What is Benralizumab? Benralizumab, known by its brand name Fasenra, is a monoclonal antibody used to treat severe asthma and eosinophilic granulomatosis with polyangiitis (EGPA). Developed by MedImmune and marketed by AstraZeneca, this medication targets eosinophils and basophils, reducing inflammation by inducing cell death. Administered via subcutaneous injection, it offers significant relief for patients whose symptoms are not controlled by standard asthma treatments. Clinical trials have shown its effectiveness in reducing exacerbations and improving lung function. Approved by the FDA in 2017, benralizumab has become a vital option for managing severe respiratory conditions.
Key Takeaways:
- Benralizumab, or Fasenra, is a medication for severe asthma and EGPA. It reduces inflammation by targeting specific cells, improving lung function and preventing severe attacks.
- Proper dosage, administration, and storage of benralizumab are crucial for its effectiveness and safety. It has shown significant reductions in exacerbations and improved lung function in clinical trials.
What is Benralizumab?
Benralizumab, known by its brand name Fasenra, is a monoclonal antibody used to treat severe asthma and eosinophilic granulomatosis with polyangiitis (EGPA). This medication has been developed by MedImmune and is marketed by AstraZeneca.
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Mechanism of Action: Benralizumab binds to the alpha subunit of the interleukin-5 receptor (IL-5Rα) on eosinophils and basophils, leading to the apoptosis of these cells, reducing eosinophilic inflammation.
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Type of Medication: It is a monoclonal antibody, a protein-based medication designed to target specific cells or proteins in the body.
Target Diseases
Benralizumab is primarily used to treat severe asthma and EGPA, conditions characterized by inflammation and high eosinophil counts.
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Severe Asthma: It helps prevent severe asthma attacks and improves breathing by reducing airway inflammation.
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Eosinophilic Granulomatosis with Polyangiitis (EGPA): This condition involves asthma, high white blood cell levels, and blood vessel swelling. Benralizumab reduces eosinophil counts in EGPA patients.
Clinical Trials and Efficacy
The effectiveness of benralizumab has been evaluated through rigorous clinical trials.
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Clinical Trials: Three randomized, double-blind, placebo-controlled trials lasting 28 to 56 weeks involved patients aged 12 to 75 years.
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Clinical Efficacy: Trials showed significant reductions in exacerbations and improved lung function. The median reduction in airway mucosa eosinophils was 96% in the benralizumab group compared to 47% in the placebo group.
Dosage and Administration
Understanding how to properly use benralizumab is crucial for its effectiveness.
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Dosage: Administered via subcutaneous injection, the initial dose is 30 mg every 4 weeks for the first three doses, then every 4 or 8 weeks depending on the patient's response.
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Injection Technique: Patients should be taught how to prepare and administer the medication correctly. The autoinjector device should be used as directed.
Regulatory Approvals and Designations
Benralizumab has received various approvals and designations from regulatory bodies.
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FDA Approval: Approved by the FDA in November 2017 for severe eosinophilic asthma.
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Orphan Drug Designation: Granted by the FDA for eosinophilic oesophagitis in August 2019, a designation for medications treating rare diseases.
Side Effects and Safety
Like all medications, benralizumab has potential side effects.
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Common Adverse Effects: Injection site reactions were reported in 2.2% of patients in clinical trials compared to 1.9% in the placebo group.
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Serious Side Effects: These can include wheezing, hives, rash, swelling of the face, mouth, and tongue, and fainting or dizziness.
Long-Term Effectiveness
The long-term benefits of benralizumab have been studied to ensure sustained efficacy.
- Long-Term Effectiveness: Trials showed that the reduction in annual exacerbation rate observed in the placebo-controlled trials was maintained over the second year of treatment.
Patient Considerations
Benralizumab is suitable for a wide range of patients, but there are specific considerations for different age groups.
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Adults and Children: Indicated for use in adults and children aged 12 years and older.
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Geriatric Considerations: Elderly patients may be more sensitive to the effects of this medication compared to younger adults.
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Pediatric Considerations: Safety and efficacy have not been established in children younger than 6 years.
Storage and Handling
Proper storage and handling of benralizumab ensure its effectiveness and safety.
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Storage: Should be stored in a refrigerator at 2°C to 8°C, protected from light, and kept in the original container until use.
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Handling: Any unused drug should be discarded after the expiration date.
Interactions and Overdosage
Understanding potential interactions and what to do in case of overdosage is important for patient safety.
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Medication Interactions: No expected interactions with other medications, but patients should inform their healthcare provider about all medications they are taking.
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Overdosage: If a patient thinks they have taken too much, they should contact a poison control center or emergency room immediately.
Reporting Adverse Events
Patients should be vigilant about reporting any unusual problems while receiving benralizumab.
- Reporting Adverse Events: Serious side effects should be immediately reported to the FDA’s MedWatch Adverse Event Reporting program.
Additional Facts
Here are some more interesting facts about benralizumab.
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Hospitalization and Emergency Room Visits: The rate of exacerbations requiring hospitalization or emergency room visits was significantly lower in patients receiving benralizumab compared to those receiving placebo.
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Exacerbation Trials: The SIROCCO and CALIMA trials showed a greater exacerbation rate reduction and improvements in FEV1 with increasing baseline blood eosinophils.
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Mechanism of Action in Detail: Benralizumab's binding to IL-5Rα leads to enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), resulting in the apoptosis of eosinophils and basophils.
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Dosage Adjustments: The dosage may need to be adjusted based on the patient's response and the severity of their condition, with lower doses for children weighing less than 35 kg.
Benralizumab: A Game-Changer for Severe Asthma and EGPA
Benralizumab, known as Fasenra, offers a significant breakthrough for those battling severe asthma and eosinophilic granulomatosis with polyangiitis (EGPA). By targeting and reducing eosinophils, it helps manage symptoms and prevent severe asthma attacks. Clinical trials have shown its effectiveness in reducing exacerbations and improving lung function. Administered via subcutaneous injection, it’s a convenient option for many patients. While common side effects include injection site reactions, serious side effects are rare but should be reported immediately. Approved by the FDA in 2017, benralizumab continues to be a valuable treatment option. Proper storage and handling are crucial for its effectiveness. Patients should always consult their healthcare provider for personalized advice. Benralizumab represents a promising option for those struggling with severe asthma and EGPA, offering hope and improved quality of life.
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