Generic Name
Omalizumab
Brand Names
Xolair PFS, Xolair
FDA approval date: June 20, 2003
Classification: Anti-IgE
Form: Injection
What is Xolair PFS (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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Brand Information
XOLAIR (omalizumab)
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 XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR 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 XOLAIR should be based on criteria to mitigate risk from anaphylaxis
1DOSAGE FORMS AND STRENGTHS
Injection:
- 75 mg/0.5 mL is a clear to slightly opalescent and colorless to pale brownish-yellow solution in a single-dose prefilled syringe with needle shield or single-dose prefilled autoinjector
- 150 mg/mL is a clear to slightly opalescent and colorless to pale brownish-yellow solution in a single-dose prefilled syringe with needle shield or single-dose prefilled autoinjector
- 300 mg/2 mL is a clear to slightly opalescent and colorless to pale brownish-yellow solution in a single-dose prefilled syringe with needle shield or single-dose prefilled autoinjector
- For injection: 150 mg white lyophilized powder in a single-dose vial for reconstitution
2CONTRAINDICATIONS
XOLAIR is contraindicated in patients with severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR
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 XOLAIR. 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 XOLAIR.
In patients with asthma, CRSwNP, and IgE-mediated food allergy the concomitant use of XOLAIR and allergen immunotherapy has not been evaluated
In patients with CSU, the use of XOLAIR in combination with immunosuppressive therapies has not been studied.
5DESCRIPTION
Omalizumab 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. XOLAIR is produced by a Chinese hamster ovary cell suspension culture.
XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
7PRINCIPAL DISPLAY PANEL - 150 mg Vial Carton
NDC 50242-040-62
150 mg
Xolair
KEEP REFRIGERATED. DO NOT FREEZE.
Genentech
NOVARTIS
10198215
8PRINCIPAL DISPLAY PANEL - 75 mg/0.5 mL Syringe Carton - 214-01
Xolair
75 mg/0.5 mL
For Subcutaneous Use. Single-Dose Prefilled Syringe.
Dispense the accompanying
1 prefilled syringe
Do not use for emergency treatment.
NDC 50242-214-01
Caution: The needle cap may contain natural rubber latex
Rx only
Genentech
NOVARTIS
11011555
9PRINCIPAL DISPLAY PANEL - 75 mg/0.5 mL Syringe Carton - 214-03
Xolair
75 mg/0.5 mL
For Subcutaneous Use.
1 Single-Dose Prefilled Syringe
Do not use for emergency treatment.
NDC 50242-214-03
Dispense the accompanying Medication Guide to each patient.
Rx only
Must be refrigerated
Genentech
NOVARTIS
11011485
10PRINCIPAL DISPLAY PANEL - 75 mg/0.5 mL Autoinjector Carton
Xolair
75 mg/0.5 mL
For Subcutaneous Use.
1 Single-Dose Autoinjector
Do not use for emergency treatment.
NDC 50242-214-55
Dispense the accompanying Medication Guide to each patient.
Genentech
NOVARTIS
11011505
11PRINCIPAL DISPLAY PANEL - 150 mg/mL Syringe Carton - 215-01
Xolair
150 mg/mL
For Subcutaneous Use. Single-Dose Prefilled Syringe.
Dispense the accompanying
1 prefilled syringe
Do not use for emergency treatment.
NDC 50242-215-01
Caution: The needle cap may contain natural rubber latex
Rx only
Genentech
NOVARTIS
11011498
12PRINCIPAL DISPLAY PANEL - 150 mg/mL Syringe Carton - 215-03
Xolair
150 mg/mL
For Subcutaneous Use.
1 Single-Dose Prefilled Syringe
Do not use for emergency treatment.
NDC 50242-215-03
Dispense the accompanying Medication Guide to each patient.
Rx only
Must be refrigerated
Genentech
NOVARTIS
11011522
13PRINCIPAL DISPLAY PANEL - 150 mg/mL Autoinjector Carton
Xolair
150 mg/mL
For Subcutaneous Use.
1 Single-Dose Autoinjector
Do not use for emergency treatment.
NDC 50242-215-55
Dispense the accompanying Medication Guide to each patient.
Genentech
NOVARTIS
11011532
14PRINCIPAL DISPLAY PANEL - 300 mg/2 mL Syringe Carton
Xolair
300 mg/2 mL
For Subcutaneous Use.
1 Single-Dose Prefilled Syringe
Do not use for emergency treatment.
NDC 50242-227-01
Dispense the accompanying Medication Guide to each patient.
Rx only
Must be refrigerated
Genentech
NOVARTIS
11011496
15PRINCIPAL DISPLAY PANEL - 300 mg/2 mL Autoinjector Carton
Xolair
300 mg/2 mL
For Subcutaneous Use.
1 Single-Dose Autoinjector
Do not use for emergency treatment.
NDC 50242-227-55
Dispense the accompanying Medication Guide to each patient.
Genentech
NOVARTIS
11011548
