BOSENTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BOSENTAN (UNII: Q326023R30) (BOSENTAN ANHYDROUS - UNII:XUL93R30K2)

Available from:

West-Ward Pharmaceuticals Corp.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): Use of bosentan is contraindicated in females who are or may become pregnant. To prevent pregnancy, females of reproductive potential must use two reliable forms of contraception during treatment and for one month after stopping bosentan [see Boxed Warning, Warnings and Precautions (5.2),Drug Interactions (7.2), Use in Specific Populations (8.1)] . Co-administration of cyclosporine A and bosentan resulted in markedly increased plasma concentrations of bosentan. Therefore, concomitant use of bosentan and cyclosporine A is contraindicated [see Cytochrome P450 Drug Interactions (7.1) ] . An increased risk of liver enzyme elevations was observed in patients receiving glyburide concomitantly with bosentan. Therefore co-administration of glyburide and bosentan is contraindicated [see Cytochrome P450 Drug Interactions (7.1) ] . Bosentan is contraindicated in patients who are hypersensitive to bosentan or any component o

Product summary:

Bosentan Tablets 62.5 mg tablets are supplied as a film-coated, round, biconvex, orange tablet, debossed with identification marking “54” on one side and “101” on the other side. NDC 0054-0520-21: Bottle of 60 Tablets NDC 0054-0520-18: 30 Unit-Dose Tablets (For Hospital Use) 125 mg tablets are supplied as a film-coated, oval, biconvex, orange tablet, debossed with identification marking “54” on one side and “333” on the other side. NDC 0054-0521-21: Bottle of 60 Tablets NDC 0054-0521-22: Bottle of 90 Tablets NDC 0054-0521-18: 30 Unit-Dose Tablets (For Hospital Use) Store at 20ºC to 25ºC (68ºF to 77ºF). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

West-Ward Pharmaceuticals Corp.
----------
MEDICATION GUIDE
Bosentan Tablets
(boe sen’ tan)
Rx only
Read the Medication Guide that comes with Bosentan Tablets before you
start taking it and each time
you get a refill. There may be new information. This Medication Guide
does not take the place of talking
with your healthcare provider about your medical condition or your
treatment.
What is the most important information I should know about bosentan?
Bosentan is only available through the Bosentan REMS Program. Before
you begin taking bosentan, you
must read and agree to all of the instructions in the Bosentan REMS
Program.
Bosentan can cause serious side effects including:
Liver damage.
•
Liver damage may not cause symptoms at first. Only a blood test can
show if you have early liver
damage. You must have your blood tested to check your liver function
before you start bosentan
and each month after that. Your healthcare provider will order these
tests. Regular blood tests are
important because they will help your healthcare provider adjust or
stop your treatment before
there is permanent damage.
•
Tell your healthcare provider if you have had liver problems,
including liver problems while taking
other medicines. Call your healthcare provider right away if you have
any of these symptoms of
liver problems while taking bosentan:
o
nausea
o
vomiting
o
fever
o
unusual tiredness
o
stomach area (abdominal) pain
o
yellowing of the skin or the whites of your eyes (jaundice)
Serious birth defects.
•
Bosentan can cause serious birth defects if taken during pregnancy.
You must not be pregnant
when you start taking bosentan or during bosentan treatment. Serious
birth defects from bosentan
can happen early in pregnancy. Females who are able to get pregnant
must have a negative
pregnancy test before starting treatment with bosentan each month
during treatment with bosentan
and 1 month after stopping treatment with bosentan.
o
Talk to your healthcare provider about your menstrual cycle. Your
healthcare provider will
decide

Summary of Product characteristics

BOSENTAN- BOSENTAN TABLET
WEST-WARD PHARMACEUTICALS CORP.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BOSENTAN TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR BOSENTAN TABLETS.
BOSENTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: RISK OF HEPATOTOXICITY AND EMBRYO-FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
Bosentan is available only through a restricted distribution program
called the Bosentan REMS Program because of
these risks (5.3): Elevations of liver aminotransferases (ALT, AST)
and liver failure have been reported with
bosentan (5.1).
•
•
Based on animal data, bosentan is likely to cause major birth defects
if used during pregnancy (4.1, 5.2, 8.1).
•
•
INDICATIONS AND USAGE
Bosentan is an endothelin receptor antagonist indicated for the
treatment of pulmonary arterial hypertension (PAH) (WHO
Group 1):
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
Measure liver aminotransferases prior to initiation of treatment and
then monthly (2.1, 5.1).
Discontinue bosentan if aminotransferase elevations are accompanied by
signs or symptoms of liver
dysfunction or injury or increases in bilirubin ≥2 x ULN (2.4, 5.1).
Must exclude pregnancy before and during treatment (2.1, 4.1, 8.1).
To prevent pregnancy, females of reproductive potential must use two
reliable forms of contraception during
treatment and for one month after stopping bosentan (4.1, 5.2, 8.1).
in adults to improve exercise ability and to decrease clinical
worsening. Studies establishing effectiveness included
predominantly patients with WHO Functional Class II-IV symptoms and
etiologies of idiopathic or heritable PAH
(60%), PAH associated with connective tissue diseases (21%), and PAH
associated with congenital heart disease with
left-to-right shunts (18%) (1).
Patients older than 12 years of age: initiate at 62.5 mg