TERIFLUNOMIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TERIFLUNOMIDE (UNII: 1C058IKG3B) (TERIFLUNOMIDE - UNII:1C058IKG3B)

Available from:

Alembic Pharmaceuticals Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Teriflunomide tablets  are indicated for the treatment of patients with relapsing forms of multiple sclerosis.  Teriflunomide tablet is contraindicated in/with: ·         Patients with severe hepatic impairment [see Warnings and Precautions (5.1)] . ·         Pregnant women and females of reproductive potential not using effective contraception. Teriflunomide tablet may cause fetal harm [see Warnings and Precautions (5.2, and 5.3) and Use in Specific Populations (8.1)] . ·         Patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in teriflunomide tablet. Reactions have included anaphylaxis, angioedema, and serious skin reactions [see Warnings and Precautions (5.5)]. ·         Coadministration with leflunomide [see Clinical Pharmacology (12.3)]. Risk Summary Teriflunomide tablets are contraindicated for use in pregnant women and females of reproductive potential not using effective contraception because of the potential for fetal harm ba

Product summary:

Teriflunomide tablets are available as 7 mg and 14 mg tablets. The 7 mg tablet is pale blue to pastel blue, hexagonal film-coated tablet debossed with “L” on one side and “597” on other side. Each tablet contains 7 mg of teriflunomide. Teriflunomide tablets 7 mg are supplied as: NDC 46708-313-14            Carton of 28 tablets containing 1 wallet composed of 2 folded blister cards of 14 tablets per blister card NDC 46708-313-30            Bottle of 30 tablets with child-resistant closure The 14 mg tablet is pale blue to pastel blue, pentagonal film-coated tablet debossed with “L” on one side and “598” on other side. Each tablet contains 14 mg of teriflunomide. Teriflunomide tablets 14 mg are supplied as: NDC 46708-314-14            Carton of 28 tablets containing 1 wallet composed of 2 folded blister cards of 14 tablets per blister card NDC 46708-314-30            Bottle of 30 tablets with child-resistant closure NDC 46708-314-91            Bottle of 1,000 tablets Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TERIFLUNOMIDE - TERIFLUNOMIDE TABLET, FILM COATED
Alembic Pharmaceuticals Limited
----------
MEDICATION GUIDE
Teriflunomide (ter'' i floo'noe mide) Tablets
Read this Medication Guide before you start using teriflunomide
tablets and each time you get a refill. There
may be new information. This information does not take the place of
talking with your doctor about your
medical condition or your treatment.
What is the most important information I should know about
teriflunomide tablets?
Teriflunomide tablets may cause serious side effects, including:
•
Liver problems: Teriflunomide tablets 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:
•
within 6 months before you start taking teriflunomide tablets
•
1 time a month for 6 months after you start taking teriflunomide
tablets
Call 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 the whites of your eyes turn yellow
•
dark urine
•
Harm to your unborn baby: Teriflunomide tablets may cause harm to your
unborn baby. Do not take
teriflunomide tablets if you are pregnant. Do not take teriflunomide
tablets unless you are using
effective birth control.
•
If you are a female, you should have a pregnancy test before you start
taking teriflunomide
tablets. Use effective birth control during your treatment with
teriflunomide tablets.
•
After stopping teriflunomide tablets, continue using effective birth
control until you have
blood tests to make sure your blood levels of teriflunomide tablets
are low enough. If you
become pregnant while taking teriflunomide tablets or within 2 years
after you stop taking it,
tell your doctor right away.
•
For men taking teriflunomide tablets:
•
If your female partner plans to become pregnant, you should stop
taking teriflunomide
tablets and ask

Summary of Product characteristics

TERIFLUNOMIDE - TERIFLUNOMIDE TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TERIFLUNOMIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TERIFLUNOMIDE TABLETS.
TERIFLUNOMIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
WARNING: HEPATOTOXICITY AND RISK OF TERATOGENICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
• 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 TERIFLUNOMIDE BECAUSE RECOMMENDED DOSES OF TERIFLUNOMIDE
AND
LEFLUNOMIDE RESULT IN A SIMILAR RANGE OF PLASMA CONCENTRATIONS OF
TERIFLUNOMIDE. OBTAIN
TRANSAMINASE AND BILIRUBIN LEVELS WITHIN 6 MONTHS BEFORE INITIATION OF
TERIFLUNOMIDE
TABLETS AND MONITOR ALT LEVELS AT LEAST MONTHLY FOR SIX MONTHS (5.1).
IF DRUG INDUCED
LIVER INJURY IS SUSPECTED, DISCONTINUE TERIFLUNOMIDE TABLETS AND START
ACCELERATED
ELIMINATION PROCEDURE (5.3).
• RISK OF TERATOGENICITY
TERATOGENICITY AND EMBRYOLETHALITY OCCURRED IN ANIMALS ADMINISTERED
TERIFLUNOMIDE
(5.2, 8.1). EXCLUDE PREGNANCY PRIOR TO INITIATING TERIFLUNOMIDE
TABLETS THERAPY (4, 5.2,
8.1). ADVISE USE OF EFFECTIVE CONTRACEPTION IN FEMALES OF REPRODUCTIVE
POTENTIAL DURING
TREATMENT AND DURING AN ACCELERATED DRUG ELIMINATION PROCEDURE (4,
5.2, 5.3, 8.1).
STOP TERIFLUNOMIDE TABLETS AND USE AN ACCELERATED DRUG ELIMINATION
PROCEDURE IF THE
PATIENT BECOMES PREGNANT (5.2, 5.3, 8.1).
RECENT MAJOR CHANGES
Boxed Warning, Risk of Teratogenicity 11/2016
Dosage and Administration (2) 11/2016
Contraindications, Hypersensitivity (4) 06/2016
Warnings and Precautions, Teratogenicity (5.2) 11/2016
Warnings and Precautions, Bone Marrow Effects/ Immunosuppression
Potential/Infections (5.4) 06/2016
Warnings and Precautions, Hypersensitivity and Serious Skin Reactions
(5.5) 06/2016
Warnings and Precautions, Respiratory Effe