Xolair

• Approved Indications:
• Moderate to severe persistent allergic asthma in patients aged 6 years and older with a positive skin test or in vitro reactivity to a perennial aeroallergen whose symptoms are inadequately controlled with inhaled corticosteroids.
• Chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older who remain symptomatic despite H1-antihistamine treatment.
• Nasal polyps associated with chronic rhinosinusitis in adults.
• Off-label Uses:
• Allergic bronchopulmonary aspergillosis (ABPA).
• Other IgE-mediated disorders resistant to standard therapies.

• Asthma:
• Dosage is based on body weight (kg) and baseline serum IgE levels (IU/mL).
• Dose ranges from 150 mg to 375 mg administered subcutaneously every 2 or 4 weeks.
• Dose adjustments are made according to IgE level and clinical response.
• Chronic Spontaneous Urticaria:
• 300 mg subcutaneously every 4 weeks.
• Treatment duration is usually at least 6 months, with continuation based on response.
• Nasal Polyps:
• 300 mg subcutaneously every 4 weeks.
• Special Populations:
• Pediatric patients (6 to <12 years) receive doses based on IgE and weight per standard dosing tables.
• No specific dose adjustment for elderly patients.
• Use caution in patients with severe renal or hepatic impairment; no formal dose adjustments established.
• Administration Notes:
• Administer subcutaneously by healthcare professionals.
• Observe patients for at least 2 hours after the first three doses and for at least 30 minutes after subsequent doses due to risk of anaphylaxis.

Omalizumab is a recombinant humanized monoclonal antibody that binds selectively to the Fc portion of free Immunoglobulin E (IgE) in the circulation. By preventing free IgE from binding to high-affinity IgE receptors (FcεRI) on mast cells and basophils, omalizumab inhibits the release of inflammatory mediators responsible for allergic symptoms. This action reduces airway inflammation in asthma, decreases urticaria symptoms, and diminishes nasal polyp formation.

• Absorption: Slowly absorbed after subcutaneous injection, with peak serum concentrations reached approximately 7 to 8 days post-dose.
• Distribution: Volume of distribution is approximately 78 mL/kg.
• Metabolism: Degraded by proteolytic enzymes into small peptides and amino acids; no involvement of hepatic cytochrome P450 enzymes.
• Elimination: Half-life is approximately 26 days; eliminated mainly by reticuloendothelial system degradation.
• Bioavailability: Approximately 62%.
• Steady State: Achieved after about 14 weeks of repeated dosing.

• Pregnancy: Classified as FDA Pregnancy Category B. Animal studies have not demonstrated risk, but adequate human studies are lacking. Use only if clearly needed and benefits outweigh risks.
• Lactation: Limited data on secretion into human breast milk. Potential immunologic effects on nursing infants are unknown; use with caution.
• Data Status: Human safety data are limited; clinical judgment is advised.

• Primary class: Monoclonal antibody (Anti-IgE antibody)
• Subclass: Biological immunomodulator

• Known hypersensitivity to omalizumab or any excipients in the formulation.
• History of anaphylaxis or severe hypersensitivity reaction to previous omalizumab administration.

• Anaphylaxis: Can occur after any dose, including first. Requires immediate treatment and prolonged monitoring.
• Malignancy: Post-marketing data show inconclusive evidence of increased risk; monitor patients accordingly.
• Parasitic Infections: IgE suppression may increase risk of parasitic infections. Treat infections before starting therapy.
• Cardiovascular and Cerebrovascular Risk: Monitor patients with pre-existing conditions.
• Immunogenicity: Rare development of anti-omalizumab antibodies reported.
• Monitoring: Observe patients post-injection for hypersensitivity reactions, especially during initial doses.

• Common:
• Injection site reactions (pain, erythema, swelling)
• Headache
• Upper respiratory tract infections
• Viral infections
• Sinusitis
• Serious (rare):
• Anaphylaxis
• Serum sickness-like reactions
• Thrombocytopenia
• Possible malignancies (unconfirmed association)
• Onset: Injection site reactions usually occur shortly after administration; anaphylaxis can occur up to 24 hours post-dose.

• No significant drug-drug interactions identified.
• Does not inhibit or induce cytochrome P450 enzymes.
• No known interactions with corticosteroids, bronchodilators, or antihistamines.
• Concurrent immunosuppressive therapy may increase infection risk.

• Recent asthma management guidelines endorse omalizumab as an add-on treatment for moderate-to-severe allergic asthma inadequately controlled with standard therapy.
• Expanded indication approved for nasal polyps treatment.
• Updated recommendations stress strict monitoring for anaphylaxis.
• No new major safety warnings or dosing changes in the latest regulatory updates.

• Store refrigerated between 2°C and 8°C (36°F to 46°F).
• Protect from light; keep in original carton until use.
• Do not freeze.
• Allow to reach room temperature before administration (approximately 30 minutes).
• Do not shake the vial or syringe.
• Use prepared solutions immediately; discard any unused portion.