Baloxavir Marboxil Tablets

LuciBal (Baloxavir marboxil Tablet 20mg)

EACH FILM-COATED LUCIBAL TABLET CONTAINS: Baloxavir marboxil……………..20mg

INDICATIONS

Treatment of Influenza

LuciBal is indicated for treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications.

Post-Exposure Prophylaxis of Influenza

LuciBal is indicated for post-exposure prophylaxis of influenza in persons 5 years of age and older following contact with an individual who has influenza.

Limitations of Use

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 LuciBal.

DOSAGE

LuciBal should be taken as soon as possible after influenza symptom onset or exposure to influenza and may be taken with or without food. However, coadministration of LuciBal 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.

• Recommended Dosage

Treatment of Acute Uncomplicated Influenza or Post-Exposure Prophylaxis in Adults, and Pediatric Patients (5 Years of Age and Older)

LuciBal should be taken as a single dose as soon as possible and within 48 hours of influenza symptom onset for treatment of acute uncomplicated influenza or following contact with an individual who has influenza. The recommended dosage of LuciBal in patients 5 years of age or older is a single weight-based dose displayed in Tables 1.

Table 1 Recommended LuciBal Tablet Dosage in Adults and Pediatric Patients 5 Years of Age and Older

STORAGE

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.

MANUFACTURED AND MARKETED BY

LUCIUS PHARMACEUTICALS(LAO) CO., LTD

Address: Thongmang village, Xaythany district, Vientiane Capital, Laos