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What is PRALUENT® (alirocumab)?

Some people need extra help managing their bad cholesterol. Statins can only do so much, but adding PRALUENT to the highest tolerated dose of a statin can help provide additional lowering of bad cholesterol. PRALUENT works differently than statins to lower bad (LDL) cholesterol. It works by blocking a protein (called PCSK9) that may contribute to high levels of bad cholesterol.

What is PRALUENT?

PRALUENT is an injectable prescription medicine called a PCSK9 inhibitor. PRALUENT is used along with diet and the highest tolerated dose of a statin in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL cholesterol) or atherosclerotic heart problems, who need additional lowering of LDL cholesterol.

The effect of PRALUENT on heart problems such as heart attacks, stroke, or death is not known.

It is not known if PRALUENT is safe and effective in children.

Who should not use PRALUENT?

Do not use PRALUENT if you are allergic to alirocumab or to any of the ingredients in PRALUENT.

What should I tell my doctor before using PRALUENT?

Before you start using PRALUENT, tell your doctor about all your medical conditions, including allergies, and if you:

  • Are pregnant or plan to become pregnant. It is not known if PRALUENT will harm your unborn baby. Tell your doctor if you become pregnant while taking PRALUENT.

  • Are breastfeeding or plan to breastfeed. You and your doctor should decide if you will take PRALUENT or breastfeed. You should not do both without talking to your doctor first.

Tell your doctor or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.

How should I use PRALUENT?

See the detailed “Instructions for PRALUENT Pre-filled pen” that come with the patient information about the right way to prepare and give your PRALUENT injections.

  • Use PRALUENT exactly as your doctor tells you to use it. Your doctor will prescribe the dosage that is best for you.
  • If your doctor decides that you or a caregiver can give the injections of PRALUENT, you or your caregiver should receive training on the right way to prepare and administer PRALUENT. Do not try to inject PRALUENT until you have been shown the right way by your doctor or nurse.
  • PRALUENT is injected under the skin (subcutaneously) every 2 weeks or every 4 weeks (monthly).
  • If your doctor prescribes you the monthly dose, you will give yourself 2 separate injections in a row, using a different pen for each injection and two different injection sites.
  • Do not inject PRALUENT together with other injectable medicines at the same injection site.
  • Always check the label of your pen to make sure you have the correct medicine and the correct dose of PRALUENT before each injection.
  • If you forget to use PRALUENT or are not able to take the dose at your regular time, inject your missed dose as soon as you remember, within 7 days. Then, if you inject every 2 weeks take your next dose in 2 weeks from the day you missed your dose or if you inject every 4 weeks take your next dose in 4 weeks from the day you missed your dose. This will put you back on your original schedule.
  • If you missed a dose by more than 7 days and you inject every 2 weeks, wait until your next scheduled dose to re-start PRALUENT or if you inject every 4 weeks, start a new schedule from the time you remember to take your dose.
  • If you are not sure when to re-start PRALUENT, ask your doctor or pharmacist.
  • If you use more PRALUENT than you should, talk to your doctor or pharmacist.
  • Do not stop using PRALUENT without talking with your doctor. If you stop using PRALUENT, your cholesterol levels can increase.

What are the possible side effects of PRALUENT?

PRALUENT can cause serious side effects, including:

Allergic reactions. PRALUENT may cause allergic reactions that can be severe and require treatment in a hospital. Call your doctor or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, severe itching, a swollen face, or trouble breathing.

The most common side effects of PRALUENT include: redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of PRALUENT. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

General information about the safe and effective use of PRALUENT

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PRALUENT for a condition for which it was not prescribed. Do not give PRALUENT to other people, even if they have the same symptoms that you have. It may harm them.

The Patient Information summarizes the most important information about PRALUENT. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about PRALUENT that is written for health professionals. For more information about PRALUENT, go to www.PRALUENT.com or call 1-844-PRALUENT (1-844-772-5836).

What are the ingredients in PRALUENT?

  • Active ingredient: alirocumab

  • Inactive ingredients: histidine, polysorbate 20, sucrose, and water for injection

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