HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciFida safely and effectively. See full prescribing information for LuciFida.

INDICATIONS AND USAGE

LuciFida is a macrolide antibacterial indicated in adult and pediatric patients6 months of age and older for the treatment of C. difficile-associated diarrhea.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of LuciFida and other antibacterial drugs, LuciFida should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile.

DOSAGE AND ADMINISTRATION

· LuciFida is administered orally with or without food.

· Adults ：One 200 mg tablet orally twice daily for 10 days.

· Pediatrics (6 Months to Less than 18 Years of Age) ： Pediatric patients weighing at least 12.5 kg and able to swallow tablets: One 200 mg tablet orally twice daily for 10 days.

DOSAGE FORMS AND STRENGTHS

Tablets: 200 mg×20 tablets

CONTRAINDICATIONS

LuciFida is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in LuciFida.

WARNINGS AND PRECAUTIONS

· Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash) have been reported. If a severe hypersensitivity reaction occurs, discontinue LuciFida.

· LuciFida is not expected to be effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin. LuciFida should only be used for the treatment of C. difficile-associated diarrhea.

· Development of drug-resistant bacteria: Only use LuciFida for infection proven or strongly suspected to be caused by C. difficile.

ADVERSE REACTIONS

The most common adverse reactions in adults (incidence ≥2%) are nausea, vomiting, abdominal pain, gastrointestinal hemorrhage, anemia, and neutropenia.

The most common adverse reactions in pediatric patients (incidence ≥5%) treated with LuciFida are pyrexia, abdominal pain, vomiting, diarrhea, constipation, increased aminotransferases, and rash.

USE IN SPECIFIC POPULATIONS

Pediatrics: The safety and effectiveness of LuciFida have not been established in pediatric patients younger than 6 months of age.

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.