Inclisiran

What is Inclisiran?

• Inclisiran (Leqvio) is a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA used as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH).

Inclisiran 01

What are the uses of this medicine?

• Inclisiran (Leqvio) is used as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C).

Limitations of Use:

• The effect of Leqvio on cardiovascular morbidity and mortality has not been determined.

How does this medicine work?

• Inclisiran is a double-stranded small interfering ribonucleic acid (siRNA), conjugated on the sense strand with triantennary N-Acetylgalactosamine (GalNAc) to facilitate uptake by hepatocytes.
• In hepatocytes, inclisiran utilizes the RNA interference mechanism and directs catalytic breakdown of mRNA for PCSK9.
• This increases LDL-C receptor recycling and expression on the hepatocyte cell surface, which increases LDL-C uptake and lowers LDL-C levels in the circulation.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No drug-drug interaction studies were conducted.

Is this medicine FDA approved?

• In December 2021, it was approved for medical use in the United States.

How should this medicine be used?

Recommended dosage:

• The recommended dosage of Leqvio, in combination with maximally tolerated statin therapy, is 284 mg administered as a single subcutaneous injection initially, again at 3 months, and then every 6 months.

Administration:

• Leqvio should be administered by a healthcare professional.
• Inject Leqvio subcutaneously into the abdomen, upper arm, or thigh.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 284 mg/1.5 mL (189 mg/mL) in a single-dose prefilled syringe.

This medicine is available in fallowing brand namesː

• Leqvio

What side effects can this medication cause?

The most common side effects of this medicine include:

• injection site reaction
• arthralgia
• urinary tract infection
• diarrhea
• bronchitis
• pain in extremity
• dyspnea

What special precautions should I follow?

• Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus.
• Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if Leqvio should be discontinued.
• Advise patients that injection site reactions can occur with Leqvio.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Discontinue Leqvio when pregnancy is recognized.
• There are no available data on the use of Leqvio in pregnant patients to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Leqvio have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• INCLISIRAN SODIUM

Inactive ingredient:

• WATER
• SODIUM HYDROXIDE
• PHOSPHORIC ACID

Who manufactures and distributes this medicine?

Distributed by:

• Novartis Pharmaceuticals Corporation
• East Hanover, New Jersey

What should I know about storage and disposal of this medication?

• Store Leqvio at controlled room temperature 20°C to 25°C (68°F to 77°F) with allowable excursions between 15°C and 30°C (59°F and 86°F).

• Dailymed label info on Inclisiran
• FDA Inclisiran