Xolair 150 mg/vial
Omalizumab
Category: SC Injection
Manufacturer: Novartis (Bangladesh) Ltd.
Price: 18795.0 ৳
150 mg vial
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Related Medicines
Asthma: Omalizumab is indicated for adults and pediatric patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids ... Read moreAsthma: Omalizumab is indicated for adults and pediatric patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.Nasal Polyps: Omalizumab is indicated for add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.Chronic Spontaneous Urticaria (CSU): Omalizumab is indicated for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
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.
Subcutaneous-
Poorly controlled, moderate to severe asthma:
Adult: Doses (mg) and dosing frequency are based on pre-treatment serum IgE levels (IU/mL) and body wt (kg) as follows: ≥30-100 IU/mL: 150 mg (30-90 kg); 300 mg (>90-150 kg). >100-200 IU/mL: 300 mg (30-90 kg). >200-300 IU/mL: 300 mg (30-60 kg). All doses to be taken every 4 wk. >100-200 IU/mL: 225 mg (>90-150 kg). >200-300 IU/mL: 225 mg (>60-90 kg); 300 mg (>90-150 kg). >300-400 IU/mL: 225 mg (30-70 kg); 300 mg (>70-90 kg). >400-500 IU/mL: 300 mg (30-70 kg); 375 mg (>70-90 kg). >500-600 IU/mL: 300 mg (30-60 kg); 375 mg (>60-70 kg). 375 mg (30-60 kg). All doses to be taken every 2 wk. Doses no more than 150 mg should be admin at 1 inj site.
Child: ≥12 yr Same as adult dose.
Chronic idiopathic urticaria:
Adult: 150 or 300 mg every 4 wk.
Child: ≥12 yr Same as adult dose.
Omalizumab is contraindicated in patients with severe hypersensitivity reaction to Omalizumab or any ingredient of Omalizumab.
Asthma: The most common adverse reactions (≥1% of patients) in clinical studies with adult and adolescent patients ≥12 years of age were arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In clinical studies with pediatric patients 6 to <12 years of age, the most common adverse reactions were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis.Nasal Polyps: The most common adverse reactions (≥3% of patients) in clinical studies with adult patients included the following: headache, injection site reaction, arthralgia, upper abdominal pain, and dizziness.Chronic Spontaneous Urticaria: The most common adverse reactions (≥2% of patients) included the following: nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, arthralgia, headache, and cough.
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.
Samm Care