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Omalizumab: Brands, Price & Uses in Bangladesh
Omalizumab is a recombinant humanized monoclonal antibody that targets immunoglobulin E (IgE) and is used across several IgE-mediated allergic conditions.
About Omalizumab
Indications of Omalizumab
Omalizumab is a recombinant humanized monoclonal antibody that targets immunoglobulin E (IgE) and is used across several IgE-mediated allergic conditions. Its approved and evidence-supported uses include:
Established / Approved Indications
- Moderate-to-severe persistent allergic asthma (age 6 years and above) with a positive skin test or in vitro reactivity to a perennial aeroallergen, in patients whose symptoms are inadequately controlled with inhaled corticosteroids.
- Chronic idiopathic (spontaneous) urticaria (CIU/CSU) (age 12 years and above) in patients who remain symptomatic despite H1-antihistamine treatment.
- Chronic rhinosinusitis with nasal polyps (CRSwNP) (age 18 years and above), as add-on maintenance treatment.
- IgE-mediated food allergy (age 1 year and above), to reduce the risk and severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods. Omalizumab does not treat an acute allergic reaction and must be used together with continued food allergen avoidance.
Not an Indicated Use
Omalizumab is not indicated for the relief of acute bronchospasm or status asthmaticus, and is not a rescue medication.
Dosage & Administration of Omalizumab
The dose and dosing interval of Omalizumab depend on the indication being treated and, for several indications, on the patient's baseline serum total IgE level and body weight, using the manufacturer's dosing table. Omalizumab is given only as a subcutaneous (under-the-skin) injection.
| Indication | Approved age | Typical dose | Frequency |
|---|---|---|---|
| Allergic asthma | 6 years and above | 75–375 mg (individualized by baseline IgE and body weight, per dosing table) | Every 2 or 4 weeks |
| Chronic idiopathic (spontaneous) urticaria | 12 years and above | 150 mg or 300 mg (fixed dose, not based on IgE or weight) | Every 4 weeks |
| Chronic rhinosinusitis with nasal polyps | 18 years and above | 75–600 mg (individualized by baseline IgE and body weight) | Every 2 or 4 weeks |
| IgE-mediated food allergy | 1 year and above | 75–600 mg (individualized by baseline IgE and body weight) | Every 2 or 4 weeks |
Doses above 150 mg are usually divided across more than one injection site. Omalizumab must be administered by, or under the supervision of, a healthcare professional; for certain prefilled forms, self-injection by the patient or caregiver may be appropriate after proper training. Omalizumab must be given in a healthcare setting where anaphylaxis can be recognized and treated (see Precautions and Warnings) and is not intended for use during an acute asthma exacerbation.
Response to Omalizumab should be periodically reassessed by the prescribing physician; if no improvement is seen after an adequate treatment trial, continued therapy should be reconsidered (see Duration of Treatment).
Side Effects of Omalizumab
Most patients tolerate Omalizumab reasonably well; adverse effects range from common and mild to rare but serious reactions.
Common Side Effects
- Injection-site reactions (pain, swelling, redness, itching, bruising)
- Headache
- Upper respiratory tract infection
- Sinusitis
- Joint pain (arthralgia)
- Fatigue
- Dizziness
Serious but Less Common Side Effects
- Anaphylaxis (see boxed warning under Precautions and Warnings)
- Serum-sickness-like reactions (fever, joint pain/swelling, rash, lymphadenopathy), typically 1–5 days after an injection
- Malignancy (numerically higher rate observed in some early trials; a causal relationship has not been established — see Precautions and Warnings)
- Cardiovascular and cerebrovascular events have been reported in some observational data, though a causal link to Omalizumab has not been established
Patients should seek immediate medical attention for any signs of a severe allergic reaction after receiving Omalizumab.
Contraindications of Omalizumab
Omalizumab is contraindicated in patients with a known history of severe hypersensitivity (including anaphylaxis) to Omalizumab or to any excipient in the formulation.
Frequently Asked Questions about Omalizumab
What is Omalizumab used for?
Omalizumab is a biologic (anti-IgE monoclonal antibody) injection used to treat moderate-to-severe allergic asthma not controlled by inhaled corticosteroids, chronic idiopathic (spontaneous) urticaria not controlled by antihistamines, chronic rhinosinusitis with nasal polyps, and to reduce the risk of allergic reactions from accidental exposure in IgE-mediated food allergy. It is not a rescue medicine for sudden asthma attacks or acute allergic reactions.
How is Omalizumab given?
Omalizumab is given only as a subcutaneous (under-the-skin) injection, usually into the upper arm or thigh, every 2 or 4 weeks. It must be administered in a healthcare setting equipped to treat a severe allergic reaction, and you will usually be observed for a period after each injection.
What is the most serious risk with Omalizumab?
The most serious risk is anaphylaxis, a severe, potentially life-threatening allergic reaction that can occur after any dose of Omalizumab, even after you have received it safely before. Signs include difficulty breathing, swelling of the throat or tongue, dizziness, fainting, or hives. Seek emergency medical help immediately if these occur after an injection of Omalizumab.
Can Omalizumab be used during pregnancy or breastfeeding?
Omalizumab should be used during pregnancy only if your physician determines the potential benefit justifies the potential risk to the baby, since Omalizumab, like other antibody-based medicines, can cross the placenta. Small amounts of Omalizumab may pass into breast milk; discuss the risks and benefits of continuing Omalizumab while breastfeeding with your physician.
Who should not take Omalizumab?
Omalizumab should not be used by anyone who has had a severe hypersensitivity reaction (such as anaphylaxis) to Omalizumab or any of its ingredients in the past.
Does Omalizumab replace my regular asthma inhaler or antihistamine?
No. Omalizumab is an add-on therapy and does not replace inhaled corticosteroids, rescue inhalers, or antihistamines. Any change to these other medicines while using Omalizumab should be made gradually and only under your physician's supervision.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.