Alirocumab

Alirocumab is used as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C); and to reduce the risk of heart attack (myocardial infarction, or MI), stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

Alirocumab is available under the following different brand names: Praluent.

Dosage Forms and Strengths

SC Injection

• 75mg/mL
• 150mg/mL

Dosage Considerations – Should be Given as Follows:

Hyperlipidemia Treatment and/or CV Risk Reduction

Indications

• Primary hyperlipidemia (including heterozygous familial hypercholesterolemia)
  • Indicated as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)
• Prevention of cardiovascular events
  • Indicated to reduce the risk of MI, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease

Dosage Considerations – Should be Given as Follows:

Laboratory tests

• Conduct the following laboratory tests at baseline and prior to each dose and as clinically needed
• Platelet count
• Prothrombin time (PT); activated partial thromboplastin time (aPTT)
• Quantitative spot urine protein testing

Every 2-week schedule

• Recommended starting dose: 75 mg subcutaneously (SC) every 2 weeks
• Measure CLC-C levels within 4-8 week of initiating; if inadequate response, may increase to 150 mg SC every 2 weeks; reassess LDL-C within 4-8 weeks
• Not to exceed 150 mg SC every 2 weeks

Every 4-week schedule

• Recommended starting dose: 300 mg SC every 4 weeks (i.e., two 150-mg injections consecutively at 2 different injection sites)
• Measure LDL-C just prior to the next scheduled dose; if inadequate response, may adjust dose to 150 mg every 2 weeks, starting the new dose on the next scheduled dosing date; reassess LDL-C within 4-8 weeks

Patients with HeFH undergoing apheresis

• 150 mg SC every 2 weeks
• May be administered without regard to timing of apheresis

Dosage Modifications

Renal impairment

• Mild or moderate: No dose adjustment required
• Severe: Not studied

Hepatic impairment

• Mild or moderate: No dose adjustment required
• Severe: Not studied

Dosing Considerations

• Limitation of use: Effect on cardiovascular morbidity and mortality not determined
• Safety and efficacy not established in pediatric patients

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.

• 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.