Lerochol

Lerochol is used to reduce low-density lipoprotein cholesterol (LDL-C) or bad cholesterol in adults with high blood cholesterol levels (hypercholesterolemia), including heterozygous familial hypercholesterolemia (HeFH), along with diet and exercise. It is a PCSK9 inhibitor given under the skin (subcutaneously) once a month and can be stored at room temperature for up to 3 months.

Lerochol comes as a single-dose prefilled syringe and a single-dose autoinjector. Both deliver the same 300 mg dose, and both can be used by you or a caregiver once you have been trained.

Why does lowering LDL cholesterol matter?

Cardiovascular outcomes trials have shown that lowering LDL cholesterol reduces the risk of serious heart and blood vessel problems, known as major adverse cardiovascular events (MACE), in adults at increased risk. These trials studied adults treated with statins, or with a monoclonal antibody PCSK9 inhibitor added on to statin therapy.

Lerochol itself is approved to lower LDL cholesterol. It has not been approved to reduce the risk of major adverse cardiovascular events, and it is a different type of PCSK9 inhibitor to the monoclonal antibodies studied in those trials. Lerochol is a recombinant fusion protein. Talk to your healthcare provider about what lowering your LDL cholesterol means for your own heart health.

Lerochol gained FDA approval on December 12, 2025. The autoinjector was added to the label in August 2026.

Lerochol (lerodalcibep-liga) works by blocking a substance called PCSK9. Normally, PCSK9 attaches to LDL receptors on liver cells and causes these receptors to break down. When this happens, there are fewer receptors available to remove "bad" cholesterol (LDL-C) from the bloodstream. Lerochol's mechanism of action prevents PCSK9 from destroying these receptors. With more LDL receptors intact and working, the liver can clear more LDL cholesterol from the blood, lowering overall cholesterol levels.

Lerochol belongs to the drug class called proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. It is a third-generation PCSK9 inhibitor.

Before you start using Lerochol, tell your healthcare provider about all of your medical conditions, including if you:

• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Lerochol will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking Lerochol.

Breastfeeding

You and your healthcare provider should decide if you will take Lerochol or breastfeed. You should not do both without talking to your healthcare provider first.

Common side effects

The most common side effects of Lerochol are:

• Redness, itching, swelling, pain, bruising, or tenderness at the injection site
• Runny or stuffy nose, sore throat (nasopharyngitis)
• Diarrhea
• Nausea
• Swelling in arms, hands, legs, or feet (peripheral edema).

Serious side effects and warnings

No serious side effects of Lerochol are listed in the prescribing information.

The most frequent adverse reaction leading to treatment discontinuation in clinical trials was injection site reactions (1% discontinued due to 0% with placebo).

It is unknown if Lerochol is safe and effective in children.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800- FDA1088.

Lerochol is injected under the skin (subcutaneously) 1 time every month. See the detailed Instructions for Use that comes with the Lerochol package insert about the right way to prepare and give your injections. There is a separate Instructions for Use for the prefilled syringe and for the autoinjector, so make sure you are reading the one that matches your device. Use Lerochol exactly as your healthcare provider tells you to use it.

• Lerochol comes as a single-dose (1 time) prefilled syringe or a single-dose (1 time) autoinjector.
• If your healthcare provider decides that you or a caregiver can give the injections of Lerochol, you or your caregiver should receive training on the right way to prepare and give Lerochol. Do not try to inject Lerochol until you have been shown the right way by your healthcare provider or nurse.
• If your Lerochol has been in the refrigerator, take the carton out and let it warm to room temperature for at least 30 minutes before injecting. This makes the injection more comfortable. Do not warm it any other way, such as in a microwave.
• It can be self-injected in the stomach area, at least 2 inches away from the belly button, or in the upper front of the legs (thighs). A caregiver or healthcare provider can inject it in the back of the upper arm.
• Do not choose an area where the skin is tender, bruised, red, or hard. Choose a different spot each month.
• Do not inject with other injectable medicines at the same injection site.
• Always check the label on your prefilled syringe or autoinjector to make sure you have the correct medicine, and check that the expiry date has not passed.
• Do not stop using Lerochol without talking with your healthcare provider. If you stop using Lerochol, your cholesterol levels can increase.

How do you use the Lerochol prefilled syringe?

After cleaning the injection site, pinch a fold of skin and insert the needle at a 45 to 90 degree angle. Slowly push the plunger rod all the way down until the syringe is empty, then remove the needle. Pushing the plunger fully down is what delivers the complete 300 mg dose.

How do you use the Lerochol autoinjector?

Pull off the clear protective cap, hold the autoinjector at a 90 degree angle, and press it firmly against the cleaned injection site. You will hear two clicks. The first click means the injection has started and the second means it is almost finished. After the second click, keep holding the autoinjector against your skin for 10 seconds and check that the green plunger in the viewing window has stopped moving before you lift it away. Lifting too early means you may not get the full dose.

What happens if I forget or miss a dose?

Less than 7 days since the missed dose: Inject your missed dose as soon as you remember, then continue your original monthly dosage schedule.

7 days or more from the missed dose: Inject the missed dose as soon as you remember. This injection date becomes your new monthly schedule going forward. If you are not sure when to restart Lerochol, ask your healthcare provider or pharmacist.

FDA approval was based on the Phase 3 LIBerate clinical trials involving over 2,900 patients without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia administered Lerochol once-monthly for up to 72 weeks.

• Lerochol reduced LDL cholesterol by ≥60% in high-risk patients and ≥50% in those with severe elevations.
• The treatment was well tolerated with no serious treatment-related adverse events.

Tell your healthcare provider or pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

No formal clinical drug interaction studies have been performed with Lerochol.

Yes. Lerochol is available as a single-dose autoinjector as well as a single-dose prefilled syringe. The FDA added the autoinjector to the Lerochol label in August 2026. Both devices contain the same 300 mg dose in 1.2 mL and are injected under the skin once a month. The autoinjector hides the needle and delivers the dose automatically, so you do not push a plunger yourself. Your prescription will specify which device you receive.

Store Lerochol in the refrigerator between 36°F and 46°F (2°C and 8°C) in the original carton until ready to use, to protect it from light.

If needed, Lerochol may be kept in the original carton at room temperature up to 77°F (25°C) for up to 3 months after being taken out of the refrigerator. Throw away Lerochol that has been stored at room temperature for more than 3 months.

Do not put the autoinjector back in the refrigerator once it has reached room temperature.

Do not freeze or shake. Do not use an autoinjector that has been frozen or shaken.

Keep out of reach of children.

Active ingredient: lerodalcibep-liga

Inactive ingredients: histidine, L-histidine monohydrochloride, polysorbate 80, sodium chloride, and Water for Injection, USP.

Lerochol is manufactured by LIB Therapeutics, Inc., 5375 Medpace Way, Cincinnati, OH 45227-1543, U.S. License # 2352.