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.

Alirocumab is used in adults with heart disease to lower the risk of heart attack, stroke, and certain types of chest pain conditions (unstable angina) requiring hospitalization.

Alirocumab is also used together with a low-fat diet, alone or together with other cholesterol-lowering medications ("statin" 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.

Alirocumab 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.

Use alirocumab only as directed. Tell your doctor if you use other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements, or have other medical conditions or allergies.

Before taking this medicine

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

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.

Do not breastfeed.

Take alirocumab 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.

Alirocumab is injected under the skin, usually once every 2 to 4 weeks. It may take up to 20 seconds to inject each dose.

Ask your doctor or pharmacist if you don't understand how to use an injection.

Do not shake alirocumab. Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Throw away an injection pen after one use, even if there is still medicine left inside.

If you use alirocumab 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 will need frequent blood tests.

Do not shake the alirocumab syringe. 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 the injection pen in the original carton 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 alirocumab 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.

You should not stop using alirocumab without your doctor's advice, or your LDL cholesterol levels may increase.

Usual Adult Dose of Alirocumab 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

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.

Usual Adult Dose of Alirocumab 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.

Usual Adult Dose of Alirocumab for Cardiovascular Risk Reduction:

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

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.

Usual Adult Dose of Alirocumab for Homozygous Familial Hypercholesterolemia:

150 mg subcutaneously once every 2 weeks.

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

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.

Do not breastfeed.

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 alirocumab into skin that is sunburned, infected, swollen, or otherwise irritated.

Get emergency medical help if you have signs of an allergic reaction to alirocumab: hives, severe rash and itching; difficult breathing; swelling of your face, lips, tongue, or throat.

Common alirocumab 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 your doctor about all other medicines you use.