Ocaliva

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

Obeticholic acid

זמין מ:

ADVANZ PHARMA Limited

קוד ATC:

A05AA04

INN (שם בינלאומי):

obeticholic acid

קבוצה תרפויטית:

Bile and liver therapy

איזור תרפויטי:

Liver Cirrhosis, Biliary

סממני תרפויטית:

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.

leaflet_short:

Revision: 17

מצב אישור:

Authorised

תאריך אישור:

2016-12-12

עלון מידע

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OCALIVA 5 M
G FILM-COATED TABLETS
OCALIVA 10 MG FILM-COATED TABLETS
obeticholic acid
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ocaliva is and what it is used for
2.
What you need to know before you take Ocaliva
3.
How to take Ocaliva
4.
Possible side effects
5.
How to store Ocaliva
6.
Contents of the pack and other information
1.
WHAT OCALIVA IS AND WHAT IT IS USED FOR
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.
This medicine is used to treat adult patients with a type of liver
disease known as primary biliary
cholangitis, either by itself or together with another medicine,
ursodeoxycholic acid.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OCALIVA
_ _
DO NOT TAKE OCALIVA
-
if you are allergic to obeticholic acid or any of the other
ingredients of this medicine (listed in
section 6).
-
if you have primary biliary cholangitis with liver cirrhosis with
symptoms such as fluid in the
belly or confusion (decompensated liver cirrhosis).
-
if you have a complete blockage of the biliary tract (liver,
gallbladder and bile

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
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
m
g 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 m
g film-coated tablets
Yellow, 8 mm × 7 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
(PBC) 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.
3
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 re