Precautions of Fidaxomicin

1.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, 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.  

2.Not 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. Fidaxomicin has not been studied for the treatment of  infections other than CDAD. Fidaxomicin should only be used for the treatment of CDAD.  

3.Development 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.

FDA,2020.05