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omalizumab

Xolair · ATC code R03DX05

Key facts
Active substance
omalizumab
ATC code
R03DX05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Xolair 75 mg solution for injection in pre-filled syringe / Xolair 75 mg solution for injection in pre-filled pen · Xolair 150 mg solution for injection in pre-filled syringe / Xolair 300 mg solution for injection in pre-filled syringe / Xolair 150 mg solution for injection in pre-filled pen · Xolair 75 mg powder and solvent for solution for injection · Xolair 150 mg powder and solvent for solution for injection
Marketing authorisation holder
Novartis Europharm Limited
Information as of
2026-10-27

Key facts

Omalizumab (Xolair) is a humanised anti-IgE monoclonal antibody. It is used as add-on therapy in severe allergic asthma, severe chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria.

What it is used for

  • Severe persistent IgE-mediated allergic asthma as add-on therapy in adults, adolescents and children (6 to <12 years) despite high-dose inhaled corticosteroids plus a LABA
  • Severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults (18 years and above) as add-on to intranasal corticosteroids
  • Chronic spontaneous urticaria in adults and adolescents (12 years and above) with inadequate response to H1 antihistamines

Dosing

  • Subcutaneous injection; initiated by physicians experienced in the condition
  • Asthma and CRSwNP: dose and frequency are determined from baseline IgE (IU/ml) and body weight (kg) using dose tables; 75 to 600 mg in 1 to 4 injections per administration
  • Maximum recommended dose: 600 mg every two weeks
  • Patients whose IgE level or body weight is outside the dose table limits should not be given omalizumab
  • The first 3 doses must be given by or under the supervision of a healthcare professional
  • Dosing in chronic spontaneous urticaria: see the full text

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Type I allergic reactions including anaphylaxis, mostly within 2 hours of injection, also after long treatment
  • Serum sickness and serum sickness-like reactions (arthritis/arthralgia, rash, fever, lymphadenopathy)
  • Not indicated for acute asthma exacerbations, acute bronchospasm or status asthmaticus
  • Corticosteroids should not be stopped abruptly after starting omalizumab; reductions under physician supervision
  • Rarely systemic eosinophilia and vasculitis (Churg-Strauss syndrome), commonly linked to oral corticosteroid reduction
  • Caution in patients at high risk of helminth infection

Side effects

  • Asthma (12 years and older): most commonly headache and injection site reactions (pain, swelling, erythema, pruritus)
  • Children (6 to <12 years): headache, pyrexia, upper abdominal pain
  • CRSwNP: headache, dizziness, arthralgia, upper abdominal pain, injection site reactions
  • Urticaria: including sinusitis, headache, arthralgia, upper respiratory tract infection
  • Serious: anaphylaxis, serum sickness

Interactions

  • Little interaction potential; CYP450, efflux pumps and protein binding are not involved in clearance
  • May indirectly reduce the efficacy of treatments for helminthic or other parasitic infections

Pregnancy and breastfeeding

  • Registry and post-marketing data (between 300-1 000 pregnancy outcomes) indicate no malformative or foeto/neonatal toxicity
  • Omalizumab is expected to be present in human milk; the EXPECT study did not indicate adverse effects on breast-fed infants

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • Omlyclo · biosimilarCelltrion Healthcare Hungary Kft. · EMEA/H/C/005958
  • XolairNovartis Europharm Limited · EMEA/H/C/000606

Source: European Medicines Agency (EMA), product information

Turkey

  • OmlycloCELLTRİON HEALTHCARE İLAÇ SAN. VE TİC. LTD. ŞTİ. · 2 register entries
  • XolairNOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNLERİ SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Omlyclo, Xolair
Liechtenstein
Omlyclo, Xolair
Norway
Omlyclo, Xolair

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Xolair – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/xolair-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.