XOLAIR 150MG.1 VIAL

Omalizumab is a humanised monoclonal antibody that selectively binds to free immunoglobulin E (IgE) in the blood and on the surface of basophils and mast cells. By capturing circulating IgE, it prevents IgE from binding to high-affinity IgE receptors (FcepsilonRI) on mast cells and basophils — thereby preventing the allergic cascade that triggers allergy symptoms, bronchoconstriction, and anaphylaxis.

Xolair is indicated for:

•       Severe persistent allergic (IgE-mediated) asthma in adults, adolescents, and children aged 6 years and older — who have a positive skin test or in vitro reactivity to a perennial allergen, and whose asthma is inadequately controlled with high-dose inhaled corticosteroids plus a long-acting beta-agonist.

•       Chronic spontaneous urticaria (CSU) — in adults and adolescents aged 12 years and older who remain symptomatic despite H1-antihistamine therapy.

•       Chronic rhinosinusitis with nasal polyps (CRSwNP) — in adults as add-on therapy.

Omalizumab is given by subcutaneous (SC) injection by a healthcare professional (or by trained patients/caregivers for some indications). The dose and frequency are determined by the patient's total serum IgE level and body weight (for asthma), or by flat dosing for CSU (300 mg every 4 weeks). The dose ranges from 75 to 600 mg per administration, with injections every 2 or 4 weeks.

The lyophilised powder is reconstituted with sterile water for injection — this takes approximately 15–20 minutes to dissolve (the solution is viscous). Volumes > 150 mg per injection should be split across two or more injection sites. Patients should be observed for 30–60 minutes after the first three injections because of the risk of anaphylaxis.

Omalizumab must not be used in: known hypersensitivity to omalizumab or any excipient; and for acute asthma attacks or acute bronchospasm (not a rescue therapy).

Use with caution in: pregnancy and breastfeeding (discuss benefit vs risk with specialist — omalizumab crosses the placenta; limited data but generally considered acceptable in severe asthma); and patients at high risk of parasitic infections.

No significant pharmacokinetic drug interactions have been identified with omalizumab due to its biological clearance pathway. It is safe to use alongside inhaled corticosteroids, LABAs, antihistamines, and most standard medications. Systemic corticosteroids: can be reduced or withdrawn in some patients after omalizumab stabilises disease — this should be done gradually under specialist supervision.

Store at 2–8°C (refrigerate). Do not freeze. Keep in original carton to protect from light. Once reconstituted, use within 8 hours if kept refrigerated, or within 4 hours at room temperature. The reconstituted solution should be clear to slightly opalescent and colourless to pale brownish-yellow with no particulates.

Omalizumab targets the root cause of allergic asthma and urticaria — the IgE antibody — rather than just managing symptoms. For patients with difficult-to-control severe asthma or chronic urticaria, it can dramatically reduce exacerbations, emergency visits, oral steroid use, and significantly improve quality of life. Clinical response is assessed at 16 weeks (asthma) or 12 weeks (CSU) — if there is no meaningful response, continuing treatment is unlikely to be of benefit.

Even if your asthma is well-controlled on omalizumab, do NOT stop your regular inhaled preventer (corticosteroid) inhaler without your specialist's instruction. Omalizumab works alongside your regular medicines, not instead of them.

Carry your adrenaline auto-injector (EpiPen) at all times after starting omalizumab, as delayed anaphylaxis (up to 24 hours after injection) has been reported. Ensure you and a family member or caregiver know how to use it.

Omalizumab dosing for asthma is determined by a dosing table based on baseline serum total IgE (IU/mL) and body weight (kg). The dose ranges from 75 mg every 4 weeks (lowest IgE/weight) to 600 mg every 2 weeks (highest IgE/weight).

The 150 mg vial is one of two vial sizes (75 mg and 150 mg); multiple vials are combined for higher doses. For CSU: 300 mg every 4 weeks, irrespective of IgE or weight.

For CRSwNP: 300 mg every 4 weeks. Reconstitution: add 1.4 mL sterile water per 150 mg vial; use a 1-inch needle for SC injection; allow 15–20 min for complete dissolution (thick solution).

Response assessment at 16 weeks for asthma — document with ACQ/ACT or equivalent; consider discontinuation if no response. Biologic treatment in asthma is typically continued long-term if response is maintained; some patients can be trialled on extended intervals after sustained remission.

Why do I need an EpiPen if I am being treated for allergy?

Although rare, omalizumab itself can occasionally trigger anaphylaxis. An adrenaline auto-injector (EpiPen) is prescribed as a precautionary measure. Carry it at all times, especially for 24 hours after each injection.

Can I stop my preventer inhaler once I start omalizumab?

No — never stop your preventer inhaler without your specialist's advice. Omalizumab supplements your existing therapy; any reduction in inhaled corticosteroids must be guided by your specialist, done gradually, and monitored carefully.

Is omalizumab safe in pregnancy?

Omalizumab is a large protein that crosses the placenta. Data from pregnancy registries (over 250 pregnancies) have not shown increased risks. For women with severe uncontrolled asthma, the risks of poorly controlled disease during pregnancy generally outweigh the theoretical risks of continuing omalizumab. Discuss your individual situation with your specialist and obstetrician.

How long will I need this treatment?

For asthma and CRSwNP, treatment is typically long-term, continued as long as meaningful benefit is maintained. For CSU: treatment may be time-limited — some patients achieve sustained remission and can discontinue after 1–2 years. Your specialist will review regularly.