OCALIVA Film-coated tablet Ref.[7573] Active ingredients: Obeticholic acid

Posology

Prior to initiation of treatment with obeticholic acid the patient’s hepatic status must be known. Whether the patient has decompensated cirrhosis (including Child-Pugh Class B or C) or has had a prior decompensation event should be determined prior to initiation of treatment because obeticholic acid is contraindicated in these patients (see sections 4.3 and 4.4).

The starting dose of obeticholic acid is 5 mg once daily for the first 6 months.

After the first 6 months, for patients who have not achieved an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin and who are tolerating obeticholic acid, increase to a maximum dose of 10 mg once daily.

No dose adjustment of concomitant UDCA is required in patients receiving obeticholic acid.

Management and dose adjustment for severe pruritus

Management strategies include the addition of bile acid binding resins or antihistamines.

For patients experiencing severe intolerability due to pruritus, one or more of the following should be considered:

• The dose of obeticholic acid may be reduced to:
  • 5 mg every other day, for patients intolerant to 5 mg once daily
  • 5 mg once daily, for patients intolerant to 10 mg once daily
• The dose of obeticholic acid may be temporarily interrupted for up to 2 weeks followed by restarting at a reduced dose.
• The dose may be increased to 10 mg once daily, as tolerated, to achieve optimal response.

Discontinuing treatment with obeticholic acid may be considered for patients who continue to experience persistent, intolerable pruritus.

Bile acid binding resins

For patients taking bile acid binding resins, obeticholic acid should be administered at least 4 to 6 hours before or 4 to 6 hours after taking a bile acid binding resin, or at as great an interval as possible (see section 4.5).

Missed dose

If a dose is missed, the missed dose should be skipped and the normal schedule should be resumed for the following dose. A double dose should not be taken to make up for the missed dose.

Special populations

Hepatic impairment

Obeticholic acid is contraindicated in patients with decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event (see sections 4.3 and 4.4).

Elderly (≥65 years)

Limited data exists in elderly patients. No dose adjustment is required for elderly patients (see section 5.2).

Renal impairment

No dose adjustment is required for patients with renal impairment (see section 5.2).

Paediatric population

There is no relevant use of obeticholic acid in the paediatric population in the treatment of PBC.

Method of administration

The tablet should be taken orally with or without food.

The highest single dose exposure of obeticholic acid in healthy volunteers has been at the 500 mg dose. Repeated doses of 250 mg have been administered for 12 consecutive days and some subjects experienced pruritus and reversible transaminase liver elevations. In the clinical trials, PBC patients who received obeticholic acid 25 mg once daily (2.5-times the highest recommended dose) or 50 mg once daily (5-times the highest recommended dose), experienced a dose-dependent increase in the incidence of hepatic adverse reactions (e.g., ascites, primary biliary cholangitis flare, new onset jaundice), and transaminase and bilirubin elevations (up to greater than 3-times upper limit of normal [ULN]). In the case of overdose, patients should be carefully observed and supportive care administered, as appropriate.

4 years.

This medicinal product does not require any special storage conditions.

High-density polyethylene (HDPE) bottles with a child resistant polypropylene closure and an aluminium foil induction seal.

Pack size: 30 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.