When should a patient hold Leqvio (inclisiran)?

When to Hold Leqvio (Inclisiran)

Patients should hold Leqvio (inclisiran) if they experience muscle weakness, have severe hepatic impairment, are pregnant or breastfeeding, or have active infection at the injection site. 1, 2

Specific Conditions Requiring Discontinuation

Muscle-Related Symptoms

• Hold Leqvio immediately if the patient experiences:
  • Generalized muscle weakness
  • Severe myalgia that interferes with daily activities
  • Symptoms suggestive of myopathy or rhabdomyolysis 2
• Evaluate CK levels and renal function if muscle symptoms occur

Pregnancy and Breastfeeding

• Discontinue Leqvio if pregnancy is confirmed or planned
• Not recommended during breastfeeding 1

Hepatic Impairment

• Hold in patients with severe hepatic impairment
• No dose adjustment needed for mild to moderate hepatic impairment 2, 3

Injection Site Reactions

• Postpone administration if there is active infection or inflammation at the planned injection site
• Consider alternative site if mild injection site reaction is present 3

Temporary Holds vs. Permanent Discontinuation

Temporary Holds (Resume when resolved)

• Acute infection with systemic symptoms
• Planned major surgery
• Active infection at the injection site
• Temporary use of interacting medications

Consider Permanent Discontinuation

• Severe allergic reaction
• Persistent muscle symptoms despite holding the medication
• Pregnancy (if planning to continue pregnancy)
• Development of severe hepatic impairment

Monitoring Recommendations

Before Each Dose

• Assess for any new symptoms or side effects
• Review current medications for potential interactions
• Check injection site for any signs of infection or inflammation

Laboratory Monitoring

• No specific laboratory monitoring is required solely for Leqvio administration
• Consider checking lipid levels 3-6 months after initiation and periodically thereafter 1, 2
• If muscle symptoms occur, check CK levels and renal function

Special Considerations

Elderly Patients

• No dose adjustment needed based on age
• Evaluate frailty status and consider overall cardiovascular risk profile
• Monitor more closely for adverse effects 2, 4

Renal Impairment

• No dose adjustment needed for any degree of renal impairment 2, 4

Concomitant Medications

• No significant drug-drug interactions have been reported
• Can be safely administered with statins and other lipid-lowering therapies 4

Resuming Treatment

When resuming Leqvio after a temporary hold:

• If ≤3 months since last dose: resume regular schedule
• If >3 months since last dose: restart with the initial dosing regimen (doses at day 1 and day 90, then every 6 months) 3, 5

Leqvio's unique twice-yearly dosing schedule (after initial doses at day 1 and day 90) provides a significant advantage for adherence compared to other lipid-lowering therapies, but appropriate monitoring and knowing when to hold treatment are essential for optimal patient outcomes 3, 5.