OCALIVA- obeticholic acid tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OBETICHOLIC ACID (UNII: 0462Z4S4OZ) (OBETICHOLIC ACID - UNII:0462Z4S4OZ)

Available from:

Intercept Pharmaceuticals Inc

INN (International Name):

Obeticholic Acid

Composition:

Obeticholic Acid 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

OCALIVA® is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) - without cirrhosis or - with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP) [see Clinical Studies (14)] . An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OCALIVA is contraindicated in patients with: - decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event [see Warnings and Precautions (5.1)] . - compensated cirrhosis who have evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia) [see Warnings and

Product summary:

OCALIVA tablets are packaged in a 40 mL high density polyethylene bottle closed with a 33 mm polypropylene child resistant cap containing an induction seal. Each bottle contains 30 tablets. 5 mg Tablets OCALIVA tablets are available as off-white to yellow, round tablets debossed with INT on one side and 5 on the other side. Each tablet contains 5 mg of obeticholic acid. 10 mg Tablets OCALIVA tablets are available as off-white to yellow, triangular tablets debossed with INT on one side and 10 on the other side. Each tablet contains 10 mg of obeticholic acid. Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

Intercept Pharmaceuticals Inc
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: April 2022
MEDICATION GUIDE
OCALIVA® (o-CAL-eh-vah)
(obeticholic acid) tablets
What is the most important information I should know about OCALIVA?
•
Before you start OCALIVA, and during your treatment with OCALIVA, your
healthcare provider
will do tests to check your liver. These tests will help your
healthcare provider decide if it is safe for
you to start taking OCALIVA and safe for you to continue taking
OCALIVA.
OCALIVA can cause serious side effects including:
Worsening of liver problems or liver failure, in some cases leading to
liver transplant or death, has happened
in people with primary biliary cholangitis (PBC) with liver cirrhosis
when taking OCALIVA.
•
Tell your healthcare provider right away if you have any of the
following symptoms of worsening
liver problems during treatment with OCALIVA:
•
swelling of your stomach-area from a
build-up of fluid
•
yellowing of your skin or the whites of
your eyes
•
black, tarry, or bloody stools
•
coughing up or vomiting blood, or your
vomit looks like "coffee grounds"
•
mental changes such as confusion, sleepier than
usual or harder to wake up, slurred speech, mood
swings, or changes in personality
•
Tell your healthcare provider right away if you have any of the
following symptoms during treatment
with OCALIVA and they are severe or do not go away:
•
stomach-area pain
•
nausea, vomiting, or diarrhea
•
loss of appetite or weight loss
•
new or worsening fatigue
•
weakness
•
fever and chills
•
light-headedness
•
less frequent urination
What is OCALIVA?
OCALIVA is a prescription medicine used to treat primary biliary
cholangitis (PBC) in combination with
ursodeoxycholic acid (UDCA) in adults who have not responded well
enough to UDCA, or alone in adults
who cannot tolerate UDCA.
It is not known if taking OCALIVA will improve your chance of survival
or improve your symptoms of
PBC.
It is not known if OCALI

Summary of Product characteristics

OCALIVA- OBETICHOLIC ACID TABLET, FILM COATED
INTERCEPT PHARMACEUTICALS INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OCALIVA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OCALIVA.
OCALIVA (OBETICHOLIC ACID) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2016
WARNING: HEPATIC DECOMPENSATION AND FAILURE IN PRIMARY BILIARY
CHOLANGITIS PATIENTS WITH CIRRHOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
HEPATIC DECOMPENSATION AND FAILURE, SOMETIMES FATAL OR RESULTING IN
LIVER TRANSPLANT,
HAVE BEEN REPORTED WITH OCALIVA TREATMENT IN PRIMARY BILIARY
CHOLANGITIS (PBC)
PATIENTS WITH EITHER COMPENSATED OR DECOMPENSATED CIRRHOSIS. (5.1)
OCALIVA IS CONTRAINDICATED IN PBC PATIENTS WITH DECOMPENSATED
CIRRHOSIS, A PRIOR
DECOMPENSATION EVENT, OR WITH COMPENSATED CIRRHOSIS WHO HAVE EVIDENCE
OF PORTAL
HYPERTENSION. (4)
PERMANENTLY DISCONTINUE OCALIVA IN PATIENTS WHO DEVELOP LABORATORY OR
CLINICAL
EVIDENCE OF HEPATIC DECOMPENSATION, HAVE COMPENSATED CIRRHOSIS AND
DEVELOP
EVIDENCE OF PORTAL HYPERTENSION, OR EXPERIENCE CLINICALLY SIGNIFICANT
HEPATIC ADVERSE
REACTIONS WHILE ON TREATMENT. (2.3, 5.1)
INDICATIONS AND USAGE
OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the
treatment of adult patients with primary
biliary cholangitis (PBC)
without cirrhosis or
with compensated cirrhosis who do not have evidence of portal
hypertension,
either in combination with ursodeoxycholic acid (UDCA) with an
inadequate response to UDCA or as
monotherapy in patients unable to tolerate UDCA.
This indication is approved under accelerated approval based on a
reduction in alkaline phosphatase
(ALP). An improvement in survival or disease-related symptoms has not
been established. Continued
approval for this indication may be contingent upon verification and
description of clinical benefit in
confirmatory trials. (1)
DOSAGE AND ADMINISTRATION
Recommended Dosage Regimen
The recommended starting dosage of OCALIVA, for PBC patients without