Fidaxomicin

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Clostridium difficile infections

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Severe renal impairment
• Moderate to severe hepatic impairment
• Macrolide allergy
• Pseudomembranous colitis
• Fulminant or life threatening Clostridium difficile infections

Forms avail. in SA and covered in this monograph: tab

Clostridium difficile infections 

• Oral (tab): 200mg, 12hrly; Treatment duration: 10 days

Not established for use in South Africa for children below 18 years

Pregnancy

• Caution; not recommended
• No human data. Animal data suggest low risk
• There is no data available from the use of fidaxomicin in pregnant women 4
• Animal studies did not indicate direct or indirect harmful effects with respect to reproductive toxicity
• It is not known if fidaxomicin crosses the human placenta. Minimal concentrations of other macrolide antibacterials cross the placenta (e.g. azithromycin and erythromycin) and fidaxomicin might also cross. However, fidaxomicin plasma concentrations are minimal and any exposure of the embryo-foetus should be clinically insignificant
• As a precautionary measure, it is preferable to avoid the use of fidaxomicin during pregnancy

Breastfeeding

• Caution; not recommended
• It is unknown whether fidaxomicin and its metabolites are excreted in human milk. Although no effects on the breastfed newborns/infants are anticipated since the systemic exposure to fidaxomicin is low, a risk to the newborns/infants cannot be excluded
• Because plasma concentrations of the antibacterial are minimal (ng/ml range), adverse effects in a nursing infant are not expected
• A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from fidaxomicin therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Fertility

• Fidaxomicin had no effects on fertility when evaluated in rats

Renal impairment

• Severe: Caution; no dose adjustment recommended

Hepatic impairment

• Moderate to severe: Caution; no dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness
• Headache

Gastrointestinal Disorders

• Nausea and vomiting
• Constipation
• Abdominal distention
• Flatulence
• Dry mouth

Hepatobiliary Disorders

• Alanine aminotransferase increased

Endocrine and Metabolic Disorders

• Decreased appetite

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritis

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions

Sensory Disorders

• Dysgeusia

• Potent P-glycoprotein inhibitors
• Cyclosporine
• Ketoconazole
• Erythromycin
• Clarithromycin
• Verapamil
• Dronedarone
• Amiodarone
• P-glycoprotein substrates
• Dabigatran etexilat

None routine

Fidaxomicin belongs to the macrocyclic class of antibacterials.  It is bactericidal and inhibits RNA synthesis by bacterial RNA polymerase. Fidaxomicin has been shown to inhibit C. difficile sporulation in vitro.

Tablet 200mg

• Fidicid (Astellas)