Adult Dosing

Heterozygous familial hypercholesterolemia and atherosclerotic cardiovascular disease

• Recommended initial dose: 75 mg SC once every 2 weeks
• Inadequate LDL-C lowering response: Increase dose to maximum of 150 mg SC every 2 weeks

Note:

• Measure LDL-C levels within 4-8 weeks of initiating or titrating the dose
• If a dose is missed, administer the injection within 7 days from the missed dose and then resume the original schedule
• If the missed dose is not administered within 7 days, wait until the next dose on the original schedule

Pediatric Dosing

• Safety and efficacy in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

Primary Hyperlipidemia

• As an adjunct to diet and maximally tolerated statin therapy for the treatment of heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease, requiring additional lowering of LDL-cholesterol (LDL-C)

• The effect of alirocumab on cardiovascular morbidity and mortality has not been established

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Mild to moderate renal impairment: No dose adjustments
• Severe renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Mild to moderate hepatic impairment: No dose adjustments
• Severe hepatic impairment: Dose adjustments not defined

• Hypersensitivity reactions such as pruritus, rash, urticaria and serious events such as hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization have been reported with alirocumab treatment
• Discontinue treatment if signs and symptoms of serious allergic reactions occur, treat according to the standard of care, and monitor until signs and symptoms resolve

Pregnancy category: Not Rated

• However, consider benefits and risks of alirocumab and possible risk to the fetus before prescribing to pregnant women because alirocumab can cross the placental barrier

Breastfeeding: Safety unknown.

• RESP: Bronchitis, cough
• GI: Diarrhea
• GU: Urinary tract infection
• EENT: Nasopharyngitis, sinusitis
• LOCAL: Injection site reactions
• MUSC: Myalgia, muscle spasms, musculoskeletal pain
• DERM: Contusion
• MISC: Influenza

• A human monoclonal antibody: Inhibits the binding of PCSK9 (proprotein convertase subtilisin kexin type 9) to low-density lipoprotein receptors (LDLR) present on the surface of hepatocytes which results in increase in the number of LDLRs available to clear LDL and thus lowers LDL-C levels
• Absolute bioavailability: 85%
• Metabolism: Unknown; CYP450: CYP3A4 and CYP2C9 activities were not affected by alirocumab when administered in combination with atorvastatin or rosuvastatin
• Half-life: 17-20 days

US Trade Name(s)

• Praluent

US Availability

Praluent

• INJ: 75 mg/mL or 150 mg/mL solution in a single-dose pre-filled pen
• INJ: 75 mg/mL or 150 mg/mL solution in a single-dose pre-filled syringe

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Praluent

UK Availability

Praluent

• INJ: 75 mg/mL or 150 mg/mL solution in a single-dose pre-filled pen
• INJ: 75 mg/mL or 150 mg/mL solution in a single-dose pre-filled syringe

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Endocrine/Metabolic

Antihyperlipidemic Agents

Human Monoclonal Antibody

Cardiovascular

Antihyperlipidemic Agents

Human Monoclonal Antibody