Alirocumab

Alirocumab is a prescription medication used:

• To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. 
• As adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C. 
• As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C. 
• As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.

Alirocumab is available under the following different brand names: Praluent

Common side effects of Alirocumab include:

• Allergic reactions
• Injection site reactions
• Influenza
• Antidrug antibodies
• Muscle pain
• Muscle spasms
• Bruising
• Musculoskeletal pain

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Adult and pediatric dosage

Injection, solution

• Prefilled, single-dose pen for SC injection
  • 75mg/mL
  • 150mg/mL

Hyperlipidemia Treatment and/or CV Risk Reduction

Adult dosage

• Established CV disease or primary hyperlipidemia, including HeFH
  • 75 mg SC every 2 weeks or 300 mg SC every 4 weeks initially
  • For patients on 300 mg every 4 weeks, measure LDL-C just before the next scheduled dose; LDL-C can vary between doses in some patients
  • If LDL-C response is inadequate,  may adjust dose by 150 mg SC every 2 weeks
  • Patients with HeFH undergoing apheresis or with HoFH
    • 150 mg SC every 2 weeks
    • May be administered without regard to timing of apheresis

Heterozygous Familial Hypercholesterolemia

Pediatric dosage

• Children less than 50 kg
  • 150 mg SC every 4 weeks
  • If inadequate LDL-C lowering response, may adjust the dose to 75 mg SC every 2 weeks
• Children more than or equal to 50 kg
  • 300 mg SC every 4 weeks
  • If inadequate LDL-C lowering response, may adjust the dose to 150 mg SC every 2 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

• Alirocumab has no listed severe interactions with other drugs.
• Alirocumab has no listed serious interactions with other drugs.
• Alirocumab has no listed moderate interactions with other drugs.
• Alirocumab has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains alirocumab. Do not take Praluent if you are allergic to alirocumab or any ingredients contained in this drug.

Contraindications

• History of serious hypersensitivity reaction to alirocumab; reactions have included hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization.

Effects of Drug Abuse

• No information available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Alirocumab?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Alirocumab?"

Cautions

• Hypersensitivity reactions (e.g., itching, rash, hives), including some serious events (e.g., hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization), have been reported; discontinue and treat if signs or symptoms of serious allergic reactions occur

Pregnancy and Lactation

There are no available data on use of alirocumab in pregnant women. There is a pregnancy exposure registry (1-877-311-8972 or https://mothertobaby.org/ongoing-study/praluent/) that monitors pregnancy outcomes in women exposed to alirocumab during pregnancy.

It is unknown if alirocumab is distributed in human breast milk. Human IgG is present in human milk, but published data suggest that breastmilk IgG antibodies do not enter the neonatal and infant circulation in substantial amounts. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for alirocumab and any potential adverse effects on the breastfed infant.