Applies to inclisiran: subcutaneous solution.

Other side effects of Inclisiran

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

• Chest tightness
• cough producing mucus
• trouble breathing

For Healthcare Professionals

Applies to inclisiran: subcutaneous solution.

Hepatic

Very common (10% or more): Serum hepatic transaminase elevations, elevated ALT (up to 19.7%), elevated AST (up to 17.2%)

In clinical studies, more frequent elevations of serum hepatic transaminases between greater than 1 times the upper limit of normal (1 x ULN) and up to 3 x ULN in patients receiving this drug compared to placebo. ALT and AST elevations were reported in 19.7%, and 17.2%, respectively, of patients using this drug compared with 13.6% and 11.1%, respectively, of patients on placebo; these elevations did not progress to exceed the clinically relevant threshold of 3 x ULN, were asymptomatic, and were not associated with adverse reactions or other evidence of liver dysfunction.

Metabolic

Very common (10% or more): Diabetes mellitus (up to 11.6%)

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]