Source: FDA, National Drug Code (US) Revision Year: 2020
XOFLUZA is indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are:
Influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use XOFLUZA [see Microbiology (12.4) and Clinical Studies (14)].
Initiate treatment with XOFLUZA within 48 hours of influenza symptom onset. XOFLUZA is taken orally as a single dose and may be taken with or without food. However, co-administration of XOFLUZA with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc) should be avoided [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].
The recommended dose of XOFLUZA in patients 12 years of age or older is a single weight-based dose as follows:
Table 1. Recommended XOFLUZA Dosage in Adults and Adolescents 12 Years and Older:
| Patient Body Weight (kg) | Recommended Single Oral Dose |
|---|---|
| 40 kg to less than 80 kg | Two 20 mg tablets taken at the same time for a total single dose of 40 mg (blister card contains two 20 mg tablets) |
| At least 80 kg | Two 40 mg tablets taken at the same time for a total single dose of 80 mg (blister card contains two 40 mg tablets) |
Treatment of an overdose of XOFLUZA should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with XOFLUZA.
Baloxavir is unlikely to be significantly removed by dialysis due to high serum protein binding [see Clinical Pharmacology (12.3)].
Product: 50090-4104
NDC: 50090-4104-0 2 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON
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