HeFH, heterozygous familial hypercholesterolemia; LDL-C, low-density lipoprotein cholesterol; PCSK9, proprotein convertase subtilisin/kexin type 9 inhibitor.
*Indicated as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including HeFH.2
†Store refrigerated at 2°C to 8°C (36°F to 46°F). LEROCHOL may be kept at room temperature up to 25°C (77°F) in the original carton and must be used within 3 months of being removed from the refrigerator. If not used within 3 months, discard LEROCHOL.2
ABOUT LEROCHOL
LEROCHOL: Designed to be different
LEROCHOL is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including HeFH.2
|
mAb, monoclonal antibody.
|
Meet Adriane
A real patient navigating life with familial hypercholesterolemia (FH)
Listen to her story about her long journey to diagnosis, time in the clinical trial for LEROCHOL, and how her experience taking PCSK9 inhibitors helped her realize what matters most to her in a treatment. Adriane was compensated for her time.
Efficacy & Safety
LEROCHOL delivered robust and sustained LDL-C reduction across a broad range of patients1,3,4
At 52 weeks, more than 90% of patients with or at very high risk for ASCVD achieved their study targets for both absolute and percentage reduction of LDL-C.1,4,||
||Treatment goals are defined based on cardiovascular risk. For very-high-risk patients, targets are a ≥50% reduction in LDL-C and an absolute level <55 mg/dL. For high‑risk patients, targets are a ≥50% reduction and <70 mg/dL.1,4
Mean Week 50/52 LDL-C change from baseline:
-61%
(P<0.0001)
The co-primary endpoints were percent change from baseline in LDL-C at Week 52 and mean LDL-C at Weeks 50 and 52
At Week 52,
the mean LDL-C change
from baseline was
-55%
(P<0.0001)
Mean Week 50/52 LDL-C change from baseline:
-55%
(P<0.0001)
The co-primary endpoints were percent change from baseline in LDL-C at Week 52 and mean LDL-C at Weeks 50 and 52
At Week 52,
the mean LDL-C change
from baseline was
-49%
(P<0.0001)
Highly significant LDL-C reduction in adults with HeFH3
Mean Week 22/24 LDL-C change from baseline:
-65%
(P<0.0001)
The co-primary endpoints were percent change from baseline in LDL-C at Week 24 and mean LDL-C at Weeks 22 and 24
Mean Week 24 LDL-C change from baseline:
-58.6%
(P<0.0001)
ASCVD, atherosclerotic cardiovascular disease.
Safety for LEROCHOL was demonstrated across phase 3 trials and was generally comparable with placebo.2
The most commonly occurring adverse reactions in clinical trials in primary hyperlipidemia in adults (including HeFH) ≥2% of patients treated with LEROCHOL (lerodalcibep-liga) and occurring more frequently than with placebo were nasopharyngitis (15% and 14% versus placebo), local injection site reactions (12% and 5% versus placebo) and peripheral edema (2% and <1% versus placebo).2
The most commonly occurring adverse reactions in clinical trials in HeFH (≥2% of patients treated with LEROCHOL and occurring more frequently than with placebo) were injection site reactions (18% and 3% versus placebo), nasopharyngitis (13% and 9% versus placebo), diarrhea (3% and 1% versus placebo), nausea (2% and 0% versus placebo) and peripheral edema (2% and <1% versus placebo).2
The most frequent adverse reaction leading to treatment discontinuation in trials in primary hypercholesterolemia in adults was injection site reactions, with a higher frequency in the LEROCHOL-treated group compared to placebo-treated patients (1% versus 0%).1
Dosing & Administration
Designed with patient convenience in mind
- Each LEROCHOL prefilled syringe is packaged individually2
- LEROCHOL is a convenient, single, subcutaneous injection
taken once a month via self-administration2 - LEROCHOL can be stored at room temperature for up to 3 months2,§
§If LEROCHOL is not refrigerated for more than 3 months, it must be discarded.2
Dosing & Administration
Designed with patient convenience in mind
- Each LEROCHOL prefilled syringe is packaged individually2
- LEROCHOL is a convenient, single, subcutaneous injection taken once a month via self-administration2
- LEROCHOL can be stored at room temperature for up to 3 months2,§
For full dosing information and easy step-by-step instructions to support your patients, download the Instructions for Use Reference Guide.
§If LEROCHOL is not refrigerated for more than 3 months, it must be discarded.2
Access
How to get LEROCHOL
Cash-Pay Program‡
Follow these steps to ensure your cash-paying patients get LEROCHOL for $199:
Enter prescription in EMR and select HealthDyne Pharmacy for home-delivery fulfillment
Instruct patient to expect a text from 833-772-4142, which is HealthDyne reaching out with instructions to register on the patient portal, where they will:
- Create an account
- Provide prescription details
- Submit a payment method
Questions for HealthDyne Pharmacy?
Please call 866-778-6350
If your patient prefers to submit through their insurance, prescription must still be submitted through HealthDyne for fulfillment. Please note, some insurance companies may not cover at this time.
‡LEROCHOL prescriptions filled by HealthDyne Pharmacy, the licensed pharmacy provider. Terms and conditions apply. See below.
Terms and Conditions for the Cash-Pay Program
The LIB Therapeutics direct-to-patient program (the "Program") is available to patients at least 18 years old who have been prescribed LEROCHOL by their physician and who pay out-of-pocket with cash or credit card for LEROCHOL. By participating in this Program, you agree to these terms and conditions.
See full terms and conditionsfor the Cash-Pay Program +
Resources for LEROCHOL are available to help support your practice and your patients.
|
Essential information about LEROCHOL for your practice, including cash-pay access
| LEROCHOL Overview |
|
Information for your patients about LEROCHOL including details on the cash-pay offer and tips to stay on treatment
| Patient Brochure |
|
Step-by-step instructions for your patients detailing how to take LEROCHOL
| Instructions for Use Reference Guide |
Frequently Asked Questions
What is LEROCHOL?
LEROCHOL is a novel, third-generation PCSK9 inhibitor indicated as an adjunct to diet and exercise to reduce LDL‑C in adults with hypercholesterolemia, including those with HeFH.1,2
Lerochol delivers:
- Robust, sustained LDL‑C lowering up to 60%1-3,*
- A single subcutaneous injection once a month, self-administered2
- Extended room temperature storage for up to 3 months2, †
How is LEROCHOL administered?
LEROCHOL is self-administered subcutaneously once monthly via a small-volume, prefilled syringe, delivering convenience for patients even while on the go.2
Does LEROCHOL need to be refrigerated?
No, LEROCHOL does not need refrigeration and can be stored at room temperature for up to 3 months, offering convenience for patients who frequently travel or need more flexibility. If LEROCHOL is not refrigerated for more than 3 months, it must be discarded.2
What makes LEROCHOL a
different PCSK9 inhibitor?
LEROCHOL is a third-generation, small-binding protein PCSK9 inhibitor self-administered as a single, small-volume, subcutaneous injection once a month, with extended room-temperature stability (up to 3 months), designed with the convenience patients need to stay on treatment.1,3, *,†
View LEROCHOL’s full Prescribing Information.