IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ALIROCUMAB - SUBCUTANEOUS INJECTION

(AL-i-ROK-ue-mab)

COMMON BRAND NAME(S): Praluent

USES: Alirocumab is used by people who have blockage in the heart blood vessels to reduce the risk of heart attack, stroke, and certain types of chest pain that require treatment in a hospital. It is also used by people who have an inherited condition that causes high levels of LDL. Treatment with alirocumab, a proper diet, and cholesterol-lowering drugs can help lower \"bad\" cholesterol (LDL) in the blood. Alirocumab belongs to a class of drugs known as monoclonal antibodies. It works by improving how well your body gets rid of LDL cholesterol. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

HOW TO USE: Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using alirocumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Before use, take alirocumab out of the refrigerator and let it warm up to room temperature for 30 to 40 minutes. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. If needed, this medication may be kept in the original package at room temperature for up to 30 days. Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Inject this medication under the skin of the thigh, abdomen, or upper arm as directed by your doctor, usually once every 2 weeks, or once every 4 weeks (monthly). The dosage is based on your medical condition and response to treatment. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into any areas of skin that are injured, tender, hard, red, or hot. Use this medication regularly to get the most benefit from it. To help you remember, mark the day on the calendar when you need to receive the medication. Learn how to store and discard medical supplies safely.

SIDE EFFECTS: Redness, itching, swelling, or pain at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using alirocumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Lab and/or medical tests (such as LDL cholesterol levels) should be done while you are using this medication. Keep all medical and lab appointments.

MISSED DOSE: If you are using this medication every 2 weeks and miss a dose, use it as soon as you remember if it is within 7 days after the missed dose. If it is longer than 7 days from the missed dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up. If you are using this medication once a month and miss a dose, use it as soon as you remember if it is within 7 days after the missed dose, then use your next dose at the regular time. If it is longer than 7 days from the missed dose, use it as soon as you remember and start a new monthly schedule based on this date. Do not double the dose to catch up.

STORAGE: Store in the refrigerator away from light and moisture. Do not freeze. If needed, this medication may be kept at room temperature. If stored at room temperature, keep it in the original package and use within 30 days. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2021. Copyright(c) 2023 First Databank, Inc.