Alirocumab

Pronunciation: AL-i-ROK-ue-mab
Generic name: alirocumab
Brand names: Praluent Pen, Praluent Syringe
Dosage form: subcutaneous solution (150 mg/mL; 75 mg/mL)
Drug class: PCSK9 inhibitors

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 21, 2022.

What is alirocumab?

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.

Warnings

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.

How should I use alirocumab?

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.

Dosing information

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.

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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using alirocumab?

Do not inject alirocumab into skin that is sunburned, infected, swollen, or otherwise irritated.

Alirocumab side effects

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.

What other drugs will affect alirocumab?

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.

Where can I get more information?

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use alirocumab only for the indication prescribed.

Popular FAQ

More FAQ

• Does it lower triglycerides?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2023 Cerner Multum, Inc. Version: 5.01.

Alirocumab (Subcutaneous)

Medically reviewed by Drugs.com. Last updated on Feb 15, 2023.

Commonly used brand name(s)

In the U.S.

• Praluent

Available Dosage Forms:

• Solution

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: Monoclonal Antibody

Uses for alirocumab

Alirocumab injection is used together with a proper diet and other medicines (eg, ezetimibe, statin medicine) to treat patients with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) or with homozygous familial hypercholesterolemia (HoFH), who need additional lowering of their bad cholesterol (LDL). It is also used to reduce the risk of heart attack, stroke, and unstable angina (chest pain) requiring hospitalization in adults with existing heart or blood vessel disease. Alirocumab is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor.

Alirocumab is available only with your doctor''s prescription.

Before using alirocumab

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For alirocumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to alirocumab or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of alirocumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alirocumab injection in the elderly. However, elderly patients are more sensitive to the effects of alirocumab than younger adults.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper use of alirocumab

Alirocumab is given as a shot under your skin, usually in the stomach, thighs, or upper arms.

Alirocumab may sometimes be given at home to patients who do not need to be in the hospital. If you are using alirocumab at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

Alirocumab should come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Alirocumab comes in 2 forms: single-dose prefilled pen (autoinjector) and single-dose prefilled syringe. Your doctor will prescribe the type and dose that is right for you.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

Do not inject other medicines together with alirocumab injection at the same injection site.

Do not inject on skin areas that are bruised, red, hard, or tender.

Allow the medicine to warm to room temperature for at least 30 to 40 minutes before using it. Do not warm it in any other way. Do not shake the medicine.

Use each autoinjector pen or syringe only one time. Do not save an open pen or syringe. If the medicine in the pen or syringe has changed color, or if you see particles in it, do not use it.

In addition to alirocumab, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor''s order about any special diet.

Dosing

The dose of alirocumab will be different for different patients. Follow your doctor''s orders or the directions on the label. The following information includes only the average doses of alirocumab. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For primary hyperlipidemia and lowering the risk of heart attack, stroke, and chest pain:
    • Adults—
      • Every 2-week dose: 75 milligrams (mg) injected under your skin once every 2 weeks. Your doctor may increase your dose as needed. However, the dose is usually not more than 150 mg injected under your skin once every 2 weeks.
      • Every 4-week dose: 300 mg injected under your skin once every 4 weeks, given as two 150 mg injections at two different sites. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg injected under your skin once every 2 weeks.
    • Children—Use and dose must be determined by your doctor.
  • For homozygous familial hypercholesterolemia:
    • Adults—150 milligrams (mg) injected under your skin once every 2 weeks.
    • Children—Use and dose must be determined by your doctor.

Missed dose

Alirocumab needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Every 2-week dose: If you missed a dose, use alirocumab within 7 days from the missed dose. Then, go back to your original schedule. If the missed dose is not given within 7 days, wait until your next scheduled dose to re-start alirocumab. If you are not sure when to re-start alirocumab, ask your doctor or pharmacist.

Every 4-week dose: If you missed a dose, use alirocumab within 7 days from the missed dose. Then, go back to your original schedule. If the missed dose is not given within 7 days, use alirocumab right away and re-start alirocumab based on this date. If you are not sure when to re-start alirocumab, ask your doctor or pharmacist.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

You may also store alirocumab in its original carton at room temperature for up to 30 days. Do not expose to extreme heat. After removing alirocumab from the refrigerator, use it within 30 days. Throw away any unused medicine after 30 days.

Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

Precautions while using alirocumab

It is very important that your doctor check your progress within 4 to 8 weeks of using alirocumab. This will allow your doctor to see if the medicine is working properly to lower your cholesterol levels and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

Serious allergic reactions (eg, angioedema, vasculitis) may occur while you are using alirocumab. Tell your doctor right away if you have a rash, itching skin, difficulty with breathing or swallowing, fever, hives, sores, welting, or blisters, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, nausea, reddening of the skin, especially around the ears, swelling of the eyes, face, or inside of the nose, or unusual tiredness or weakness.

Alirocumab side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Chest pain or tightness
• difficulty with breathing or swallowing
• fast heartbeat
• fever
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• nausea
• reddening of the skin, especially around the ears
• swelling of eyelids, face, lips, hands, or feet
• unusual tiredness or weakness

Less common

• Cough producing mucus

Incidence not known

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• chills
• cough
• diarrhea
• general feeling of discomfort or illness
• headache
• loss of appetite
• muscle aches, cramps, stiffness, or pains
• shivering
• sore throat
• stuffy or runny nose
• sweating
• trouble sleeping
• vomiting

Less common

• Bladder pain
• bloody or cloudy urine
• bone pain
• bruise
• difficult, burning, or painful urination
• difficulty with moving
• frequent urge to urinate
• lower back or side pain
• muscle spasms
• pain or tenderness around the eyes and cheekbones

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Frequently asked questions

• Praluent vs Repatha: What''s the difference?
• Does it lower triglycerides?
• How does Praluent work?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer