Lerodalcibep
LEROCHOL
“Leroy doll says beep (to lower cholesterol)”
Pesky K-9 → PCSK9, which targets LDL receptors for destruction
Albumin in the backpack → fused to albumin, which is why a monthly dose holds
What it isSmall recombinant PCSK9-binding fusion protein with human serum albumin — not an antibody; FDA-approved 2025 for hypercholesterolemia including HeFH.
Why this oneOnce-monthly small-volume subcutaneous injection with room-temperature stability up to three months distinguishes it from earlier PCSK9 therapies.
What limits itInjection-site reactions and access are the main practical constraints; no cardiovascular outcome data yet.
FDA-approved for
- hypercholesterolemia incl. HeFH (2025)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Primary hypercholesterolemia incl. HeFH / ASCVD risk (indications section not in extract; population from trial descriptions) | Adults | SC: 300 mg once monthly | SC: 300 mg once monthly | 300 mg once monthly |
Renal Mild-moderate impairment (eGFR 30 to <90): no adjustment; severe (eGFR <30)/ESRD not studied
Hepatic Mild or moderate impairment: no adjustment; severe not studied
Instructions
- Inject SC into abdomen or upper front thighs; back of upper arm only if given by caregiver/HCP; rotate sites; avoid tender, bruised, red, or indurated skin
- If refrigerated, warm to room temperature (up to 25 C) for at least 30 min before use
- Inspect: clear to slightly opalescent, brownish-yellow to amber; do not use if cloudy or contains particles
- Push plunger fully until syringe is empty to deliver full 300 mg dose
- Missed dose <7 days: give ASAP, keep original monthly schedule; missed >=7 days: give ASAP and start new monthly schedule from that date
- Assess LDL-C when clinically indicated; effect measurable as early as 4 weeks after initiation
Available strengths
- inj 300 mg/1.2 mL
Adverse reactions
- Injection site reactions (12-18%)
- Nasopharyngitis (13-15%)
- Diarrhea (3%)
- Nausea (2%)
- Peripheral edema (2%)
- Injection site reactions were the most frequent reason for discontinuation
Pregnancy Discontinue when pregnancy recognized (or weigh ongoing need); may cause fetal harm based on mechanism (lowers LDL-C/cholesterol-derived substances); treatment of hypercholesterolemia generally unnecessary during pregnancy
Lactation No human data; present in monkey milk — weigh benefits of breastfeeding against maternal need and infant risk
Cost
| Strength | #/mo | generic $/unit | CostPlus | |
|---|---|---|---|---|
| 300 mg/1.2 mL | inj | per unit | not offered |
NO BOXED WARNINGS
Classes and tags
Clinical profile
Legacy pregnancy categoryN/A (post-2015 labeling)
Defining liabilityInjection-site reactions and limited long-term pregnancy evidence
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