| name | Omalizumab |
| classification | Monoclonal antibody, anti-IgE |
| pharmacokinetics | Omalizumab is administered subcutaneously. It is primarily eliminated by the reticuloendothelial system. The half-life is approximately 11 to 14 days. Protein binding is high. Pharmacokinetics in patients with severe asthma or other conditions may vary. |
| suggested dosage | Dosage for omalizumab in severe asthma is individualized and determined by the patient's IgE level and weight. A starting dose is often 150 mg every 2-4 weeks, but this is a guideline and adjustments need to be made in accordance with the prescribing information and the patient's response. |
| indications | Omalizumab is primarily indicated for severe, persistent allergic asthma not controlled by standard therapy, including inhaled corticosteroids, long-acting beta-agonists, and potentially oral corticosteroids. It's also used in some severe forms of allergic rhinitis. |
| safety in pregnancy | Limited data are available regarding the safety of omalizumab during pregnancy. While the drug is thought to not cross the placental barrier to a significant extent, no large-scale, well-controlled studies exist. Therefore, omalizumab should be used during pregnancy only when the potential benefit outweighs the potential risk. The prescriber should carefully consider the potential benefits and risks to both the mother and the fetus. It's essential to document and monitor the patient closely. |
| safety in breastfeeding | Limited clinical data exists on the transfer of omalizumab into breast milk. Consequently, omalizumab use during breastfeeding should be approached with caution. The benefits and risks should be discussed with the patient and the risks and potential benefits carefully weighed. The treating physician should monitor the patient for any adverse effects in the infant. |
| side effects | | 1 | Injection site reactions (e.g., pain, redness, swelling) | | 2 | Headache | | 3 | Nasal congestion | | 4 | Upper respiratory tract infection | | 5 | Urticaria | | 6 | Injection-site reactions are common, usually mild and often temporary. | | 7 | More serious, though less frequent, adverse effects can include hypersensitivity reactions (anaphylaxis), infections, and skin conditions. | | 8 | The risk of serious adverse effects is relatively low with careful monitoring and appropriate patient selection. |
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| alternatives | | 1 | Mepolizumab | | 2 | Dupilumab | | 3 | Benralizumab | | 4 | These biologics can be considered as alternatives, but their specific indications and suitability need to be evaluated based on the individual patient's case. |
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| contraindications | Known hypersensitivity to omalizumab or any of its components. Active, uncontrolled infections. Severe hepatic impairment. |
| interactions | Limited drug interactions have been documented. However, prescribers should always consider potential interactions with other medications, particularly immunomodulators. A complete medication history should be taken. |
| warnings and precautions | | 1 | Careful monitoring of asthma symptoms and potential adverse events is crucial during therapy. | | 2 | Patients should be educated on the signs and symptoms of anaphylaxis and instructed on what to do if they experience a reaction. | | 3 | Close monitoring of liver function and overall health is essential during treatment with biologics. | | 4 | The risk of infection may be slightly elevated. Careful patient selection and monitoring of infectious disease events are necessary. |
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| additional information | Omalizumab should be administered by a healthcare professional trained in subcutaneous injections. Patient education and a thorough discussion of the potential benefits, risks, and alternatives is vital. Frequent follow-up visits are necessary. |
| patient profile | |
