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Comments
• See Section 4.2.11, "Management of Statin-Attributed Muscle Symptoms"
• Myositis/myopathy (CK >ULN) with concerning symptoms or objective weakness
is rare; rhabdomyolysis (CK >10 times ULN with renal injury) is rare; immune-
mediated necrotizing myopathy (with HMGCR antibodies) is very rare
• Transaminase elevations (>3 times ULN) are rare
• Postmarketing reports of cognitive impairment (eg, memory loss, forgetfulness) are
rare, generally nonserious, reversible upon statin discontinuation, and not observed in
prospective clinical trials
• See Section 4.2.8.4, "Management of Dyslipidemia in Persons Planning Pregnancy,
During Pregnancy, or While Lactating", pregnancy is not a contraindication, but
statins should be avoided while lactating
†
• Not recommended in patients with moderate or severe hepatic impairment
• Persistent elevations in hepatic transaminase (>3 times ULN) can occur when added
to a statin; monitor hepatic transaminase levels before and after initiating statin with
ezetimibe combination therapy
• Hypersensitivity reactions (including angioedema) are rare
• Latex is in some evolocumab single-dose prefilled syringe covers; alirocumab products
do not contain latex
• Elevated BUN, creatinine, and uric acid have been reported (monitoring serum urate
level necessary in patients with preexisting and untreated hyperuricemia)
• Hypersensitivity reactions (including angioedema) are rare
• Poor tolerability due to side effects and potential drug-drug interactions limits use;
may decrease absorption of fat-soluble vitamins and folic acid; generally considered
the safest medication in pregnancy
