Praluent

Uses of  Praluent

Praluent (alirocumab) is an injectable medicine that is given under your skin (subcutaneously) which may be used in adults with:

• cardiovascular disease to reduce the risk of heart attack, stroke, and certain types of
  chest pain conditions (unstable angina) that would normally require hospitalization
• high blood cholesterol (also called primary hyperlipidemia) including an inherited type of high cholesterol called heterozygous familial hypercholesterolemia (HeFH), to reduce low-density lipoprotein cholesterol (LDL-C) or bad cholesterol together with dietary changes. Praluent can be used alone or in addition to other cholesterol-lowering medicines
• another inherited type of high cholesterol called homozygous familial hypercholesterolemia, who require additional lowering of their LDL-C.

Praluent may also be used in children aged 8 years and older with HeFH to reduce LDL-C, alongside dietary changes and other LDL-lowering treatments.

Praluent works by helping your liver reduce levels of “bad” cholesterol (low-density lipoprotein, or LDL) circulating in your blood. It does this by blocking the effects of the PCSK9 enzyme, which is an enzyme that binds to LDL receptors preventing LDL from being removed from the blood. This results in more receptors being available to remove LDL from the blood, which decreases LDL blood levels.

Precautions and Warnings

Hypersensitivity reactions including inflammation of the blood vessels (vasculitis), swelling under the skin (angioedema), and other allergic reactions requiring hospitalization, have been reported with Praluent. Discontinue Praluent and tell your healthcare provider right away if you have an allergic reaction.

It is not known if Praluent is safe and effective in children who are younger than 8 years of age or in children with other types of high cholesterol (hyperlipidemias).

You should not use Praluent if you are allergic to alirocumab, Praulent, or any of the inactive ingredients in the injection.

It is not known if Praluent will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking Praluent, you are encouraged to call Regeneron at 1-844-734-6643 to share information about the health of you and your baby.

It is not known whether Praluent passes into breast milk or if it could harm a nursing baby. You should not breastfeed while using it.

Dosage

Follow all your healthcare provider’s instructions.

• 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 before the next scheduled dose.

Usual Adult Dose for Hyperlipidemia or Heterozygous Familial Hypercholesterolemia

• 75 mg SC every 2 weeks OR 300 mg SC once every 4 weeks
• May be adjusted up to 150mg SC every 2 weeks with an inadequate LDL-C (low-density lipoprotein) response.
• Maximum dose: 150 mg SC every 2 weeks.

Usual Adult Dose for Heterozygous Familial Hypercholesterolemia (HeFH) undergoing LDL Apheresis

• 150 mg SC once every 2 weeks; dose may be administered without regard to the timing of apheresis

Side Effects

Common side effects:

• redness, itching, swelling, pain, or tenderness at the injection site
• muscle pain
• flu or flu-like symptoms
• muscle spasms
• diarrhea
• bruising.