HIGHLIGHTS OF PRESCRIBING INFORMATION ...

1 1 HIGHLIGHTS OF PRESCRIBING INFORMATIONT hese HIGHLIGHTS do not include all the INFORMATION needed to useDIFICID safely and effectively. See full PRESCRIBING INFORMATION (fidaxomicin) tablets, for oral useDIFICID (fidaxomicin) for oral suspensionInitial Approval: 2011 --------------------------- INDICATIONS AND USAGE ---------------------------- DIFICID 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 theeffectiveness of DIFICID and other antibacterial drugs, DIFICID should beus ed only to treat infections that are proven or strongly suspected to be causedby C.

2 Difficile. ( ) ----------------------- DOSAGE AND ADMINISTRATION ----------------------- DIFICID is administered orally with or without food. ( ) Adultso One 200 mg tablet orally twice daily for 10 days. (2 .2) Pediatrics (6 Months to Less than 18 Years of Age) Tabletso Pediatric patie nts weighing at least kg and able to swallowtablets: One 200 mg tablet orally twice daily for 10 days. ( ) Oral Suspensiono Pediatric patients weighing at least 4 kg: Weight-based dosing ofthe oral suspension twice daily for 10 da ys using an oral dosingsyringe, as specified in Table 1 in the full PRESCRIBING INFORMATION .

3 ( )o For instructions on preparation and administration of DIFICID oralsuspension, see full PRESCRIBING INFORMATION . ( ) --------------------- DOSAGE FORMS AND STRENGTHS ---------------------- Film-coated tablets: 200 mg (3) For oral suspension: 40 mg/mL (200 mg/5 mL) when reconstituted (3) ------------------------------ CONTRAINDICATIONS ------------------------------ DIFICID is contraindicated in patients who have known hypersensitivity tofidaxomicin or any other ingredient in DIFICID. (4) ----------------------- WARNINGS AND PRECAUTIONS ----------------------- Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, andrash) have been reported.

4 If a severe hypersensitivity reaction occurs,discontinue DIFICID. ( ) DIFICID is not expected to be effective for the treatment of other typesof infections due to minimal systemic absorption of should only be used for the treatment of C. difficile-associateddiarrhea. ( ) Development of drug-resistant bacteria: Only use DIFICID for infectionproven 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, andneutropenia.

5 (6) The most common adverse reactions in pediatric patients (incidence 5%)treated with DIFICID are pyrexia, abdominal pain, vomiting, diarrhea,constipation, increased aminotransferases, and rash. (6)To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp& Dohme LLC at 1-877 -888 -4231 or FDA at 1-800 -FDA-1088 . ----------------------- US E IN SPE CIFIC POPULATIONS ----------------------- Pediatrics: The safety and effectiveness of DIFICID have not been establishedin pediatric patients younger than 6 months of age. ( )See 17 for PATIENT COUNSELING INFORMATION and FD A-approved patient labeling.

6 Re vised: 06/2022 FULL PRESCRIBING INFORMATION : CONTENTS*1 INDICATIONS AND Clostridioides difficile-Associated Usage2 DOSAGE AND Important Administration Adult Pediatric Patients (6 Months to Les s t han 18 Years of Age) Preparation and Administration of DIFICID Oral Suspension3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND Hypersensitivity Not fo r Use in In fections Other than C. Development of Drug-Resistant Bacteria6 ADVERSE Clinical Trials Post Marketing Experience7 DRUG Cyclosporine8 USE IN SPECIFIC Pregnancy8.

7 2 Pediatric Geriatric Use10 OVERDOSAGE11 DESCRIPTION12 CLINICAL Mechanism of Microbiology13 NONCLINICAL Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL Cl inical Studies of DIFICID in Adult Patients with Clinical Studies of DIFICID in Pediatric Patient s with CDAD16 HOW SUPPLIED/STORAGE AND How Storage17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full PRESCRIBING INFORMATION are PRESCRIBING INFORMATION1 INDICATIONS AND US Clostridioides difficile-Associated DiarrheaDIFICID is indicated in adult and pediatric patients aged 6 months and older for the treatment of C.

8 Difficile-associated diarrhea (CDAD). UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and otherantibacterial dr ugs, DIFICID should be used only to treat infections that are proven or strongly suspected to becaused by C. difficile. When culture and susceptibility INFORMATION are available, they should be considered inselecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibilitypatterns may contribute to the empiric selection of DOSAGE AND Important Administration Ins tructionsDIFICID is available for oral administration as 200 mg tablets and as granules for oral suspension (40 mg/mL(200 mg/5 mL) when reconstituted).

9 DIFICID is administered orally with or without Adu lt PatientsThe recommended dosage for ad ults is one 200 mg DIFICID tablet orally twice daily for 10 days. Pe diatric Pati ent s (6 Mont hs to Less than 18 Years of Age)TabletsThe recommended dosag e for pediatric patients weighing at least kg and able to swallow tablets is one 200 mgDIFICID tablet administered orally twice daily fo r 10 days. If unable to swallow tablets, pediatric patients may bedosed with DIFICID oral suspension as recommended in Table 1 SuspensionThe recommended dosage for pediatric patients based on weight are shown in Table 1.

10 Administer DIFICID oralsuspension orally twice daily for 10 days using an oral dosing syringe [see Dosage and Administr ation ( )].Table 1: Recommended Dosage of DIFICID Oral Suspension i n Pediatric Patients, Based on WeightBody WeightDose Administered Twice DailyVolume of 40 mg/mL Suspension to beAd ministered Orally Twice Daily4 kg to less than 7 kg80 mg2 mL7 kg to less than 9 kg120 mg3 mL9 kg to less than kg160 mg4 kg and above200 mg5 Preparation and Administration of DIFICID Oral SuspensionPr eparation1. Shake the glass bottle to ensure the granules move around freely and no cak ing has occurr Measure 130 mL of purified water, add to the glass bottle, and cap Hold bottle in a horizontal position and shake bottle vigorously in that position for at least 2 Verify that a homogeneous suspension is obtained.