What is the maximum delay for a Leqvio (inclisiran) injection if a patient misses their scheduled dose?

Maximum Delay for Leqvio (Inclisiran) Injection

If a Leqvio injection is missed by less than 3 months, administer it as soon as possible and maintain the original dosing schedule; if missed by more than 3 months, restart the entire dosing sequence with a new initial dose, followed by another dose at 3 months, then every 6 months thereafter. 1

Standard Dosing Schedule

• Leqvio is administered as 284 mg subcutaneous injections initially, again at 3 months, and then every 6 months 1
• This twice-yearly maintenance dosing (after the loading phase) provides a significant convenience advantage over daily oral lipid-lowering therapies and may improve adherence 2, 3

Management of Missed Doses

Delay Less Than 3 Months

• Administer the missed dose immediately and continue with the patient's original 6-month schedule 1
• No adjustment to future dosing dates is required 1
• For example, if a patient's dose due in January is given in March (2 months late), the next dose would still be due in July (6 months from the original January date)

Delay of 3 Months or More

• Restart the entire dosing regimen as if initiating therapy for the first time 1
• Give the first dose immediately, the second dose at 3 months, then resume every 6 months 1
• This "reloading" approach ensures adequate PCSK9 suppression is re-established 1

Clinical Considerations

• LDL-C lowering effects can be measured as early as 30 days after any injection and at any time thereafter, regardless of timing relative to the dose 1
• Inclisiran achieves approximately 50% reduction in LDL-C levels with its twice-yearly dosing regimen 2, 4, 5
• The drug works by inhibiting hepatic PCSK9 synthesis, leading to sustained LDL-C reductions between doses 2, 4

Safety Profile

• Injection site reactions are the most common adverse event (28% vs 2% with placebo), but are typically mild and transient 1
• The safety profile is otherwise similar to placebo, with no significant differences in liver function, kidney function, or creatine kinase levels 5
• Adverse events leading to discontinuation occur in only 2.5% of patients 1

Important Caveats

• The 3-month cutoff is critical: delays beyond this threshold require complete reloading to ensure therapeutic PCSK9 suppression is maintained 1
• Patients should be counseled about the importance of maintaining their scheduled injections, as the drug's efficacy depends on consistent twice-yearly dosing after the initial loading phase 2
• Healthcare providers should assess LDL-C levels when clinically indicated to confirm therapeutic response, particularly after missed doses 1