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Fidaxomicin

Class
Antibiotics
Subclass
Macrolides
Substance name
Fidaxomicin
Brand names
Dificid®
Common formulations
Film-coated tablet, Granule for oral suspension
Dosage and administration
Adults patients
Treatment of C. difficile infection
•
200 mg PO BID for 10 days
Taken with or without food.
Indications for use
Labeled indications
Adults
•
Treatment of C. difficile infection
Safety risks
Contraindications
Hypersensitivity to fidaxomicin or its components
Infections other than C. difficile
•
Do not use fidaxomicin for the treatment of other infections, as it has not been studied in infections other than C. difficile and increases the risk of developing drug-resistant bacteria.
Warnings and precautions
Drug hypersensitivity reaction
•
Use caution in patients with a history of macrolide allergy.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. UK SPC advises to use with caution if GFR<30 mL/min due to lack of data.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Any severity
•
No guidance available. Hepatic impairment is not expected to alter the elimination of fidaxomicin.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B1
•
Consider safer alternatives. The American College of Gastroenterology guidelines recommend vancomycin as the treatment of choice for C. difficile infection in pregnant and peripartum patients.
Breastfeeding
Use only if benefits outweigh potential risks.
•
The American College of Gastroenterology guidelines recommend vancomycin as the treatment of choice for C. difficile infection in breastfeeding patients.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Nausea
Common 1-10%
•
Anemia, ↓ blood neutrophil count, ↓ serum bicarbonate, ↓ platelet count, ↑ serum ALP, ↑ liver enzymes, gastrointestinal bleeding, metabolic acidosis, abdominal distension, abdominal tenderness, dyspepsia, dysphagia, flatulence, megacolon, ↑ blood glucose, skin rash, itching, abdominal pain, constipation, vomiting
Unknown frequency
•
Angioedema, dyspnea
Interactions
Drug(s)
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