Fidaxomicin 200 mg Tablet, Film Coated, 20-count — NDC 0480-2596-34 (Billing 00480-2596-34)
This is a package of 20 tablets of Fidaxomicin 200 mg Tablet, Film Coated from Teva Pharmaceuticals, Inc., marketed since Jul 2025 and currently FDA-listed; retail pharmacies pay about $90.50 per tablet (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 067471
- GCN: 30035
- HICL (First Databank): 037674
- AHFS class code: 08:12.12.08
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Fidaxomicin is used to treat diarrhea caused by Clostridium difficile (C. difficile; a type of bacteria that may cause severe or life-threatening diarrhea). Fidaxomicin is in a class of medications called macrolide antibiotics. It works by killing bacteria in the stomach. Fidaxomicin will not treat infections in any other part of the body. Antibiotics such as fidaxomicin will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Read the full MedlinePlus article ↗- Fidaxomicin treats diarrhea caused by a C. difficile infection in your gut. It only works for this infection, not for other kinds.
- Take it by mouth twice a day for 10 days, with or without food. Finish the full course as your prescriber directs, even if you start feeling better.
- The most common are nausea, vomiting and belly pain. Some people also have gut bleeding, anemia or low white blood cells. Let your doctor know if anything bothers you or worsens.
- Get help right away if you have trouble breathing or swelling of your face, mouth or throat. Also call if you get a rash or itching. These could be signs of an allergic reaction.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Fidaxomicin — tap one for details:
Fidaxomicin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $90.505 | $1,810.09 / 20 tablets |
| Medicaid paysCMS SDUD · 12 mo | $190.85 | $3,817.02 / 20 tablets |
| Medicare drug plans payPart D · Q2 2026 | $196.45 | $3,928.93 / 20 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00480-2596-34 You're viewing this Main listing | 20 TABLET, FILM COATED in 1 BOTTLE | 2025-07-15 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fidaxomicin 200 mgthis 00480-2596-34 | Teva | 20 tablets | $90.505 | AB | Availability likely | — |
| Fidaxomicin 200 mg 13668-0745-21 | Torrent | 20 tablets | $90.505 | AB | Availability likely | — |
| Fidaxomicin 200 mg 60505-4833-02 | Apotex | 20 tablets | $90.505 | AB | Availability likely | — |
| Dificid 200 mg 52015-0080-01 | Merck | 20 tablets | $248.379 | AB | Availability likely | +174% |
| Fidaxomicin 200 mg 00781-5194-20 | Sandoz | 20 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
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UNII 9XZ8H6N6OH
A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
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UNII 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII G2M7P15E5P
Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
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UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
11 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Fidaxomicin tablets are a macrolide antibacterial indicated in adult patients for the treatment of C. difficile -associated diarrhea. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of fidaxomicin and other antibacterial drugs, fidaxomicin should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile . ( 1.2 )
1.1Clostridioides difficile -Associated Diarrhea Fidaxomicin tablets are indicated in adult patients for the treatment of C. difficile -associated diarrhea (CDAD).
1.2Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of fidaxomicin tablets and other antibacterial drugs, fidaxomicin tablets 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.
Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Fidaxomicin tablets are administered orally with or without food. ( 2.1 ) Adults One 200 mg tablet orally twice daily for 10 days. ( 2.2 )
2.1Important Administration Instructions Fidaxomicin tablets are available for oral administration as 200 mg tablets. Fidaxomicin tablets are administered orally with or without food.
2.2Adult Patients The recommended dosage for adults is one 200 mg fidaxomicin tablet orally twice daily for 10 days. Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Film-coated tablets: Each white, film-coated, modified capsule shape tablet debossed with A205 on one side and plain on the other side contains 200 mg of fidaxomicin. Film-coated tablets: 200 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Fidaxomicin is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in fidaxomicin tablets [see Warnings and Precautions ( 5.1 )] . Fidaxomicin is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in fidaxomicin tablets. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash) have been reported. If a severe hypersensitivity reaction occurs, discontinue fidaxomicin. ( 5.1 ) Fidaxomicin is not expected to be effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin.
Fidaxomicin should only be used for the treatment of C. difficile -associated diarrhea. ( 5.2 ) Development of drug-resistant bacteria: Only use fidaxomicin for infection proven or strongly suspected to be caused by C. difficile . ( 5.3 )
5.1Hypersensitivity Reactions Acute hypersensitivity reactions, including dyspnea, rash, pruritus, and angioedema of the mouth, throat, and face have been reported with fidaxomicin. If a severe hypersensitivity reaction occurs, fidaxomicin should be discontinued and appropriate therapy should be instituted. Some patients with hypersensitivity reactions to fidaxomicin also reported a history of allergy to other macrolides.
Physicians prescribing fidaxomicin to patients with a known macrolide allergy should be aware of the possibility of hypersensitivity reactions.
5.2Not for Use in Infections Other than C. difficile -Associated Diarrhea Fidaxomicin 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 )] . Fidaxomicin has not been studied for the treatment of infections other than CDAD. Fidaxomicin should only be used for the treatment of CDAD.
5.3Development of Drug-Resistant Bacteria Prescribing fidaxomicin 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.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions in adults (incidence ≥2%) are nausea, vomiting, abdominal pain, gastrointestinal hemorrhage, anemia, and neutropenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults The safety of fidaxomicin 200 mg tablets taken twice a day for 10 days was evaluated in 564 adult patients with CDAD in two active-controlled trials with 86.7% of patients receiving a full course of treatment. Thirty-three adult patients receiving fidaxomicin (5.9%) withdrew from trials as a result of adverse reactions (AR).
The types of AR resulting in withdrawal from the study varied considerably. Vomiting was the primary adverse reaction leading to discontinuation of dosing; this occurred at an incidence of 0.5% in both the fidaxomicin and vancomycin patients in Phase 3 trials. The most common selected adverse reactions occurring in ≥2% of adult patients treated with fidaxomicin are listed in Table 2.
Table 2: Selected Adverse Reactions with an Incidence of ≥2% Reported in Fidaxomicin-Treated Adult Patients in Controlled Trials System Organ Class Adverse Reaction Fidaxomicin (N=564) Vancomycin (N=583) n (%) n (%) Blood and Lymphatic System Disorders Anemia 14 (2%) 12 (2%) Neutropenia 14 (2%) 6 (1%) Gastrointestinal Disorders Nausea 62 (11%) 66 (11%) Vomiting 41 (7%) 37 (6%) Abdominal Pain 33 (6%) 23 (4%) Gastrointestinal Hemorrhage 20 (4%) 12 (2%) The following adverse reactions were reported in <2% of adult patients taking fidaxomicin tablets in controlled trials: Gastrointestinal Disorders: abdominal distension, abdominal tenderness, dyspepsia, dysphagia, flatulence, intestinal obstruction, megacolon Investigations: increased blood alkaline phosphatase, decreased blood bicarbonate, increased hepatic enzymes, decreased platelet count Metabolism and Nutrition Disorders: hyperglycemia, metabolic acidosis Skin and Subcutaneous Tissue Disorders: drug eruption, pruritus, rash
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of fidaxomicin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity reactions (dyspnea, angioedema, rash, pruritus) Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets.
However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Fidaxomicin and its main metabolite, OP-1118, are substrates of the efflux transporter, P-glycoprotein (P-gp), which is expressed in the gastrointestinal tract.
7.1Cyclosporine Cyclosporine is an inhibitor of multiple transporters, including P-gp. When cyclosporine was coadministered with fidaxomicin, plasma concentrations of fidaxomicin and OP-1118 were significantly increased but remained in the ng/mL range [see Clinical Pharmacology ( 12.3 )] . Concentrations of fidaxomicin and OP-1118 may also be decreased at the site of action (i.e., gastrointestinal tract) via P-gp inhibition; however, concomitant P-gp inhibitor use had no attributable effect on safety or treatment outcome of fidaxomicin-treated adult patients in controlled clinical trials.
Based on these results, fidaxomicin may be coadministered with P-gp inhibitors and no dose adjustment is recommended.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatrics: The safety and effectiveness of fidaxomicin have not been established in pediatric patients younger than 6 months of age. ( 8.4 ) Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information.
8.1Pregnancy Risk Summary The limited available data on use of fidaxomicin 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 fidaxomicin 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 fidaxomicin 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 fidaxomicin recommended dose.
8.2Lactation 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 fidaxomicin and any potential adverse effects on the breastfed infant from fidaxomicin or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of fidaxomicin have not been established in pediatric patients younger than 6 months of age. Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information.
8.5Geriatric Use Of the total number of patients in controlled trials of fidaxomicin, 50% were 65 years of age and over, while 31% were 75 and over. No overall differences in safety or effectiveness of fidaxomicin 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.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The limited available data on use of fidaxomicin 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 fidaxomicin 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 fidaxomicin 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 fidaxomicin recommended dose.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of fidaxomicin have not been established in pediatric patients younger than 6 months of age. Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of patients in controlled trials of fidaxomicin, 50% were 65 years of age and over, while 31% were 75 and over. No overall differences in safety or effectiveness of fidaxomicin 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.
🆘 Overdosage ▾
10 OVERDOSAGE No cases of acute overdose have been reported in humans. No drug-related adverse effects were seen in dogs dosed with fidaxomicin tablets at 9,600 mg/day (over 100 times the human dose, scaled by weight) for 3 months.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Fidaxomicin is an antibacterial drug [see Microbiology ( 12.4 )] .
12.2Pharmacodynamics Fidaxomicin acts locally in the gastrointestinal tract on C. difficile . In a dose-ranging trial (N=48) of fidaxomicin using 50 mg, 100 mg, and 200 mg twice daily for 10 days, a dose-response relationship was observed for efficacy.
12.3Pharmacokinetics The pharmacokinetic parameters of fidaxomicin and its main metabolite OP-1118 following a single dose of 200 mg in healthy adult males (N=14) are summarized in Table 4. Table 4: Mean (± Standard Deviation) Pharmacokinetic Parameters of Fidaxomicin 200 mg in Healthy Adult Males Parameter Fidaxomicin OP-1118 N Value N Value C max (ng/mL) 14 5.20 ± 2.81 14 12.0 ±
6.06T max (h)* 14 2.00 (1.00 to 5.00) 14 1.02 (1.00 to 5.00) AUC 0-t (ng-h/mL) 14 48.3 ± 18.4 14 103 ±
39.4AUC 0-∞ (ng-h/mL) 9 62.9 ± 19.5 10 118 ± 43.3 t 1/2 (h) 9 11.7 ± 4.80 10 11.2 ± 3.01 * T max , reported as median (range). C max , maximum observed concentration; T max , time to maximum observed concentration; AUC 0-t , area under the concentration-time curve from time 0 to the last measured concentration; AUC 0-∞ , area under the concentration-time curve from time 0 to infinity; t 1/2 , elimination half-life Absorption Fidaxomicin has minimal systemic absorption following oral administration, with plasma concentrations of fidaxomicin and OP-1118 in the ng/mL range at the therapeutic dose.
In fidaxomicin-treated patients from controlled trials, plasma concentrations of fidaxomicin and OP-1118 obtained within the T max window (1 to 5 hours) were approximately 2- to 6-fold higher than C max values in healthy adults. Following administration of fidaxomicin tablets 200 mg twice daily for 10 days, OP-1118 plasma concentrations within the T max window were approximately 50% to 80% higher than on Day 1, while concentrations of fidaxomicin were similar on Days 1 and 10. In a food-effect study involving administration of fidaxomicin to healthy adults (N=28) with a high-fat meal versus under fasting conditions, C max of fidaxomicin and OP-1118 decreased by 21.5% and 33.4%, respectively, while AUC 0-t remained unchanged.
This decrease in C max is not considered clinically significant, and thus, fidaxomicin may be administered with or without food. Distribution Fidaxomicin is mainly confined to the gastrointestinal tract following oral administration. In selected patients (N=8) treated with fidaxomicin 200 mg twice daily for 10 days from controlled trials, fecal concentrations of fidaxomicin and OP-1118 obtained within 24 hours of the last dose ranged from 639 to 2710 mcg/g and 213 to 1210 mcg/g, respectively.
In contrast, plasma concentrations of fidaxomicin and OP-1118 within the T max window (1 to 5 hours) ranged 2 to 179 ng/mL and 10 to 829 ng/mL, respectively. Elimination Metabolism Fidaxomicin is primarily transformed by hydrolysis at the isobutyryl ester to form its main and microbiologically active metabolite, OP-1118. Metabolism of fidaxomicin and formation of OP-1118 are not dependent on cytochrome P450 (CYP) enzymes.
At the therapeutic dose, OP-1118 was the predominant circulating compound in healthy adults, followed by fidaxomicin. Excretion Fidaxomicin is mainly excreted in feces. In one trial of healthy adults (N=11), more than 92% of the dose was recovered in the stool as fidaxomicin and OP-1118 following single doses of 200 mg and 300 mg.
In another trial of healthy adults (N=6), 0.59% of the dose was recovered in urine as OP-1118 only following a single dose of 200 mg. Specific Populations Geriatric Patients In controlled trials of patients treated with fidaxomicin 200 mg twice daily for 10 days, mean and median values of fidaxomicin and OP-1118 plasma concentrations within the T max window (1 to 5 hours) were approximately 2- to 4-fold higher in elderly patients (≥65 years of age) versus non-elderly patients (<65 years of age). Despite greater exposures in elderly patient… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Fidaxomicin is an antibacterial drug [see Microbiology ( 12.4 )] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Fidaxomicin tablets are supplied as follows: 200 mg – Each white, film-coated, modified capsule shape tablet, debossed with A205 on one side and plain on the other side contains 200 mg of fidaxomicin. Tablets are supplied as bottles of 20 tablets NDC 0480-2596-34. Store in the original bottle.
16.2Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Fidaxomicin is a macrolide antibacterial drug for oral administration. Its CAS chemical name is Oxacyclooctadeca-3,5,9,13,15-pentaen-2-one, 3-[[[6-deoxy-4- O -(3,5-dichloro-2-ethyl-4,6-dihydroxybenzoyl)- 2- O -methyl-β-D-mannopyranosyl]oxy]methyl]-12-[[6-deoxy-5- C -methyl-4- O -(2-methyl-1-oxopropyl)-β-D- lyxo -hexopyranosyl]oxy]-11-ethyl-8-hydroxy-18-[(1 R )-1-hydroxyethyl]-9,13,15-trimethyl-, (3 E ,5 E ,8 S ,9 E ,11 S ,12 R ,13 E ,15 E ,18 S )-. The molecular formula is C 52 H 74 Cl 2 O 18 and the molecular weight is 1058.04 g/mol.
The structural formula of fidaxomicin is shown in Figure 1. Figure 1: Structural Formula of Fidaxomicin Fidaxomicin tablets are film-coated and contain 200 mg of fidaxomicin per tablet and the following inactive ingredients: butylated hydroxytoluene, hydroxypropyl cellulose, lecithin (soy), magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, pregelatinized corn starch, sodium starch glycolate Type A, talc, and titanium dioxide. 1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Administration with Food Inform patients and caregivers that fidaxomicin tablets may be taken with or without food. Antibacterial Resistance Patients should be counseled that antibacterial drugs, including fidaxomicin tablets, should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold). When fidaxomicin tablets are prescribed to treat a C. difficile infection, patients should be told that, although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by fidaxomicin tablets or other antibacterial drugs in the future.
Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Iss. 5/2024
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The pharmacokinetic parameters of fidaxomicin and its main metabolite OP-1118 following a single dose of 200 mg in healthy adult males (N=14) are summarized in Table 4. Table 4: Mean (± Standard Deviation) Pharmacokinetic Parameters of Fidaxomicin 200 mg in Healthy Adult Males Parameter Fidaxomicin OP-1118 N Value N Value C max (ng/mL) 14 5.20 ± 2.81 14 12.0 ±
6.06T max (h)* 14 2.00 (1.00 to 5.00) 14 1.02 (1.00 to 5.00) AUC 0-t (ng-h/mL) 14 48.3 ± 18.4 14 103 ±
39.4AUC 0-∞ (ng-h/mL) 9 62.9 ± 19.5 10 118 ± 43.3 t 1/2 (h) 9 11.7 ± 4.80 10 11.2 ± 3.01 * T max , reported as median (range). C max , maximum observed concentration; T max , time to maximum observed concentration; AUC 0-t , area under the concentration-time curve from time 0 to the last measured concentration; AUC 0-∞ , area under the concentration-time curve from time 0 to infinity; t 1/2 , elimination half-life Absorption Fidaxomicin has minimal systemic absorption following oral administration, with plasma concentrations of fidaxomicin and OP-1118 in the ng/mL range at the therapeutic dose.
In fidaxomicin-treated patients from controlled trials, plasma concentrations of fidaxomicin and OP-1118 obtained within the T max window (1 to 5 hours) were approximately 2- to 6-fold higher than C max values in healthy adults. Following administration of fidaxomicin tablets 200 mg twice daily for 10 days, OP-1118 plasma concentrations within the T max window were approximately 50% to 80% higher than on Day 1, while concentrations of fidaxomicin were similar on Days 1 and 10. In a food-effect study involving administration of fidaxomicin to healthy adults (N=28) with a high-fat meal versus under fasting conditions, C max of fidaxomicin and OP-1118 decreased by 21.5% and 33.4%, respectively, while AUC 0-t remained unchanged.
This decrease in C max is not considered clinically significant, and thus, fidaxomicin may be administered with or without food. Distribution Fidaxomicin is mainly confined to the gastrointestinal tract following oral administration. In selected patients (N=8) treated with fidaxomicin 200 mg twice daily for 10 days from controlled trials, fecal concentrations of fidaxomicin and OP-1118 obtained within 24 hours of the last dose ranged from 639 to 2710 mcg/g and 213 to 1210 mcg/g, respectively.
In contrast, plasma concentrations of fidaxomicin and OP-1118 within the T max window (1 to 5 hours) ranged 2 to 179 ng/mL and 10 to 829 ng/mL, respectively. Elimination Metabolism Fidaxomicin is primarily transformed by hydrolysis at the isobutyryl ester to form its main and microbiologically active metabolite, OP-1118. Metabolism of fidaxomicin and formation of OP-1118 are not dependent on cytochrome P450 (CYP) enzymes.
At the therapeutic dose, OP-1118 was the predominant circulating compound in healthy adults, followed by fidaxomicin. Excretion Fidaxomicin is mainly excreted in feces. In one trial of healthy adults (N=11), more than 92% of the dose was recovered in the stool as fidaxomicin and OP-1118 following single doses of 200 mg and 300 mg.
In another trial of healthy adults (N=6), 0.59% of the dose was recovered in urine as OP-1118 only following a single dose of 200 mg. Specific Populations Geriatric Patients In controlled trials of patients treated with fidaxomicin 200 mg twice daily for 10 days, mean and median values of fidaxomicin and OP-1118 plasma concentrations within the T max window (1 to 5 hours) were approximately 2- to 4-fold higher in elderly patients (≥65 years of age) versus non-elderly patients (<65 years of age). Despite greater exposures in elderly patients, fidaxomicin and OP-1118 plasma concentrations remained in the ng/mL range [see Use in Specific Populations ( 8.5 )] .
Pediatric Patients Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that informati… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Fidaxomicin acts locally in the gastrointestinal tract on C. difficile . In a dose-ranging trial (N=48) of fidaxomicin using 50 mg, 100 mg, and 200 mg twice daily for 10 days, a dose-response relationship was observed for efficacy.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Clinical Studies of Fidaxomicin in Adult Patients with CDAD In two randomized, double-blinded trials, a non-inferiority design was utilized to demonstrate the efficacy of fidaxomicin (200 mg tablets twice daily for 10 days) compared to vancomycin (125 mg four times daily for 10 days) in adults with CDAD. Enrolled patients were 18 years of age or older and received no more than 24 hours of pretreatment with vancomycin or metronidazole. CDAD was defined by >3 unformed bowel movements (or >200 mL of unformed stool for subjects having rectal collection devices) in the 24 hours before randomization, and presence of either C. difficile toxin A or B in the stool within 48 hours of randomization.
Enrolled patients had either no prior CDAD history or only one prior CDAD episode in the past three months. Subjects with life-threatening/fulminant infection, hypotension, septic shock, peritoneal signs, significant dehydration, or toxic megacolon were excluded. The demographic profile and baseline CDAD characteristics of enrolled subjects were similar in the two trials.
Patients had a median age of 64 years, were mainly white (90%), female (58%), and inpatients (63%). The median number of bowel movements per day was 6, and 37% of subjects had severe CDAD (defined as 10 or more unformed bowel movements per day or WBC ≥15000/mm 3 ). Diarrhea alone was reported in 45% of patients and 84% of subjects had no prior CDAD episode.
The primary efficacy endpoint was the clinical response rate at the end of treatment, based upon improvement in diarrhea or other symptoms such that, in the investigator's judgment, further CDAD treatment was not needed. An additional efficacy endpoint was sustained clinical response 25 days after the end of treatment. Sustained response was evaluated only for patients who were clinical successes at the end of treatment.
Sustained response was defined as clinical response at the end of treatment, and survival without proven or suspected CDAD recurrence through 25 days beyond the end of treatment. The results for clinical response at the end of treatment in both trials, shown in Table 6, indicate that fidaxomicin is non-inferior to vancomycin based on the 95% confidence interval (CI) lower limit being greater than the non-inferiority margin of -10%. The results for sustained clinical response at the end of the follow-up period, also shown in Table 6, indicate that fidaxomicin is superior to vancomycin on this endpoint.
Since clinical success at the end of treatment and mortality rates were similar across treatment arms (approximately 6% in each group), differences in sustained clinical response were due to lower rates of proven or suspected CDAD during the follow-up period in fidaxomicin patients. Table 6: Clinical Response Rates at End-of-Treatment and Sustained Response at 25 days Post-Treatment in Adult Patients Clinical Response at End of Treatment Sustained Response at 25 days Post-Treatment Fidaxomicin % (N) Vancomycin % (N) Difference (95% CI)* Fidaxomicin % (N) Vancomycin % (N) Difference (95% CI)* Trial 1 88% (N=289) 86% (N=307) 2.6% (-2.9%, 8.0%) 70% (N=289) 57% (N=307) 12.7% (4.4%, 20.9%) Trial 2 88% (N=253) 87% (N=256) 1.0% (-4.8%, 6.8%) 72% (N=253) 57% (N=256) 14.6% (5.8%, 23.3%) * Confidence interval (CI) was derived using Wilson's score method.
Approximately 5%-9% of the data in each trial and treatment arm were missing sustained response information and were imputed using multiple imputation method. Restriction Endonuclease Analysis (REA) was used to identify C. difficile baseline isolates in the BI group, isolates associated with increasing rates and severity of CDAD in the US in the years prior to the clinical trials. Similar rates of clinical response at the end of treatment and proven or suspected CDAD during the follow-up period were seen in fidaxomicin-treated and vancomycin-treated patients infected with a BI isolate.
However, fidaxomicin did not demonstrate superiority in su… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies have not been conducted to evaluate the carcinogenic potential of fidaxomicin. Neither fidaxomicin nor OP-1118 was mutagenic in the Ames assay. Fidaxomicin was also negative in the rat micronucleus assay.
However, fidaxomicin was clastogenic in Chinese hamster ovary cells. Fidaxomicin did not affect the fertility of male and female rats at intravenous doses of 6.3 mg/kg. The exposure (AUC 0-t ) was approximately 100 times that in humans.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies have not been conducted to evaluate the carcinogenic potential of fidaxomicin. Neither fidaxomicin nor OP-1118 was mutagenic in the Ames assay. Fidaxomicin was also negative in the rat micronucleus assay.
However, fidaxomicin was clastogenic in Chinese hamster ovary cells. Fidaxomicin did not affect the fertility of male and female rats at intravenous doses of 6.3 mg/kg. The exposure (AUC 0-t ) was approximately 100 times that in humans.
📄 Patient Package Insert ▾
PATIENT INFORMATION Fidaxomicin (fye dax" oh mye' sin) Tablets, for oral use What You Need to Know About Your Medicine Before you take fidaxomicin tablets, be sure you understand what it is for and how to take it. If you have questions about fidaxomicin tablets, ask your doctor or pharmacist. Remember that your doctor has prescribed fidaxomicin tablets only for you.
Never give this medicine to anyone else. Keep this Patient Information for fidaxomicin tablets so you can read it again. What are fidaxomicin tablets?
Fidaxomicin tablets are an antibiotic medicine used to treat an infection called Clostridioides difficile -associated diarrhea (CDAD) in adults. Clostridioides difficile (C-diff) is a bacterium that can cause an infection that can damage your colon and cause stomach pain and severe diarrhea. Fidaxomicin tablets are not to be used to treat other types of infections in the body.
Sometimes infections are caused by viruses rather than bacteria. Antibiotic medicines, including fidaxomicin tablets, do not kill viruses. It is not known if fidaxomicin tablets are safe and effective in children under 6 months old.
Who should not take fidaxomicin tablets? Do not take fidaxomicin tablets if you are allergic to fidaxomicin, or any other ingredient in fidaxomicin tablets. See the end of this Patient Information for a complete list of ingredients in fidaxomicin tablets.
What should I tell my doctor before taking fidaxomicin tablets? Pregnancy If you are pregnant or plan to become pregnant, tell your doctor before you take fidaxomicin tablets. It is not known if fidaxomicin tablets will harm your baby while you are pregnant.
If you are pregnant, you and your doctor should decide together if you will take fidaxomicin tablets. Breastfeeding If you are breastfeeding or plan to breastfeed, tell your doctor before you take fidaxomicin tablets. It is not known if fidaxomicin passes into breast milk.
If you are breastfeeding, you and your doctor should decide together if you will take fidaxomicin tablets. Other Medicines Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal and dietary supplements. Know the medicines you take.
Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine. Allergic Reactions See “ Who should not take fidaxomicin tablets? ” If you are allergic to other kinds of antibiotics called macrolides (for example: azithromycin (Zithromax ® ) or clarithromycin (Biaxin ® )) or any other ingredient in fidaxomicin tablets, tell your doctor. See the end of this Patient Information for a complete list of ingredients in fidaxomicin tablets.
How do I take fidaxomicin tablets? Take fidaxomicin tablets exactly as prescribed by your doctor. Take fidaxomicin tablets twice a day (approximately every 12 hours).
For example, if you take your first dose at 8:00 a.m. you should take your second dose at 8:00 p.m. You can take fidaxomicin tablets with or without food. Do not skip any doses or stop taking fidaxomicin tablets until you finish your prescribed treatment, even if you begin to feel better, unless you have a serious allergic reaction (see “ What are the possible side effects of fidaxomicin tablets? ”).
This will lower the chance that the bacteria will become resistant to fidaxomicin tablets. If this happens, fidaxomicin tablets and other antibiotic medicines may not work in the future. What are the possible side effects of fidaxomicin tablets?
Fidaxomicin tablets can cause serious side effects, including : Allergic reaction . If you get a severe allergic reaction while taking fidaxomicin tablets, including problems breathing or shortness of breath, rash, itching or hives, or swelling of the mouth, throat, or face, stop taking fidaxomicin tablets and get emergency medical help right away. Common side effects of fidaxomicin tablets include: The most common side effects of fidaxomicin tablets in adults include: nausea vomit… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
Principal Display Panel NDC 0480-2596-34 Fidaxomicin Tablets 200 mg Rx only 20 Tablets label