Medical Professionals Reference (MPR)Once-Monthly, Self-Administered PCSK9 Inhibitor Lerochol Now Available

📋 Regulatory Action / Label Change

Lerochol (lerodalcibep-liga) is now available as a once-monthly self-administered subcutaneous PCSK9 inhibitor for LDL-C lowering. The therapy carries a $199 monthly direct-to-patient cash price and supports room-temperature storage for up to 3 months.

Professional Impact:

• Approval covers adults with hypercholesterolemia, including HeFH, as adjunct to diet, exercise, and maximally tolerated statin therapy.
• Phase 3 program enrolled 2,017 adults across three randomized placebo-controlled trials in HeFH, ASCVD, or elevated ASCVD risk populations.
• Self-injection into the abdomen or upper front thigh expands patient autonomy versus in-office administration models.
• Most common adverse reactions: injection site reactions, nasopharyngitis, diarrhea, nausea, and peripheral edema.

Action Items:

• Review patient candidacy among those requiring additional LDL-C lowering on maximally tolerated statins.
• Train patients on subcutaneous self-injection technique before initiating therapy.
• Document baseline LDL-C and ASCVD risk classification to support appropriate use.
• Evaluate the cash-pay pathway for patients facing access barriers to other PCSK9 inhibitors.