Leqvio (inclisiran sodium)

Dosage of inclisiran sodium is expressed in terms of inclisiran. Each 1.5-mL syringe contains the equivalent of 284 mg inclisiran (present as 300 mg inclisiran sodium salt).

Inclisiran is administered by subcutaneous injection. The drug is available as an injection for subcutaneous use in single-dose prefilled syringes containing 284 mg/1.5 mL (189 mg/mL).

Inclisiran should be administered by a healthcare professional. Inject inclisiran subcutaneously into the abdomen, upper arm, or thigh; do not inject in areas of active skin disease or injury (e.g., sunburns, skin rashes, inflammation, skin infections).

Store inclisiran prefilled syringes at controlled room temperature between 20-25degreesC (excursions permitted between 15-30degreesC).

Inspect the drug visually before use; the solution should be clear and colorless to pale yellow. Do not use if particulate matter or discoloration is observed.

No dosing information is available for this tab.

No formal drug interaction studies have been performed with inclisiran. Inclisiran is not a substrate, inhibitor, or inducer of cytochrome P-450 (CYP) enzymes or transporters.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

None.

There are no contraindication contraindications for this drug.

• Pregnancy

• Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
• Chronic kidney disease stage 5 (failure) GFr<15 ml/min
• Severe hepatic disease

Common adverse reactions in clinical trials (>=3%) include injection site reaction, arthralgia, and bronchitis.

Less Frequent

• Angioedema

Rare or Very Rare

• Anaphylaxis
• Hypersensitivity drug reaction

More Frequent

• Arthralgia
• Bronchitis
• Diarrhea
• Dyspnea
• Injection site sequelae
• Pain in extremities
• Urinary tract infection

Less Frequent

• Skin rash
• Urticaria

Rare or Very Rare

• Pruritus of skin

No enhanced messaging available.

The safety and efficacy of inclisiran have not been established in pediatric patients.

There are no available data on the use of inclisiran in pregnant women to assess drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, based on the mechanism of action of inclisiran, the drug may cause fetal harm when administered to pregnant women. Inclisiran increases low-density lipoprotein cholesterol (LDL-C) uptake and lowers its levels in the circulation, thus decreasing cholesterol and possibly other biologically active substances derived from cholesterol.

Discontinue inclisiran when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Treatment of hyperlipidemia is not generally necessary during pregnancy and discontinuation of lipid-lowering agents during pregnancy should have little impact on long-term therapy outcomes for most patients with primary hyperlipidemia.

In animal reproduction studies, no evidence of embryo-fetal toxicity or teratogenicity was observed in rats and rabbits with subcutaneous administration of inclisiran during organogenesis at doses <=5-10 times the maximum recommended human dose (MRHD). Inclisiran crosses the placenta and was detected in rat fetal plasma at concentrations that were 65-154 times lower than maternal levels. No adverse developmental outcomes were observed in offspring of rats administered inclisiran (doses <=5 times the MRHD based on body surface area comparison) from organogenesis through lactation; there was also no evidence of maternal toxicity.

It is not known whether inclisiran is distributed into human milk; the effects of the drug on breast-fed infants or on milk production are also unknown. Inclisiran was detected in the milk of lactating rats in all dose groups; therefore, it is likely that the drug will be present in human milk. Since oligonucleotide-based products typically have poor oral bioavailability; low levels of inclisiran present in breast milk are unlikely to adversely impact an infant's development. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for inclisiran and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients.

In clinical studies, no overall differences in safety or efficacy of inclisiran were observed between patients >=65 years of age and younger patients; however, greater sensitivity to adverse reactions of some older individuals cannot be ruled out.