Dificid
(fidaxomicin)Dosage & Administration
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Dificid Prescribing Information
Clostridioides difficile-Associated Diarrhea
DIFICID® is indicated in adult and pediatric patients aged 6 months and older for the treatment of C. difficile-associated diarrhea (CDAD).
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Important Administration Instructions
DIFICID is available for oral administration as 200 mg tablets and as granules for oral suspension (40 mg/mL (200 mg/5 mL) when reconstituted). DIFICID is administered orally with or without food.
Adult Patients
The recommended dosage for adults is one 200 mg DIFICID tablet orally twice daily for 10 days.
Pediatric Patients (6 Months to Less than 18 Years of Age)
Tablets
The recommended dosage for pediatric patients weighing at least 12.5 kg and able to swallow tablets is one 200 mg DIFICID tablet administered orally twice daily for 10 days. If unable to swallow tablets, pediatric patients may be dosed with DIFICID oral suspension as recommended in Table 1 below.
Oral Suspension
The recommended dosage for pediatric patients based on weight are shown in Table 1. Administer DIFICID oral suspension orally twice daily for 10 days using an oral dosing syringe [see Dosage and Administration (2.4)].
| Body Weight | Dose Administered Twice Daily | Volume of 40 mg/mL Suspension to be Administered Orally Twice Daily |
|---|---|---|
| 4 kg to less than 7 kg | 80 mg | 2 mL |
| 7 kg to less than 9 kg | 120 mg | 3 mL |
| 9 kg to less than 12.5 kg | 160 mg | 4 mL |
| 12.5 kg and above | 200 mg | 5 mL |
Preparation and Administration of DIFICID Oral Suspension
Preparation
- Shake the glass bottle to ensure the granules move around freely and no caking has occurred.
- Measure 130 mL of purified water, add to the glass bottle, and cap tightly.
- Hold bottle in a horizontal position and shake bottle vigorously in that position for at least 2 minutes.
- Verify that a homogeneous suspension is obtained. If not, repeat the shaking step.
- Once a homogeneous suspension is visually confirmed, shake an additional 30 seconds.
- Let bottle stand for 1 minute.
- Verify that the suspension is still homogeneous. If not, repeat steps 3 through 6.
- Once reconstituted, DIFICID oral suspension is white to yellowish white in color.
- Write discard date (current date plus 12 days) on the bottle [see How Supplied/Storage and Handling (16.1, 16.2)].
Storage of Reconstituted Oral Suspension
- Store the reconstituted oral suspension in a refrigerator [between 36°F-46°F (2°C-8°C)] for up to 12 days. Discard after 12 days.
Administration
- Remove bottle from refrigerator 15 minutes prior to each administration.
- Shake vigorously until suspension has an even consistency.
- Remove cap, then administer orally with or without food using an oral dosing syringe.
- Between doses, replace cap and store in a refrigerator.
DIFICID tablets
200 mg white to off-white film-coated, oblong tablets; each tablet is debossed with "FDX" on one side and "200" on the other side.
DIFICID for oral suspension
White to yellowish white granules; following reconstitution, each mL of white to yellowish white oral suspension contains 40 mg of fidaxomicin (200 mg of fidaxomicin per 5 mL).
Pregnancy
Risk Summary
The limited available data on use of DIFICID in pregnant women are insufficient to inform any drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. Embryo-fetal reproduction studies in rats and rabbits dosed intravenously during organogenesis revealed no evidence of harm to the fetus at fidaxomicin and OP-1118 (its main metabolite) exposures 65-fold or higher than the clinical exposure at the DIFICID recommended dose [see Data].
The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data
Animal Data
In pregnant rats, fidaxomicin was administered intravenously at doses of 4, 8, and 15 mg/kg/day from gestation day 6 through 17 (during the period of organogenesis). No embryo/fetal effects were noted in this study at exposures (AUC) 193-fold higher for fidaxomicin, and 65-fold higher for OP-1118 than the clinical exposure at the DIFICID recommended dose.
In pregnant rabbits, fidaxomicin was administered intravenously at doses of 2, 4, and 7.5 mg/kg/day from gestation day 6 through 18 (during the period of organogenesis). No embryo/fetal effects were noted in this study at exposures 66-fold higher for fidaxomicin, and 245-fold higher for OP-1118 than the clinical exposure at the DIFICID recommended dose.
Lactation
Risk Summary
There is no information on the presence of fidaxomicin or its main metabolite, OP-1118, in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DIFICID and any potential adverse effects on the breastfed infant from DIFICID or from the underlying maternal condition.
Pediatric Use
The safety and effectiveness of DIFICID for the treatment of CDAD have been established in pediatric patients 6 months to less than 18 years of age. Use of DIFICID in these age groups is supported by evidence from adequate and well-controlled trials of DIFICID in adults with CDAD and pharmacokinetic, safety and efficacy data from pediatric trials [see Clinical Pharmacology (12.3), Clinical Studies (14.2)]. No new safety signals associated with the use of DIFICID in pediatric patients were identified in the pediatric trials [see Adverse Reactions (6.1)].
The safety and effectiveness of DIFICID have not been established in pediatric patients younger than 6 months of age.
Geriatric Use
Of the total number of patients in controlled trials of DIFICID, 50% were 65 years of age and over, while 31% were 75 and over. No overall differences in safety or effectiveness of DIFICID compared to vancomycin were observed between these subjects and younger subjects.
In controlled trials, elderly patients (≥65 years of age) had higher plasma concentrations of fidaxomicin and its main metabolite, OP-1118, versus non-elderly patients (<65 years of age) [see Clinical Pharmacology (12.3)]. However, greater exposures in elderly patients were not considered to be clinically significant. No dose adjustment is recommended for elderly patients.
DIFICID is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in DIFICID [see Warnings and Precautions (5.1)].
Hypersensitivity Reactions
Acute hypersensitivity reactions, including dyspnea, rash, pruritus, and angioedema of the mouth, throat, and face have been reported with DIFICID. If a severe hypersensitivity reaction occurs, DIFICID should be discontinued and appropriate therapy should be instituted.
Some patients with hypersensitivity reactions to DIFICID also reported a history of allergy to other macrolides. Physicians prescribing DIFICID to patients with a known macrolide allergy should be aware of the possibility of hypersensitivity reactions.
Not for Use in Infections Other than C. difficile-Associated Diarrhea
DIFICID is not expected to be effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin [see Clinical Pharmacology (12.3)]. DIFICID has not been studied for the treatment of infections other than CDAD. DIFICID should only be used for the treatment of CDAD.
Development of Drug-Resistant Bacteria
Prescribing DIFICID in the absence of proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.