OCALIVA 5mg film-coated tablets
1. Name of the medicinal product
OCALIVA 5 mg film-coated tablets
OCALIVA 10 mg film-coated tablets
2. Qualitative and quantitative composition
OCALIVA 5 mg film-coated tablets
Each film-coated tablet contains 5 mg of obeticholic acid.
OCALIVA 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of obeticholic acid.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
OCALIVA 5 mg film-coated tablets
Yellow, 8 mm round tablet debossed with 'INT' on one side and '5' on the other side.
OCALIVA 10 mg film-coated tablets
Yellow, 7.6 mm X 7.4 mm triangular tablet debossed with 'INT' on one side and '10' on the other side.
4. Clinical particulars
4.1 Therapeutic indications
OCALIVA is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
4.2 Posology and method of administration
Posology
Prior to initiation of treatment with obeticholic acid the patient's hepatic status must be known.
The starting dose and dosage titration by PBC patient population is shown in Table 1.
Table 1: Dosage Regimen by PBC Patient Population
Staging/Classification
Non-Cirrhotic or Child-Pugh Class A
Child-Pugh Class B or C or Decompensated Cirrhotic
Starting Dosage
5 mg once daily
5 mg once weekly
Dosage Titration
For patients who have not achieved an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin after 6 months of treatment and the patient is tolerating obeticholic acid, titrate up to 10 mg once daily
For patients who have not achieved an adequate reduction in ALP and/or total bilirubin after 3 months of treatment and the patient is tolerating obeticholic acid, titrate up to 5 mg twice weekly (at least 3 days apart) and subsequently to 10 mg twice weekly (at least 3 days apart) based on response and tolerability
Maximum Dosage
10 mg once daily
10 mg twice weekly (at least 3 days apart)
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:
For Non-Cirrhotic or Child-Pugh Class A patients:
• Reducing the dosage of obeticholic acid 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
• Temporarily interrupting obeticholic acid dosing for up to 2 weeks followed by restarting at a reduced dosage.
• Continue to increase the dosage to 10 mg once daily, as tolerated, to achieve optimal response.
For Child-Pugh Class B or C or Decompensated Cirrhotic patients:
• Reducing the dosage of obeticholic acid to:
▪ 5 mg once weekly, for patients intolerant to 5 mg twice weekly
▪ 10 mg once weekly, for patients intolerant to 10 mg twice weekly
• Temporarily interrupting obeticholic acid dosing for up to 2 weeks followed by restarting at a reduced dosage if applicable.
• Continue to increase the dosage to 10 mg twice weekly, as tolerated, to achieve optimal response.
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