Applies to lumasiran: subcutaneous solution.
Serious side effects of Lumasiran
Along with its needed effects, lumasiran may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Other side effects of Lumasiran
Some side effects of lumasiran 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
- stomach pain
For Healthcare Professionals
Applies to lumasiran: subcutaneous solution.
Local
The most common side effect reported was injection site reaction. During clinical studies, injection site reactions occurred in 10% of injections. The most commonly reported symptoms included erythema, pain, pruritus, and swelling. Injection site reactions were generally mild, resolved within 2 days, and did not lead to interruption/discontinuation of therapy.[Ref]
Very common (10% or more): Injection site reaction (included injection site reaction, injection site erythema, injection site pain, injection site pruritus, injection site swelling, injection site discomfort, injection site discoloration, injection site mass, injection site induration, injection site rash, injection site bruising, injection site hematoma, injection site exfoliation; up to 38%)[Ref]
Gastrointestinal
Very common (10% or more): Abdominal pain (included abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, abdominal tenderness; up to 15%)[Ref]
Immunologic
Common (1% to 10%): Anti-drug antibodies[Ref]
Anti-drug antibody titers were low and generally transient. No clinically significant differences in efficacy, safety, pharmacokinetic, or pharmacodynamic profiles of this drug were observed in patients who tested positive for anti-drug antibodies.[Ref]
