Inclisiran

Class
Hypolipidemic agents
Subclass
PCSK9-blocking siRNA
Substance name
Inclisiran
Brand names
Leqvio®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Heterozygous familial hypercholesterolemia
•
Start at: 284 mg SC q3 months for 2 doses
•
Maintenance: 284 mg SC q6 months
Administered subcutaneously in the abdomen, upper arm, or thigh.
Primary hyperlipidemia
•
Start at: 284 mg SC q3 months for 2 doses
•
Maintenance: 284 mg SC q6 months
Administered subcutaneously in the abdomen, upper arm, or thigh.
Indications for use
Labeled indications
Adults
•
Adjunctive treatment for heterozygous familial hypercholesterolemia
•
Adjunctive treatment for primary hyperlipidemia
Safety risks
Contraindications
Hypersensitivity to inclisiran or its components
Specific populations
Renal impairment
eGFR ≥ 15 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR < 15 mL/min/1.73 m²
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Consider safer alternatives. Inclisiran may cause fetal harm based on the mechanism of action. Discontinue inclisiran when pregnancy is detected.
Breastfeeding
Use with caution during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Common 1-10%
•
Bronchitis, arthralgia, injection site reactions
Unknown frequency
•
Skin rash, urticaria, angioedema
Interactions
Drug(s)
Check Interactions
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