How Evolocumab (Repatha) Affects AST Levels

At a glance

  • Drug / Repatha (evolocumab), a PCSK9 inhibitor given by subcutaneous injection [1]
  • Liver warning / None; the only Warning and Precaution is hypersensitivity including angioedema [1]
  • Trial reactions / AST elevation not among those listed from the 52-week placebo-controlled trial [1]
  • Liver monitoring / The label's dosing section mentions LDL-C measurement as early as 4 weeks, not AST testing [1]
  • Hepatic impairment / No dose adjustment for mild to moderate hepatic impairment [1]
  • Elimination / Target binding and proteolysis [1]

Does Evolocumab Raise AST?

In the 52-week placebo-controlled trial, 599 people received Repatha 420 mg monthly and 302 received placebo. The adverse reactions listed from that trial were nasopharyngitis (10.5 percent versus 9.6 percent), upper respiratory tract infection (9.3 versus 6.3 percent), influenza (7.5 versus 6.3 percent), back pain (6.2 versus 5.6 percent), injection site reactions (5.7 versus 5.0 percent), cough (4.5 versus 3.6 percent), urinary tract infection (4.5 versus 3.6 percent), sinusitis (4.2 versus 3.0 percent), headache (4.0 versus 3.6 percent), myalgia (4.0 versus 3.0 percent) and dizziness (3.7 versus 2.6 percent) [1]. AST elevation is not on that list.

The label carries no boxed warning. Its only Warning and Precaution is hypersensitivity reactions including angioedema, and a history of serious hypersensitivity reaction is the contraindication [1].

What the Label Says About Liver Function

The label gives no dose adjustment for renal impairment or mild to moderate hepatic impairment [1]. In people with mild to moderate hepatic impairment, evolocumab peak concentration (Cmax) was 20 to 30 percent lower and total exposure (AUC) was 40 to 50 percent lower [1]. Age, sex, race and creatinine clearance did not affect its pharmacokinetics [1].

Evolocumab is eliminated by target binding and proteolysis [1]. The label's dosing section says the LDL-lowering effect may be measured as early as 4 weeks after starting [1].

Frequently asked questions

Does Repatha raise AST?
AST elevation is not among the adverse reactions listed from the 52-week placebo-controlled trial, and the Repatha label has no liver warning. The listed reactions were nasopharyngitis, upper respiratory tract infection, influenza, back pain, injection site reactions, cough, urinary tract infection, sinusitis, headache, myalgia and dizziness [1].
Does Repatha lower AST?
The label does not report an AST-lowering effect for Repatha. The label's dosing section refers to measuring LDL-C, as early as 4 weeks after starting [1].
Is liver monitoring required with Repatha?
The label's dosing section mentions LDL-C measurement, not an AST or liver panel schedule [1].
Can Repatha be used with liver impairment?
The label says no dose adjustment is needed for mild to moderate hepatic impairment. Exposure was lower in that group, with Cmax 20 to 30 percent lower and AUC 40 to 50 percent lower [1].
Does Repatha cause liver damage?
The label and trial information available do not establish that Repatha causes liver damage or changes AST. The label's only Warning and Precaution is hypersensitivity, including angioedema [1].

References

  1. DailyMed - REPATHA- evolocumab injection, solution. DailyMed - REPATHA- evolocumab injection, solution
Evidence overview for how evolocumab affects: How Evolocumab (Repatha) Affects AST Levels