Omalirel 150mg Injection Combikit

Omalirel 150mg Injection Combikit contains Omalizumab, a monoclonal antibody used to manage moderate to severe allergic asthma, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergies.

Benefits

Omalirel 150mg works by targeting immunoglobulin E (IgE) in the body, which plays a key role in allergic reactions. By binding to free IgE, it helps prevent the release of inflammatory chemicals, thereby reducing symptoms like wheezing, breathlessness, chest tightness, and hives. This can lead to improved asthma control and better management of chronic urticaria and other allergic conditions.

Uses and Indications

• Moderate to severe persistent allergic asthma in adults and children aged 6 years and older, whose symptoms are inadequately controlled with inhaled corticosteroids.
• Chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older who remain symptomatic despite H1 antihistamine treatment.
• Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients aged 18 years and older with an inadequate response to nasal corticosteroids.
• To reduce allergic reactions after unplanned exposure to a food allergen in adults and children aged 1 year and older.

The Omalirel 150mg Injection Combikit contains:

• Omalizumab 150 mg (active ingredient).
• Excipients (such as L-histidine, polysorbate 20, and sucrose).
• The combikit also includes a sterile Water for Injection (WFI) vial, syringes, needles, and alcohol swabs for reconstitution and administration.

Dosage and Administration

1. Omalirel 150mg Injection is administered via subcutaneous injection.
2. The initial doses should be given under the supervision of a healthcare professional in a clinical setting due to the risk of allergic reactions.
3. For chronic spontaneous urticaria, the typical dosage is 150 mg or 300 mg every 4 weeks, as determined by your doctor.
4. For allergic asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy, the dose and frequency (every 2 or 4 weeks) are determined by your doctor based on your body weight and pre-treatment serum total IgE levels.
5. Doses exceeding 150 mg should be divided and administered at multiple injection sites, with no more than 150 mg per site.
6. Allow the injection to reach room temperature for 15 to 30 minutes before administration for a more comfortable injection. Do not use external heat sources.
7. Rotate injection sites, typically using the upper arms, thighs, or abdomen (avoiding the 2-inch area around the navel).

Storage and Disposal

• Store the Omalirel 150mg Injection Combikit in a refrigerator between 2°C to 8°C (36°F to 46°F).
• Do not freeze the product.
• Keep the combikit in its original carton to protect it from light.
• If removed from the refrigerator, the total combined time out of refrigeration should not exceed 2 days (48 hours).
• After reconstitution, the solution should be used within 8 hours if stored at 2-8°C, or within 4 hours if stored at room temperature, protected from direct sunlight.
• Dispose of used syringes and needles safely in a sharps disposal container.

Precautions and Safety

• Omalirel 150mg Injection may cause serious, life-threatening allergic reactions (anaphylaxis). These can occur immediately or up to several days after administration.
• Patients should be closely monitored in a healthcare setting for an appropriate period after each injection, especially the first few doses.
• This medicine is not intended for the relief of acute bronchospasm or status asthmaticus.
• Do not abruptly discontinue systemic or inhaled corticosteroids when starting Omalirel therapy.
• Use with caution in patients with kidney or liver problems, or autoimmune diseases.
• The needle cap of the syringe may contain latex; inform your doctor if you have a latex allergy.

Side Effects and Risks

• Common side effects include injection site reactions (pain, redness, swelling, itching, lumps), headache, cold or flu-like symptoms (nasopharyngitis, stuffy/runny nose, sore throat), joint pain, dizziness, and fatigue.
• Serious side effects, though rare, can include anaphylaxis (wheezing, shortness of breath, chest tightness, low blood pressure, fainting, rapid heartbeat, swelling of the throat or tongue), cancer, inflammation of blood vessels, fever with muscle aches and rash, and parasitic infections.
• Consult your doctor if any side effects persist or worsen.

Disclaimer

Use this medicine only under the prescription and guidance of a qualified doctor or pharmacist.