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:

Apotex Corp

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)]. - Coadministration with leflunomide [see Clinical Pharmacology (12.3)]. Risk Summary Teriflunomide tablets are contraindicated for use in pregnant women and females of reproduct

Product summary:

Teriflunomide tablets are available as 7 mg and 14 mg tablets. The 7 mg tablet is a greenish bluish grey, arc hexagonal, biconvex film-coated tablet, engraved "7" on one side, "APO" on the other side. Each tablet contains 7 mg of teriflunomide. The 14 mg tablet is a pale blue, arc pentagonal, biconvex film-coated tablet, engraved "14" on one side, "APO" on the other side. Each tablet contains 14 mg of teriflunomide. Teriflunomide 7 mg tablets are supplied as: NDC 60505-4477-3 Bottles of 30 tablets NDC 60505-4477-2 Carton of 28 tablets containing 2 blister cards of 14 tablets per blister card NDC 60505-4477-5 Carton of 5 tablets with one blister card with five tablets Teriflunomide14 mg tablets are supplied as: NDC 60505-4478-3 Bottles of 30 tablets NDC 60505-4478-2 Carton of 28 tablets containing 2 blister cards of 14 tablets per blister card NDC 60505-4478-5 Carton of 5 tablets with one blister card with five tablets Store at 20° to 25°C (68° to 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

Apotex Corp
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Medication Guide
Teriflunomide Tablets, for oral use (ter” i floo’ noe mide)
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 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.
•
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 teriflunomide tablets:
•
If your female partner plans to become pregnant, you should stop
takin

Summary of Product characteristics

TERIFLUNOMIDE- TERIFLUNOMIDE TABLET, FILM COATED
APOTEX CORP
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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 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
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).
RECENT MAJOR CHANGES
Boxed Warning 11/2020
Warnings and Precautions (5.1, 5.6, 5.7) 11/2020
Warnings and Precautions (5.11) 4/2021
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