Intercept, in agreement with the European Medicines Agency and the National Competent Authority, is reminding prescribers about OCALIVA dosing in patients with moderate to severe hepatic impairment.
8TH FEB 2018
Intercept, in agreement with the European Medicines Agency and the National Competent Authority, is reminding prescribers about OCALIVA dosing in patients with moderate to severe hepatic impairment. You can download the complete letter using the link below.
In Summary
Due to the risk of serious liver injury in patients with moderate to severe liver impairment, doctors are reminded:
- that prior to initiation of treatment with obeticholic acid the patient’s hepatic status must be known
- to adjust doses of OCALIVA in patients with moderate to severe hepatic impairment (see Table 1 in attached letter below)
- to monitor all patients for progression of PBC disease with laboratory and clinical assessment to determine whether dosage adjustment is needed
- to monitor patients at an increased risk of hepatic decompensation more closely, including those with laboratory evidence of worsening liver function or progression to cirrhosis
- to reduce dosing frequency in patients who progress to advanced disease (i.e. from Child-Pugh Class A to Child-Pugh Class B or C)
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