What is the dosing for Xolair (Omalizumab)?

From the Guidelines

Xolair (omalizumab) dosing for chronic spontaneous urticaria should start with 300 mg every 4 weeks, with consideration for updosing to a maximum of 600 mg every 14 days if there is an insufficient response, as recommended by the most recent guidelines 1. The dosing of Xolair is crucial for managing chronic spontaneous urticaria effectively, and the latest guidelines provide a clear approach to its use.

• The initial dose of 300 mg every 4 weeks is based on well-designed, robust double-blind placebo-controlled studies demonstrating its efficacy in chronic spontaneous urticaria (CSU) 1.
• Updosing can be considered in patients with an insufficient response, which may involve shortening the interval and/or increasing the dosage, with a maximum recommended dose of 600 mg every 14 days 1.
• The decision to updose should be based on individual patient needs and response to treatment, taking into account factors such as body mass index and the presence of other health conditions.
• It is essential to monitor patients closely for potential adverse events, particularly anaphylaxis, which can occur with any dose of Xolair.
• The use of Xolair should be part of a comprehensive treatment plan that includes other medications and lifestyle modifications as needed to manage chronic spontaneous urticaria effectively. Key considerations in the management of chronic spontaneous urticaria with Xolair include:
• Starting with a standard dose and adjusting as needed based on patient response
• Monitoring for potential adverse events and adjusting the treatment plan accordingly
• Considering the use of other medications, such as cyclosporine, in patients who do not respond to Xolair
• Individualizing treatment based on patient needs and response to therapy, as recommended by the latest guidelines 1.

From the FDA Drug Label

XOLAIR (omalizumab) injection is supplied as a sterile, preservative-free, clear to slightly opalescent and colorless to pale brownish-yellow solution for subcutaneous injection XOLAIR (omalizumab) injection is available as a single-dose prefilled syringe or a single-dose autoinjector. Each 75 mg prefilled syringe or autoinjector delivers 75 mg omalizumab in 0.5 mL Each 150 mg prefilled syringe or autoinjector delivers 150 mg omalizumab in 1 mL Each 300 mg prefilled syringe or autoinjector delivers 300 mg omalizumab in 2 mL

The dosing for XOLAIR is as follows:

• Available doses: 75 mg, 150 mg, and 300 mg
• Administration: Subcutaneous injection
• Formulation: Prefilled syringe, autoinjector, or vial for injection 2

From the Research

Omalizumab Dosing Overview

• Omalizumab, also known as Xolair, is a recombinant humanized anti-immunoglobulin-E antibody used to treat chronic spontaneous urticaria (CSU) and allergic asthma 3, 4, 5, 6, 7.
• The dosing of omalizumab is based on serum IgE levels and body weight, with a recommended dose range of 150-375 mg every 2 or 4 weeks for allergic asthma 7.
• For CSU, the licensed doses of omalizumab are 150 mg and 300 mg, with some patients requiring updosing to achieve complete symptom control 3, 4.

Dosing Strategies

• An individualized tiered dosing table has been developed to simplify dosing and ensure that free IgE reduction is achieved, taking into account the patient's weight and baseline IgE level 7.
• Studies have shown that patients with severe allergic asthma above the recommended dosing criteria can still benefit from omalizumab treatment without dose escalation above 750 mg 6.
• Omalizumab treatment should be started with 300 mg every 4 weeks for CSU, monitored with validated patient-reported outcome measures, and maintained until remission of CSU 4.

Efficacy and Safety

• Omalizumab has been shown to be effective in reducing symptoms and improving quality of life in patients with CSU and allergic asthma 3, 4, 5, 6, 7.
• The treatment has a good safety profile, with no significant differences in response between patients above and within the recommended dosing ranges 6.
• However, patients should be monitored for potential side effects, including anaphylaxis, and treated accordingly 5.