Generic Name: alirocumab (AL i ROK ue mab)
Brand Name: Praluent Pen, Praluent Syringe
Drug class: PCSK9 inhibitors
Praluent (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.
Praluent is used in adults with heart disease to reduce the risk of heart attack, stroke, and certain types of chest pain conditions (unstable angina) requiring hospitalization.
Praluent is used together with a low-fat diet, alone or together with other cholesterol-lowering 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.
Praluent 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
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.
Before taking this medicine
You should not use Praluent if you are allergic to alirocumab.
To make sure Praluent is safe for you, tell your doctor about all your medical conditions or allergies.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether alirocumab passes into breast milk or if it could harm a nursing baby. You should not breastfeed while using Praluent.
Praluent is not approved for use by anyone younger than 18 years old.
How should I use Praluent?
Use Praluent 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.
Praluent 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 Praluent 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.
Store this medicine 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 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.
Praluent is only part of a complete treatment program that also includes diet, statin medication, and regular blood testing. Follow your doctor's instructions very closely.
You should not stop using Praluent without your doctor's advice, or your LDL cholesterol levels may increase.
Dosing information
Usual Adult Dose 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
Patients with Heterozygous Familial Hypercholesterolemia (HeFH) undergoing LDL Apheresis: 150 mg subcutaneously once every 2 weeks; dose may be administered without regard to the timing of apheresis
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 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
Patients with Heterozygous Familial Hypercholesterolemia (HeFH) undergoing LDL Apheresis: 150 mg subcutaneously once every 2 weeks; dose may be administered without regard to the timing of apheresis
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 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
Patients with Heterozygous Familial Hypercholesterolemia (HeFH) undergoing LDL Apheresis: 150 mg subcutaneously once every 2 weeks; dose may be administered without regard to the timing of apheresis
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 for Homozygous Familial Hypercholesterolemia:
150 mg subcutaneously once 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.
Uses:
-As an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH), to reduce low density lipoprotein cholesterol (LDL-C).
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 Praluent?
Do not inject Praluent into skin that is sunburned, infected, swollen, or otherwise irritated.
Praluent side effects
Get emergency medical help if you have symptoms of a serious allergic reaction to Praluent. Reactions have included hypersensitivity, hives, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat.
Common Praluent 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 Praluent?
Other drugs may interact with alirocumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.