Crushing Xofluza (Baloxavir Marboxil)
Xofluza (baloxavir marboxil) should not be crushed for patients with swallowing difficulties. Instead, use the FDA-approved oral suspension formulation that is specifically designed for patients who have difficulty swallowing tablets or require enteral administration.
FDA-Approved Administration Options
- Xofluza is available in two dosage forms: tablets and oral suspension 1
- The oral suspension formulation is specifically intended for "patients who are unable to or have difficulty swallowing tablets, or those who require enteral administration" 1
- For patients with swallowing difficulties, healthcare providers should prescribe the oral suspension rather than attempting to crush tablets 1
Administration of Xofluza Oral Suspension
- The oral suspension must be constituted by a healthcare provider with 20 mL of drinking water or sterile water 1
- After constitution, the suspension contains 40 mg of baloxavir marboxil per 20 mL (2 mg/mL) 1
- The suspension can be administered orally or through a feeding tube 1
- For enteral administration, draw up suspension with an enteral syringe and flush with 1 mL of water before and after administration 1
Why Crushing Is Not Recommended
- Crushing tablets can alter drug absorption, potentially resulting in overdose or underdosing 2
- The FDA-approved labeling specifically provides an oral suspension alternative rather than recommending crushing 1
- Xofluza tablets contain inactive ingredients including croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone, sodium stearyl fumarate, talc, and titanium dioxide 1, which may affect bioavailability if crushed
Important Administration Considerations
- Xofluza (in any form) should not be taken with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing iron, zinc, selenium, calcium, or magnesium 1, 3
- Coadministration with these products should be avoided as they can reduce the efficacy of the medication 1, 3
- Xofluza should be taken as soon as possible after influenza symptom onset and within 48 hours for optimal effectiveness 1
Dosing Guidelines
- For patients 12 years and older weighing less than 80 kg: 40 mg (20 mL of suspension) as a single dose 1
- For patients 12 years and older weighing 80 kg or more: 80 mg (40 mL of suspension) as a single dose 1
- For children 5 years and older weighing less than 20 kg: 2 mg/kg as a single dose 4
Clinical Considerations
- Baloxavir marboxil is effective against both influenza A and B viruses 5, 6
- The medication works through a novel mechanism of action by inhibiting cap-dependent endonuclease required for viral replication 5, 6
- Common side effects include diarrhea, bronchitis, nausea, sinusitis, and headache 1
Remember that when patients have difficulty swallowing medications, it's important to use FDA-approved alternative formulations rather than modifying dosage forms in ways not supported by the manufacturer or regulatory guidance.