Description

Xolair (Omalizumab) is a monoclonal antibody used primarily for the treatment of moderate to severe persistent allergic asthma and chronic spontaneous urticaria (hives) in patients aged 12 years and older. It works by inhibiting the action of immunoglobulin E (IgE), which plays a key role in allergic responses.

Uses

• Allergic Asthma: Xolair is prescribed as an add-on therapy for patients whose asthma is inadequately controlled with inhaled corticosteroids and long-acting beta2-agonists.
• Chronic Spontaneous Urticaria: It is also used for treating chronic hives in patients who do not respond adequately to antihistamines.

Administration

• Dosage: The dosage is based on the patient’s weight and baseline IgE levels, typically administered every 4 weeks. For chronic spontaneous urticaria, doses can be 150 mg or 300 mg.
• Method: Xolair is administered via subcutaneous injection. If the dose exceeds 150 mg, it should be divided among multiple injection sites.

• Key Benefits of Xolair (Omalizumab)

  1. Effective Treatment for Chronic Spontaneous Urticaria: Xolair has been shown to significantly reduce symptoms of chronic hives (urticaria) in patients who do not respond to antihistamines. Clinical studies indicate a reduction in itch severity by 48% with 150 mg and 67% with 300 mg doses after 12 weeks of treatment.
  2. Management of Allergic Asthma: Xolair is effective in treating moderate to severe allergic asthma by preventing IgE from binding to its receptors, thus inhibiting the release of histamine and other inflammatory mediators. This can lead to fewer asthma attacks and improved overall control of asthma symptoms.
  3. Long-lasting Effects: The drug is administered via subcutaneous injection every 4 weeks, providing sustained relief from symptoms without the need for daily oral medications.
  4. Reduction in Medication Use: Patients using Xolair may be able to reduce their reliance on other asthma medications, such as inhaled corticosteroids, while maintaining asthma control.
  5. FDA Approval: Xolair is the first biologic treatment approved by the FDA for chronic spontaneous urticaria, affirming its safety and efficacy for this condition.

  Key Ingredients of Xolair

  • Active Ingredient: Omalizumab is the primary active ingredient in Xolair. It is a monoclonal antibody that specifically targets IgE, a key player in allergic reactions.
  • Inactive Ingredients: Xolair also contains other components that may include stabilizers and preservatives, which help maintain the stability and efficacy of the medication. Specific inactive ingredients are typically listed in the product’s prescribing information.

  • Mechanism of Action of Xolair (Omalizumab)

    Xolair (omalizumab) works by inhibiting the binding of immunoglobulin E (IgE) to its high-affinity receptor FcεRI on the surface of mast cells and basophils. This mechanism of action is key to its effectiveness in treating allergic asthma, chronic spontaneous urticaria (hives), and nasal polyps.

    In Allergic Asthma

    • In allergic asthma, exposure to an allergen leads to the release of IgE, which can trigger an inflammatory response in the lungs.
    • Omalizumab binds to free IgE, preventing it from binding to FcεRI receptors on mast cells and basophils.
    • This inhibits the release of histamine and other inflammatory mediators, reducing asthma symptoms and exacerbations.

    In Chronic Spontaneous Urticaria

    • In chronic hives, IgE plays a key role in triggering the release of histamine and other inflammatory substances from mast cells.
    • Omalizumab binds to IgE, reducing the amount available to bind to receptors on mast cells.
    • This inhibits the release of histamine and other mediators, leading to a decrease in hives and itching.

    In Nasal Polyps

    • Nasal polyps are often associated with chronic inflammation, which may be driven in part by IgE.
    • By binding to IgE, omalizumab can help reduce inflammation and decrease the size of nasal polyps.
    • 

    • Xolair Interactions with Other Medications

      Xolair (omalizumab) is not known to have any significant interactions with other medications based on current reports. However, it’s still important to inform your doctor about all prescription, over-the-counter, and other drugs you are taking before starting Xolair treatment.Some key points about Xolair interactions:

      • There are currently no reports of Xolair interacting with other medications, herbs, or supplements.
      • However, this doesn’t mean interactions won’t be discovered in the future.
      • Sharing information about all medications, vitamins, herbs, and supplements with your doctor and pharmacist can help prevent potential interactions that may be identified during your treatment.
      • Xolair may affect the results of blood tests used to measure immunoglobulin E (IgE) levels, which can remain elevated for up to 1 year after stopping treatment.

      While Xolair itself does not appear to interact with other drugs, your doctor may prescribe it along with other medications depending on your condition:

      • For chronic hives, corticosteroid creams or non-drowsy antihistamines may be used with Xolair.
      • For asthma, Xolair is used as an add-on therapy to inhaled corticosteroids and can be taken with these medications.
      • For nasal polyps, Xolair is used with corticosteroid nasal sprays, leukotriene modifiers, and sometimes antibiotics for sinus infections.
      • key precautions to take when using Xolair (omalizumab):
        

        Severe Allergic Reactions

        • Xolair has a boxed warning about the risk of anaphylaxis, a severe, life-threatening allergic reaction that can occur after any dose, even if you’ve been using Xolair for a long time.
        • Seek immediate medical attention if you experience symptoms like swelling of the tongue/throat, trouble breathing, chest tightness, low blood pressure, feeling warm/itchy, or hives.

        Pregnancy and Breastfeeding

        • It’s not known if Xolair is safe to use during pregnancy or breastfeeding. Discuss the potential risks and benefits with your doctor.

        Parasitic Infections

        • Xolair may increase the risk of parasitic infections, especially if you live in or have traveled to areas where these infections are common. Your doctor may test you for parasites before starting treatment.

        Cancer

        • Taking Xolair may cause new cancers or worsen existing cancers. Discuss your cancer risk with your doctor before starting treatment.

        Latex Allergy

        • The needle cap on the Xolair prefilled syringe contains natural rubber latex. If you have a latex allergy, you may not be able to use this form of Xolair.

        Acute Asthma Symptoms

        • Xolair should not be used to treat sudden, acute asthma symptoms or asthma attacks. Talk to your doctor about which medications to use for sudden symptoms while taking Xolair.

        Steroid Withdrawal

        • If you’re taking oral steroids for asthma or nasal polyps, do not suddenly stop them when starting Xolair. Your doctor will have you slowly taper off steroids to avoid withdrawal symptoms.
        • To minimize the risk of anaphylaxis when taking Xolair (omalizumab), follow these key precautions:
          

          Receive Initial Doses Under Medical Supervision

          • Your doctor will administer your first few doses of Xolair in a healthcare setting equipped to manage anaphylaxis.
          • You will be closely monitored for at least 2 hours after each injection for signs of anaphylaxis.

          Recognize and Treat Anaphylaxis Promptly

          • Your doctor will educate you on the signs and symptoms of anaphylaxis, which can include trouble breathing, low blood pressure, severe hives, and swelling of the throat or tongue.
          • If you experience any symptoms of anaphylaxis, seek immediate medical attention and call 911 if symptoms feel life-threatening.

          Disclose Your Medical History

          • Inform your doctor if you have a history of anaphylaxis to foods, medications, or other causes, as this increases your risk with Xolair.
          • Discuss your full medical history and any allergies before starting treatment.

          Avoid Self-Administration if High Risk

          • If your doctor determines you are at high risk for anaphylaxis, you may not be a candidate for self-administration of Xolair injections.
          • Your doctor will assess your ability to recognize and treat anaphylaxis before allowing self-administration.

          Monitor for Signs of Anaphylaxis After Each Dose

          • Anaphylaxis can occur after any dose of Xolair, even if you’ve been taking it for a long time.
          • Continue to monitor for symptoms for at least 2 hours after each injection, even if you’ve tolerated previous doses well.

          • Dosage of Xolair (Omalizumab)

            Recommended Dosage

            The dosage of Xolair varies based on the condition being treated, patient weight, and pre-treatment IgE levels:

            • Chronic Spontaneous Urticaria (CSU):
              • 150 mg or 300 mg administered by subcutaneous injection every 4 weeks.
            • Allergic Asthma:
              • Dosage typically ranges from 75 mg to 375 mg, given as a subcutaneous injection every 2 or 4 weeks, depending on body weight and IgE levels.
            • Nasal Polyps:
              • 75 mg to 600 mg once every 2 or 4 weeks, with the exact dosage determined by weight and IgE levels.

            Pediatric Dosage

            • For children aged 12 years and older, dosages for CSU and allergic asthma are the same as for adults.
            • For children aged 6 to 11 years, the dosage is also based on body weight and IgE levels, typically administered every 2 to 4 weeks.

            Missed Dose

            If a dose is missed, contact your healthcare professional to reschedule. If self-administering, consult your doctor for guidance on handling missed injections.

            Storage of Xolair

            • Storage Conditions: Xolair should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F).
            • Avoid Freezing: Do not freeze the medication. If it has been frozen, it should not be used.
            • Room Temperature: It can be kept at room temperature (up to 25°C or 77°F) for a maximum of 14 days before use. If left at room temperature for this duration, it should not be returned to the refrigerator.
            • Expiration: Always check the expiration date on the vial or prefilled syringe before use.

            Reviews and Patient Feedback

            • Efficacy: Many patients report significant improvements in their asthma control and reduction in hives after starting Xolair. Users often note fewer asthma attacks and a decrease in the severity of allergic reactions.
            • Side Effects: Common side effects include injection site reactions, headaches, and upper respiratory infections. Some patients have experienced more severe reactions, including anaphylaxis, though these are rare.
            • Overall Satisfaction: Overall, patient reviews tend to be positive, particularly regarding the effectiveness of Xolair in managing symptoms that were previously difficult to control with standard treatments.

            • Storage Instructions

              1. Refrigeration:
                 • Keep Xolair in the refrigerator at a temperature between 2°C to 8°C (36°F to 46°F).
                 • Store it in its original carton to protect it from light.
              2. Avoid Freezing:
                 • Do not freeze Xolair. If it has been frozen, do not use it.
              3. Time Out of Refrigeration:
                 • If you need to remove a prefilled syringe from the refrigerator, it can be returned but must not be out of the fridge for more than 48 hours (2 days) in total.
                 • If the prefilled syringe is left at temperatures above 25°C (77°F), it should be discarded.
              4. Before Injection:
                 • Allow the prefilled syringe to reach room temperature before injecting. However, do not open the carton until you are ready to inject.
              5. Check for Damage:
                 • Do not use the prefilled syringe if the carton is damaged or appears tampered with.
                 • Ensure the prefilled syringe is not damaged or has not been dropped on a hard surface.
              6. Keep Away from Children:
                 • Store Xolair and all medications out of reach of children.