Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Hypersensitivity reactions

Hypersensitivity reactions including severe angioedema have been reported (see section 4.8). If a severe allergic reaction occurs during treatment with DIFICLIR, the medicinal product should be discontinued and appropriate measures taken.
Some patients with hypersensitivity reactions reported a history of allergy to macrolides. Fidaxomicin should be used with caution in patients with a known macrolides allergy.

Renal and hepatic impairment

Due to limited clinical data, fidaxomicin should be used with caution in patients with severe renal impairment or moderate to severe hepatic impairment (see section 5.2).

Pseudomembranous colitis, fulminant or life threatening CDI

Due to limited clinical data, fidaxomicin should be used with caution in patients with pseudomembranous colitis, fulminant or life threatening CDI.

Co-administration of potent P-glycoprotein inhibitors

Co-administration of potent P-glycoprotein inhibitors such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see sections 4.5 and 5.2). In case fidaxomicin is administered concomitantly with potent P-glycoprotein inhibitors, caution is advised.

Paediatric population

Only one paediatric patient below 6 months of age has been exposed to fidaxomicin in clinical trials.
Therefore, patients below 6 months of age should be treated with caution.
Testing for C. difficile colonization or toxin is not recommended in children younger than 1 year due to high rate of asymptomatic colonisation unless severe diarrhoea is present in infants with risk factors for stasis such as Hirschsprung disease, operated anal atresia or other severe motility disorders.
Alternative aetiologies should always be sought and C. difficile enterocolitis be proven.

Effects on Driving

4.7    Effects on ability to drive and use machines

DIFICLIR has no or negligible influence on the ability to drive and use machines.