BALOXAVIR TAB,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Severe influenza requiring hospitalization unless oseltamivir/zanamivir is contraindicated or not tolerated
- Pregnancy
Inclusion Criteria
- Patient with documented influenza by PCR/rapid flu test OR strongly suspected influenza during a time of significant influenza activity in the community (as evidenced by at least fever PLUS one or more of the following: severe fatigue, muscle aches, severe respiratory symptoms)
- Presenting within 48 hours of onset of flu-like symptoms
- Was exposed to influenza as a household contact who is within 48 hours of symptom onset
- AND at least one of the following additional conditions:
- Prior intolerance and/or allergy to oseltamivir and/or zanamivir
- Documented oseltamivir-resistant influenza in the community
- Inability to receive oseltamivir within the 48-hour time window from symptom onset (such as CBOCs, or after pharmacy hours, shortages of oseltamivir limiting supply)
Dosing and Administration
- Given as a single oral dose taken with or without food
- Should be separated from dairy products or di/trivalent cations
- Recommended dosage: 40 mg for patients weighing < 80 kg and 80 mg for those weighing ≥ 80 kg
Additional Clinical Considerations
- Emergence of mutants with reduced susceptibility to baloxavir emerged in 3-11% of subjects receiving baloxavir in clinical trials
- Use may be considered in situations where oseltamivir and zanamivir are contraindicated or not tolerated, or cannot be used due to logistical constraints which prevent adherence to or timely receipt of oseltamivir or zanamivir (such as homelessness, inability to fill prescription in a timely manner due to distance or after pharmacy hours, or other situations where directly observed therapy is preferred)