Drug: Dificid

DIFICID (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-(3,5dichloro-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-ethyl8-hydroxy-18-[(1R)-1-hydroxyethyl]-9,13,15-trimethyl-, (3E,5E,8S,9E,11S,12R,13E,15E,18S)-. The structural formula of fidaxomicin is shown in Figure 1. Figure 1: Structural Formula of Fidaxomicin
DIFICID tablets (200 mg) are film-coated and contain the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, hydroxypropyl cellulose, butylated hydroxytoluene, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol, and lecithin (soy).

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Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of any other drug and may not reflect the rates observed in practice. The safety of DIFICID 200 mg tablets taken twice a day for 10 days was evaluated in 564 patients with CDAD in two active-comparator controlled trials with 86.7% of patients receiving a full course of treatment. Thirty-three patients receiving DIFICID (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 studies. Table 1: Selected Adverse Reactions with an Incidence of ≥ 2% Reported in DIFICID Patients in Controlled Trials
  DIFICID (N=564) Vancomycin (N=583) System Organ Class Preferred Term 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 patients taking DIFICID 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 Post Marketing Experience Adverse reactions reported in the post marketing setting arise from a population of unknown size and are voluntary in nature. As such, reliability in estimating their frequency or in establishing a causal relationship to drug exposure is not always possible. Hypersensitivity reactions (dyspnea, angioedema, rash, and pruritus) have been reported. Read the Dificid (fidaxomicin tablets for oral administration) Side Effects Center for a complete guide to possible side effectsLearn More »

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The recommended dose is one 200 mg DIFICID tablet orally twice daily for 10 days with or without food.

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Fidaxomicin and its main metabolite, OP-1118, are substrates of the efflux transporter, P-glycoprotein (P-gp), which is expressed in the gastrointestinal tract. Cyclosporine Cyclosporine is an inhibitor of multiple transporters, including P-gp. When cyclosporine was co-administered with DIFICID, plasma concentrations of fidaxomicin and OP-1118 were significantly increased but remained in the ng/mL range [see CLINICAL PHARMACOLOGY]. 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 patients in controlled clinical trials. Based on these results, fidaxomicin may be co-administered with P-gp inhibitors and no dose adjustment is recommended. Last reviewed on RxList: 4/18/2013
This monograph has been modified to include the generic and brand name in many instances.

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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 Clostridium difficile. Clostridium difficile-Associated Diarrhea DIFICID is a macrolide antibacterial drug indicated in adults ( ≥ 18 years of age) for treatment of Clostridium difficile-associated diarrhea (CDAD).

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Hypersensitivity to fidaxomicin. Last reviewed on RxList: 4/18/2013
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

No cases of acute overdose have been reported in humans. No drug-related adverse effects were seen in dogs dosed with fidaxomicin tablets at 9600 mg/day (over 100 times the human dose, scaled by weight) for 3 months.

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Dosage Forms And Strengths 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. Storage And Handling DIFICID tablets are white to off-white film-coated, oblong tablets containing 200 mg of fidaxomicin; each tablet is debossed with “FDX” on one side and “200” on the other side. DIFICID tablets are supplied as: Bottles of 20 tablets, (NDC 52015-080-01)
Bottles of 60 tablets, (NDC 52015-080-02)
10 tablet aluminum blister cards, with 10 cards per carton, (NDC 52015-080-12) Storage Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). See USP Controlled Room Temperature. Manufactured for Optimer Pharmaceuticals, Inc., San Diego CA 92121 by Patheon, Inc., Optimer Pharmaceuticals, Inc. 10110 Sorrento Valley Road, Suite C San Diego, CA 92121. Revised: 2011 Last reviewed on RxList: 4/18/2013
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Not for Systemic Infections Since there is minimal systemic absorption of fidaxomicin, DIFICID is not effective for treatment of systemic infections. Hypersensitivity 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, DIFICID should be discontinued and appropriate therapy should be instituted. Some patients with hypersensitivity reactions 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. Development of Drug-Resistant Bacteria Prescribing DIFICID in the absence of a 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. Nonclinical Toxicology Carcinogenesis, Mutagenesis, and 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 (AUC0-t) was approximately 100 times that in humans. Use In Specific Populations Pregnancy Pregnancy Category B Reproduction studies have been performed in rats and rabbits by the intravenous route at doses up to 12.6 and 7 mg/kg, respectively. The plasma exposures (AUC0-t) at these doses were approximately 200- and 66-fold that in humans, respectively, and have revealed no evidence of harm to the fetus due to fidaxomicin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether fidaxomicin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when DIFICID is administered to a nursing woman. Pediatric Use The safety and effectiveness of DIFICID in patients < 18 years of age have not been established. 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 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]. However, greater exposures in elderly patients were not considered to be clinically significant. No dose adjustment is recommended for elderly patients. Last reviewed on RxList: 4/18/2013
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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