Alirocumab is a monoclonal antibody that belongs to the class of medications called proprotein convertase inhibitors (PCSK9 inhibitors). It blocks a protein in the liver, allowing the liver to remove more low-density lipoproteins (LDL or "bad" cholesterol) from the blood.

This medication is used in addition to diet and other medications when diet and maximum doses of "statin" cholesterol medication are not enough to lower the LDL levels of people who have high cholesterol levels. Alirocumab is also used to reduce the risk of heart attack, stroke, and a type of chest pain called unstable angina for adults who have been diagnosed with cardiovascular disease.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended starting dose of alirocumab is 75 mg injected subcutaneously (under the skin) every 2 weeks. Depending on the effectiveness of the medication, your doctor may increase your dose to 150 mg every 2 weeks, but most people find that the lower dose is enough. Alternatively, your doctor may recommend a dose of 300 mg injected once every 4 weeks. This will involve 2 separate injections of 150 mg of alirocumab.

Subcutaneous injections are administered in the abdomen, upper arm, or thigh area. Change the injection site with each injection to keep your skin healthy.

Do not use the injection if it is discoloured or if particles are present.

If you are injecting this medication yourself, your doctor will show you how to use this medication properly. If you are not sure how to use it or have questions about how to use it, contact your doctor. Before using this medication, thoroughly read the patient information provided and ask your doctor if you have any questions. If a family member or caregiver will be giving you the injections, your doctor should instruct them on how to give the injection.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you are injecting alirocumab every 2 weeks and you miss a dose, and it is within 7 days of the missed dose, take it as soon as possible and continue with your regular dosing schedule. If it is more than 7 days since the missed dose, skip the missed dose and continue with your regular dosing schedule. If you are injecting alirocumab every 4 weeks and it is within 7 days of the missed dose, take it as soon as possible and continue with your regular dosing schedule. If it is more than 7 days since the missed dose, take the missed dose, and start a new schedule from the day you remember to take your dose. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication in the refrigerator, protect it from light and moisture, and keep it out of the reach of children. Do not freeze this medication. Allow the medication to warm to room temperature for 30 to 40 minutes before you inject it. Once it is removed from the refrigerator, it must be used within 24 hours and must not be put back into the refrigerator.

Pre-filled syringe

Pre-filled pen

75 mg/mL
Each 1 mL single-use, pre-filled pen contains a clear, colourless-to-pale yellow, sterile, preservative-free solution that contains 75 mg of alirocumab. Nonmedicinal ingredients: histidine, sucrose, polysorbate 20, and water for injection (USP), to pH 6.0.

150 mg/mL
Each 1 mL single-use, pre-filled pen contains a clear, colourless-to-pale yellow, sterile, preservative-free solution that contains 150 mg of alirocumab. Nonmedicinal ingredients: histidine, sucrose, polysorbate 20 and water for injection (USP), to pH 6.0.

The rubber needle shield does NOT contain natural latex.

Do not take this medication if you are allergic to alirocumab or any ingredients of the medication.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• cold-like symptoms (e.g., tiredness, sore throat, nasal congestion)
• itchiness
• redness, swelling, pain, or bruising at the injection site

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• hives
• rash
• reddish skin spots, sometimes with blisters

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of hypersensitivity vasculitis (e.g., diarrhea, rash, purple spots on the skin)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: As with other monoclonal antibodies, alirocumab may cause your body to produce antibodies to "defend" your body from the medication. When this happens, an allergic reaction develops. Often, allergic reactions are experienced as a rash, hives or itching. On rare occasions, a severe allergic reaction may occur, causing difficulty breathing, abdominal cramps, nausea and vomiting, or swelling of the throat (anaphylaxis). Another form of allergic reaction that may occur is hypersensitivity vasculitis, where the blood vessels become inflamed, causing small purplish spots to form on the skin. If you experience any unusual symptoms, contact your doctor.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if alirocumab passes into breast milk. If you are a breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children and adolescents less than 18 years old.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.