TERIFLUNOMIDE- 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:

Biocon Pharma Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Teriflunomide tablet is 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 tablet 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 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 is contraindicated for use in pregnant women and females of reproductive potential

Product summary:

Teriflunomide is available as 7 mg and 14 mg tablets. The 14 mg tablet is white to off white, pentagonal, film coated tablet debossed with B on one side and 14 on the other side. Each tablet contains 14 mg of teriflunomide. The 7 mg tablet is white to off white, hexagonal, film coated tablet debossed with B on one side and 7 on the other side. Each tablet contains 7 mg of teriflunomide. Teriflunomide tablet 14 mg are supplied as: NDC 70377-018-91 Carton of 28 tablets containing 1 wallet composed of 2 folded blister cards of 14 tablets per blister card NDC 70377-018-11 Bottle of 30 tablets Teriflunomide tablet 7 mg are supplied as: NDC 70377-017-91 Carton of 28 tablets containing 1 wallet composed of 2 folded blister cards of 14 tablets per blister card NDC 70377-017-11 Bottle of 30 tablets Store at 68°F to 77°F (20°C to 25°C). Excursions permitted between 59°F and 86°F (15°C and 30°C).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Biocon Pharma Inc.
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MEDICATION GUIDE
Teriflunomide (ter" i floo' noe mide) tablet, for oral use
Read this Medication Guide before you start using teriflunomide tablet
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 tablet?
Teriflunomide tablet may cause serious side effects, including:
•
Liver problems: Teriflunomide tablet may cause serious liver problems,
including liver failure that
can be life-threatning 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 tablet
•
1 time a month for 6 months after you start taking teriflunomide
tablet
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 tablet may cause harm to your
unborn baby. Do not
take teriflunomide tablet if you are pregnant. Do not take
teriflunomide tablet unless you are using
effective birth control.
•
If you are a female, you should have a pregnancy test before you start
taking teriflunomide
tablet. Use effective birth control during your treatment with
teriflunomide tablet.
•
After stopping teriflunomide tablet, 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 tablet or within 2 years after you
stop taking it, tell
your doctor right away.
•
For men taking teriflunomide tablet:
•
If your female partner plans to become pregnant, you should

Summary of Product characteristics

TERIFLUNOMIDE - TERIFLUNOMIDE TABLET, FILM COATED
BIOCON PHARMA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TERIFLUNOMIDE TABLET
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TERIFLUNOMIDE TABLET.
TERIFLUNOMIDE TABLET, 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
IN THE POSTMARKETING SETTING (5.1). CONCOMITANT USE OF TERIFLUNOMIDE
WITH OTHER
HEPATOTOXIC DRUGS MAY INCREASE THE RISK OFSEVERE 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)
EMBRYOFETAL TOXICITY
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).
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
Severe hepatic impairment (4, 5.1)
Pregnancy (4,