Drug Detail:Inclisiran (Inclisiran [ in-kli-sir-an ])
Drug Class: Miscellaneous antihyperlipidemic agents
Usual Adult Dose for Hyperlipidemia
Initial dose: 284 mg subcutaneously once, and repeat in 3 months
Maintenance dose (after initial dose): 284 mg subcutaneously every 6 months
Comments:
- Limitations of Use: The effect of this drug on cardiovascular morbidity and mortality has not been established.
- Low-density lipoprotein (LDL) cholesterol should be assessed when clinically indicated; the LDL-lowering effect of this drug may be measured as soon as 30 days after start and anytime thereafter without regard to the timing of the dose.
Use: As an adjunct to diet and maximally tolerated statin therapy for the treatment of patients with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL cholesterol
Renal Dose Adjustments
Mild, moderate, or severe renal dysfunction: No adjustment recommended.
ESRD: Data not available
Liver Dose Adjustments
Mild to moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction: Data not available
Precautions
CONTRAINDICATIONS: None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- This drug should be administered by a health care professional.
- Inject subcutaneously into the abdomen, upper arm, or thigh; do not inject in areas of active skin disease/injury (e.g., sunburns, skin rashes, inflammation, skin infections).
- If a planned dose is missed by less than 3 months, administer this dose and continue dosing according to patient's original schedule; if a planned dose is missed by more than 3 months, restart with a new dosing schedule (administer dose initially, again at 3 months, and then every 6 months).
Storage requirements:
- Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
Monitoring:
- Investigations: LDL cholesterol (when clinically indicated)
Patient advice:
- Patients of childbearing potential: Notify health care provider of known/suspected pregnancy to discuss if this drug should be stopped.
Frequently asked questions
- What is the difference between Leqvio and Repatha?
- Can Leqvio be taken without a statin?
- Does Leqvio cause weight gain?
- How is Leqvio injection administered?
- What is the mechanism of action for Leqvio (inclisiran)?
- Is Leqvio FDA approved as a high cholesterol treatment?
- Who is the actor in the Leqvio commercial?
- How does Leqvio work in treating high cholesterol?
- Where can I find the Leqvio FDA package insert?
