Alirocumab

What is alirocumab used for?

• Alirocumab is used to lower cholesterol.
• It is used to lower the risk of heart attack, stroke, and a type of chest pain (unstable angina) in people with heart disease.

Before taking alirocumab, tell your doctor:

• If you are allergic to alirocumab; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take alirocumab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take alirocumab?

• Tell all of your health care providers that you take alirocumab. This includes your doctors, nurses, pharmacists, and dentists.
• Follow the diet and workout plan that your doctor told you about.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Allergic reactions have happened with alirocumab. Sometimes, these have been very bad and people have had to go to the hospital. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is alirocumab best taken?

Use alirocumab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• If stored in a refrigerator, let alirocumab come to room temperature before using it. Leave it at room temperature for at least 30 minutes. Do not heat alirocumab.
• Move site where you give the shot each time.
• Do not give into skin within 2 inches of the belly button.
• If the dose is more than 1 injection, give the injections into 2 different places.
• Do not remove the cap or cover until ready to use.
• Do not shake.
• Do not use alirocumab if it has been dropped or if it is broken.
• Do not give into the same place as another shot.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Do not give into skin that is sunburned.
• Do not use if the solution is cloudy, leaking, or has particles.
• This medicine is colorless to a faint yellow. Do not use if the solution changes color.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

If you take alirocumab every 2 weeks:

• Take a missed dose as soon as you think about it.
• If it has been 7 days or more since the missed dose, skip the missed dose and go back to your normal time.

If you take alirocumab every 4 weeks:

• Take a missed dose as soon as you think about it.
• If it has been 7 days or more since the missed dose, take a missed dose and start a new schedule based on when the dose is given.

For all uses of alirocumab:

• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

What are the side effects of alirocumab that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of alirocumab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Nose or throat irritation.
• Pain, redness, or swelling where the shot was given.
• Itching where the shot is given.
• Flu-like signs.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out alirocumab?

• Store in a refrigerator. Do not freeze.
• Store in the original container to protect from light.
• If needed, you may store at room temperature for up to 30 days. If stored at room temperature and not used within 30 days, throw alirocumab away.
• Do not put alirocumab back in the refrigerator after it has been stored at room temperature.
• Protect from heat and light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about alirocumab, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take alirocumab or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to alirocumab. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.