AMBRISENTAN TABLETS
5 mg and 10 mg tablets

INDICATION:
Ambrisentan tablets are for the treatment of Pulmonary Arterial Hypertension (PAH), which is high blood pressure in the arteries of the lungs. Ambrisentan can improve your ability to exercise and it can help slow down the worsening of your physical condition and symptoms.

When taken with tadalafil, ambrisentan is used to reduce the risks of your disease progressing and hospitalization due to worsening PAH, and to improve your ability to exercise.

It is not known if ambrisentan tablets are safe and effective in children.

 

WHAT IS THE MOST IMPORTANT INFORMATION I NEED TO KNOW ABOUT AMBRISENTAN?

Ambrisentan can cause serious birth defects if taken during pregnancy.

• Ambrisentan tablets may cause fetal harm when administered during pregnancy.
• Do not take Ambrisentan tablets if you are pregnant, plan to become pregnant, or become pregnant during Serious birth defects can happen early in pregnancy.
• Females who are able to get pregnant must have a negative pregnancy test before starting ambrisentan, every month while taking ambrisentan, and one month after stopping ambrisentan.
• Females who are able to get pregnant must use two acceptable forms of birth control while taking ambrisentan and for one month after stopping ambrisentan.
• Do not have unprotected sex. Talk to your doctor or pharmacist right away if you have unprotected sex or if you think your birth control has failed.
• Tell your doctor right away if you miss a menstrual period or think you may be pregnant.
• Do not breastfeed. It is not known if ambrisentan passes into your breast milk.

WHAT ARE THE POSSIBLE SERIOUS SIDE EFFECTS OF AMBRISENTAN?
Possible serious side effects include:

• Swelling all over the bodycan happen within weeks after starting ambrisentan. Tell your doctor right away if you have any unusual weight gain, tiredness, or trouble breathing while taking ambrisentan.
• Low red blood cell levels can occur during the first weeks after starting ambrisentan. If this happens, you may need a blood transfusion. Your doctor will do blood tests to check your red blood cells before starting ambrisentan and while you are taking it.
• Decreased sperm counts have happened in some men taking a medicine that is like ambrisentan.

 

WHAT ARE THE MORE COMMON SIDE EFFECTS FROM TAKING AMBRISENTAN?

• The most common side effects are swelling of hands, legs, ankles and feet, stuffy nose, sinusitis, hot flashes or getting red in the face.
• The most common side effects of ambrisentan when taken with tadalafil are swelling of the hands, legs, ankles and feet, headache, stuffy nose, cough, low red blood cell levels, indigestion, or upper respiratory tract infection.
• Tell your doctor if you have any of these side effects.

 

WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING AMBRISENTAN?

• Tell your doctor if you have a low red blood cell level or liver problems.
• Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.. Do not start any new medicines until you check with your doctor.
• Especially tell your doctor if you take cyclosporine (Gengraf, Neoral, Sandimmune).

 

HOW SHOULD I TAKE AMBRISENTAN?

• Take ambrisentan tablets exactly as your doctor instructs Do not stop taking ambrisentan tablets unless your doctor tells you to stop.
• Do not split, crush, or chew the
• Do not take two doses at the same time to make up for a missed If you take more than your regular dose of ambrisentan tablets, call your doctor right away.
• If you miss a dose, take it as soon as you remember that Take your next dose at the regular time. Patients are to take Ambrisentan Tablets exactly as directed by their doctor.

 

AMBRISENTAN RISK EVALUATION & MITIGATION STRATEGY (REMS) PROGRAM

• All females, regardless of reproductive potential must enroll in the Ambrisentan Risk Evaluation & Mitigation Strategy (REMS) Program and agree to all of the instructions including compliance with the pregnancy testing and contraception requirements of the program.
• Male patients are not enrolled in the REMS Program.
• For complete information on the Ambrisentan REMS Program, or for complete Prescribing Information about ambrisentan, visit https://www.ambrisentanrems.us.com/

 

REPORT SUSPECT OR ADVERSE SIDE EFFECTS:
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.