TERIFLUNOMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Teriflunomide (UNII: 1C058IKG3B) (Teriflunomide - UNII:1C058IKG3B)

Available from:

Breckenridge Pharmaceutical, Inc.

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: - Patients with severe hepatic impairment [see Warnings and Precautions (5.1)] . - Pregnant women and females of reproductive potential not using effective contraception. Teriflunomide may cause fetal harm [see Warnings and Precautions (5.2, 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 tablets. Reactions have included anaphylaxis, angioedema, and serious skin reactions [see Warnings and Precautions (5.5)] . - Co-administration with leflunomide [see Clinical Pharmacology (12.3)] . Risk Summary Teriflunomide is contraindicated for use in pregnant women and females of reproductive potential not using

Product summary:

Teriflunomide tablets is available as 7 mg and 14 mg tablets. The 14 mg tablet is a white to off-white, round film-coated tablet with the dose strength "14" engraved on one side and engraved with "B" on other side. Each tablet contains 14 mg of teriflunomide. The 7 mg tablet is a yellow to light yellow, round film-coated tablet with the dose strength "7" engraved on one side and engraved with "B" on other side. Each tablet contains 7 mg of teriflunomide. Teriflunomide 14 mg tablets are supplied as: NDC 51991-882-28 Carton of 28 tablets containing 1 wallet composed of 2 folded blister cards of 14 tablets per blister card NDC 51991-882-90 90 count bottle Teriflunomide 7 mg tablets are supplied as: NDC 51991-881-28 Carton of 28 tablets containing 1 wallet composed of 2 folded blister cards of 14 tablets per blister card NDC 51991-881-90 90 count bottle Store at 68°F to 77°F (20°C to 25°C) with excursions permitted between 59°F and 86°F (15°C and 30°C).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TERIFLUNOMIDE- TERIFLUNOMIDE TABLET
Breckenridge Pharmaceutical, Inc.
----------
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
teriflunomide tablets?
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
•
stomach pain
•
tiredness
•
dark urine
•
vomiting
•
loss of appetite
•
your skin or the
whites of your
eyes turn yellow
•
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:

Summary of Product characteristics

TERIFLUNOMIDE- TERIFLUNOMIDE TABLET
BRECKENRIDGE PHARMACEUTICAL, INC.
----------
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_
HEPATOTOXICITY
CLINICALLY SIGNIFICANT AND POTENTIALLY LIFE-THREATENING LIVER INJURY,
INCLUDING ACUTE LIVER
FAILURE REQUIRING TRANSPLANT, HAS BEEN REPORTED IN PATIENTS TREATED
WITH
TERIFLUNOMIDE TABLETS IN THE POSTMARKETING SETTING (5.1). CONCOMITANT
USE OF
TERIFLUNOMIDE TABLETS WITH OTHER HEPATOTOXIC DRUGS MAY INCREASE THE
RISK OF SEVERE
LIVER INJURY. 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).
EMBRYOFETAL TOXICITY
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, 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 TABLETS AND USE AN ACCELERATED DRUG
ELIMINATION
PROCEDURE IF THE PATIENT BECOMES PREGNANT (5.2, 5.3, 8.1).
INDICATIONS AND USAGE
Teriflunomide tablets are 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)
CONTR