Safety: Asthma adverse reactions

Xolair® adverse reactions in severe allergic asthma2

The adverse reactions observed in severe allergic asthma patients include:2

Infections and infestations
Uncommon Pharyngitis
Rare Parasitic infection
Blood and lymphatic system disorders
Not known Idiopathic thrombocytopenia, including severe cases
Immune system disorders
Rare Anaphylactic reaction, other serious allergic conditions, anti-omalizumab antibody development
Not known Serum sickness, may include fever and lymphadenopathy
Nervous system disorders
Common Headache
Uncommon Syncope, paraesthesia, somnolence, dizziness
Vascular disorders
Uncommon Postural hypotension, flushing
Respiratory, thoracic and mediastinal disorders
Common Allergic bronchospasm, coughing
Rare Laryngoedema
Not known Allergic granulomatous vasculitis (i.e Churg-Strauss syndrome)
Gastrointestinal disorders
Common Abdominal pain Upper††
Uncommon Dyspeptic signs and symptoms, diarrhoes, nausea
Skin and subcutaneous tissue disorders
Uncommon Photosensitivy, urticaria, rash, pruritua
Rare Angioedema
Not know Alopecia
Musculoskeketal and connective tissue disorders
Not known Arthralgia, myalgia, Joint swelling
General disorders and administration site conditions
Very common Pyrexia††
Common Injection site reactions such as swelling, erythema, pain, pruritus
Uncommon Influenza-like illness, swelling arms, weight increase, fatigue

Very common in children 6-<12 years of age.
††In children 6-<12 years years of age.
Frequency categories are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000)

Model is a hypothetical patient profile, for illustrative purposes only

*Data from ASTERIA II; two other phase III studies (ASTERIA I and GLACIAL) were also conducted to assess efficacy and safety of Xolair® in inadequately controlled CSU patients

§Xolair® 300mg vs. baseline at 12 weeks; p<0.001 vs. placebo.

Xolair® is also available as a lyophilized formulation

References: 1. Maurer M, et al. N Engl J Med 2013;368:924-935. 2. Xolair® Summary of Product Characteristics 2016. 3. Maurer M et al. Allergy 2011;66:317-330. 4. Weller K, et al. J Eur Acad Dermatol Venereol 2013;27:43-50

NP4 code: GLDEIM/IGE025E/0181

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