LEQVIO® (inclisiran) injection, for subcutaneous use by Novartis Pharmaceuticals Corporation


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Indications & Usage

INDICATIONS AND USAGE

 

LEQVIO is a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA indicated 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.

 

 

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Dosage & Administration

DOSAGE AND ADMINISTRATION

 

  • 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.
  • LEQVIO should be administered by a health care professional.
  • Inject LEQVIO subcutaneously into the abdomen, upper arm, or thigh.

 

DOSAGE FORMS AND STRENGTHS

 

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

 

 

Please click here for LEQVIO full Prescribing Information.

Contraindications

CONTRAINDICATIONS

 

None.

 

 

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Adverse Reactions

ADVERSE REACTIONS

 

Common adverse reactions in clinical trials (≥ 3%): injection site reaction, arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity, and dyspnea.

 

To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

 

Please click here for LEQVIO full Prescribing Information.

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Please click here for LEQVIO full Prescribing Information.

Indication & Important Safety Information


INDICATION

LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) 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.

 

IMPORTANT SAFETY INFORMATION

Adverse reactions in clinical trials (≥3% of patients treated with LEQVIO and more frequently than placebo) were injection site reaction, arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity and dyspnea.

Adverse reactions led to discontinuation in 2.5% and 1.9% of LEQVIO- and placebo-treated patients, respectively. Discontinuation due to injection site reactions, which included injection site pain, erythema and rash, were 0.2% and 0% of LEQVIO- and placebo-treated patients, respectively.

 

 

Please click here for LEQVIO full Prescribing Information.