Applies to alirocumab: parenteral solution for injection.

Side effects include:

Adverse effects (≥5%) in primary hyperlipidemia studies: nasopharyngitis, injection site reactions (e.g., erythema/redness, itching, swelling, pain/tenderness), influenza.

Adverse effects (≥5%) in patients with established cardiovascular disease: noncardiac chest pain, nasopharyngitis, myalgia.

For Healthcare Professionals

Applies to alirocumab: subcutaneous solution.

General

The most commonly reported adverse reactions have included nasopharyngitis, injection site reactions, and influenza.^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reaction, nummular eczema, hypersensitivity vasculitis

Postmarketing reports: Angioedema^[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (11.3%)

Common (1% to 10%): Influenza, bronchitis, sinusitis, cough^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection^[Ref]

Hepatic

Common (1% to 10%): Elevated liver enzymes^[Ref]

During clinical trials, 2.5% of patients treated with this drug reported abnormal liver enzymes (placebo=1.8%); treatment discontinuation occurred in 0.4% and 0.2% of patients receiving this drug and placebo, respectively. Increases in serum transaminases to greater than 3 times the upper limit of normal occurred in 1.7% of patients treated with this drug (placebo=1.4%).^[Ref]

Immunologic

Common (1% to 10%): Development of antidrug antibody (ADA), neutralizing antibodies (NAb)

Postmarketing reports: Flu-like illness^[Ref]

Local

Patients who developed ADA (antidrug antibody) had a higher incidence of injection site reactions compared with patients who did not develop ADA (10.2% vs 5.9%).^[Ref]

Common (1% to 10%): Injection site reaction (erythema, redness, itching, swelling, pain, tenderness)^[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, muscle spasm, contusion, musculoskeletal pain^[Ref]

Nervous system

Uncommon (0.1% to 1%): Neurocognitive events, confusion or memory impairment^[Ref]

Metabolic

During clinical trials with both every 2 week or every 4 week dosing, reports of 2 consecutive calculated LDL-C values less than 25 mg/dL, and less than 15 mg/dL were reported in 914 and 335 patients, respectively. Low LDL-C values were observed more frequently in patients treated with 150 mg every 2 weeks or 400 mg every 4 weeks. Changes to background lipid therapy was not made and adverse consequences were not identified, but the long-term effects of very low levels of LDL-C are not known.

Frequency not reported: Low LDL-C values