Xolair150 mg/vial

Asthma: Xolair 150 mg/vial 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: Xolair 150 mg/vial 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: Xolair 150 mg/vial 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): Xolair 150 mg/vial 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: Xolair 150 mg/vial 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 Xolair 150 mg/vial also reduces the number of FcεRI receptors on basophils in atopic patients.Chronic Idiopathic Urticaria: Xolair 150 mg/vial binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of Xolair 150 mg/vial 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.

For subcutaneous (SC) administration only. Divide doses of more than 150 mg among more than one injection site to limit injections to not more than 150 mg per site.Asthma: Xolair 150 mg/vial 75 to 375 mg SC every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts.Nasal Polyps: Xolair 150 mg/vial 75 to 600 mg SC every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts.Chronic Spontaneous Urticaria: Xolair 150 mg/vial 150 or 300 mg SC every 4 weeks. Dosing in CSU is not dependent on serum IgE level or body weight.

Xolair 150 mg/vial is contraindicated in patients with severe hypersensitivity reaction to Xolair 150 mg/vial or any ingredient of Xolair 150 mg/vial.

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 Xolair 150 mg/vial 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 Xolair 150 mg/vial 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 Xolair 150 mg/vial if patients develop signs and symptoms similar to serum sickness.

The maximum tolerated dose of Xolair 150 mg/vial 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.

Xolair 150 mg/vial prefilled syringe should be shipped and stored under refrigerated conditions 2°C to 8°C in the original carton. Protect from direct sunlight. Xolair 150 mg/vial 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.

Xolair 150 mg/vial is a sterile, white, preservative free, lyophilized powder contained in a single use vial that is reconstituted with Sterile Water for Injection (SWFI), USP, and administered as a subcutaneous (SC) injection. Each 202.5 mg vial of Xolair 150 mg/vial also contains L-histidine (1.8 mg), L-histidine hydrochloride monohydrate (2.8 mg), polysorbate 20 (0.5 mg) and sucrose (145.5 mg) and is designed to deliver 150 mg of Xolair 150 mg/vial in 1.2 mL after reconstitution with 1.4 mL SWFI, USP.

Antihistamines anti-allergies & hypo-sensitisation

Asthma and Nasal Polyps: Xolair 150 mg/vial 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 Xolair 150 mg/vial 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): Xolair 150 mg/vial binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of Xolair 150 mg/vial 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 Xolair 150 mg/vial in human milk or the effects on milk production. However, Xolair 150 mg/vial is a human monoclonal antibody (IgG1 kappa), and immunoglobulin (IgG) is present in human milk in small amounts.