TERIFLUNOMIDE tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Zydus Pharmaceuticals USA Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Teriflunomide 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 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 may cause fetal harm [see Warnings and Precautions (5.2 and 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. 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 po

Produktbesonderheiten:

Teriflunomide Tablets, 7 mg and 14 mg are film-coated tablets. Teriflunomide Tablets, 7 mg are white to off white, round shaped, coated tablets debossed with "1114" on one side and plain on other side of tablet and are supplied as:. NDC 70710-1114-3 in bottle of 30 tablets with child-resistant closure NDC 70710-1114-8 in cartons of 28 tablets (2 x 14 tablets) (Unit-dose blisters are child-resistant) Teriflunomide Tablets, 14 mg are blue to light blue, round shaped, coated tablets debossed with "1115" on one side and plain on other side of tablet and are supplied as:. NDC 70710-1115-3 in bottle of 30 tablets with child-resistant closure NDC 70710-1115-8 in cartons of 28 tablets (2 x 14 tablets) (Unit-dose blisters are child-resistant) 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).

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

Zydus Pharmaceuticals USA 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 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 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.
•
For men taking teriflunomide tablets :
•
If your female partner pla

Fachinformation

TERIFLUNOMIDE - TERIFLUNOMIDE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA 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
_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 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 (4,5.2, 8.1)
Hypersensitivity (4,5.5)