Uses of Xolair: - Asthma

Antihistamines anti-allergies & hypo-sensitisation

Asthma: Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells and basophils. Reduction in surface-bound IgE on FcεRI-bearing cells limits the degree of release of mediators of the allergic response. Treatment with Omalizumab also reduces the number of FcεRI receptors on basophils in atopic patients.Chronic Idiopathic Urticaria: Omalizumab binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of omalizumab result in an improvement of CIU symptoms is unknown.

How to use Omalizumab: Your doctor or nurse will give you this medicine. Kindly do not self administer.

Omalizumab is contraindicated in patients with severe hypersensitivity reaction to Omalizumab or any ingredient of Omalizumab.

Common - Headache - Fever - Application site reactions (burning, irritation, itching and redness)

Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Anaphylaxis: Initiate omalizumab therapy in a healthcare setting prepared to manage anaphylaxis which can be life-threatening and observe patients for an appropriate period of time after administration. Malignancy: Malignancies have been observed in clinical studies. Acute Asthma Symptoms: Do not use for the treatment of acute bronchospasm or status asthmaticus. Corticosteroid Reduction: Do not abruptly discontinue corticosteroids upon initiation of omalizumab therapy. Eosinophilic Conditions: Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids. Fever, Arthralgia, and Rash: Stop omalizumab if patients develop signs and symptoms similar to serum sickness.

The maximum tolerated dose of Omalizumab has not been determined. Single intravenous doses of up to 4,000 mg have been administered to patients without evidence of dose limiting toxicities. The highest cumulative dose administered to patients was 44,000 mg over a 20 week period, which was not associated with toxicities.

Omalizumab prefilled syringe should be shipped and stored under refrigerated conditions 2°C to 8°C in the original carton. Protect from direct sunlight. Omalizumab prefilled syringe can be removed from and placed back in the refrigerator if needed. The total combined time out of the refrigerator may not exceed 2 days. Do not use if the prefilled syringe is exposed to temperatures above 25°C. Do not freeze. Do not use if the syringe has been frozen.

Antihistamines anti-allergies & hypo-sensitisation

Asthma and Nasal Polyps: Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and dendritic cells, resulting in FcεRI down-regulation on these cells. In allergic asthmatics, treatment with omalizumab inhibits IgE-mediated inflammation, as evidenced by reduced blood and tissue eosinophils and reduced inflammatory mediators, including IL-4, IL-5, and IL-13.Chronic Spontaneous Urticaria (CSU): Omalizumab binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of omalizumab result in an improvement of CSU symptoms is unknown.

There are risks associated with poorly or moderately controlled asthma in pregnancy. There is no information regarding the presence of omalizumab in human milk or the effects on milk production. However, omalizumab is a human monoclonal antibody (IgG1 kappa), and immunoglobulin (IgG) is present in human milk in small amounts.