AUBERIF TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Sanofi Industries South Africa (Pty) Ltd

Dosage:

14,0 mg

Pharmaceutical form:

TABLET

Composition:

EACH FILM-COATED TABLET CONTAINS TERIFLUNOMIDE 14,0 mg

Authorization status:

Registered

Patient Information leaflet

sanofi-aventis south africa (pty) ltd
AUBERIF
™ Teriflunomide, 14 mg per tablet
Revision date: 2023.10.26 Film-coated tablets
Page 1 of 12
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
AUBERIF
™ 14 MG FILM-COATED TABLETS
TERIFLUNOMIDE
CONTAINS SUGAR (76 MG LACTOSE MONOHYDRATE PER TABLET)
AUBERIF may cause serious side effects, including:
1.
Liver problems: AUBERIF 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 AUBERIF
•
once a month for 6 months after you start taking AUBERIF.
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: AUBERIF may cause harm to your unborn baby.
Do not take
AUBERIF if you are pregnant. Do not take AUBERIF unless you are using
effective birth
control.
•
If you are a female, you should have a pregnancy test before you start
taking
AUBERIF. Use effective birth control during your treatment with
AUBERIF.
sanofi-aventis south africa (pty) ltd
AUBERIF
™ Teriflunomide, 14 mg per tablet
Revision date: 2023.10.26 Film-coated tablets
Page 2 of 12
•
After stopping AUBERIF, continue using effective birth control until
you have blood
tests to make sure your blood levels of AUBERIF are low enough. If you
become
pregnant while taking AUBERIF or within 2 years after you stop taking
it, tell your
doctor right away.
•
FOR MEN TAKING AUBERIF: While taking AUBERIF 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 AUBERIF.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,

Summary of Product characteristics

sanofi-aventis south africa (pty) ltd
AUBERIF
™ Teriflunomide, 14 mg per tablet
Revision date: 2023.10.26 Film-coated tablets
Page 1 of 22
PROFESSIONAL INFORMATION
SCHEDULING STATUS: S4
1.
NAME OF THE MEDICINE
AUBERIF
™ 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 AUBERIF BECAUSE RECOMMENDED DOSES OF AUBERIF AND
LEFLUNOMIDE
RESULT IN A SIMILAR RANGE OF PLASMA CONCENTRATIONS OF AUBERIF. OBTAIN
TRANSAMINASE
AND BILIRUBIN LEVELS WITHIN 6 MONTHS BEFORE INITIATION OF AUBERIF AND
MONITOR ALANINE
AMINOTRANSFERASE (ALT) LEVELS AT LEAST MONTHLY FOR SIX MONTHS. IF
DRUG-INDUCED LIVER
INJURY IS SUSPECTED, DISCONTINUE AUBERIF AND START ACCELERATED
ELIMINATION PROCEDURE.
CONCOMITANT USE OF AUBERIF WITH OTHER POTENTIALLY HEPATOTOXIC
MEDICINES MAY
INCREASE THE RISK OF SEVERE LIVER INJURY.
RISK OF TERATOGENICITY:
BASED ON ANIMAL DATA, AUBERIF MAY CAUSE MAJOR BIRTH DEFECTS IF USED
DURING
PREGNANCY. AUBERIF IS CONTRAINDICATED IN PREGNANT WOMEN OR WOMEN OF
CHILDBEARING
POTENTIAL WHO ARE NOT USING RELIABLE CONTRACEPTION. PREGNANCY MUST BE
AVOIDED DURING
AUBERIF TREATMENT.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 14 mg of teriflunomide.
Contains sugar (76 mg lactose monohydrate per tablet).
sanofi-aventis south africa (pty) ltd
AUBERIF
™ Teriflunomide, 14 mg per tablet
Revision date: 2023.10.26 Film-coated tablets
Page 2 of 22
For the full list of excipients, see section 6.1.
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
AUBERIF is indicated for the treatment of adult patients with
relapsing forms of multiple sclerosis
(MS), including clinically isola