Xolair 150 mg - Omalizumab Powder and Solvent for Solution for Injection

Xolair 150 mgvil

Description:

Xolair 150 mg s.c. vial is a prescription biological medicine containing omalizumab, a recombinant DNA-derived humanized IgG1k monoclonal antibody. It is administered by subcutaneous injection and is used as an add-on therapy for certain allergic and inflammatory conditions that are driven by immunoglobulin E (IgE). Xolair works by selectively binding to IgE, helping to reduce allergic inflammation and decrease the frequency and severity of symptoms in appropriately selected patients. This product is intended for use under the supervision of a specialist healthcare professional and is not a vitamin, supplement, or over-the-counter remedy.

Indications:

• Add-on maintenance treatment of moderate to severe persistent allergic asthma in patients with a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids (according to approved local labeling).
• Reduction of asthma exacerbations and improvement of asthma symptom control in eligible patients as determined by a specialist.
• In many countries, omalizumab is also indicated for chronic spontaneous (idiopathic) urticaria in adults and adolescents who remain symptomatic despite H1-antihistamine treatment; however, indication may vary by country. Patients in Egypt must follow the indications on the local approved leaflet.
• Used in patients where IgE-mediated mechanisms play a key role in disease pathophysiology and where standard therapies alone are insufficient.

Active Ingredients / Key Components:

• Omalizumab – 150 mg per vial (recombinant DNA-derived humanized IgG1k monoclonal antibody targeting IgE).
• Excipients: Specific excipients (such as stabilizers, buffers, and solvents) are included in the vial formulation, but the full excipient list and their concentrations , please check the product leaflet or the manufacturer’s official website. Please refer to the official package leaflet for complete excipient details.

Dosage & Administration / How to Use:

• Xolair 150 mg is for subcutaneous (s.c.) injection only. It must not be administered intravenously or intramuscularly.
• Dosage is individualized and is based on the patient’s baseline serum total IgE level (IU/ml) and body weight (kg), according to an approved dosing table in the prescribing information.
• Typical dosing intervals are every 2 or 4 weeks, with the total dose divided into one or more 150 mg injections, depending on the required total dose.
• Reconstitution: The 150 mg vial is supplied as a powder for solution. It must be reconstituted with the recommended volume of sterile water for injection by a trained healthcare professional, following aseptic technique and the manufacturer’s instructions. The solution should be inspected visually for particulate matter or discoloration before administration.
• Administration should be performed by a physician or qualified healthcare professional experienced in the diagnosis and treatment of allergic diseases and trained in the management of anaphylaxis.
• Patients should remain under observation for a period after injection, as recommended in the local prescribing information, to monitor for signs of hypersensitivity or anaphylaxis.
• Do not adjust or discontinue other asthma or allergy medications (such as inhaled corticosteroids) abruptly when starting Xolair. Any changes must be done gradually and only under medical supervision.
• Use in children, adolescents, adults, and the elderly must follow the age limitations and dosing recommendations in the locally approved product leaflet. Not all age groups may be approved in all countries.

Clinical Benefits:

• Helps reduce the frequency and severity of asthma exacerbations in patients with moderate to severe persistent allergic asthma inadequately controlled with standard therapy.
• Improves asthma symptom control, including wheezing, shortness of breath, and nighttime symptoms, when used as an add-on to inhaled corticosteroids and other controller medications.
• May reduce the need for rescue medications (such as short-acting beta-agonists) and, in some patients, may allow for a reduction in the dose of inhaled corticosteroids under medical supervision.
• Targets IgE-mediated allergic pathways specifically, providing a more focused biologic treatment option for appropriate patients.

Warnings & Contraindications:

• Contraindicated in patients with known severe hypersensitivity to omalizumab or to any of the excipients in the formulation.
• Serious allergic reactions, including anaphylaxis, can occur after Xolair administration, sometimes with delayed onset. Treatment must be initiated and supervised by healthcare professionals prepared to manage anaphylaxis. Patients should be informed about the signs and symptoms of anaphylaxis (such as difficulty breathing, swelling of the face or throat, dizziness, or severe rash) and instructed to seek immediate medical attention if they occur.
• Use with caution in patients with a history of anaphylaxis to other medications, foods, or allergens. Close monitoring is recommended.
• Parasitic (helminth) infections: Omalizumab may potentially increase susceptibility to certain parasitic infections. In endemic areas, patients should be monitored and treated promptly if infection occurs.
• Not intended for the relief of acute asthma attacks, status asthmaticus, or acute bronchospasm. Patients must have access to appropriate rescue medication at all times.
• Consult your doctor before use if pregnant, planning pregnancy, or breastfeeding. The safety of omalizumab in pregnancy and lactation should be evaluated on an individual risk–benefit basis.
• Consult your doctor before use if you have any significant medical conditions, including but not limited to: immune system disorders, chronic infections, helminth infections, or if you are taking other biologic therapies or immunosuppressive medications.
• Not intended to diagnose, treat, cure, or prevent any disease without proper medical supervision. It is a prescription-only medicine that must be used strictly according to a physician’s instructions.
• Keep out of reach of children.
• Do not use if the vial is damaged, the solution (after reconstitution) is discolored or contains visible particles, or if the product is past its expiry date.

Side Effects:

• Common side effects may include: injection-site reactions (such as pain, redness, swelling, itching, or bruising), headache, mild fever, fatigue, arthralgia (joint pain), and upper respiratory tract infections (such as sore throat or nasal congestion).
• Less common but potentially serious side effects can include: anaphylaxis or severe hypersensitivity reactions, angioedema, serum sickness-like reactions, and, rarely, eosinophilic conditions or vasculitis. Any sudden difficulty breathing, chest tightness, swelling of the face, lips, tongue, or throat, severe dizziness, or widespread rash requires immediate emergency medical attention.
• Other adverse events reported with omalizumab therapy include abdominal pain, dizziness, urticaria (hives), and, in rare cases, cardiovascular or cerebrovascular events. Causality may not be established in all cases; patients should discuss any new or worsening symptoms with their doctor.
• If you experience any side effects, including those not listed in the leaflet, inform your doctor or pharmacist. They can advise whether treatment should be continued, adjusted, or discontinued.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Keep container tightly closed. Keep out of reach of children. Specific storage conditions (such as recommended temperature range and whether refrigeration is required) are not provided in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.); please refer to the official package insert for exact storage requirements and shelf-life details. Do not use after the expiry date printed on the pack and vial.

Specifications:

• Form: Powder for solution for subcutaneous injection in a vial.
• Strength: 150 mg omalizumab per vial.
• Route of administration: Subcutaneous injection only.
• Intended use: Prescription biological medicine for eligible patients with IgE-mediated conditions such as moderate to severe persistent allergic asthma (and other indications as per local labeling).
• Pack details (number of vials per pack, volume of solvent, etc.) are not specified in the provided information; please refer to the product packaging or official leaflet for full specifications.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.