Praluent

Generic name: Alirocumab
Drug class: PCSK9 inhibitors

Usage of Praluent

Praluent 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.

Praluent is also used along with other LDL-lowering treatments in adults with a type of high cholesterol called homozygous familial hypercholesterolemia, who need additional lowering of LDL-C.

Praluent side effects

Get emergency medical help if you have signs of an allergic reaction to Praluent: hives, severe rash and 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.

    Before taking Praluent

    You should not use Praluent if you are allergic to alirocumab.

    Not approved for use by anyone younger than 18 years old.

    It is not known if alirocumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

    If you are pregnant, your name may be listed on a pregnancy registry to track the effects of alirocumab on the baby.

    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.

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    How to use Praluent

    Usual Adult Dose of Praluent for Hyperlipidemia:

    75 mg suBCutaneously every 2 weeks OR 300 mg subcutaneously once every 4 weeks -For inadequate LDL-C (low density lipoprotein) response, may adjust dose to 150 mg subcutaneously every 2 weeks Maximum dose: 150 mg subcutaneously every 2 weeks..

    Usual Adult Dose of Praluent for Heterozygous Familial Hypercholesterolemia:

    75 mg subcutaneously every 2 weeks OR 300 mg subcutaneously once every 4 weeks -For inadequate LDL-C (low density lipoprotein) response, may adjust dose to 150 mg subcutaneously every 2 weeks Maximum dose: 150 mg subcutaneously every 2 weeks Patients with Heterozygous Familial Hypercholesterolemia (HeFH) undergoing LDL Apheresis: 150 mg subcutaneously once every 2 weeks; dose may be administered without regard to the timing of apheresis Comments: -Assess LDL-C when clinically appropriate, the LDL-C lowering effect may be measured as early as 4 weeks after initiating therapy. -In some patients, LDL-C can vary considerably during 4-week dosing intervals, therefore measure LDL-C just prior to the next scheduled dose. -If LDL-C reduction is inadequate, consider adjusting dose to 150 mg every 2 weeks starting new dose on the next scheduled dosing date. Uses: -As an adjunct to diet, alone or in combination with other lipid-lowering therapies for the treatment of primary hyperlipidemia including HeFH to reduce LDL-C. -To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

    Warnings

    Use Praluent only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

    What other drugs will affect Praluent

    Other drugs may interact with alirocumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

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