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:

Glenmark Pharmaceuticals Inc., USA

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Teriflunomide tablets are contraindicated in/with: Risk Summary Teriflunomide is contraindicated for use in pregnant women and females of reproductive potential not using effective contraception because of the potential for fetal harm based on animal data [see Contraindications (4) and Warnings and Precautions (5.2)]. In animal reproduction studies in rat and rabbit, oral administration of teriflunomide during organogenesis caused teratogenicity and embryolethality at plasma exposures (AUC) lower than that at the maximum recommended human dose (MRHD) of 14 mg/day [see Data] . Available human data from pregnancy registries, clinical trials, pharmacovigilance cases, and published literature are too limited to draw any conclusions, but they do not clearly indicate increased birth defects or m

Product summary:

Teriflunomide is available as 7 mg and 14 mg tablets. The 14 mg tablet is a light blue to blue, biconvex, round film-coated tablet debossed with ‘G’ on one side and ‘42’ on the other side. Each tablet contains 14 mg of teriflunomide. Teriflunomide tablets 14 mg are supplied as follows: Carton of 28 (Two blisters of 14 tablets), NDC 68462-312-84 Carton of 5 (One blister of 5 tablets), NDC 68462-312-85 The 7 mg tablet is a light green to green, biconvex, round film-coated tablet debossed with ‘G’ on one side and ‘43’ on the other side. Each tablet contains 7 mg of teriflunomide. Teriflunomide tablets 7 mg are supplied as follows: Carton of 28 (Two blisters of 14 tablets), NDC 68462-311-84 Carton of 5 (One blister of 5 tablets), NDC 68462-311-85 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TERIFLUNOMIDE- TERIFLUNOMIDE TABLET, FILM COATED
Glenmark Pharmaceuticals Inc., USA
----------
MEDICATION GUIDE
Teriflunomide
(ter i FLOO noe mide)
tablets, for oral use
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
teriflunomidetablets?
Teriflunomide tablets may cause serious side effects, including:
•
Liver problems: Teriflunomide tablets may cause serious liver
problems, including liver failure that
can be life-threatening and may require a liver transplant. Your risk
of developing serious liver
problems may be higher if you already have liver problems or 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 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 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 teriflunomidetab

Summary of Product characteristics

TERIFLUNOMIDE- TERIFLUNOMIDE TABLET, FILM COATED
GLENMARK PHARMACEUTICALS INC., USA
----------
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 EMBRYOFETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
•
CLINICALLY SIGNIFICANT AND POTENTIALLY LIFE-THREATENING LIVER INJURY,
INCLUDING ACUTE LIVER
FAILURE REQUIRING TRANSPLANT, HAS BEEN REPORTED IN PATIENTS TREATED
WITH TERIFLUNOMIDE
IN THE POSTMARKETING SETTING (5.1). CONCOMITANT USE OF TERIFLUNOMIDE
WITH OTHER
HEPATOTOXIC DRUGS MAY INCREASE THE RISK OF SEVERE LIVER INJURY. OBTAIN
TRANSAMINASE
AND BILIRUBIN LEVELS WITHIN 6 MONTHS BEFORE INITIATION OF
TERIFLUNOMIDE AND MONITOR ALT
LEVELS AT LEAST MONTHLY FOR SIX MONTHS (5.1). IF DRUG INDUCED LIVER
INJURY IS SUSPECTED,
DISCONTINUE TERIFLUNOMIDE AND START ACCELERATED ELIMINATION PROCEDURE
(5.3).
•
TERATOGENICITY AND EMBRYOLETHALITY OCCURRED IN ANIMALS ADMINISTERED
TERIFLUNOMIDE
(5.2, 8.1). EXCLUDE PREGNANCY PRIOR TO INITIATING TERIFLUNOMIDE
THERAPY (4, 5.2, 8.1, 8.3).
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, 8.3).
STOP TERIFLUNOMIDE AND USE AN ACCELERATED DRUG ELIMINATION PROCEDURE
IF THE PATIENT
BECOMES PREGNANT (5.2, 5.3, 8.1).
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Teriflunomide is a pyrimidine synthesis inhibitor indicated for the
treatment of relapsing forms of multiple
sclerosis (MS), to include clinically isolated syndrome,
relapsing-remitting disease, and active secondary
progressive disease, in adults. (1)
DOSAGE AND ADMINISTRATION
7 mg or 14 mg orally once daily, with or without food. (2)
DOSAGE FORMS AND STRENGTHS
7 mg and 14 mg film-coated tablets (3)
CONTRAINDICATIONS
•
•
•
•
WARNINGS AND PRECAUTI