Xolair Prefilled Syr

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.

Xolair (Omalizumab) is an FDA-approved biologic therapy primarily used to manage moderate to severe persistent asthma and chronic idiopathic urticaria (CIU) when other treatments fail to provide adequate relief. Its main ingredient, omalizumab, is a monoclonal antibody designed to target immunoglobulin E (IgE), a protein involved in allergic reactions. By neutralizing IgE, Xolair helps control asthma symptoms and reduces the occurrence of hives in CIU patients.

Xolair is available in the form of two prefilled syringe strengths: 75 mg/0.5 ml and 150 mg/1 ml, as well as a lyophilized powder vial containing 150 mg, which requires reconstitution before injection. It is administered subcutaneously under the supervision of a healthcare professional. Xolair is suitable for adults and children aged 6 years and older for asthma and 12 years and older for CIU. The therapy works by lowering IgE levels in the bloodstream, thereby reducing inflammation and alleviating symptoms associated with allergic conditions.

Potential side effects of Xolair include severe allergic reactions (anaphylaxis), an increased risk of malignancies, and heightened susceptibility to infections. Before starting Xolair, patients should inform their doctor or healthcare provider of any medical conditions, ongoing treatments, or allergies. In case of a missed dose, get in touch with your doctor rather than doubling up doses. Store Xolair in its original packaging in a refrigerator, away from light, and do not freeze it. Consult a licensed healthcare practitioner for personalized advice and guidance on dosing and monitoring to ensure safe and effective treatment. If you want to buy Xolair for Chronic Idiopathic Urticaria online from Canada, you can obtain it using your doctor’s prescription.

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. Below are the general guidelines, which are usually the same for everyone, whether referring to Xolair dosing for urticaria or asthma. But if you have been prescribed a different dosage by your doctor, you should use it exactly as they have directed and do not make dosage changes without consulting them, as it can cause unwanted side effects. Do not take it more or less than recommended, in large quantities, or more often than prescribed by a licensed medical practitioner. 

For Asthma

• Dosing Formula: The dose of Xolair for Allergic 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.]

Xolair is administered as an injection, typically by a healthcare professional in a medical setting or hospital. In some cases, it can also be given at home. If you are required to self-administer Xolair, your doctor or medical professional will teach you how to prepare and inject it properly. Make sure to use it exactly as directed for safe and effective Xolair use. 

This medicine comes with instructions for use in the form of a patient information leaflet or, if available, the medication guide. Read and understand the information carefully before using it for the first time, and each time you get a refill. If you have any queries or if you have difficulty understanding any part of the instructions, ask your doctor or healthcare provider beforehand. Continue using the medicine unless instructed otherwise by a medical practitioner.

• Before you start receiving treatment with Xolair, your doctor may perform certain tests, such as an allergy test or blood test, to ensure that this medication is suitable for you to use.
• Xolair is given as a subcutaneous injection, i.e., injected under the skin.
• After starting using Xolair, your healthcare provider will monitor you closely to make sure that you do not have any hypersensitivity to the medicine.
• Your healthcare provider will determine whether this injection should be administered by you or a caregiver. If they decide that it is safe for you to self-administer, you will be given training on how to properly prepare and inject this medicine. If you have any questions or if you have difficulty understanding any step of the procedure, ask your doctor.
• For pediatric patients aged 12 or more, the prefilled syringe can be self-injected under supervision. For children aged between six and eleven years of age, the injection should be administered by a caregiver.
• Xolair is usually given every two or four weeks, depending on the condition it is being used to manage.
• Your doctor may prescribe you a combination of drugs to manage your condition. Use all medicines exactly as your doctor has prescribed.
• If you also use a steroid, you should not discontinue using it abruptly without consulting with your doctor first, or you may experience unfavorable withdrawal symptoms. Consult your doctor if you think your asthma medicines are not working as well as they should or if your symptoms worsen.
• While using Xolair, you may require frequent medical tests, such as allergy tests or lung function tests. Your doctor may also recommend that you have your stool checked for parasites, especially if you travel.
• Your medical condition may not get better immediately. To get the most benefit from the medicine you are using, you should use it exactly as prescribed. Talk to your doctor if your symptoms do not get better or if they worsen after a few weeks of treatment.

Steps on How to Administer Xolair Prefilled Syringe:

• If you keep the Xolair container in the refrigerator, take it out and let it set aside for at least fifteen to thirty minutes so it can warm up on its own to room temperature.
• Do not warm it by using any heat sources such as a microwave or warm water.
• You should not speed up the warming using any external heat sources such as a microwave or warm water.
• Check the contents of the Xolair prefilled syringe for discoloration or other visual changes before administering the dose. If particles or color changes are present, do not use them and discard them in an FDA-approved sharps container.
• Check the number of prefilled syringes needed according to the dose prescribed by a healthcare practitioner.
• For individuals requiring more than one injection to complete their dose, you should administer each injection at least one inch apart from other injection sites.
• You should use Xolair injection for allergies within four hours of removing it from the refrigerator.
• You should administer the subcutaneous injection into the abdomen or thigh. However, you should avoid injecting the 2-inch area directly around the navel area. The outer area of the upper arms may be used only if a caregiver or healthcare provider is giving the injection.
• Administering the medicine usually takes 5-10 seconds. Dispose of the used syringe in an FDA-approved puncture-resistant container.

[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.]

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.

Common Side Effects of Xolair: Similar to other medicines, Xolair can cause certain temporary side effects in some users. These side effects disappear independently within a few days or weeks without medical intervention. If you are concerned about any risks associated with the use of Xolair, get in touch with your doctor or healthcare provider. Also, report any new or worsening symptoms to them. Common side effects of Xolair include: 

• Rash: An allergic reaction to Xolair can cause skin rashes, which range from mild redness to more severe hives. To prevent this, you should monitor your skin for any changes after the dose is administered. If you experience a rash, you should talk to your doctor or healthcare provider. They are most likely to recommend you use antihistamine medications or topical corticosteroids to alleviate symptoms. 
• Fever: Some users experience fever after injecting the medicine. This occurs possibly due to the body’s immune response to Xolair. To manage fever, you should stay hydrated and take adequate amounts of rest. You can also take over-the-counter medicines after consulting your doctor to help reduce symptoms of fever. 
• Nosebleeds: Patients, particularly children, can have nosebleeds while using Xolair. This may be due to nasal dryness or irritation. Using a humidifier or applying saline nasal sprays can keep nasal passages moist. If you have frequent or severe nosebleeds, let your doctor know. 
• • Joint pain and bone fracture: The exact mechanism behind why these symptoms occur, they can cause a change in the body’s immune system. You should engage in regular, low-impact exercises to maintain joint health and bone density. 
• Arm or leg pain: This medication can cause pain in the limbs. This can be due to the injection site reactions or systemic effects of the drug. To minimize the chance of arm or leg pain, you should ensure that you follow proper injection techniques and rotate injection sites. You should apply a cold pack to the area post-injection to reduce discomfort. If the pain is persistent or severe, have it evaluated by a medical practitioner. 
• Nausea, vomiting, diarrhea, or stomach pain: Due to the body’s response to the treatment, you may have gastrointestinal symptoms, including abdominal pain, nausea, diarrhea, and vomiting. You should try eating small, bland meals and staying hydrated to manage these symptoms. Contact your doctor for further evaluation if you experience severe or persistent symptoms. 
• Headache: This is one of the most common side effects of Xolair and may be due to the body’s effect on the medication. To manage this, you should stay hydrated, ensure that you take adequate rest, and use over-the-counter medications. If your headache is severe or persistent, discuss it with a healthcare provider. 
• Dizziness or fatigue: You may experience these symptoms as your body adjusts to Xolair. To manage these symptoms, you should avoid sudden movements, ensure adequate sleep, and avoid driving, using heavy machinery, or engaging in hazardous activities unless you determine how this medicine affects you. If these symptoms persist, get in touch with your doctor. 
• Ear pain and ear infection: Ear-related issues, including infections and pain, have been reported, especially in children. You should monitor yourself for signs and symptoms of an ear infection, including earache, fever, or hearing issues. Seek medical intervention if these symptoms persist. 
• Cold symptoms: Upper respiratory symptoms may occur. These include pain, bruising, swelling, or irritation at the injection site. To alleviate symptoms, you should stay hydrated, use saline nasal sprays, and take over-the-counter medications. If symptoms of cold persist or worsen, consult with your doctor.

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. It is important to let your healthcare provider know if you or your family has a history of cancer, as a small number of people using Xolair have developed cancer.
• 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. Tell your healthcare provider if you have or develop a parasitic infection such as pinworm before or during Xolair treatment. Treatment of the infection may be necessary before resuming Xolair.
• 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. Fever, joint pain, rash &swollen lymph nodes can also occur within five days of receiving a dose of Xolair. Immediately report such symptoms to your healthcare provider.
• High Eosinophil Levels: Xolair can cause eosinophil levels to rise, which may lead to inflammation of the lungs or blood vessels in some cases. This can present with symptoms such as chest pain, cough (worse than normal), fever, numbness or tingling in the arms/legs, shortness of breath (worse than normal), and rash. Tell your healthcare provider if these symptoms occur.

[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.]

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 for asthma is designed as a maintenance medication 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 injection for allergies. 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.

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.

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.

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.]

You should not administer Xolair more than the prescribed dose, in large quantities, or more often than prescribed, as it can lead to an overdose. 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.]

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.]

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 using 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.]

While Xolair is usually tolerable, some individuals may find it unsuitable or contraindicated for use. In such cases, people look for Xolair substitutes. While there are many effective medications available in the market, you should not use them without consulting your doctor. Based on your medical condition, age, needs, and other factors, they will help you determine the medicine that works best for you. Some of the most popular Xolair alternatives include:

• 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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