Xolair
Rx150 mg/ml • SC Injection
Indications & Uses
Pharmacology
In asthma and nasal polyps, omalizumab stops IgE from binding to the high-affinity IgE receptor (FcεRI) on the surface of mast cells, basophils and dendritic cells. This leads to FcεRI down-regulation on these cells. In people with allergic asthma, treatment with omalizumab inhibits IgE-mediated inflammation. You can see this in the reduced blood and tissue eosinophils and in the reduced inflammatory mediators, including IL-4, IL-5 and IL-13.
In chronic spontaneous urticaria (CSU), omalizumab binds to IgE and lowers free IgE levels. After that, the IgE receptors (FcεRI) on cells down-regulate. How these effects improve CSU symptoms is not known.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Omalizumab is given by subcutaneous (SC) injection only. If a dose is more than 150 mg, split it between more than one injection site so that no site gets more than 150 mg.
Asthma: the dose is 75 to 375 mg SC every 2 or 4 weeks. The dose (mg) and how often it is given depend on the serum total IgE level (IU/mL), measured before treatment starts, and on body weight (kg). The dose determination charts should be checked.
Nasal polyps: the dose is 75 to 600 mg SC every 2 or 4 weeks. Here too, the dose (mg) and the frequency depend on the serum total IgE level (IU/mL), measured before treatment starts, and on body weight (kg). Again, see the dose determination charts.
Chronic spontaneous urticaria (CSU): the dose is 150 or 300 mg SC every 4 weeks. In CSU, the dose doesn't depend on serum IgE level or body weight.
Side Effects
Asthma: In clinical studies of omalizumab in adults and adolescents aged ≥12 years, the most common adverse reactions (seen in ≥1% of patients) were arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis and earache. In children aged 6 to <12 years, the most common ones were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites and epistaxis. Nasal Polyps: In clinical studies in adults, the most common adverse reactions (≥3% of patients) were headache, injection site reaction, arthralgia, upper abdominal pain and dizziness. Chronic Spontaneous Urticaria: The most common adverse reactions (≥2% of patients) were nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, arthralgia, headache and cough.
Cautions & Contraindications
Warnings & Precautions
Anaphylaxis can be life-threatening, so start Omalizumab in a healthcare setting that is prepared to manage it, and watch patients for a suitable period after each administration. Malignancy: malignancies have been seen in clinical studies. Acute asthma symptoms: don't use Omalizumab to treat acute bronchospasm or status asthmaticus. Corticosteroid reduction: don't stop corticosteroids suddenly when Omalizumab therapy begins. Eosinophilic conditions: watch for eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications and/or neuropathy, especially when oral corticosteroids are being reduced. Fever, arthralgia and rash: if a patient develops signs and symptoms similar to serum sickness, stop Omalizumab.
Contraindications
Omalizumab must not be given to anyone who has had a severe hypersensitivity reaction to omalizumab itself or to any of the ingredients in it.
Pregnancy & Breastfeeding
Asthma that is poorly or only moderately controlled carries risks in pregnancy. There is no information on whether omalizumab passes into human milk, or on what it does to milk production. Omalizumab is a human monoclonal antibody (IgG1 kappa), though, and immunoglobulin (IgG) is present in human milk in small amounts.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Keep the Omalizumab prefilled syringe in a refrigerator at 2°C to 8°C, and keep it in its original carton. The same applies when it is shipped. Protect it from direct sunlight.
You can take the syringe out of the refrigerator and put it back if you need to. But the total time it spends outside the refrigerator, added together, may not go beyond 2 days. Don't use the syringe if it has been exposed to temperatures above 25°C.
Do not freeze it. If the syringe has been frozen, don't use it.
Common questions about Xolair 150 mg/ml
What is Xolair 150 mg/ml SC Injection?
Xolair 150 mg/ml SC Injection is a medicine that contains Omalizumab. It is made by Nevian Lifescience PLC. It belongs to the Antihistamines anti-allergies & hypo-sensitisation group of medicines.
What is Xolair used for?
Xolair is used for: Asthma, Urticaria, Allergy.
What are the side effects of Xolair?
Asthma: In clinical studies of omalizumab in adults and adolescents aged ≥12 years, the most common adverse reactions (seen in ≥1% of patients) were arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis and earache. In children aged 6 to <12 years, the most common ones were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites and epistaxis.
Can I take Xolair during pregnancy or while breastfeeding?
Asthma that is poorly or only moderately controlled carries risks in pregnancy. There is no information on whether omalizumab passes into human milk, or on what it does to milk production. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Xolair?
Keep the Omalizumab prefilled syringe in a refrigerator at 2°C to 8°C, and keep it in its original carton. The same applies when it is shipped.
Do I need a prescription for Xolair?
Xolair is a prescription (Rx) medicine. Take it as your doctor advises.