lerochol
Lerochol (Lerodalcibep-Liga) is a medication used to treat Hypercholesterolemia.
Lerodalcibep-Liga · by Lib Therapeutics, Inc.
Key facts
- Active ingredient
- Lerodalcibep-Liga
- Form
- Injectable
- Strength
- LERODALCIBEP-LIGA 300MG/1.2ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- hypercholesterolemia
- Manufacturer
- Lib Therapeutics, Inc.
- FDA application
- BLA761427
What is Lerochol?
From the FDA label:Lerodalcibep-liga is a recombinant fusion protein therapeutic agent comprised of a proprotein convertase subtilisin/kexin type 9 (PCSK9)-binding domain and human serum albumin (HSA). Lerodalcibep-liga is produced in genetically engineered mammalian (Chinese hamster ovary) cells as a single protein with an approximate molecular weight of 77 kDa. LEROCHOL (lerodalcibep-liga) injection is a clear to slightly opalescent, brownish-yellow to amber, sterile, preservative-free solution for subcutaneous injection. Each single-dose prefilled syringe contains 1.2 mL of lerodalcibep-liga (300 mg), histidine (3.07 mg), L-histidine monohydrochloride (0.88), polysorbate 80 (0.24 mg), sodium chloride (10.52), and Water for Injection. The pH is 6.8.
How to use
The recommended dosage of LEROCHOL is 300 mg administered subcutaneously once monthly. ( 2.1 ) Inject LEROCHOL subcutaneously into the abdomen or thigh. A caregiver or healthcare professional can administer into the upper arm. ( 2.2 ) Refer to the Instructions for Use for administration of prefilled syringe. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of LEROCHOL is 300 mg once monthly administered subcutaneously. Assess LDL-C when clinically indicated. The LDL-lowering effect of LEROCHOL may be measured as early as 4 weeks after initiation and, provided monthly dosing is continued, anytime thereafter without regard to timing of the dose. 2.2 Recommendations Regarding Missed Dose(s) If a dose is missed by: Less than 7 days, instruct the patient to administer LEROCHOL as soon as possible and resume the patient's original monthly dosage schedule. Seven (7) or more days, instruct the patient to administer LEROCHOL as soon as possible and start a new monthly dosage schedule based on this date. 2.3 Important Administration Instructions Train patients and/or their caregivers on how to prepare and administer LEROCHOL, according to the Instructions for Use, and instruct them to read and follow the Instructions for Use each time they use LEROCHOL. Prior to use, allow LEROCHOL to warm to room temperature up to 25°C (77°F) for at least 30 minutes if LEROCHOL has been…
Side effects
Common adverse reactions occurring in ≥1% of patients treated with LEROCHOL were injection site reactions, nasopharyngitis, diarrhea, nausea and peripheral edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LIB Therapeutics, Inc. at 1-877-2-LEROCHOL or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults with Primary Hypercholesterolemia Adverse Reactions in Two Pooled 52-week Controlled Trials In two pooled 52-week, double-blind, randomized, placebo-controlled trials (Trials 1 and 2), 1,229 patients received 300 mg of LEROCHOL subcutaneously every 4 weeks [see Clinical Studies ( 14 )] . The mean age was 64 years (range 25 to 90 years), 52% were 65 years of age or older, 37% female, 79% White, 18% Black or African American, 4% Asian; 7% identified as Hispanic or Latino ethnicity. At baseline, 9% of patients had a diagnosis of HeFH, 74% had established atherosclerotic cardiovascular disease (ASCVD), and 26% were at increased risk for ASCVD. Adverse reactions reported in at least 2% of LEROCHOL-treated patients and more frequently than in placebo-treated…
Who should not take Lerochol
None. None. ( 4 )
Storing Lerochol, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “If needed, 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.”
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Lerochol treat?
- Lerochol (Lerodalcibep-Liga) may be used to treat hypercholesterolemia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Lerochol?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Lerochol. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Lerochol?
- Lerochol is marketed by Lib Therapeutics, Inc.. You can see Lib Therapeutics, Inc.'s full profile, rating, and other products on pharmaranks.
- Is Lerochol a brand-name or generic drug?
- Lerochol is a brand-name product with the active ingredient Lerodalcibep-Liga.
- Is Lerochol available over the counter?
- No. Lerochol is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Lerochol come in?
- Lerochol is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Lerochol FDA-registered?
- Lerochol is on record with the U.S. FDA under application number BLA761427. You can verify this on its official FDA label.
- Is Lerochol safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Lerochol. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Lerochol?
- Lerochol's side effects are taken directly from its FDA label. From the label: Common adverse reactions occurring in ≥1% of patients treated with LEROCHOL were injection site reactions, nasopharyngitis, diarrhea, nausea and peripheral edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LIB Therapeutics, Inc.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
repatha
Evolocumab
crestor
Rosuvastatin Calcium
gemfibrozil
Gemfibrozil
juxtapid
Lomitapide Mesylate
leqvio
Inclisiran Sodium
praluent
Alirocumab
Compare Lerochol head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
lerochol
New