Alirocumab

DEA Class; Rx

Common Brand Names; Praluent

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.

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