Omlyclo (Omalizumab-Igec) for Asthma

Overview
Omlyclo is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe persistent asthma in adults and children aged 6 and older. It is prescribed for individuals who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose asthma symptoms are not adequately controlled with inhaled corticosteroids. Omlyclo is a biosimilar to Xolair (omalizumab), which means it is highly similar to Xolair with no clinically meaningful differences in safety, purity, or effectiveness. Omlyclo is also known by its drug name, omalizumab-igec.

Omlyclo works by targeting and blocking immunoglobulin E (IgE), an antibody involved in allergic reactions and inflammation. By reducing IgE levels, Omlyclo helps prevent asthma symptoms and exacerbations in individuals with allergic asthma.

How do I take it?
Prescribing information states that Omlyclo is administered as a subcutaneous (under the skin) injection. The dose and frequency depend on the recipient’s body weight and baseline IgE levels. It is typically given every two or four weeks. Omlyclo should be taken exactly as prescribed by a healthcare provider.

Side effects
Common side effects of Omlyclo include joint pain, general pain, leg pain, fatigue, dizziness, fractures, arm pain, itching, dermatitis (skin inflammation), earache, nasopharyngitis (common cold), headache, fever, upper abdominal pain, streptococcal throat infection, ear infections, viral gastroenteritis (stomach flu), insect bites, and nosebleeds.

Rare but serious side effects may include anaphylaxis (a severe allergic reaction that can cause difficulty breathing, swelling, and low blood pressure), malignancies (cancers), eosinophilic conditions (high levels of certain white blood cells that can cause inflammation), serum sickness-like reactions (fever, joint pain, rash), and cardiac (heart-related) complications.

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Prescribing Information: Omlyco (Omalizumab-Igec) Injection, for Subcutaneous Use — Celltrion