FREQUENTLY ASKED QUESTIONS

– Ambrisentan tablets are a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.

– Ambrisentan tablets can improve your ability to exercise and it can help slow down the worsening of your physical condition and symptoms.

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

See the Full Prescribing Information for more details.

Do not take ambrisentan tablets if:.
– you are pregnant, plan to become pregnant, or become pregnant during treatment with
ambrisentan tablets. Ambrisentan tablets can cause serious birth defects. (See “What is the most important information I should know about ambrisentan tablets?”) Serious birth defects
from ambrisentan tablets happen early in pregnancy.

– you have a condition called Idiopathic Pulmonary Fibrosis (IPF)

For a full list of warnings and precautions see the attached Prescribing Information

Pulmonary Arterial Hypertension is a condition where the arteries in the lungs narrow, making it more difficult for blood to flow through those arteries. This in turn raises the pressure in the lungs, which in turn then causes the heart to pump harder to get the blood through the narrowed arteries. PAH is a life-threatening condition that worsens over time. However, your doctor can develop a treatment plan that may allow you to do your normal activity as you did before being diagnosed with the disease.

Before you take Ambrisentan tablets, tell your doctor if you:

– have been told that you have a low red blood cell level (anemia)

– have liver problems

– have any other medical conditions

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

– Ambrisentan tablets and other medicines may affect each other, causing side effects.

– Do not start any new medicines until you check with your doctor.

Especially tell your doctor if you take the medicine cyclosporine (Gengraf*, Neoral*, Sandimmune*). Your doctor may need to change your dose of Ambrisentan tablets.

See the Full Prescribing Information for more details.

– Do not get pregnant while taking ambrisentan tablets. (Click here to see the serious birth defects section of the Full Prescribing Information called “What is the most important information I should know about ambrisentan tablets?”) If you miss a menstrual period, or think you might be pregnant, call your doctor right away.

– It is not known if ambrisentan passes into your breast milk. You should not breastfeed if you are taking ambrisentan tablets. Talk to your doctor about the best way to feed your baby if you take ambrisentan tablets.

See the Full Prescribing Information for more details.

Ambrisentan tablets can cause serious side effects including:

See the attached Full Prescribing Information section called “What is the most important information I should know about ambrisentan tablets?”

– Swelling all over the body (fluid retention) can happen within weeks after starting ambrisentan tablets. Tell your doctor right away if you have any unusual weight gain, tiredness, or trouble breathing while taking ambrisentan tablets. These may be symptoms of a serious health problem. You may need to be treated with medicine or need to go to the hospital.

– Decreased sperm count. Decreased sperm counts have happened in some men taking a medicine that is like ambrisentan tablets. A decreased sperm count may affect the ability to father a child. Tell your doctor if being able to have children is important to you.

– Low red blood cell levels (anemia) can happen during the first weeks after starting ambrisentan tablets. If this happens, you may need a blood transfusion. Your doctor will do blood tests to check your red blood cells before starting ambrisentan tablets. Your doctor may also do these tests during treatment with ambrisentan tablets.

See the Full Prescribing Information for more details.

The most common side effects of ambrisentan tablets include:

– swelling of hands, legs, ankles and feet (peripheral edema)

– stuffy nose (nasal congestion)

– inflamed nasal passages (sinusitis)

– hot flashes or getting red in the face (flushing)

See the Full Prescribing Information for more details.

Some medicines that are like ambrisentan tablets can cause liver problems.
Tell your doctor if you get any of these symptoms of a liver problem while taking ambrisentan tablets:

– loss of appetite

– nausea or vomiting

– fever

– achiness

– generally do not feel well

– pain in the upper right stomach (abdominal) area

– yellowing of your skin or the whites of your eyes

– dark urine

– itching

See the Full Prescribing Information for more details.

– Ambrisentan tablets will be mailed to you by a certified pharmacy. Your doctor will give you complete details.

– Take ambrisentan tablets exactly as your doctor tells you to take it. Do not stop taking ambrisentan tablets unless your doctor tells you to stop.

– You can take ambrisentan tablets with or without food.

– Do not split, crush or chew ambrisentan tablets.

– It will be easier to remember to take ambrisentan tablets if you take it at the same time each day.

– 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 day. Take your next dose at the regular time.

– Do not take two doses at the same time to make up for a missed dose.

See the Full Prescribing Information for more details.

Store ambrisentan tablets at room temperature between 68ºF to 77ºF (20ºC to 25ºC), in the package they come in.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of ambrisentan tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. For more information call 800-818-4555.

Patients can also speak to a Sun Pharma Patient Care Specialist Toll Free at: 844-502-5950

General information about the safe and effective use of ambrisentan tablets:

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ambrisentan tablets for a condition for which it was not prescribed. Do not give ambrisentan tablets to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about ambrisentan tablets. If you would like more information, ask your doctor. You can ask your doctor or pharmacist for information about ambrisentan tablets that is written for health professionals.

Keep Ambrisentan tablets and all medicines out of the reach of children.

See the Full Prescribing Information for more details.