Omalizumab (1 brand name, 2 dosage forms, 0 routes)
Available dosage forms: SYRINGE, VIAL.
Brand Names
- XOLAIR
Boxed Warning
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 [see Dosage and Administration (2.6), Warnings and Precautions (5.1) and Adverse Reactions (6.1, 6.2)].
Contraindications
XOLAIR is contraindicated in patients with severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR [see Warnings and Precautions (5.1)].
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis [see Boxed Warning and Warnings and Precautions (5.1)] Malignancies [see Warnings and Precautions (5.2)]
Drug 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.