Lerodalcibep

Lerodalcibep is used along with diet and exercise to reduce "bad" cholesterol (low-density lipoprotein, or LDL) in adults with high cholesterol (hypercholesterolemia), which includes a genetic form known as heterozygous familial hypercholesterolemia.

Lerodalcibep may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Lerodalcibep is injected under the skin, usually once every month.

A healthcare provider may give you this injection or may teach you or your caregiver how to properly use this medicine. Read and carefully follow the Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Your healthcare provider will show you where to inject lerodalcibep. Do not inject it into the same place two times in a row.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

You should not stop using lerodalcibep without your doctor's advice, or your LDL cholesterol levels may increase.

Store this medicine in the original carton in the refrigerator. Protect from light and do not freeze or shake.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before using it.

You may store this medicine at room temperature in the original carton for up to 3 months. Throw away the medicine kept at room temperature if you have not used it within 3 months.

Use only as directed. Inform your doctor if you are taking other medicines or if you have any other medical conditions or allergies.

Tell your doctor if you have or have ever had health problems or use other medications.

It is not known if lerodalcibep will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using lerodalcibep.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Less serious side effects may happen more often, or you may have none at all.

Common side effects of lerodalcibep may include:

• diarrhea;
• nausea;
• runny or stuffy nose, sore throat;
• swelling in arms, hands, legs, or feet; or
• pain, bruising, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

300 mg subcutaneously once monthlyComments:-Assess LDL-C when clinically appropriate. The LDL-lowering effect of this drug may be measured as early as 4 weeks after starting therapy and, with continued monthly dosing, at any time thereafter regardless of when the last dose was given.-To administer the full 300 mg dose, push plunger down until the syringe is empty before removing from the injection site.Use: As an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia

Usual Adult Dose for Heterozygous Familial Hypercholesterolemia:

300 mg subcutaneously once monthlyComments:-Assess LDL-C when clinically appropriate. The LDL-lowering effect of this drug may be measured as early as 4 weeks after starting therapy and, with continued monthly dosing, at any time thereafter regardless of when the last dose was given.-To administer the full 300 mg dose, push plunger down until the syringe is empty before removing from the injection site.Use: As an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia

Use the medicine as soon as you remember and continue with your regular schedule. However, if you are 7 days late or more for the dose, start a new monthly schedule on the day you remember.

Do not take two doses at the same time.

Call your doctor for guidance if you are unsure what to do if you miss a dose.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

Other drugs may impact lerodalcibep, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.

Find detailed information on biosimilars for this medication.