TERIFLUNOMIDE tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

TERIFLUNOMIDE (UNII: 1C058IKG3B) (TERIFLUNOMIDE - UNII:1C058IKG3B)

Tillgänglig från:

Alembic Pharmaceuticals Inc.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 tablet is 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 tablets are contraindicated for use in pregnant women and

Produktsammanfattning:

Teriflunomide tablets are available as 7 mg and 14 mg tablets. The 7 mg tablet is pale blue to pastel blue, hexagonal film-coated tablet debossed with “L” on one side and “597” on other side. Each tablet contains 7 mg of teriflunomide. Teriflunomide tablets 7 mg are supplied as: NDC 62332-313-14      Carton of 28 tablets containing 1 wallet composed of 2 folded blister cards of 14 tablets per blister card NDC 62332-313-30      Bottle of 30 tablets with child-resistant closure The 14 mg tablet is pale blue to pastel blue, pentagonal film-coated tablet debossed with “L” on one side and “598” on other side. Each tablet contains 14 mg of teriflunomide. Teriflunomide tablets 14 mg are supplied as: NDC 62332-314-14       Carton of 28 tablets containing 1 wallet composed of2 folded blister cards of 14 tablets per blister card NDC 62332-314-30       Bottle of 30 tablets with child-resistant closure NDC 62332-314-91       Bottle of 1,000 tablets Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].  

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Alembic Pharmaceuticals Inc.
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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 liver transplant. Your risk of
developing serious liver problems may be
higher if you already have liver problems of or take other medicines
that also affect your liver. Your doctor
should do blood tests to check your liver:
o within 6 months before you start taking teriflunomide tablets
o 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:
o nausea
o vomiting
o stomach pain
o loss of appetite
o tiredness
o your skin or the whites of your eyes turn yellow
o 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.
o 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.
o 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.
o For men taking teriflunomide tablets:
● If your female partner plans to become pregnant,

Produktens egenskaper

TERIFLUNOMIDE - TERIFLUNOMIDE TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS INC.
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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
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 tablet 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) (1)
DOSAGE AND ADMINISTRATION
7