Note: This document contains side effect information about inclisiran. Some dosage forms listed on this page may not apply to the brand name Leqvio.
Applies to inclisiran: subcutaneous solution.
Serious side effects of Leqvio
Along with its needed effects, inclisiran (the active ingredient contained in Leqvio) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking inclisiran:
Less common
- Trouble breathing
Other side effects of Leqvio
Some side effects of inclisiran may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- difficulty in moving
- muscle pain or stiffness
- pain in the joints
Less common
- Bladder pain
- bloody or cloudy urine
- chest tightness
- cough producing mucus
- diarrhea
- difficulty, burning, or painful urination
- frequent urge to urinate
- lower back or side pain
- pain in the arms or legs
For Healthcare Professionals
Applies to inclisiran: subcutaneous solution.
Metabolic
Very common (10% or more): Diabetes mellitus (up to 11.6%)
Note: in Pooled Safety Analysis-Treatment Emergent AEs
Diabetes mellitus
Inclisiran: n=212, 11.6%
Placebo: n=207, 11.4%
Local
Common (1% to 10%): Injection site reactions (included injection site pain, injection site erythema, injection site rash)[Ref]
Injection site reactions occurred in 8.2% of patients and included injection site reaction (3.1%), injection site pain (2.2%), injection site erythema (1.6%), and injection site rash (0.7%). These reactions were mild or moderate in severity, transient, and resolved without sequelae.[Ref]
Musculoskeletal
Common (1% to 10%): Arthralgia, back pain, pain in extremity[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection[Ref]
Respiratory
Common (1% to 10%): Bronchitis, nasopharyngitis, cough, dyspnea[Ref]
Gastrointestinal
Common (1% to 10%): Diarrhea[Ref]
Nervous system
Common (1% to 10%): Dizziness, headache
Cardiovascular
Common (1% to 10%): Angina pectoris
Immunologic
Common (1% to 10%): Anti-drug antibodies[Ref]
