What is the recommended dose of Fasenra (benralizumab) for a patient who has a gap in treatment?

Recommended Dosage of Fasenra (Benralizumab) After a Gap in Treatment

For patients who have experienced a gap in Fasenra (benralizumab) treatment, the recommended approach is to restart with the initial loading dose regimen of 30 mg administered subcutaneously every 4 weeks for the first 3 doses, followed by 30 mg every 8 weeks thereafter.

Dosing Rationale and Evidence

The FDA-approved dosing for Fasenra (benralizumab) follows a specific pattern that should be maintained even after treatment gaps 1:

• Initial phase: 30 mg administered subcutaneously every 4 weeks for the first 3 doses
• Maintenance phase: 30 mg administered subcutaneously every 8 weeks thereafter

This dosing schedule is designed to achieve rapid eosinophil depletion during the loading phase, followed by sustained control during maintenance therapy.

Specific Recommendations Based on Gap Duration

While the FDA label doesn't explicitly address treatment gaps, clinical practice guidelines support restarting the full loading dose regimen after significant interruptions:

1. For any significant gap in therapy (typically considered >8 weeks):

   • Restart with the full loading regimen: 30 mg every 4 weeks for 3 doses
   • Then continue with 30 mg every 8 weeks

2. For brief gaps (less than 8 weeks):

   • If in maintenance phase: Resume with 30 mg every 8 weeks
   • If still in loading phase: Complete the remaining loading doses every 4 weeks, then transition to every 8 weeks

Administration Considerations

• Fasenra is administered subcutaneously into the thigh, abdomen, or upper arm 1
• The medication should be warmed to room temperature for about 30 minutes prior to administration
• Visually inspect the solution before use - it should be clear to opalescent, colorless to slightly yellow

Monitoring After Restarting Therapy

• Monitor patients after administration, especially after restarting therapy following a gap 1
• Assess for potential hypersensitivity reactions
• Evaluate treatment response through:
  • Reduction in exacerbation rates
  • Improvement in lung function
  • Reduction in oral corticosteroid use (if applicable)
  • Improvement in asthma symptoms

Special Patient Populations

For pediatric patients aged 6-11 years, the dosing is weight-based 1:

• Less than 35 kg: 10 mg every 4 weeks for 3 doses, then every 8 weeks
• 35 kg or more: 30 mg every 4 weeks for 3 doses, then every 8 weeks

Clinical Evidence Supporting Efficacy

Long-term studies have demonstrated that benralizumab maintains its efficacy and safety profile when administered according to the recommended dosing schedule 2, 3. The XALOC-1 study showed that even in biologic-experienced patients, benralizumab provided significant reductions in exacerbation rates (72.9%) and oral corticosteroid use (34.9%) 3.

Important Considerations

• Fasenra is not indicated for the relief of acute bronchospasm or status asthmaticus 1
• Treatment gaps may result in loss of eosinophil suppression, potentially leading to symptom recurrence
• Restarting with the loading dose regimen helps to rapidly re-establish therapeutic effect

By following the recommended dosing regimen after a treatment gap, patients can expect to regain the clinical benefits of Fasenra, including reduced exacerbation rates and improved asthma control.