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Alirocumab

    Brands

    DEA Class; Rx

    Common Brand Names; Praluent

    • Lipid-Lowering Agents, PCSK9 Inhibitors

    Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor
    For use in heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, and reduction of myocardial infarction, stroke, or hospitalization for unstable angina in adults with established cardiovascular disease
    Reports of serious hypersensitivity reactions including hypersensitivity vasculitis

    Indicated for the treatment of primary hypercholesterolemia, including heterozygous familial hypercholesterolemia, as an adjunct to diet, alone or in combination with other LDL-C-lowering therapies to reduce LDL-C.

    For the treatment of patients with homozygous familial hypercholesterolemia as an adjunct to other LDL-C-lowering therapies to reduce LDL-C.
    For myocardial infarction prophylaxis, stroke prophylaxis, and to reduce the risk of unstable angina requiring hospitalization in patients with established cardiovascular disease.

    History of serious hypersensitivity reaction to alirocumab or its exceipeints; reactions have included hypersensitivity vasculitis, angioedema, and hypersensitivity reactions requiring hospitalization

    • Nasopharyngitis (11.3%)
    • Allergic reactions (8.6%)
    • Injection site reactions (7.2%)
    • Influenza (5.7%)
    • Antidrug antibodies (4.8%)
    • Urinary tract infection (4.8%)
    • Diarrhea (4.7%)
    • Bronchitis (4.3%)
    • Myalgia (4.2%)
    • Muscle spasms (3.1%)
    • Sinusitis (3%)
    • Liver-related disorders (2.5%)
    • Cough (2.5%)
    • Contusion (2.1%)
    • Musculoskeletal pain (2.1%)
    • Angioedema
    • Vasculitis

    Hypersensitivity reactions (eg, pruritus, rash, urticaria), including some serious events (eg, hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization), have been reported; discontinue and treat if signs or symptoms of serious allergic reactions occur

    Available data from clinical trials and postmarketing reports in pregnant females are insufficient to evaluate for drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

    Unknown if distributed in human breast milk

    Adults

    300 mg subcutaneously once every month.

    Geriatric

    300 mg subcutaneously once every month.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Alirocumab

    injection, solution

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