Omalizumab

Xolair 

Xolair is a specialized biologic therapy designed to treat moderate to severe persistent asthma and chronic idiopathic urticaria (CIU) when standard treatments are ineffective. Administered via subcutaneous injection, Xolair targets and neutralizes immunoglobulin E (IgE), a crucial antibody in allergic responses. This action prevents IgE from activating immune cells that release inflammatory substances, thus reducing asthma symptoms and hives. Available in prefilled syringes (75 mg/0.5 mL and 150 mg/1 mL) and lyophilized powder (150 mg vials), Xolair’s dosage is tailored based on the patient’s body weight and initial IgE levels, with treatments typically given every two to four weeks. While Xolair is highly effective, it carries an FDA-mandated boxed warning about the risk of anaphylaxis, a severe allergic reaction. Other potential side effects comprise an increased risk of infections, possible malignancies, and interactions with other medications, such as allergen immunotherapy and warfarin. Alternative biologic treatments include Nucala, Fasenra, and Dupixent, while traditional asthma management may involve inhaled corticosteroids and long-acting beta-agonists.

Product Overview

Xolair (omalizumab) is an innovative biologic therapy primarily used to manage moderate to severe persistent asthma and chronic idiopathic urticaria (CIU) when other treatments have failed to provide relief. This injectable medication targets and neutralizes immunoglobulin E (IgE), a key player in the body’s allergic response. By binding to IgE, Xolair prevents it from interacting with receptors on immune cells, effectively lowering the secretion of inflammatory mediators resulting in asthma symptoms and hives. Xolair is available in two forms: prefilled syringes and lyophilized powder. The prefilled syringes come in strengths of 75 mg/0.5 mL and 150 mg/1 mL, while the lyophilized powder is provided in vials of 150 mg, each requiring reconstitution before administration. 

Despite its effectiveness, Xolair has several precautions. It carries an FDA-mandated boxed warning regarding the risk of anaphylaxis, a potentially life-threatening allergic reaction that can occur after any dose. Other notable side effects include potential malignancies, serum sickness, and increased susceptibility to parasitic infections. Xolair is not recommended to immediately relieve acute bronchospasm or other acute symptoms.

Patients considering Xolair should discuss potential interactions with other medications, including allergen immunotherapy and warfarin. Regular monitoring and consultations with healthcare providers are crucial to managing side effects and adjusting treatment. For those seeking alternatives, medications such as Nucala (mepolizumab), Fasenra (benralizumab), and Dupixent (dupilumab) offer other biologic approaches to treating severe asthma. At the same time, traditional options like inhaled corticosteroids and long-acting beta-agonists provide foundational asthma management.

What Are the Uses of Xolair?

Xolair is used for the following conditions:

• Moderate to severe persistent asthma
• Chronic idiopathic urticaria (CIU)

What Are the Forms & Strengths of Xolair?

Xolair (omalizumab) is available in two primary forms for administration, and it comes in several dosage strengths to accommodate various treatment needs based on the patient’s body weight and IgE levels. Here are the forms and strengths:

Forms:

• Prefilled Syringes: Xolair is available in prefilled syringes, which are used for subcutaneous (under the skin) injection.
• Lyophilized Powder: This form of Xolair is provided as a lyophilized powder in a single-use vial. It must be reconstituted with sterile water for injection before it is administered subcutaneously.

Strengths:

• Prefilled Syringes:

• • • 75 mg/0.5 mL
    • 150 mg/1 mL

• Lyophilized Powder:

• • 150 mg per vial

What Are the Recommended Dosage of Xolair?

The recommended dosage of Xolair (omalizumab) depends on the specific condition being treated and the patient’s body weight and serum IgE levels measured before treatment. Here are the general guidelines:

For Asthma

• Dosing Formula: The dose of Xolair for asthma is calculated based on the patient’s body weight and initial serum total IgE level (measured in IU/mL), which must be obtained before starting treatment. The dosing ranges from 150 to 375 mg every two or four weeks.
• Frequency: Xolair is administered as a subcutaneous injection every two or four weeks. The specific dosage & frequency depend on the calculated dose based on the IgE levels and body weight.

For Chronic Idiopathic Urticaria (CIU)

• Standard Dosage: For CIU, the recommended dose of Xolair is 150 mg or 300 mg administered by subcutaneous injection every four weeks, regardless of the serum IgE level or body weight.

[Note: Remember, these recommendations may vary from person to person. Discuss it with your medical professional, and they’ll customize your dosage accordingly.]

How to Use Xolair? 

Xolair is administered as an injection, typically by a healthcare professional. Here’s how Xolair is usually used:

• Form of Administration: Xolair is given as a subcutaneous injection, which is injected under the skin.
• Dosage and Frequency: The dosage & frequency of Xolair injections depend on the patient’s body weight and serum IgE levels, measured before treatment starts. They are usually given every two to four weeks.
• Injection Sites: Common injection sites include the upper arms, thighs, or abdomen. Rotate the injection sites to avoid skin issues.
• Preparation: A healthcare provider will visually check the medication for particulate matter and discoloration before injection. Xolair should be at room temperature before administration.
• Observation Post-Injection: Patients are often observed for a period after the injection due to the risk of anaphylaxis, a severe allergic reaction. This observation period can vary but is typically around two hours after the first few injections and may be reduced if no adverse reactions occur.
• Continued Monitoring: Regular follow-ups are necessary to monitor effectiveness and adjust dosages if needed.

Administration Process

• Reconstitution: The powder is mixed with sterile water, and the solution must stand until it is clear, which can take about 15 to 20 minutes. The solution should not be shaken.
• Injection Sites: Common injection sites include the upper arms, thighs, or abdomen, avoiding areas where the skin is tender, bruised, red, or hard.
• Observation Post-Injection: Due to the risk of anaphylaxis, it’s recommended that healthcare providers observe patients for some time after receiving the injection. The exact duration of observation can vary, but it is typically around two hours after the first few injections.

[Note: Your medical professional will decide the appropriate amount for you based on your health condition, following guidelines & studies on the drug. They’ll adjust it as needed over time.]

How Does Xolair Work?

Xolair (omalizumab) specifically targets and neutralizes immunoglobulin E (IgE), a key antibody in the allergic response. In individuals with allergic asthma and chronic idiopathic urticaria, IgE levels are elevated. These IgE molecules bind to allergens and then interact with IgE receptors on the surface of mast cells and basophils, triggering these cells to release histamine & other inflammatory mediators that cause allergic symptoms and asthma exacerbations. By binding to IgE, Xolair prevents it from attaching to these immune cells, thereby inhibiting the release of substances that lead to inflammation and allergic reactions. This action helps reduce the severity and frequency of asthma attacks and mitigates the symptoms of chronic urticaria by preventing new hives and itchiness. Xolair’s targeted approach is practical for patients who have not adequately responded to other treatments, providing significant relief from symptoms associated with high IgE levels.

Important Safety Information for Using Xolair

What Are the Side Effects of Xolair?

Common Side Effects of Xolair

Here are the common side effects of Xolair:

• Injection site reactions:
  • Pain
  • Swelling
  • Itching
  • Redness
• Respiratory symptoms:
  • Viral infections of the upper respiratory tract
  • Sinusitis
  • Headache
  • Sore throat
• General symptoms:
  • Fatigue
  • Dizziness
  • Joint pain
  • Leg or arm pain
• Gastrointestinal issues:
  • Nausea
  • Diarrhea
  • Abdominal pain
• Skin reactions:
  • Mild rash
  • Urticaria (hives)
• Other:
  • Earache
  • Warm feeling

Serious Side Effects of Xolair

While Xolair is generally well-tolerated, it can cause some severe side effects of this medication that require immediate medical attention. Here are the notable serious side effects associated with Xolair:

• Anaphylaxis: Xolair can cause anaphylaxis, a severe allergic reaction that can be life-threatening. Symptoms may include trouble breathing, chest tightness, swelling of the face, lips, tongue, or throat, dizziness, fainting, rapid or weak heartbeat, and hives. Anaphylaxis can occur after any dose, even if previous doses did not cause a reaction.
• Cancer: There have been cases where patients treated with Xolair have developed various types of cancers, including breast, skin, prostate, and melanoma. However, a direct causal relationship has not been established.
• Cardiovascular Events: Some patients have experienced chest pain, heart attack, mini-stroke (transient ischemic attacks), pulmonary hypertension, and blood clots in the lungs (pulmonary embolism) or veins (deep vein thrombosis).
• Arterial Thrombosis: Events including strokes and heart attacks have been reported in patients taking Xolair.
• Severe Skin Reactions: Rarely, Xolair can cause severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which can be life-threatening.
• Parasitic Infections: Since Xolair can affect the immune system, it may increase susceptibility to parasitic (helminth) infections, particularly in patients at high risk for such diseases.
• Serum Sickness: Some patients may experience serum sickness or serum sickness-like reactions, which include symptoms such as fever, rash, joint pain, swelling, and lymph node enlargement.

[Note: Remember, this list does not cover all possible side effects of this medication. Always consult with your healthcare giver for medical advice about side effects.]

Are There Any Warnings for Xolair? 

Xolair can be effective for certain medical conditions, but it also carries risks of serious health issues. Here’s what you need to know about its potential risks and how to manage them:

• Severe Allergic Reactions (Anaphylaxis): Xolair can cause life-threatening allergic reactions known as anaphylaxis. Symptoms include difficulty breathing, dizziness, itchy skin, and throat or tongue swelling. These reactions are most likely to occur after the first few doses but have been reported even after a year of treatment. When starting Xolair, you will likely receive your initial doses in a medical setting where severe allergic reactions can be treated, and you may be observed for a few hours post-injection. If you are trained to administer Xolair at home, have emergency medical contact information readily available. Also, notify your allergist if you have a latex allergy, as the syringe’s needle cap may contain latex.
• Not Suitable for Acute Asthma Attacks: Xolair is designed as a maintenance medication for asthma and should not be used to treat acute asthma attacks. For sudden breathing difficulties, use your prescribed rescue inhaler, such as albuterol.
• Inappropriate for Emergency Allergic Reactions: While Xolair helps prevent severe allergic reactions to specific allergens, it should not be used as an emergency treatment. Continue to avoid known allergens and have emergency treatments like epinephrine accessible.
• Potential Side Effects After Injection: Some patients may experience fever, joint pain, or rash within 1 to 5 days after receiving Xolair injections. These symptoms usually diminish over time. If these symptoms continue continuously, you should report them to your healthcare provider, who may consider altering your treatment.
• Possible Increased Cancer Risk: There have been instances of cancer reported in clinical studies among patients using Xolair. The direct link between Xolair and cancer remains unclear. Discuss your personal and family medical history with your allergist to thoroughly understand the risks.
• Risk of Vasculitis: Although very rare, there have been reports of vasculitis, an inflammation of the blood vessels, in patients taking Xolair. Symptoms may include intense itching, rash, breathing difficulties, and tingling or numbness in the extremities. Contact your healthcare specialist immediately if you experience these symptoms.
• Increased Risk of Parasitic Infections: Patients at high risk for parasitic infections, such as those caused by roundworm or hookworm, should be closely monitored. Xolair may increase susceptibility to these infections. Ensure your allergist is aware of your medical history, including past infections, so that appropriate preventive measures can be taken.

What are the FDA-boxed warnings for Xolair?

Xolair carries an FDA-mandated boxed warning primarily concerning the risk of anaphylaxis, which is a severe, potentially life-threatening allergic reaction. Here’s the detail of the boxed warning:

• Risk of Anaphylaxis: Xolair can cause anaphylaxis, which may be life-threatening. This severe reaction can occur after the administration of any dose of Xolair, even if the patient had no previous allergic reactions to the medication. The risk of anaphylaxis persists for some time after the injection.

What Are the Xolair Precautions?

When prescribing and administering Xolair, several precautions must be considered to ensure patient safety & the effectiveness of the treatment. Here are the key precautions associated with Xolair:

• • Monitoring for Anaphylaxis: Xolair has a risk of anaphylaxis, which can be life-threatening. Patients should be observed in a healthcare setting after each injection, particularly after the first few doses. Facilities should be prepared to manage severe allergic reactions.

• Cancer Surveillance: Although no causal relationship has been established, the incidence of various cancers in patients treated with Xolair has been higher compared to control groups. Patients should be informed about this potential risk & monitored accordingly.

• Avoidance of Allergen Immunotherapy: Xolair may increase the risk of anaphylaxis in patients receiving allergen immunotherapy (allergy shots). Coordination between care providers is essential when both treatments are used.

• Precaution with Parasitic Infections: Due to potential interference with the immune response to parasitic infections, patients at high risk for helminth infections should be monitored closely during treatment with Xolair.

• Use with Caution in Patients with Severe Asthma: Patients with severe asthma need careful monitoring as reduction in oral corticosteroids due to Xolair treatment can sometimes unmask conditions like eosinophilic conditions, Churg-Strauss syndrome, or hypereosinophilic syndrome.

• Preparation and Administration: trained healthcare personnel should prepare and administer Xolair. The lyophilized powder should be reconstituted under sterile conditions, and prefilled syringes should be inspected for particulate matter and discoloration.

• Latex Allergy: The needle cap on the Xolair prefilled syringe may contain latex, which could cause allergic reactions in sensitive individuals. Alternative administration methods should be considered for patients with latex allergies.

• Fetal and Nursing Considerations: Xolair should be used only during pregnancy if needed, and whether Xolair is excreted in human milk is unknown. Decisions about whether to continue or discontinue nursing or Xolair therapy should take into account the drug’s importance to the mother.

• • Not for Acute Symptoms: Xolair is not intended to relieve acute bronchospasm or acute symptoms of allergies and should not be used to treat acute asthma attacks or other sudden breathing problems.

• Long-term Treatment Evaluation: Xolair’s long-term safety and efficacy in chronic use are not fully established. Regular assessment of the benefits and risks is necessary to justify continued therapy.

What Are the Contraindications of Xolair?

Some specific contraindications & precautions should be considered before starting treatment with Xolair:

• Severe Hypersensitivity Reactions: Xolair is contraindicated in patients who have experienced a severe hypersensitivity reaction to omalizumab or any of its ingredients. This can include anaphylaxis, which is a potentially life-threatening condition.

What If You Missed a Dose of Xolair?

If you miss a dose of Xolair (omalizumab), taking it as soon as you remember is important. However, if it’s nearly time for your next scheduled dose, skip the missed dose & proceed with your regular dosing schedule. Do not take two doses of Xolair simultaneously to make up for a missed dose. Since Xolair is typically administered in a healthcare setting by a healthcare professional, scheduling your next appointment as soon as possible is crucial if you miss a dose. Regular injections are essential for maintaining the effectiveness of the treatment. 

[Note: If you have missed a dose of Xolair and are unsure regarding the next one, immediately consult your doctor or pharmacist.]

What Happens If You Take Too Much of Xolair?

Taking too much Xolair (omalizumab) can potentially lead to an increased risk of side effects, including severe allergic reactions, such as anaphylaxis. These reactions can be life-threatening & require immediate medical attention. Symptoms of an overdose may include hives, difficulty in breathing, and swollen face, lips, tongue, or throat. If you suspect an overdose or experience any severe reactions after receiving Xolair, seek emergency medical help immediately.

[Note: If you have consumed more than the recommended dose of Xolair, get medical help immediately or call the Poison Help line at 1-800-222-1222.]

How to Store a Xolair?

Storing Xolair properly is important to maintain its effectiveness. Here are the guidelines for storing Xolair:

• Refrigerate but Do Not Freeze: Keep Xolair in the refrigerator at 2°C to 8°C. Do not freeze the vials; keep them away from the freezer compartment.
• Keep in Original Packaging: Store the vials in the original carton to protect them from light until the time of use.
• Avoid Shaking: Do not shake the vial of Xolair, as it may affect the stability of the solution.
• Discard if Frozen: If the Xolair solution accidentally freezes, it must be discarded.
• Use Immediately After Preparation: If Xolair is reconstituted (mixed with a diluent), it should be used immediately. If not used immediately, it can be kept at room temperature for up to 8 hours after reconstitution. Beyond this time, it should be discarded.

[Note: Discuss with your healthcare specialist the proper disposal of unused medicine and any questions you may have regarding its storage.]

What Medications Interact with Xolair?

Xolair is an antibody used to treat moderate to severe asthma and chronic hives (urticaria) that are not controlled by antihistamines. When considering interactions with Xolair, it’s important to note the following:

• Allergen Immunotherapy: Xolair and allergen immunotherapy (allergy shots) may interact. Xolair may increase the risk of anaphylaxis from allergen immunotherapy. It’s important to monitor patients closely if both treatments are used together.
• Warfarin: Reports suggest a possible interaction between Xolair and warfarin, potentially affecting blood clotting time or INR (International Normalized Ratio). Patients taking both medications may require closer monitoring of their INR levels.
• Live Vaccines: While not a direct interaction, caution is advised when administering live vaccines to patients receiving Xolair because of the potential for increased risk of infection.
• Other Biologic Therapies: Combining Xolair with other biologic medications (like those used to treat other autoimmune conditions) could potentially increase the risk of immunosuppression or other immune-mediated reactions. However, specific interactions have yet to be well-documented.

What Are the Other Xolair Interactions?

While Xolair primarily has noted interactions with allergen immunotherapy and potential considerations with warfarin and live vaccines, there are a few additional factors to consider:

• Corticosteroids and Long-Acting Beta Agonists (LABAs): Many patients on Xolair for asthma also take inhaled corticosteroids and LABAs. While these are not direct interactions, the combined use of these medications is part of a broader treatment plan for asthma, and adjustments to one may affect the overall management of the condition.
• Immunosuppressive Drugs: While specific interactions between Xolair and other drugs have not been established, combining multiple immunosuppressive agents could potentially increase the risk of infections and other immune-related issues.
• Herbal Supplements and Over-the-counter (OTC) Medications: Discussing herbal supplements and OTC medications with a healthcare provider is always a good practice, as these can sometimes interact with prescription medications or exacerbate certain conditions.
• Individual Patient Factors: Conditions like renal or hepatic impairment might not directly interact with Xolair, but they could influence the overall treatment plan and the use of various medications.

[Note: This is not a complete list, and there could be other drugs that interact with Xolair. Tell your medical professional any prescription, over-the-counter medicines, and herbal products you’re taking.]

What Are the Xolair Alternatives?

• Other biologic medications:
  • Nucala (mepolizumab)
  • Fazenda (benralizumab)
  • Cinqair (reslizumab)
  • Dupixent (dupilumab)
  • Tezspire (tezepelumab)
• Leukotriene modifiers:
  • Singulair (montelukast)
  • Accolate (zafirlukast)
  • Zyflo (zileuton)
• Inhaled corticosteroids:
  • Flovent (fluticasone)
  • Pulmicort (budesonide)
  • Qvar (beclomethasone)
• Long-acting beta-agonists (LABAs):
  • Serevent (salmeterol)
  • Foradil (formoterol)
• Combination inhalers (corticosteroid + LABA):
  • Advair (fluticasone/salmeterol)
  • Symbicort (budesonide/formoterol)
• Anticholinergics:
  • Spiriva (tiotropium)
• Oral corticosteroids:
  • Prednisone
  • Methylprednisolone
• Allergy immunotherapy:
  • Allergy shots
  • Sublingual immunotherapy

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

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Frequently Asked Questions

How quickly can I expect to see results from Xolair treatment?

The time it takes for Xolair to produce noticeable effects varies based on the condition being treated. Clinical studies have demonstrated that improvements may be observed as follows: within three months for chronic hives, within four months for allergic asthma, within five months for preventing severe allergic reactions to foods, and within six months for treating nasal polyps. However, individual responses to Xolair can differ significantly. If you have concerns about the effectiveness of your treatment, it’s important to discuss them with your allergist.

What is the recommended duration for Xolair treatment?

Your allergist should determine the duration of your treatment with Xolair based on the effectiveness of the medication for your specific condition and your tolerance to the treatment. Generally, you may continue using Xolair as long as it provides benefits and you are not experiencing any severe side effects. It is important to regularly discuss your treatment plan & any concerns with your healthcare team.

Can Xolair cause fatigue?

Yes, fatigue or tiredness is a possible side effect of Xolair, particularly following an injection. This tiredness is temporary and should improve a few days after the injection. However, it’s important to consider that symptoms like fatigue could also be related to the underlying medical condition being treated, such as asthma or nasal polyps. If you find that the fatigue associated with Xolair significantly impacts your daily activities, discuss this with your allergist. They can help determine the cause of your tiredness and suggest appropriate measures or adjustments to your treatment.

Does Xolair act as an immunosuppressant?

Xolair could be considered an immunosuppressant in a broader sense because it modifies the immune response. It specifically targets and inhibits immunoglobulin E (IgE), a component of the immune system that plays a crucial role in allergic reactions. However, Xolair does not broadly suppress the immune system, Xolair does not broadly suppress the immune system, unlike stronger immunosuppressants such as those used in organ transplantation or high-dose corticosteroids. Instead, it selectively reduces hyperactivity related to IgE, thereby mitigating allergic responses without extensively weakening overall immune function. If you have concerns about how Xolair may affect your immune system, discussing them with your allergist is advisable.

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