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Oxlumo Side Effects

Generic name: lumasiran

Medically reviewed by Drugs.com. Last updated on Sep 17, 2022.

Note: This document contains side effect information about lumasiran. Some dosage forms listed on this page may not apply to the brand name Oxlumo.

Applies to lumasiran: subcutaneous solution.

Serious side effects of Oxlumo

Along with its needed effects, lumasiran (the active ingredient contained in Oxlumo) 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 Oxlumo

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]

References

1. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid" (2007):

2. "Product Information. Oxlumo (lumasiran)." Alnylam Pharmaceuticals (2020):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.