Update

2018 AASLD guidance recommends OCALIVA as the only approved second-line treatment option for PBC3 SEE THE GUIDELINES

Recommended OCALIVA Dosing

Drug-to-Drug Interactions1

  • Bile Acid Binding Resins
    Bile acid binding resins such as cholestyramine, colestipol, or
    colesevelam adsorb and reduce bile acid absorption and may
    reduce the absorption, systemic exposure, and efficacy of OCALIVA. If taking a bile acid binding resin,
    take OCALIVA at least 4 hours before or 4 hours after taking the bile acid binding resin, or at as great an
    interval as possible.
  • Warfarin
    The international normalized ratio (INR) is decreased following co-administration of warfarin and OCALIVA.
    Monitor INR and adjust the dosage of warfarin, as needed, to maintain the target INR range when
    co-administering OCALIVA and warfarin.
  • CYP1A2 Substrates With Narrow Therapeutic Index
    OCALIVA may increase the exposure to concomitant drugs that are CYP1A2 substrates. Therapeutic
    monitoring of CYP1A2 substrates with a narrow therapeutic index (eg, theophylline and tizanidine) is
    recommended when co-administered with OCALIVA.
  • Inhibitors of Bile Salt Efflux Pump
    Avoid concomitant use of inhibitors of the bile salt efflux pump (BSEP) such as cyclosporine. Concomitant
    medications that inhibit canalicular membrane bile acid transporters such as the BSEP may exacerbate
    accumulation of conjugated bile salts including taurine conjugate of obeticholic acid in the liver and result in
    clinical symptoms. If concomitant use is deemed necessary, monitor serum transaminases and bilirubin.


ALP, alkaline phosphatase.
 

OCALIVA obeticholic acid OCALIVA obeticholic acid

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Reference:

  1. OCALIVA [package insert]. New York, NY: Intercept Pharmaceuticals, Inc.; 2018.
OCALICA obeticholic acid

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OCALIVA® (obeticholic acid)

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