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XOLAIR® (omalizumab) Indications for Use

XOLAIR® (omalizumab) is an injectable biologic treatment indicated for:

1. Moderate to severe persistent asthma in patients aged 6 years and older with a positive skin test or in vitro reactivity to a perennial aeroallergen, and whose symptoms are inadequately controlled with inhaled corticosteroids.
2. Chronic idiopathic urticaria (CIU) in patients aged 12 years and older who remain symptomatic despite H1 antihistamine treatment.

• Limitations: XOLAIR is not indicated for the treatment of acute bronchospasm, status asthmaticus, or other allergic conditions beyond asthma and CIU.

XOLAIR® (omalizumab) Dosage Information

XOLAIR is administered via subcutaneous (SC) injection, and dosing depends on the condition being treated.

• Asthma:
  • Dose ranges from 75 mg to 375 mg administered every 2 or 4 weeks.
  • Dose is determined based on body weight and pre-treatment serum IgE levels (measured in IU/mL). Higher IgE levels and heavier body weight may require higher doses.
  • Tables are used to determine dosage based on these factors.
• Chronic Idiopathic Urticaria (CIU):
  • Administer 150 mg or 300 mg by subcutaneous injection every 4 weeks.
  • Dosing for CIU is not dependent on serum IgE levels or body weight.

Administration:

• Reconstitute XOLAIR from lyophilized powder with Sterile Water for Injection (SWFI).
• Administer within 8 hours of reconstitution if refrigerated, or 4 hours if kept at room temperature.
• Maximum dose per injection site: 150 mg (doses above this must be split between injection sites).

XOLAIR® (omalizumab) Side Effects and Precautions

XOLAIR has been associated with various side effects, some of which can be serious.

• Common Side Effects:
  • Injection site reactions (pain, swelling, redness).
  • Viral infections, headache, sinusitis, upper respiratory tract infection, and fatigue.
  • In children aged 6-12 years, the most common adverse events include nasopharyngitis, headache, and pyrexia.
• Serious Side Effects:
  • Anaphylaxis: There is a risk of life-threatening allergic reactions. Anaphylaxis may occur with any dose, even after long-term use.
  • Malignancies: Increased risk of cancers, such as breast cancer and skin cancer, has been observed in some studies, though later studies suggest this risk may not be significantly elevated.
  • Acute Asthma Symptoms: XOLAIR is not for acute asthma exacerbations or bronchospasms.
  • Corticosteroid Reduction: Patients using corticosteroids should not discontinue them abruptly after starting XOLAIR.
  • Eosinophilic Conditions: Patients may develop eosinophilia (high levels of eosinophils, a type of white blood cell), potentially leading to vasculitis or other complications.

XOLAIR® (omalizumab) Clinical Studies or Real-World Outcomes

Several clinical trials have demonstrated the effectiveness of XOLAIR in both asthma and CIU:

1. Asthma Trials:
   • In patients aged 12 and older, XOLAIR significantly reduced the number of asthma exacerbations in both stable and steroid-reduction phases compared to placebo. For example, in one trial, 85.8% of XOLAIR-treated patients experienced no exacerbations in the first 16 weeks, compared to 76.7% on placebo​.
   • Pediatric trials for children aged 6 to 12 years showed reductions in asthma exacerbations by up to 43%, and fewer exacerbations overall compared to placebo.
2. CIU Trials:
   • CIU trials demonstrated that 300 mg of XOLAIR every 4 weeks provided significant reductions in the weekly itch severity score and hive count score compared to placebo​.
   • In one trial, 36% of patients on 300 mg reported no itching or hives after 12 weeks, compared to just 9% of those on placebo.

XOLAIR® (omalizumab) Drug Interactions

XOLAIR has no known significant drug interactions, but the effects of combining it with other immunotherapies (such as allergen immunotherapy) have not been thoroughly studied. Additionally, the safety of combining XOLAIR with immunosuppressive therapies in CIU patients is not well understood.

XOLAIR® (omalizumab) Summary of Benefits

XOLAIR offers several therapeutic benefits:

• Asthma Control: Significantly reduces the number of exacerbations in patients with moderate to severe asthma, providing relief for those inadequately controlled by inhaled corticosteroids.
• CIU Symptom Relief: Provides substantial reduction in symptoms of chronic idiopathic urticaria, including itch severity and hive count.
• Long-Lasting Effects: Benefits in both asthma and CIU are maintained with regular dosing every 2 to 4 weeks.

XOLAIR® (omalizumab) Warnings and Precautions

Healthcare providers must monitor patients for severe allergic reactions after administration and should be prepared to manage anaphylaxis. Patients with a history of anaphylaxis to foods or medications are at higher risk of XOLAIR-induced anaphylaxis​. Physicians must also monitor for signs of malignancies, eosinophilic conditions, and worsening asthma symptoms during treatment.

• Pregnancy and Lactation: There is insufficient data to determine the risk of XOLAIR during pregnancy, though it is transported across the placenta. Caution should be used when administering to breastfeeding mothers.
• Geriatric Use: Limited data on patients aged 65 and over; no significant age-related differences have been observed.