OCALIVA 5 MG

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

OBETICHOLIC ACID

Beschikbaar vanaf:

NEOPHARM LTD, ISRAEL

ATC-code:

A05AA04

farmaceutische vorm:

FILM COATED TABLETS

Samenstelling:

OBETICHOLIC ACID 5 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

ADVANZ PHARMA LIMITED, IRELAND

Therapeutisch gebied:

OBETICHOLIC ACID

therapeutische indicaties:

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.

Autorisatie datum:

2023-02-28

Bijsluiter

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
’
REGULATIONS (PREPARATIONS) - 1986
This medicine is to be supplied upon a physician's prescription only
OCALIVA
® 5 MG
OCALIVA
® 10 MG
FILM-COATED TABLETS
FILM-COATED TABLETS
COMPOSITION:
COMPOSITION:
THE ACTIVE INGREDIENT AND ITS QUANTITY:
THE ACTIVE INGREDIENT AND ITS QUANTITY:
Each film-coated tablet contains:
Each film-coated tablet contains:
obeticholic acid 5 mg
obeticholic acid 10 mg
For the list of excipients, please see section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about the medicine. If you have any further questions,
refer to the physician or
pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others.
It may harm them, even if you think that their illness is similar to
yours.
This medicine is intended for the treatment of adults over the age of
18 years.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Ocaliva is intended for treatment of adult patients with a type of
liver disease known as primary
biliary cholangitis (also known as primary biliary cirrhosis), either
by itself or together with
another medicine, ursodeoxycholic acid.
THERAPEUTIC GROUP: Bile and liver therapy, bile acids and derivatives
OCALIVA contains the active substance obeticholic acid (farnesoid
X-receptor agonist) which
helps to improve how your liver works by reducing the production and
build up of bile in the liver
and also reducing inflammation.
2.
BEFORE USING THE MEDICINE:
DO NOT USE THE MEDICINE IF:
-
You are hypersensitive (allergic) to the active ingredient
(obeticholic acid) or to any of the
other ingredients of this medicine (_see section 6_).
-
You have primary biliary cholangitis with liver cirrhosis with
symptoms such as fluid in the
belly or confusion (decompensated liver cirrhosis).
-
You have a complete blockage of the biliary tract (liver, gallbladder
and bile ducts).
SPECIAL WARNINGS REGARDING THE USE OF OCALIVA
•
Your doctor may need to inte

Productkenmerken

Page 1 of 11
1.
NAME OF THE MEDICINAL PRODUCT
OCALIVA
®
5 mg
OCALIVA
®
10 mg
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
Off white to yellow, round tablet debossed with ‘INT’ on one side
and ‘5’ on the other side.
OCALIVA 10 mg film-coated tablets
Off white to yellow, 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.
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.
Limited data is available on Ocaliva as monotherapy.
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.
Page 2 of 11
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 seve