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:

Amneal Pharmaceuticals of New York LLC

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 tablets 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)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women expos

Product summary:

Teriflunomide tablets are available as 14 mg tablets. The 14 mg tablet is a blue (pale blue to pastel blue) colored, round, biconvex, film-coated tablet debossed with the dose strength “14” on one side. Each tablet contains 14 mg of teriflunomide. Teriflunomide tablets, 14 mg are supplied as: NDC 0115-1565-44    Carton of 28 tablets containing 1 wallet composed of 2 folded blister cards of 14 tablets per blister card Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Amneal Pharmaceuticals of New York LLC
----------
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 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.
•
Teriflunomide Tablets Pregnancy Registry. If you become pregnant while
taking
teriflunomide tablets or during the 2 years after you stop taking
teriflunomide tablets, talk
to your doctor about e

Summary of Product characteristics

TERIFLUNOMIDE- TERIFLUNOMIDE TABLET, FILM COATED
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
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._
HE PATO TO XIC ITY
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).
EMBRYOFETAL TOXICITY
TERATOGENICITY AND EMBRYOLETHALITY OCCURRED IN ANIMALS ADMINISTERED
TERIFLUNOMIDE (5.2, 8.1). EXCLUDE
PREGNANCY PRIOR TO INITIATING TERIFLUNOMIDE TABLET 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).
RECENT MAJOR CHANGES
Indications and Usage (1) 9/2019
Warnings and Precautions (5.2) 7/2019
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