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Generic Name
Omalizumab
Brand Names
Omalizumab-igec, Xolair PFS, Xolair
FDA approval date: June 20, 2003
Classification: Anti-IgE
Form: Injection
What is Omalizumab-igec (Omalizumab)?
XOLAIR is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids.
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Related Clinical Trials
Omalizumab Weight-Based Dosing Efficacy Trial
Summary: This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.
A Multicenter, Randomized, Double-Blind, Active Drug and Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in the Treatment of Patients With Moderate to Severe Persistent Allergic Asthma.
Summary: This is a multicenter, randomized, masked, active and placebo controlled, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetics of LP-003 injection in adult patients with moderate to severe persistent allergic asthma.
A Multicenter, Randomized, Double-Blind, Positive Parallel Controlled Phase III Clinical Trial to Compare Omalizumab α(CMAB007) and Xolair® in Patients With Chronic Spontaneous Urticaria
Summary: This study is a multicenter, randomized, double-blind, positive parallel controlled phase III clinical trial to compare efficacy, immunogenicity, pharmacokinetics, pharmacodynamics and safety of omalizumab α(CMAB007) and Xolair® in patients with refractory chronic spontaneous urticaria
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Brand Information
Omalizumab-igec (omalizumab-igec)
WARNING: ANAPHYLAXIS
Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early as after the first dose of omalizumab products, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate Omalizumab-igec therapy in a healthcare setting and closely observe patients for an appropriate period of time after Omalizumab-igec administration. Health care providers administering Omalizumab-igec should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of Omalizumab-igec should be based on criteria to mitigate risk from anaphylaxis
1DOSAGE FORMS AND STRENGTHS
- Injection: 75 mg/0.5 mL is a clear to opalescent and colorless to pale brownish-yellow solution in a single-dose prefilled syringe with yellow plunger rod and safety guard.
- Injection: 150 mg/mL is a clear to opalescent and colorless to pale brownish-yellow solution in a single-dose prefilled syringe with blue plunger rod and safety guard.
- Injection: 300 mg/2 mL (150 mg/mL) is a clear to opalescent and colorless to pale brownish-yellow solution in a single-dose prefilled syringe with white plunger rod and safety guard
2CONTRAINDICATIONS
Omalizumab-igec is contraindicated in patients with severe hypersensitivity reaction to omalizumab products or any ingredient of Omalizumab-igec
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Anaphylaxis
- Malignancies
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of omalizumab products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
4DRUG INTERACTIONS
No formal drug interaction studies have been performed with omalizumab products.
In patients with asthma, CRSwNP, and IgE-mediated food allergy the concomitant use of omalizumab products and allergen immunotherapy has not been evaluated
In patients with CSU, the use of omalizumab products in combination with immunosuppressive therapies has not been studied.
5DESCRIPTION
Omalizumab-igec is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. Omalizumab-igec is produced by a Chinese hamster ovary cell suspension culture.
Omalizumab-igec is administered as a subcutaneous (SC) injection and is available in prefilled syringes.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
7PRINCIPAL DISPLAY PANEL - 75 mg/0.5 mL Syringe Carton
Rx only
Omalizumab-igec
75 mg/0.5 mL
x 1
FOR SUBCUTANEOUS USE
1
Do not use for emergency treatment.
Your dose may require more than 1 injection. For questions, contact your healthcare provider.
CELLTRION USA
8PRINCIPAL DISPLAY PANEL - 150 mg/mL Syringe Carton
Rx only
Omalizumab-igec
150 mg/mL
x 1
FOR SUBCUTANEOUS USE
1
Do not use for emergency treatment.
Your dose may require more than 1 injection. For questions, contact your healthcare provider.
CELLTRION USA
9PRINCIPAL DISPLAY PANEL - 300 mg/2 mL Syringe Carton
Rx only
Omalizumab-igec
300 mg/2 mL (150 mg/mL)
x 1
FOR SUBCUTANEOUS USE
1
Do not use for emergency treatment.
Your dose may require more than 1 injection. For questions, contact your healthcare provider.
CELLTRION USA
