AMBRISENTAN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMBRISENTAN (UNII: HW6NV07QEC) (AMBRISENTAN - UNII:HW6NV07QEC)

Available from:

Sigmapharm Laboratories, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): - To improve exercise ability and delay clinical worsening. - In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability [ see Clinical Studies (14.2) ]. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%). Ambrisentan may cause fetal harm when administered to a pregnant female. Ambrisentan is contraindicated in females who are pregnant. Ambrisentan was consistently shown to have teratogenic effects when administered to animals. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus

Product summary:

Ambrisentan film-coated tablets are supplied as follows: Package Configuration Description of Tablet; Debossed on Tablet; Size Square shaped; light pink; “∑” on one side and “51” on the other side; 6.6 mm Square  Oval shaped; dark pink; “∑” on one side and “52” on the other side; 9.8 mm x 4.9 mm Oval Store at 25° C (77° F); excursions permitted to 15–30° C (59–86° F) [see USP controlled room temperature] . Store ambrisentan tablets in its original packaging.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AMBRISENTAN- AMBRISENTAN TABLET, FILM COATED
Sigmapharm Laboratories, LLC
----------
MEDICATION GUIDE
AMBRISENTAN
(AM' BRI SEN' TAN)
TABLETS
Read this Medication Guide before you start taking ambrisentan tablets
and each time you get a refill.
There may be new information. This Medication Guide 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 ambrisentan
tablets?
•
Serious birth defects.
Ambrisentan tablets can cause serious birth defects if taken during
pregnancy.
•
Females must not be pregnant when they start taking ambrisentan
tablets or become
pregnant during treatment with ambrisentan tablets.
•
Females who are able to get pregnant must have a negative pregnancy
test before
beginning treatment with ambrisentan tablets, each month during
treatment with
ambrisentan tablets, and one month after stopping ambrisentan tablets.
Talk to your doctor
about your menstrual cycle. Your doctor will decide when to do a
pregnancy test, and will
order a pregnancy test for you depending on your menstrual cycle.
•
Females who are able to get pregnant are females who:
•
have entered puberty, even if they have not started their menstrual
period,
and
•
have a uterus, and
•
have not gone through menopause. Menopause means that you have not had
a menstrual period for at least 12 months for natural reasons, or that
you
have had your ovaries removed.
•
Females who are not able to get pregnant are females who:
•
have not yet entered puberty, or
•
do not have a uterus, or
•
have gone through menopause. Menopause means that you have not had a
menstrual period for at least 12 months for natural reasons, or that
you have
had your ovaries removed, or
•
who are infertile for any other medical reason and this infertility is
permanent and cannot be reversed.
Females who are able to get pregnant must use two acceptable forms of
birth control during
treatment with ambrisentan tablets, and for one month after stop

Summary of Product characteristics

AMBRISENTAN- AMBRISENTAN TABLET, FILM COATED
SIGMAPHARM LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMBRISENTAN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AMBRISENTAN TABLETS.
AMBRISENTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2007
WARNING: EMBRYO-FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DO NOT ADMINISTER AMBRISENTAN TO A PREGNANT FEMALE BECAUSE IT MAY
CAUSE FETAL
HARM ( 4.1, 5.1, 8.1).
FEMALES OF REPRODUCTIVE POTENTIAL: EXCLUDE PREGNANCY BEFORE THE START
OF TREATMENT,
MONTHLY DURING TREATMENT, AND 1 MONTH AFTER STOPPING TREATMENT.
PREVENT
PREGNANCY DURING TREATMENT AND FOR ONE MONTH AFTER STOPPING TREATMENT
BY USING
ACCEPTABLE METHODS OF CONTRACEPTION ( 2.2, 8.3).
FOR ALL FEMALE PATIENTS, AMBRISENTAN IS AVAILABLE ONLY THROUGH A
RESTRICTED PROGRAM
CALLED THE AMBRISENTAN RISK EVALUATION AND MITIGATION STRATEGY (REMS)
( 5.2).
INDICATIONS AND USAGE
Ambrisentan is an endothelin receptor antagonist indicated for the
treatment of pulmonary arterial
hypertension (PAH) (WHO Group 1):
To improve exercise ability and delay clinical worsening.
In combination with tadalafil to reduce the risks of disease
progression and hospitalization for worsening
PAH, and to improve exercise ability.
Studies establishing effectiveness included trials predominantly in
patients with WHO Functional Class II-III
symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH
associated with connective tissue
diseases (34%) ( 1).
DOSAGE AND ADMINISTRATION
Initiate treatment at 5 mg once daily ( 2.1).
May be started with tadalafil ( 2.1).
Titrate at 4-week intervals as needed and tolerated ( 2.1).
Do not split, crush, or chew tablets ( 2.1).
DOSAGE FORMS AND STRENGTHS
Tablet: 5 mg and 10 mg ( 3)
CONTRAINDICATIONS
Pregnancy ( 4.1)
Idiopathic Pulmonary Fibrosis ( 4.2)
WARNINGS AND PRECAUTIONS
Fluid retention may require intervention ( 5.3).
If patients develop acute pulmonary edema durin