Generic
Omalizumab
1 brands available in the market
At a glance
Omalizumab is a monoclonal antibody used for moderate to severe persistent asthma, nasal polyps and chronic spontaneous urticaria. It binds to immunoglobulin E (IgE) to reduce allergic reactions.
Description
Omalizumab is a monoclonal antibody that binds to IgE and inhibits binding of IgE to the high-affinity IgE receptor (FcεRI) on mast cells, basophils and dendritic cells, resulting in FcεRI down-regulation. In allergic asthmatics, omalizumab inhibits IgE-mediated inflammation, evidenced by reduced blood and tissue eosinophils and reduced inflammatory mediators (IL-4, IL-5, IL-13).
Indications
- Moderate to severe persistent asthma (6 years+) - inadequately controlled on inhaled corticosteroids
- Nasal polyps (18 years+) - inadequate response to nasal corticosteroids
- Chronic spontaneous urticaria (12 years+) - symptomatic despite H1 antihistamine treatment
Therapeutic class
Antihistamines, Anti-allergies & Hypo-sensitisation
Pharmacological class
Monoclonal Antibody (Anti-IgE)
Pharmacology
Omalizumab binds to IgE to reduce free IgE levels and down-regulate FcεRI receptors, reducing allergic responses. In asthmatics, it reduces blood and tissue eosinophils and inflammatory mediators (IL-4, IL-5, IL-13).
Mechanism of action
Controls asthma, nasal polyps and urticaria symptoms by inhibiting IgE-mediated allergic reactions.
Dosage
Dose (SC):
- Asthma: 75-375 mg every 2 or 4 weeks (based on serum IgE and body weight)
- Nasal polyps: 75-600 mg every 2 or 4 weeks
- Chronic spontaneous urticaria: 150 or 300 mg every 4 weeks (independent of IgE or weight)
Administration
- SC administration only
- Divide doses >150 mg among multiple injection sites
- Administered by doctor or nurse
- Initiate in healthcare setting prepared to manage anaphylaxis
Missed dose
Not generally applicable (scheduled administration); consult doctor if needed.
Side effects
Asthma (≥12 years):
- Arthralgia
- Pain (general)
- Leg pain
- Fatigue
- Dizziness
- Pruritus
- Dermatitis
Asthma (6-12 years): Nasopharyngitis, headache, pyrexia, abdominal pain, otitis media
Nasal Polyps: Headache, injection site reaction, arthralgia, abdominal pain, dizziness
CSU: Nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, arthralgia, headache, cough
Precautions & warnings
- Anaphylaxis may occur; observe in healthcare setting
- Do not use for acute bronchospasm or status asthmaticus
- Do not abruptly discontinue corticosteroids
- Monitor for eosinophilic conditions, vasculitic rash, neuropathy
- Discontinue if fever, arthralgia, rash (serum sickness-like) occur
Contraindications
- Hypersensitivity
Drug interactions
No known interactions.
Food interactions
No harmful interaction with alcohol.
Use in pregnancy
Use in Pregnancy: Omalizumab is considered safe during pregnancy; animal studies show low or no adverse effects.
Pregnancy Category: B — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Omalizumab is probably unsafe during breastfeeding; may pass into breast milk and harm the baby.
Pediatric use
Indicated for asthma in children 6 years+.
Geriatric use
Elderly may require dose adjustment.
Renal / hepatic impairment
Renal Impairment: Safe in kidney disease; dose adjustment may not be needed.
Hepatic Impairment: Safe in liver disease; dose adjustment may not be needed.
Overdose effects
Limited information on overdose; symptomatic treatment.
Storage conditions
Store at 2-8°C in refrigerator; do not freeze; protect from direct sunlight; do not use if exposed above 25°C.
Chemical structure
Omalizumab