Omalizumab Brand Name– Xolair
What is Omalizumab
Omalizumab was the first monoclonal antibody directed against IgE and the first biologic therapy targeted for use for the treatment of asthma.
Omalizumab is a chimeric monoclonal antibody specific for IgE and is helpful for allergic asthma (i.e., asthma triggered by allergic responses to pollen, mold, dust mites, pet dander).
Omalizumab is indicated for use in adult and pediatric patients 6 years and older with moderate to severe persistent asthma that is inadequately controlled despite the use of inhaled corticosteroids (ICS) and who have a positive skin test or in vitro reactivity to a perennial aeroallergen.
In clinical trials, the addition of omalizumab to a patient’s drug regimen reduced the frequency of allergic asthma exacerbations compared to placebo; more patients treated with omalizumab were able to reduce or discontinue ICS use.
Omalizumab is also effective for the treatment of chronic idiopathic urticaria in patients 12 years and older who remain symptomatic despite H1 antihistamine treatment; the drug decreased hives and pruritus during clinical trials.
Anaphylactic reactions may develop after the first dose of omalizumab or during ongoing treatment, so patients should be administered each injection by a healthcare professional in a setting equipped to handle anaphylaxis.
The use of the drug requires the patient to remain under observation for an appropriate period of time (e.g., 120 minutes) after each injection is given.
While administration of omalizumab in a healthcare setting is preferred, in cases where administration by a healthcare professional is not possible, temporary self-administration may be considered in select patients with no prior history of anaphylaxis related or unrelated to omalizumab, who have received at least 3 doses of omalizumab, have the ability to recognize and manage signs and symptoms of a severe hypersensitivity reaction (including anaphylaxis), and can perform injections with proper technique and per the prescribed dosing regimen.
Indications
- asthma maintenance
- chronic idiopathic urticaria
For asthma maintenance add-on therapy in moderate or severe asthma
Side Effects
- abdominal pain
- alopecia
- angina
- angioedema
- antibody formation
- anxiety
- arthralgia
- bone fractures
- bronchospasm
- Churg-Strauss syndrome
- cough
- cystitis
- dizziness
- dyspnea
- eosinophilia
- epistaxis
- erythema
- fatigue
- fever
- headache
- hypotension
- infection
- injection site reaction
- lymphadenopathy
- migraine
- musculoskeletal pain
- myalgia
- myocardial infarction
- nausea
- new primary malignancy
- otalgia
- peripheral edema
- pharyngitis
- pruritus
- pulmonary embolism
- pulmonary hypertension
- rash
- serious hypersensitivity reactions or anaphylaxis
- serum sickness
- sinusitis
- stroke
- syncope
- thrombocytopenia
- thromboembolism
- thrombosis
- urticaria
- vasculitis
Monitoring Parameters
- pulmonary function tests (PFTs)
- serum IgE concentrations
- stool exam
- weight
Contraindications
- acute bronchospasm
- arthralgia
- breast-feeding
- children
- corticosteroid therapy
- corticosteroid withdrawal
- fever
- hamster protein hypersensitivity
- helminth infection
- history of angioedema
- infants
- latex hypersensitivity
- neonates
- neoplastic disease
- new primary malignancy
- omalizumab hypersensitivity
- pregnancy
- requires a specialized care setting
- serious hypersensitivity reactions or anaphylaxis
- status asthmaticus
- vasculitis
Interactions
There are no drug interactions associated with Omalizumab products.
