AUBAGIO TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Sanofi-Aventis South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS TERIFLUNOMIDE 14,0 mg

Authorization status:

Registered

Authorization date:

2018-06-09

Patient Information leaflet

sanofi-aventis south africa (pty) ltd
AUBAGIO
®
Revision date: 20 April 2023
Page 1 of 12
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
AUBAGIO
® 14 MG FILM-COATED TABLETS
TERIFLUNOMIDE
CONTAINS SUGAR (76 MG LACTOSE MONOHYDRATE PER TABLET)
AUBAGIO may cause serious side effects, including:
1.
Liver problems: AUBAGIO may cause serious liver problems that may lead
to death.
Your risk of liver problems may be higher if you take other medicines
that also affect
your liver. Your doctor should do blood tests to check your liver
function:
•
within 6 months before you start taking AUBAGIO
•
once a month for 6 months after you start taking AUBAGIO.
Tell your doctor right away if you have any of the following symptoms
of liver problems:
•
nausea
•
vomiting
•
stomach pain
•
loss of appetite
•
tiredness
•
your skin or whites of your eyes turn yellow
•
dark urine.
2.
Harm to your unborn baby: AUBAGIO may cause harm to your unborn baby.
Do not
take AUBAGIO if you are pregnant. Do not take AUBAGIO unless you are
using
effective birth control.
•
If you are a female, you should have a pregnancy test before you start
taking
AUBAGIO. Use effective birth control during your treatment with
AUBAGIO.
sanofi-aventis south africa (pty) ltd
AUBAGIO
®
Revision date: 20 April 2023
Page 2 of 12
•
After stopping AUBAGIO, continue using effective birth control until
you have blood
tests to make sure your blood levels of AUBAGIO are low enough. If you
become
pregnant while taking AUBAGIO or within 2 years after you stop taking
it, tell your
doctor right away.
•
FOR MEN TAKING AUBAGIO: While taking AUBAGIO you should use barrier
contraception to prevent your partner from falling pregnant (see
section 2 – _Use in _
_males_).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING AUBAGIO.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
AUBAGIO has been prescribed for you personally and you s

Summary of Product characteristics

sanofi-aventis south africa (pty) ltd
AUBAGIO
®
Revision date: 20 April 2023
Page 1 of 21
PROFESSIONAL INFORMATION
SCHEDULING STATUS: S4
1.
NAME OF THE MEDICINE
AUBAGIO
® 14 MG FILM-COATED TABLETS
WARNING: HEPATOTOXICITY AND RISK OF TERATOGENICITY
HEPATOTOXICITY:
SEVERE LIVER INJURY INCLUDING FATAL LIVER FAILURE HAS BEEN REPORTED IN
PATIENTS
TREATED WITH LEFLUNOMIDE, WHICH IS INDICATED FOR RHEUMATOID ARTHRITIS.
A SIMILAR RISK
WOULD BE EXPECTED FOR AUBAGIO BECAUSE RECOMMENDED DOSES OF AUBAGIO AND
LEFLUNOMIDE RESULT IN A SIMILAR RANGE OF PLASMA CONCENTRATIONS OF
AUBAGIO.
OBTAIN TRANSAMINASE AND BILIRUBIN LEVELS WITHIN 6 MONTHS BEFORE
INITIATION OF
AUBAGIO AND MONITOR ALANINE AMINOTRANSFERASE (ALT) LEVELS AT LEAST
MONTHLY FOR
SIX MONTHS. IF DRUG-INDUCED LIVER INJURY IS SUSPECTED, DISCONTINUE
AUBAGIO AND
START ACCELERATED ELIMINATION PROCEDURE. CONCOMITANT USE OF AUBAGIO
WITH OTHER
POTENTIALLY HEPATOTOXIC MEDICINES MAY INCREASE THE RISK OF SEVERE
LIVER INJURY.
RISK OF TERATOGENICITY:
BASED ON ANIMAL DATA, AUBAGIO MAY CAUSE MAJOR BIRTH DEFECTS IF USED
DURING
PREGNANCY. AUBAGIO IS CONTRAINDICATED IN PREGNANT WOMEN OR WOMEN OF
CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE CONTRACEPTION.
PREGNANCY MUST
BE AVOIDED DURING AUBAGIO TREATMENT.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 14 mg of teriflunomide.
Contains sugar (76 mg lactose monohydrate per tablet).
For the full list of excipients, see section 6.1.
sanofi-aventis south africa (pty) ltd
AUBAGIO
®
Revision date: 20 April 2023
Page 2 of 21
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Pale blue to pastel blue, pentagonal film-coated tablets with imprint
on one side (dose strength
given as number 14) and engraved with corporate logo on other side.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AUBAGIO is indicated for the treatment of adult patients with
relapsing forms of multiple sclerosis
(MS), including clinically isolated syndrome, relapsing-remitting
disease, and active secondary
progressive disease to reduce the