Drug Detail:Baloxavir (monograph) (Xofluza)
Drug Class:
Usual Adult Dose for Influenza
20 to less than 80 kg: 40 mg orally as a single dose
At least 80 kg: 80 mg orally as a single dose
Uses:
- For the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications
- For postexposure prophylaxis of influenza after contact with an individual who has influenza
Usual Adult Dose for Influenza Prophylaxis
20 to less than 80 kg: 40 mg orally as a single dose
At least 80 kg: 80 mg orally as a single dose
Uses:
- For the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications
- For postexposure prophylaxis of influenza after contact with an individual who has influenza
Usual Pediatric Dose for Influenza
5 years or older:
- Weight less than 20 kg: 2 mg/kg orally as a single dose
- Weight 20 to less than 80 kg: 40 mg orally as a single dose
- Weight at least 80 kg: 80 mg orally as a single dose
Uses:
- For the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours and who are:
- otherwise healthy pediatric patients at least 5 years of age, OR
- pediatric patients at least 12 years of age who are at high risk of developing influenza-related complications
- For postexposure prophylaxis of influenza after contact with an individual who has influenza
Usual Pediatric Dose for Influenza Prophylaxis
5 years or older:
- Weight less than 20 kg: 2 mg/kg orally as a single dose
- Weight 20 to less than 80 kg: 40 mg orally as a single dose
- Weight at least 80 kg: 80 mg orally as a single dose
Uses:
- For the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours and who are:
- otherwise healthy pediatric patients at least 5 years of age, OR
- pediatric patients at least 12 years of age who are at high risk of developing influenza-related complications
- For postexposure prophylaxis of influenza after contact with an individual who has influenza
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Precautions
CONTRAINDICATIONS:
- History of hypersensitivity to the active component or any of the ingredients
Safety and efficacy have not been established in patients younger than 5 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Comments:
- This drug is highly bound to serum proteins; significant removal by dialysis is unlikely.
Other Comments
Administration advice:
- Administer as a single dose as soon as possible and within 48 hours of influenza symptom onset for treatment of acute uncomplicated influenza or after contact with an individual who has influenza.
- Administer with or without food; avoid coadministration with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, zinc).
- Oral suspension: Use in patients who are unable to swallow tablets, who have difficulty swallowing tablets, or who require enteral administration.
- Oral suspension: Do not administer the contents of the full bottle(s) without use of measuring device (oral syringe). Ensure the caregiver/patient uses an oral syringe to measure the prescribed dose; patients may need to draw up the oral suspension multiple times using the oral syringe to receive the full dose.
- Oral suspension: Administer within 10 hours after constitution (product contains no preservative). Gently swirl before use; do not shake.
- Oral suspension: Provide caregiver/patient with a measuring device (oral syringe) to deliver the prescribed dose. For enteral administration (i.e., feeding tube), draw up suspension with an enteral syringe; flush with 1 mL of water before and after enteral administration.
- Tablets: For the 40 mg dose, administer one 40 mg tablet; for the 80 mg dose, administer one 80 mg tablet.
Storage requirements:
- Granules (before constitution): Store at room temperature 20C to 25C (68F to 77F) and keep in original bottle; excursions permitted to 15C to 30C (59F to 86F).
- Oral suspension (after constitution): Store no longer than 10 hours at room temperature 20C to 25C (68F to 77F); discard if not used within 10 hours of preparation or if stored above 25C (77F).
- Tablets: Store in blister package at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
Reconstitution/preparation techniques (oral suspension):
- Before dispensing to patient, constitute with drinking water or sterile water; prepare at time of dispensing.
- Gently swirl to ensure granules are evenly suspended; do not shake.
- The manufacturer product information should be consulted.
General:
- Limitations of Use: As influenza viruses change over time, factors (e.g., virus type/subtype, emergence of resistance, changes in viral virulence) could reduce clinical benefit of antiviral drugs; available drug susceptibility patterns for circulating influenza virus strains should be considered when deciding whether to use this drug.
- For "People at Higher Risk of Flu Complications", the US CDC "Influenza (Flu)" website should be consulted.
- This drug is not a substitute for annual influenza vaccination as recommended by the US CDC Advisory Committee on Immunization Practices.
- Serious allergic reactions have included anaphylaxis, angioedema, urticaria, and erythema multiforme.
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information).
- If using for prophylaxis, take as soon as possible after exposure; if using for treatment, take as soon as possible at first sign of influenza symptoms, within 48 hours of symptom onset.
- Follow the health care provider's dosing recommendations for a single, 1-time dose.
- Oral suspension: The total prescribed dose depends on patient's weight and may require less than 1 bottle (e.g., for pediatric patients 5 years or older weighing less than 20 kg), 1 bottle (e.g., for adults and adolescents weighing 20 to less than 80 kg), or 2 bottles (e.g., for adults and adolescents weighing at least 80 kg). Use a measuring device (oral syringe) to measure the prescribed dose; you may need to draw up the oral suspension multiple times using the oral syringe to receive the full dose. Take as soon as possible but no later than 10 hours after constitution by the health care provider (product has no preservative).
- Tablets: Provided as a blister card containing either 1 tablet of 40 mg or 1 tablet of 80 mg as a single dose (tablet strength to use is dependent on patient weight).
- Seek immediate medical attention if an allergic-like reaction occurs/is suspected.
- Consult health care provider before receiving a live attenuated influenza vaccine after taking this drug.
Frequently asked questions
- What is the difference between Xofluza and Tamiflu?
- How long does it take for Xofluza to work?