 7 days late for an injection:
If you inject every 2 weeks, skip the missed dose and use your next dose at the regular time.
If you inject every 4 weeks, start a new schedule based on the date you used the missed injection.
Do not use two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Do not inject Praluent into skin that is sunburned, infected, swollen, or otherwise irritated.
Get emergency medical help if you have symptoms of a serious allergic reaction to Praluent. Reactions have included hypersensitivity, hives, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat.
Common Praluent side effects may include:
redness, itching, soreness, or swelling where an injection was given;
flu symptoms; or
cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Other drugs may interact with alirocumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Praluent only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Praluent (www.drugs.com/praluent.html).
Note: This document contains side effect information about alirocumab. Some of the dosage forms listed on this page may not apply to the brand name Praluent.
For the ConsumerApplies to alirocumab: subcutaneous solution
Along with its needed effects, alirocumab (the active ingredient contained in Praluent) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking alirocumab:
More common
Less common
Some side effects of alirocumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
For Healthcare Professionals
Applies to alirocumab: subcutaneous solution
GeneralThe most commonly reported adverse reactions have included nasopharyngitis, injection site reactions, and influenza.
HypersensitivityCommon (1% to 10%): Hypersensitivity reaction, nummular eczema, hypersensitivity vasculitis
RespiratoryVery common (10% or more): Nasopharyngitis (11.3%)
Common (1% to 10%): Influenza, bronchitis, sinusitis, cough
GastrointestinalCommon (1% to 10%): Diarrhea
GenitourinaryCommon (1% to 10%): Urinary tract infection
HepaticDuring clinical trials, 2.5% of patients treated with this drug reported abnormal liver enzymes (placebo=1.8%); treatment discontinuation occurred in 0.4% and 0.2% of patients receiving this drug and placebo, respectively. Increases in serum transaminases to greater than 3 times the upper limit of normal occurred in 1.7% of patients treated with this drug (placebo=1.4%).
Common (1% to 10%): Elevated liver enzymes
ImmunologicCommon (1% to 10%): Development of antidrug antibody (ADA), neutralizing antibodies (NAb)
Postmarketing reports: Flu-like illness
LocalPatients who developed ADA (antidrug antibody) had a higher incidence of injection site reactions compared with patients who did not develop ADA (10.2% vs 5.9%).
Common (1% to 10%): Injection site reaction (erythema, redness, itching, swelling, pain, tenderness)
MusculoskeletalCommon (1% to 10%): Myalgia, muscle spasm, contusion, musculoskeletal pain
Nervous systemUncommon (0.1% to 1%): Neurocognitive events, confusion or memory impairment
MetabolicDuring clinical trials with both every 2 week or every 4 week dosing, reports of 2 consecutive calculated LDL-C values less than 25 mg/dL, and less than 15 mg/dL were reported in 914 and 335 patients, respectively. Low LDL-C values were observed more frequently in patients treated with 150 mg every 2 weeks or 400 mg every 4 weeks. Changes to background lipid therapy was not made and adverse consequences were not identified, but the long-term effects of very low levels of LDL-C are not known.
Frequency not reported: Low LDL-C values
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Praluent (www.drugs.com/praluent.html).
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