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Fidaxomicin

Pronunciation

(fye DAX oh mye sin)

Index Terms

  • Difimicin
  • Lipiarrmycin
  • OPT-80
  • PAR-101
  • Tiacumicin B

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

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Tablet, Oral:

Dificid: 200 mg [contains soybean lecithin]

Brand Names: U.S.

  • Dificid

Pharmacologic Category

  • Antibiotic, Macrolide

Pharmacology

Inhibits RNA polymerase sigma subunit resulting in inhibition of protein synthesis and cell death in susceptible organisms including C. difficile; bactericidal

Absorption

Oral: Minimal systemic absorption

Distribution

Largely confined to the gastrointestinal tract; in single- and multiple-dose studies, fecal concentrations of fidaxomicin and its active metabolite (OP-1118) are very high while serum concentrations are minimally detectable to undetectable

Metabolism

Intestinal hydrolysis to less active metabolite (OP-1118)

Excretion

Feces (>92% as unchanged drug and metabolites); urine (<1% as metabolite)

Special Populations: Elderly

Plasma concentrations were approximately 2- to 4-fold higher in elderly patients versus nonelderly patients.

Use: Labeled Indications

Treatment of Clostridium difficile-associated diarrhea (CDAD)

Contraindications

Hypersensitivity to fidaxomicin

Dosage

Oral: Adults: Diarrhea due to Clostridium difficile (CDAD): 200 mg twice daily for 10 days

Dosing adjustment in renal impairment: No dosage adjustment necessary (minimal systemic absorption).

Dosing adjustment in hepatic impairment: No dosage adjustment provided in manufacturer’s label (has not been studied); However, due to minimal systemic absorption no dosage adjustment predicted.

Administration

May be administered with or without food.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Drug Interactions

Rilpivirine: Macrolide Antibiotics may increase the serum concentration of Rilpivirine. Management: Consider the use of azithromycin or another non-macrolide alternative when appropriate to avoid this potential interaction. Consider therapy modification

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Adverse Reactions

>10%: Gastrointestinal: Nausea (11%)

2% to 10%:

Gastrointestinal: Gastrointestinal hemorrhage (4%), abdominal pain, vomiting

Hematologic & oncologic: Anemia (2%), neutropenia (2%)

<2% (Limited to important or life-threatening): Abdominal distention, abdominal tenderness, angioedema, decreased platelet count, decreased serum bicarbonate, dyspepsia, dysphagia, dyspnea, fixed drug eruption, flatulence, hepatotoxicity (idiosyncratic) (Chalasani, 2014), hyperglycemia, hypersensitivity reaction, increased liver enzymes, increased serum alkaline phosphatase, intestinal obstruction, megacolon, metabolic acidosis, pruritus, skin rash

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Hypersensitivity reactions (angioedema [mouth, face, throat], dyspnea, pruritus, and rash) to fidaxomicin have been reported. If a severe reaction occurs, discontinue drug and institute supportive care.

• Macrolide allergy: Use with caution in patients with a history of macrolide allergy; may be at increased risk for hypersensitivity.

Other warnings/precautions:

• Appropriate use: Do not use for systemic infections; fidaxomicin systemic absorption is negligible. Use only in patients with proven or strongly suspected Clostridium difficile (C. difficile) infections.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Due to the limited systemic absorption of fidaxomicin, exposure to the fetus is expected to be low.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea. Have patient report immediately to prescriber melena, hematemesis, chills, pharyngitis, significant constipation, considerable dyspepsia, or severe asthenia (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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