PCSK9 Inhibitors: Safety Profile and Adverse Reactions
| Safety Profile | Evolocumab | Alirocumab |
|---|---|---|
| Common side effects | Upper respiratory tract infection, influenza, gastroenteritis, nasopharyngitis, injection site reactions. | Upper respiratory tract infection, influenza, nasopharyngitis, gastroenteritis, injection site reactions. |
| Pregnancy | No data available on use in pregnant women to inform a drug-associated risk. | No available data on use in pregnant women to inform a drug-associated risk. |
| Lactation | No information on its presence in human milk, effects on the breastfed infant, or on milk production. | No information on its presence in human milk, effects on the breastfed infant, or on milk production. |
| Pediatric use | The safety profile of Repatha in these adolescents was similar to that described for adult patients with HoFH. Safety and efficacy not established in HoFH patients <13 years with HoFH and in pediatric patients with primary hyperlipidemia or HeFH. | Safety and efficacy in pediatric patients have not been established. |
| Geriatric use | Safety profile similar to younger adults. | Safety profile similar to younger adults. |
| Renal impairment | No dose adjustment is needed. | No dose adjustment is needed for mild or moderately impaired renal function. No data are available in severe renal impairment. |
| Hepatic impairment | No dose adjustment in mild to moderate hepatic impairment (Child-Pugh A or B). No data are available in severe impairment. | No dose adjustment in mild to moderate hepatic impairment. No data are available in severe impairment. |
PCSK9, proprotein convertase subtilisin/kexin type 9; HoFH, homozygous familial hypercholesterolemia; HeFH, heterozygous familial hypercholesterolemia.