alirocumab

What is the most important information I should know about alirocumab?

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.

What is alirocumab?

Alirocumab is used in people with heart disease, to help lower the risk of heart attack, stroke, or needing to be hospitalized because of chest pain (unstable angina).

Alirocumab is also used to help lower blood levels of LDL cholesterol in people with heterozygous familial hypercholesterolemia (an inherited type of high cholesterol). Alirocumab is used together with a low-fat diet and sometimes in combination with a "statin" medication.

Alirocumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using alirocumab?

How should I use alirocumab?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Alirocumab 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 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 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.

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.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while using alirocumab?

What are the possible side effects of alirocumab?

Common 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.

What other drugs will affect alirocumab?

Other drugs may affect alirocumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about alirocumab.