Applies to evolocumab: parenteral solution for injection.

Side effects include:

Adverse effects (reported in >5% of adults with primary hyperlipidemia): Nasopharyngitis, upper respiratory tract infection, influenza, back pain, injection site reactions (e.g., erythema, pain, bruising).

Adverse effects (reported in >5% of adults with established cardiovascular disease): Diabetes mellitus, nasopharyngitis, upper respiratory tract infection.

For Healthcare Professionals

Applies to evolocumab: subcutaneous solution.

General

The more commonly reported adverse reactions have included nasopharyngitis, upper respiratory tract infection, back pain, and injection site reactions.

Hypersensitivity

Common (1% to 10%): Hypersensitivity reactions (including rash, eczema, erythema, urticaria)

Postmarketing reports: Angioedema^[Ref]

Cardiovascular

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

Gastrointestinal

Common (1% to 10%): Diarrhea, gastroenteritis, nausea (1.8%)^[Ref]

Genitourinary

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

Local

Common (1% to 10%): Injection site reaction (including erythema, pain, bruising)^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, myalgia, musculoskeletal pain, arthralgia (1.8%)^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Neurocognitive events (0.2%)^[Ref]

Other

Common (1% to 10%): Influenza, fatigue (1.6%)

Uncommon (0.1% to 1%): Contusion^[Ref]

Respiratory

Common (1% to 10%): Influenza, fatigue (1.6%)

Uncommon (0.1% to 1%): Contusion^[Ref]

Immunologic

Rare (less than 0.1%): Development anti-drug antibody

Postmarketing reports: Influenza-like illness^[Ref]